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: 1048208
Sex: M
Age:
State: VA

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/23/2021
Hospital:

Lab Data: Test Date: 20210204; Test Name: BP; Result Unstructured Data: Test Result:checked out ok; Test Date: 20210204; Test Name: EKG; Result Unstructured Data: Test Result:checked out ok; Test Date: 20210204; Test Name: HR; Result Unstructured Data: Test Result:checked out ok

Allergies:

Symptoms: passed out; felt lightheaded; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration at the right arm on 25Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included hypertension, hypothyroidism, high cholesterol. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. On 25Jan2021, the patient felt lightheaded since vaccine. On 02Feb2021, the patient passed out. The patient has never passed out before. He went to the cardiologist on 04Feb2021 and had EKG and review of BP readings and HR readings etc., all checked out ok. Today was 08Feb2021 and still lightheaded. The cardiologist suggested we call you but cannot get through. We were extremely concerned about getting the 2nd vaccine because of reports of worse symptoms with that one. We cannot get through to you and do not know what to do. The 2nd vaccine was scheduled for 15Feb2021.The events resulted in doctor or other healthcare professional office/clinic visit. The patient has not recovered from the events. Treatment was received for the event passed out and ordered Exam-EKG-Holter Monitor. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1048209
Sex: M
Age:
State: IN

Vax Date: 02/01/2021
Onset Date: 02/06/2021
Rec V Date: 02/23/2021
Hospital:

Lab Data: Test Date: 20210206; Test Name: Renal function; Test Result: 10 %

Allergies:

Symptoms: Bleeding from right kidney; Bleeding from right kidney; Left kidney is shrunken and function at about 10%; Left kidney is shrunken and function at about 10%; This is a spontaneous report from a contactable consumer (patient). An 89-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL8982), via an unspecified route of administration on an unspecified date in Feb2021 (19:00) at single dose (at the age of 89-year-old on Left arm) for COVID-19 immunization. Medical history included arthritic knees and shoulder, prostate cancer, macro degeneration, hearing loss, congestive heart failure, Last right kidney bleed one a year ago (2020 to 2020). The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered:Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient had no known allergies to medications, food, or other products. Patient had Bleeding from right kidney into nephoscimy bag. No noticeable bold from bladder. Left kidney is shrunken and function at about 10%. All events from 06Feb2021 04:00. No treatment was received in response to the events. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 1048210
Sex: M
Age:
State: WI

Vax Date: 01/30/2021
Onset Date: 02/01/2021
Rec V Date: 02/23/2021
Hospital: Y

Lab Data: Test Date: 20210207; Test Name: Forehead temperature; Result Unstructured Data: Test Result:it was good; Test Date: 20210204; Test Name: CT scan IV; Result Unstructured Data: Test Result:unknown results; Test Date: 20210204; Test Name: CT scan abdomen; Result Unstructured Data: Test Result:unknown results; Test Date: 20210204; Test Name: CT scan Pelvis; Result Unstructured Data: Test Result:unknown results

Allergies:

Symptoms: Bleeding out of ileostomy; Did not sleep; no appetite; Feeling unwell; achy; tired; weaker; This is a spontaneous report from a contactable consumer (patient's daughter). An 88-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283), intramuscular on 30Jan2021 09:45 at SINGLE DOSE in left arm for Prevention. Medical history included Type 2 diabetes diagnosed 10 years ago, Quadruple Bypass surgery in 2003, High blood pressure. He was Diabetic, was a heart patient. Before he had his ostomy, he had colitis that causes the patient to bleed when pooping and his guts were ravaged. His stomach might be weakened from having it for years and years in his 30's, 40's to early 50's. Family medical history included Grandfather died at 42 of bleeding ulcer in his stomach. There were no concomitant medications. Prior Vaccinations within 4 weeks was none. He has allergies to pills but was not taking any. He does not have a fever. She has the names of the pills he is allergic to as follows: Simvastatin, Lisinopril, Losartan, Aggrenox cap. They are listed on his report from (institution name withheld) that he has allergies to. He received his first dose of the Pfizer COVID-19 vaccine on 30Jan2021. There was no prescriber on 30Jan2021 through 01Feb2021, everything was good. On 02Feb2021, that is when his ostomy shot out blood like a faucet when he was taking a shower. He was changing the bandage that day, he was changing his right sided ileostomy bag and he told her that blood shot out of it "like a faucet." On 3Feb2021 was nerve wracking, but there was no blood. He was changing his ostomy pad again on 04Feb2021 and it started bleeding so much that he went to the hospital. He was discharged within a few hours because "they couldn't find anything wrong." He has had colitis for years and has an ileostomy, where they take out a bunch of his colon. This week he has had some funny bleeding in his ileostomy. It was spurting out blood. He had to go to the ER on 4Feb2021 night because it was bleeding and then it stops. People in ER did not know what the bleeding was from. He was bleeding in the ileostomy on 04Feb2021 and 05Feb2021. On 05Feb2021 his ostomy bled a little bit more but it has not bled again since 06Feb2021. She also reports that he feels, " icky, tired, no appetite and achy." The feeling unwell began on 7Feb2021. That worsened since loss of blood made him weaker and worried. When he got back from the hospital/ER, he said they were rude. There was a blizzard. He checked in around 8pm and they discharged him around 11pm that same night. ER visit at the institution on 04Feb2021, 8pm to 11pm and released. They performed CT scan abdomen and Pelvis and IV. Results are unknown. Now he was good. The achiness and tiredness was between persistent and worsened. He was worrying now. She took his forehead temperature and it was good on 7Feb2021. She took everybody's and they were all good. He just feels icky and the blood thing is nerve wracking. He is convinced it is coming back. He was not on a blood thinner or anything listed on the vaccine fact sheet. The patient experienced Feeling unwell on 6Feb2021 with outcome of Not Recovered (Feeling unwell was reported as worsened), achy and tired on 5Feb2021 with outcome of unknown, No appetite on 7Feb202108:30 with outcome of Not Recovered, Bleeding out of ileostomy on 2Feb2021 09:45 with outcome of Recovering, Did not sleep on 7Feb2021 21:30 with outcome of Not Recovered. He has a lot of the risk factors; He is Diabetic, is a heart patient, and has high blood pressure, but he really wanted to get the shot. The patient's primary care provider's nurse do not believe the bleeding had anything to do with the Pfizer COVID-19 vaccine.

Other Meds:

Current Illness:

ID: 1048211
Sex: M
Age:
State: NY

Vax Date: 01/16/2021
Onset Date: 01/24/2021
Rec V Date: 02/23/2021
Hospital: Y

Lab Data: Test Name: CTA of his head; Result Unstructured Data: Test Result:normal; Test Date: 20210128; Test Name: Bacterial sepsis; Result Unstructured Data: Test Result:gram negative urinary tract infection; Test Name: iron level; Result Unstructured Data: Test Result:low at 21; Test Name: body temperature; Result Unstructured Data: Test Result:rarely 98.6 degrees, and is normally 98.2 degrees; Test Date: 20210124; Test Name: body temperature; Result Unstructured Data: Test Result:100.4 Fahrenheit; Test Name: CAT scan; Result Unstructured Data: Test Result:normal; Test Name: CT of his abdomen and pelvis; Result Unstructured Data: Test Result:Unknown results; Test Name: CT scan of his head; Result Unstructured Data: Test Result:subarachnoid hemorrhage was contained; Test Name: eye pressure; Result Unstructured Data: Test Result:normal; Test Name: dilation of his eyes; Result Unstructured Data: Test Result:Unknown results; Test Name: pictures of his left eye; Result Unstructured Data: Test Result:Unknown results; Test Name: eye test; Result Unstructured Data: Test Result:looked at a half circle and clicked a counter when; Comments: looked at a half circle and clicked a counter when he saw dots; Test Name: eye test; Result Unstructured Data: Test Result:he stared at something that looked like a hot air; Comments: he stared at something that looked like a hot air balloon; Test Name: digital prostate exam; Result Unstructured Data: Test Result:prostate was fine; Test Name: sonogram; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210206; Test Name: sonogram; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210127; Test Name: urine; Result Unstructured Data: Test Result:sample was clear and negative for nitrites; Test Name: Field of vision; Result Unstructured Data: Test Result:unknown results; Test Date: 20210206; Test Name: X-ray; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: a genitourinary infection (UTI)/diagnosed with a gram negative urinary tract infection; iron level was low at 21. He said a normal iron level for a male is 35; couldn't walk afterwards; Tiredness; another soft tissue injury; Headache; left eye was totally blurry/ one eye blurriness; has severe eye dryness; Injection site pain; Injection site redness; injection site puffiness; stated he noticed at around 2:30PM-3:00PM he had a rash on his hip and back; shingles/ shingles pain; a fever of 100.4 Degree F/Fever; This is a spontaneous report from a contactable pharmacist (patient) reported similar events for two patients. This is the first of two reports. A 64-year-old male patient receive first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), at same age intramuscular in arm left on 16Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included fallen at work and landed on his left side, hitting his head and left knee, a knot on the left side of his head, bleeding from above his left eyebrow, had a left black eye, all on Nov2020, subarachnoid hemorrhage, cataract surgery, using crutches when he walks, in the hospital from Nov2020 to 17Nov2020, pacemaker implanted while he was in the hospital on Nov2020, he couldn't walk on 19Nov2020, 6 stents, 3 cardiac stents on Oct2020, and chicken pox as a young adult. Concomitant medication included aspirin [acetylsalicylic acid], clopidogrel bisulfate (PLAVIX) from unspecified date to 27Jan2021 for 6 stents, paracetamol (TYLENOL, 500 mg, caplets, NDC Number: 5058044936, Lot Number: SJA066 and Expiration Date: Jul2024). The patient said he received his first COVID-19 Vaccine dose on 16Jan2021. He said at the time he pre-medicated with 2 paracetamol. He said he had read afterwards that it is not recommended to pre-medicate with Tylenol before receiving the COVID-19 Vaccine. On 24Jan2021 he developed a fever of 100.4 Degree F (body temperature). He stated his fever was 8 days after receiving his first COVID-19 Vaccine dose. On 27Jan2021, he was urinating blood/blood clots and was admitted to the hospital and treated for a UTI. He was diagnosed with a genitourinary infection (UTI). He clarified on the morning of 27Jan2021 his urine looked darker than normal. He said he went to physical therapy (PT) on 27Jan2021. He said when he came back from PT, and went to the bathroom, there was blood and blood clots in his urine. He said he called his urologist, and his urologist saw him on 27Jan2021. He said his urologist took a urine sample, and his urine sample was clear and negative for nitrites. He clarified his urologist did a digital prostate exam, and his prostate was fine. He said his urologist wanted him to make an appointment for a cystoscopy, and a CAT scan of his abdomen and pelvis. He said after he got home from the urologist, he went to the bathroom, and again had blood and blood clots in his urine. He went to emergency room. While he was in the Emergency Room, he was set-up on CBI (Continuous Bladder Irrigation). He said the urologist did not seem concerned about the amount of blood in his urine. He clarified he was admitted to the hospital, and had in place for approximately 16 hours. Next day (28Jan2021) he was diagnosed with a gram negative urinary tract infection. He said he was given a daily dose of IV Ceftriaxone 1gram on 29Jan2021 and 30Jan2021. He said he was also given a daily dose on 29Jan2021 and 30Jan2021 of IV Ferrlecit 125mg because his iron level was low at 21. He said a normal iron level for a male is 35. On 31Jan2021 he had injection site pain in his left arm, he said the COVID-19 Vaccine injection site was red and puffy. He said the COVID-19 Vaccine injection site pain, redness, and puffiness resolved on the same day, 31Jan2021. He said his second COVID-19 Vaccine dose was given in the same arm (left) on 06 Feb2021. He stated he asked that the second COVID-19 Vaccine dose be given in the same arm (left) because his left arm is his non-dominant arm. He was discharged from the hospital on 30Jan2021, and was given a prescription to take 1 Levaquin 250mg orally for 3 days starting on 31Jan2021. He said the Levaquin 250mg was dispensed in a pharmacy bottle, and did not have the NDC, Lot, and Expiration Date. He said he was also prescribed oral Feosol 325mg, twice a day, starting on 31Jan2021. He provided the Feosol 325mg, NDC Number: 12451-10-17 (unsure if he provided the correct NDC), Lot Number: 201167, and Expiration Date: Jul2022. At around 2:30-3:00PM on 31Jan2021, he developed a rash on his hip and back, saying the hip and back rash were along the same pathway. He said he spoke to a PA (physician assistant) about his rash. He said on 31Jan2021 he had taken 1 oral dose of the Levaquin 250mg. He said the PA discontinued the oral Levaquin 250mg, and changed his prescription to Macrobid 100mg, twice a day, for 5 days. He said he started the Macrobid 100mg, twice a day, on Monday, 01Feb2021. He said he completed the Macrobid 100mg prescription on Sunday, 07Feb2021, and did not have the Macrobid 100mg NDC, Lot and Expiration Date. He clarified his rash was raised, oozy, and looked weird, like a pimple that came to head. He said he spoke to his dermatologist on a video call Sunday, 31Jan2021. He said his dermatologist told him he had shingles and prescribed Valtrex 1gram, three times a day, for 7-10 days. He stated the Valtrex 1gram was dispensed in a pharmacy bottle. He said he took his first Valtrex 1gram dose on Sunday evening, 31Jan2021, and was still taking the Valtrex 1gram as of today (08Feb2021). He had an appointment to see his dermatologist in person on Wednesday, 03Feb2021, but woke up with a wicked headache that morning, so he took paracetamol and went back to sleep. He said when he woke, he still had headache, and his left eye was totally blurry. He said back in Nov2020 he had fallen at work and landed on his left side, hitting his head and left knee. He said his fall left him with a knot on the left side of his head, and he had bleeding from above his left eyebrow, and had a left black eye. He said he also had a subarachnoid hemorrhage. He said he had a CT scan of his head that showed the subarachnoid hemorrhage was contained, so the doctors wanted to just monitor him. He said he was on Effient at the time and the doctors changed him to Plavix. He said he also was taking Aspirin 81mg. He said he was taken off of Plavix on 27Jan2021 when he was admitted to the hospital for having blood and blood clots in his urine. He said he continues to take the Aspirin 81mg daily. He clarified he has been on compensation since his fall in Nov2020. He said he also had cataract surgery 2 years ago. He said he immediately called his eye doctor, and then went to the hospital Emergency Room because he thought he had a stroke. He said the Emergency room did a CAT scan and CTA of his head, which were both normal. He said a neurologist saw him in the Emergency Room, and said since it was a headache with one eye blurriness, he should see his eye doctor. He said the neurologist told him if he had a headache and both eyes were blurry, it would more likely have been a stroke. He stated when he was discharged from the Emergency Room on 03Feb2020, he went directly to his eye doctor. He said his eye doctor did several tests: field of vision, a sonogram, pictures of his left eye, and a dilation of his eyes. He said he had an eye test where he looked at a half circle and clicked a counter when he saw dots, and another eye test where he stared at something that looked like a hot air balloon, while the eye doctor took measurements. He said the eye doctor also measured his eye pressure, which was normal. He said he was at his eye doctor's office for a good couple of hours. He said his eye doctor told him that he has little white dots on the background area of his eyes that indicates he has severe eye dryness. He said his left eye is much worse than right eye. He said his eye doctor asked him if he took Crack, or Cocaine, or any kind of opioids in the last few weeks. He said he told his doctor he took 1 dose of an opioid on 31Jan2021 because of the shingles pai

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; PLAVIX; TYLENOL

Current Illness:

ID: 1048212
Sex: F
Age:
State:

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/23/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: lightheaded; experience funny feeling in face; HA; Vaccine Related Anxiety; This is spontaneous report from a Non-contactable Other Health Professional. An 87-year-old female patient received first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME, lot# EM9809), intramuscularly in right arm on 04Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. During her 15 minutes waiting period after the injection, the patient experienced funny feeling in face, lightheaded and HA (headache) on an unspecified date with outcome of unknown. The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling. Treatment included: no therapy. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine Related Anxiety (include misc mental health). Patient left at 15:40pm accompanied by husband. Follow up with PMP regarding blood pressure. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1048213
Sex: F
Age:
State: OH

Vax Date: 02/05/2021
Onset Date: 02/01/2021
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Site is painful to touch; looks like cellulitis/possible cellulitis; body aches; swollen at injection site; red at injection site; warm at injection site; armpit lymph node still swollen; This is a spontaneous report from a contactable nurse (patient). A female patient not pregnant of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in right arm on 05Feb2021 18:00 at single dose for COVID-19 immunization. Medical history included Allergies: sulfa. Other medical history: none. Concomitant medication in two weeks included trazodone, omeprazole and BCP. The patient previously took oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) and experienced Allergies, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Intramuscular 18Jan2021 12:00 PM in right arm for COVID-19 immunization. Facility type vaccine: Workplace clinic. If other vaccine in four weeks: No. If covid prior vaccination: No. If covid tested post vaccination: No. After second injection, right arm became red, warm and swollen at injection site 6 hrs later. After 12 hours, increased redness, warmth, swelling and total body aches. After 24 hours, same as above. After 42 hours, injection site right arm very red, swollen. looks like cellulitis. 72 hours later saw PCp for possible cellulitis vs site reaction. Site is painful to touch, very red, hot, swollen. armpit lymph node still swollen but only pink in color. Script for Keflex sent to pharmacy. Event treatment: cefalexin (KEFLEX) Po. All the events were not recovered. AE resulted in Doctor or other healthcare professional office/clinic visit.; Sender's Comments: The reported event of suspected cellulitis with injection site reactions was possibly related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), considering the temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: TRAZODONE; OMEPRAZOLE

Current Illness:

ID: 1048214
Sex: F
Age:
State: MD

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

Lab Data:

Allergies:

Symptoms: angina; angina; Fever; Chills; Cough; Sore throat; runny nose; Nausea; Diarrhea; Headache; arm heavy; muscle aches and heaviness; muscle aches and heaviness; she just woke up feeling sick; fevers may come like a hot flash; This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Unknown), via an unspecified route of administration on 23Jan2021 at a single dose, in left arm for COVID-19 immunization. Medical history included fibromyalgia diagnosed years ago, angina (some stents). There were no concomitant medications. On Jan2021, the patient experienced angina, fever, chills, cough, sore throat, runny nose, nausea, diarrhea, headache, arm heavy, muscle aches and heaviness, and she just woke up feeling sick. The patient experienced multiple AEs after 1st dose of vaccine (received on 23Jan2021). The patient experienced angina later last week. Clinical course: The patient has misplaced card, states her second appointment for the second dose is this Saturday. Caller stated she started having these experiences the day after she was vaccinated with her first dose, received first dose of 23Jan2021. She had fevers, chills, cough- not an aggressive cough, a funny kind of sore throat- like something wrapped around her throat like the muscles of her throat, no congestion but does have a runny nose, states she has some nausea, no vomiting but feeling like she needed to vomit and diarrhea, and headache. The symptoms started about the third day after the vaccine, started with the fevers, stated the fevers may come like a hot flash, lasts seconds even, states you know it is a fever because your bones get hot. These symptom's did not attack her body at one time. Her whole arm stayed heavy, the whole arm not just the injection site, for almost 10 whole days. She previously had fibromyalgia and thought maybe that made the symptoms worse. She had muscle aches and feeling heavy. Her symptoms were spread out over time, no two were at the same time, sore throat was one of the last things. Diarrhea was ongoing, not a runny diarrhea but it was enough to empty stomach and was soft. She was a medic in the military, worked as a Nurse, clarifies she was an LPN and took all the underlying courses to be a PA. One of the issues she found, she thought it may be deadly, as a prior healthcare person and in tune to her body, the people who are in the nursing homes may not be mobile, states so one of the things she felt was just feeling really really sick, that she couldn't put a pin point on it, states she just woke up feeling sick, states she had the urge to get out of bed and got up and after she got up the feeling left her, states a person in the nursing home may just feel really bad and cannot get up, thinks a protocol should be that the people that are immobile should be required to move or if they can't get up they need to move their muscles, people with these symptoms need to get up and get moving. She also has history of angina and a stent, has not had angina in a while and had 3 days where she thought she may need to go talk to her doctor. It was on Wednesday, Thursday and Friday this week. States one of her friends, 92 years old, said she got high after the vaccine and didn't want to talk to anybody, states it was her first dose, she was kind of leery about the 2nd shot, feels like this was kind of aggressive. She had both doses and had no symptoms, but 92-year-old female had no symptoms right away, other than normal body aches and pains, but the next day was high as a kite. Her son has heart disease and she advised him not to take it right now. They were losing a lot of people to the vaccine in nursing homes, no further information provided. This could be affecting good hearts more than damaged hearts, read that this virus likes to work in parts of the body that are already damaged. The outcome of event diarrhea was not recovered, outcome of the other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, a causal association between the reported angina and BNT162B2 cannot be completely excluded. Note however, that the patient has underlying angina with some stents that may also have contributed to the event. Case will be re-assess 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1048215
Sex: F
Age:
State: CA

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 02/23/2021
Hospital: Y

Lab Data: Test Date: 20210208; Test Name: nasal swab/ covid test; Test Result: Negative

Allergies:

Symptoms: Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; This is a spontaneous report from a contactable other hcp (patient). A 44-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), at same age, via an unspecified route of administration in left arm on 05Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included metoprolol. The patient previously took ampicillin and experienced drug allergy. The patient experienced dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side. Right side weakness. Only one eye blinks right eye droopy, all on 05Jan2021 10:00. Events resulted in emergency room visit. The patient was hospitalized for 1 days for all events. It was unknown whether treatment was received for all events. Patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included nasal swab/ covid test: negative on 08Feb2021. The outcomes of events were not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side, right side weakness, only one eye blinks right eye droopy, and the administration of the COVID 19 vaccine, BNT162B2, administration, 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: METOPROLOL

Current Illness:

ID: 1048216
Sex: F
Age: 49
State:

Vax Date: 11/17/2020
Onset Date: 11/01/2020
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Throat felt it would close up; Bell's palsy/my face appeared droopy/water spilled down my face when I tried to drink/face was worse/couldn't close eyes/can not blow or whistle; Heart racing; I felt kind of off, not my normal self/didn't feel right; Could not swallow/needs to drink with a straw; Could not breathe; Pain was up to her ear; Pain was up to her ear; This spontaneous case was received on 10-Feb-2021 from other non-health professional (consumer) via Agency (reference number: SEQW21-00450) and concerned a 49-year-old, female patient. The patient's concurrent conditions included asthma, acid reflux, vitamin K deficiency and fibromyalgia. The patient's concomitant medications included unspecified Nexium (esomeprazole), Cartia XT (diltiazem hydrochloride), Zyrtec (cetirizine hydrochloride) and unspecified multivitamin, all used for an unreported indication. On 17-Nov-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location, route of administration: not reported) as flu prophylaxis. The batch number was not reported. On 18-Nov-2020, next day after receiving Flucelvax Quadrivalent, the patient felt kind of off and not normal self. The patient's heart was racing. On 19-Nov-2020, two days after receiving Flucelvax Quadrivalent, the patient did not feel right and when she went to take her medicine, the water spilled down her face when she tried to drink. The patient's face appeared droopy. On 20-Nov-2020, three day after receiving Flucelvax Quadrivalent, the patient went to emergency room (ER) as her face was worse. The patient could not close her eye and throat felt it would close up. It was reported that the patient had Bell's palsy. On an unspecified date in Nov-2020 (since as reported), the patient went to the doctor and asked if this would be permanent and the doctor told her that they did not know and that they would need to wait and see. There was nothing that could be done. The patient reported that she had disabled son who liked blowing bubbles and when he asked her to blow bubbles for him, she remembered that she could not blow or whistle. The patient needed to drink with a straw and was afraid that this would last for the rest of her life. The patient also could not breathe, she could not swallow, and the pain was up to her ear. At the time of initial reporting on 10-Feb-2021, the patient was recovering from all events since that was not as bad as it was before. The reporter did not provide causality assessment. The event of 'Bell's palsy' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department. Company comment: A 49-year-old patient was administered Flucelvax Quadrivalent. Next day after receiving Flucelvax Quadrivalent, the patient developed palpitations and felt kind off and not normal self. Two days after receiving Flucelvax Quadrivalent, the patient did not feel right and when she went to take her medicine, the water spilled down her face when she tried to drink. The patient's face appeared droopy. Three day after receiving Flucelvax Quadrivalent, the patient went to emergency room (ER) as her face was worse. The patient could not close her eye and throat felt it would close up. It was reported that the patient had Bell's palsy. The patient also could not breathe, she could not swallow, and the pain was up to her ear. Causal role of the suspect vaccine was confounded for dyspnoea and throat tightness, since the patient's concurrent conditions included asthma. However, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for all events. Per Brighton collaboration criteria, presented information correspond to level 1 diagnostic certainty for Facial paralysis.; Sender's Comments: A 49-year-old patient was administered Flucelvax Quadrivalent. Next day after receiving Flucelvax Quadrivalent, the patient developed palpitations and felt kind off and not normal self. Two days after receiving Flucelvax Quadrivalent, the patient did not feel right and when she went to take her medicine, the water spilled down her face when she tried to drink. The patient's face appeared droopy. Three day after receiving Flucelvax Quadrivalent, the patient went to emergency room (ER) as her face was worse. The patient could not close her eye and throat felt it would close up. It was reported that the patient had Bell's palsy. The patient also could not breathe, she could not swallow, and the pain was up to her ear. Causal role of the suspect vaccine was confounded for dyspnoea and throat tightness, since the patient's concurrent conditions included asthma. However, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for all events. Per Brighton collaboration criteria, presented information correspond to level 1 diagnostic certainty for Facial paralysis.

Other Meds: CARTIA XT; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; MULTIVITAMIN [VITAMINS NOS]

Current Illness: Acid reflux (oesophageal); Asthma; Fibromyalgia; Vitamin K deficiency

Date Died:

ID: 1048399
Sex: F
Age: 102
State: PA

Vax Date: 02/01/2021
Onset Date: 02/10/2021
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies: Penicillin

Symptoms: Stopped eating and drinking and died

Other Meds: Prilosec 10 mg/daily,Synthroid .110, daily multivitamin

Current Illness: Covid-19 (Pos. antibody 12/20/2020), Dementia

ID: 1048400
Sex: F
Age: 40
State:

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

Lab Data: No

Allergies: No

Symptoms: Started with discomfort on arm where the vaccine was administered. When I got up to take acetaminophen, I felt very dizzy, nauseous, stay up, couldn't talk, after I drank cold water, I started with profuse sweating followed by chills, also had lower abdominal pain and pain on the left side of the chest. I went to the bathroom and did not have diarrhea. I was finally able to get up with help from my wife. Slow walking. The event lasted about 15 minutes. Since then I've take acetaminophen every 4 hrs.

Other Meds: No

Current Illness: Sinusitis

ID: 1048401
Sex: F
Age: 51
State: IN

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

Lab Data:

Allergies:

Symptoms: Headache, low grade fever, chills, body aches and insomnia.

Other Meds:

Current Illness:

ID: 1048641
Sex: M
Age: 1
State: DC

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: the consumer developed a "measles-like reaction" following MMR-11 administration; This spontaneous report was received from a nurse practitioner referring to a 12 months old male patient. There were none concomitant medication, pertinent medical history and drug reactions and allergies. On 04-FEB-2021, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: rHA) (strength was not provided, lot# was T001211 and expiration date was 20-NOV-2021), 0.5 ml with sterile diluent (manufacturer unknown) (strength, lot# and expiration date was not provided) 0.5 (unit not provided) subcutaneously for immunization. On the same day, the patient developed a measles-like reaction following measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administration. Medical attention was sought. Ibuprofen was given as treatment. The outcome of the event was not recovered. The causality between the event and both therapies was not provided. Upon internal review, the event of measles was determined to be medically significant.

Other Meds:

Current Illness:

ID: 1048642
Sex: U
Age: 27
State: NC

Vax Date: 12/23/2019
Onset Date: 12/26/2019
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Did not take the fourth dose of Vivotif; Took third dose of Vivotif on day 4; Spontaneous report received on 06JAN2020. A pharmacist reported that a consumer "took third dose of Vivotif on day 4" (PT: Inappropriate schedule of product administration) and "did not take the fourth dose of Vivotif" (PT: Incomplete course of vaccination) while being on Vivotif for immunisation. The consumer took first, second and third dose of Vivotif on 23DEC2019, 25DEC2019 and 26DEC2019 respectively. It was reported that the consumer did not take the fourth dose. Action taken with Vivotif with respect to the reported events was not applicable. The outcome of the reported events was unknown. Company Comment: A consumer took third dose of Vivotif on day 4" (Inappropriate schedule of product administration) and also did not take the fourth dose of Vivotif (Incomplete course of vaccination). Considering the nature of the events, the causality of both the events is not applicable to Vivotif.; Sender's Comments: A consumer took third dose of Vivotif on day 4" (Inappropriate schedule of product administration) and also did not take the fourth dose of Vivotif (Incomplete course of vaccination). Considering the nature of the events, the causality of both the events is not applicable to Vivotif.

Other Meds:

Current Illness:

ID: 1048643
Sex: F
Age:
State: OR

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

Lab Data:

Allergies:

Symptoms: Took her last dose of Vivotif a day early; Spontaneous report received on 07JAN2020. A female consumer "took her last dose of Vivotif a day early" (PT: Inappropriate schedule of product administration) after staring Vivotif course for immunization. It was reported that the consumer took her last dose of Vivotif a day early. Action taken with Vivotif with respect to event was not applicable. The clinical outcome of the reported event was unknown. Company Comment: A consumer took her last dose of Vivotif a day early (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not applicable.; Sender's Comments: A consumer took her last dose of Vivotif a day early (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not applicable.

Other Meds:

Current Illness:

ID: 1048644
Sex: M
Age:
State:

Vax Date: 01/04/2020
Onset Date:
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Missed second dose of Vivotif; Spontaneous report received on 07JAN2020. A male consumer reported he had "missed second dose of Vivotif" (PT: Product dose omission). He was receiving Vivotif for immunisation. The consumer took his first dose of Vivotif on 04JAN2020 and then missed second dose of Vivotif. 48 hours had passed after his second dose was due at the time of the report. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown. Company Comment: A consumer missed taking second dose of Vivotif (missed dose). Considering the nature of the event, the causality of missed dose is not applicable to Vivotif.; Sender's Comments: A consumer missed taking second dose of Vivotif (missed dose). Considering the nature of the event, the causality of missed dose is not applicable to Vivotif.

Other Meds:

Current Illness:

ID: 1048645
Sex: F
Age:
State: MI

Vax Date: 01/06/2020
Onset Date: 01/06/2020
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Took one dose of Vivotif while taking minocycline daily; Spontaneous report received on 07JAN2020. A nurse reported that an adult female (age in between 20-30 years) consumer "took one dose of Vivotif while taking minocycline daily" (PT: Labelled drug-drug interaction medication error). He was receiving Vivotif for immunisation and minocycline for acne. The consumer took first dose of Vivotif on 06JAN2020. She was also taking minocycline daily before starting Vivotif for acne. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown. Company Comment: A consumer who was taking minocycline daily for acne took one dose of Vivotif (Labelled drug-drug interaction medication error). Vaccination with Vivotif should be postponed during and for at least three days before and after antibiotic treatment. Considering the nature of the event, the causality of Labelled drug-drug interaction medication error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer who was taking minocycline daily for acne took one dose of Vivotif (Labelled drug-drug interaction medication error). Vaccination with Vivotif should be postponed during and for at least three days before and after antibiotic treatment. Considering the nature of the event, the causality of Labelled drug-drug interaction medication error is assessed as not applicable to Vivotif

Other Meds:

Current Illness:

ID: 1048646
Sex: U
Age: 64
State: AR

Vax Date: 01/06/2020
Onset Date: 01/12/2020
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Missed last dose of Vivotif; Spontaneous report received on 13JAN2020. A pharmacist reported that a 64-year-old consumer "missed last dose of Vivotif" (PT: Product dose omission). The consumer was receiving Vivotif for immunisation. The consumer started Vivotif on 06JAN2020 and took three doses as per schedule but forgot to take the last dose, which was due on 12JAN2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown. Company Comment: A consumer forgot to take the last dose and missed last dose of Vivotif (missed dose). The causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer forgot to take the last dose and missed last dose of Vivotif (missed dose). The causality of missed dose is assessed as not applicable to Vivotif.

Other Meds:

Current Illness:

ID: 1048647
Sex: U
Age:
State: CA

Vax Date: 01/12/2020
Onset Date: 01/13/2020
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Took Vivotif two days in a row; Spontaneous report received on 13JAN2020. A pharmacist reported that a consumer "took Vivotif two days in a row" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif for immunisation. The consumer took first and second dose of Vivotif on 12JAN2020 and 13JAN2020 respectively. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown. Company Comment: A consumer took first dose of Vivotif and the very next day, took the second dose (Inappropriate schedule of product administration). Vivotif doses should be taken every alternate day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took first dose of Vivotif and the very next day, took the second dose (Inappropriate schedule of product administration). Vivotif doses should be taken every alternate day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.

Other Meds:

Current Illness:

ID: 1048648
Sex: U
Age:
State: NC

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

Lab Data:

Allergies:

Symptoms: Took unrefrigerated Vivotif; Spontaneous report received on 14JAN2020. A pharmacist reported that a 50-year-old consumer who "took unrefrigerated Vivotif" (PT: Product storage error). The consumer was receiving Vivotif for immunisation. The consumer completed the course of unrefrigerated Vivotif. The pharmacist assumed that the consumer had started Vivotif approximately 8 days ago. She could not confirm the lot number of Vivotif and stated that the vaccine was likely left unrefrigerated since 17DEC2019. Moreover, she confirmed that the consumer took Vivotif every other day. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown. Company Comment: A consumer took unrefrigerated Vivotif (Incorrect product storage). Considering the nature of the event, the causality of incorrect product storage is assessed as not applicable to Vivotf.; Sender's Comments: A consumer took unrefrigerated Vivotif (Incorrect product storage). Considering the nature of the event, the causality of incorrect product storage is assessed as not applicable to Vivotf.

Other Meds:

Current Illness:

ID: 1048649
Sex: F
Age: 28
State:

Vax Date: 01/12/2020
Onset Date: 01/13/2020
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Took Vivotif incorrectly / took Vivotif two days in a row; Spontaneous report received on 13JAN2020. A female consumer reported that she "took Vivotif incorrectly / took Vivotif two days in a row" (PT: Inappropriate schedule of product administration). She was receiving Vivotif for immunization. It was reported that the consumer took Vivotif incorrectly. She took Vivotif two days in a row. She took first dose of Vivotif on 12JAN2020 at 08:00 am, and took second dose on 13JAN2020 at 07:30 am. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown. Company Comment: A consumer took first and second doses of Vivotif two days in a row instead of taking them on alternate days (Inappropriate schedule of product administration). Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took first and second doses of Vivotif two days in a row instead of taking them on alternate days (Inappropriate schedule of product administration). Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.

Other Meds:

Current Illness:

ID: 1048650
Sex: U
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: Forgot to take Vivotif dose at night and took it the following morning; Spontaneous report received on 15JAN2020. A nurse reported that a consumer "forgot to take Vivotif dose at night and took it the following morning" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif for immunisation. It was reported that one year ago, the consumer took a dose of Vivotif a day late. The dose was scheduled for night but the consumer forgot to take Vivotif dose at night and took it the following morning. The consumer stated that less than 8 hours had past when the missed dose was administered. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown. Company Comment: A consumer forgot to take Vivotif dose at night and took it the following morning (Inappropriate schedule of product administration). Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer forgot to take Vivotif dose at night and took it the following morning (Inappropriate schedule of product administration). Considering the nature of the event, the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif.

Other Meds:

Current Illness:

ID: 1048651
Sex: F
Age:
State: UT

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

Lab Data:

Allergies:

Symptoms: Took two doses of Vivotif and then diagnosed with an infection (urinary tract infection); Spontaneous report received on 15JAN2020. Additional information received on 16JAN2020. A nurse reported that an adult female consumer "took two doses of Vivotif and then diagnosed with an infection (urinary tract infection) (UTI)"(PT: Urinary tract infection). She was receiving Vivotif for immunisation. The consumer took two doses of Vivotif on an unknown date and then diagnosed with UTI on an unknown date. Action taken with Vivotif with respect to the reported event was unknown. The outcome of the reported event was unknown. Treatment medication included an antibiotic for UTI, which was a "sulfa drug" but she could not confirm the drug. She did not know the start date of the antibiotic but it was reported that she was still taking antibiotic which would be completed on 20JAN2020. Company Comment: A consumer was diagnosed with urinary tract infection (UTI) after she took two doses of Vivotif. In response to the event, consumer started taking antibiotic course on an unknown date. Information on consumer's medical history and action taken with Vivotif after diagnosed with UTI is limited. Considering the infectious pathogenesis of UTI, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer was diagnosed with urinary tract infection (UTI) after she took two doses of Vivotif. In response to the event, consumer started taking antibiotic course on an unknown date. Information on consumer's medical history and action taken with Vivotif after diagnosed with UTI is limited. Considering the infectious pathogenesis of UTI, the causality of the event is assessed as not related to Vivotif.

Other Meds:

Current Illness:

ID: 1048652
Sex: M
Age:
State: ID

Vax Date:
Onset Date: 01/15/2020
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Was not able to take his last dose of Vivotif; Spontaneous report received on 16JAN2020. Based on the information obtained from the nurse, two individual case safety reports PVX2020-120 (wife) and PVX2020-121 (husband) were created and cross-linked in the database. In this case, a male consumer "was not able to take his last dose of Vivotif" (PT: Product dose omission). He was receiving Vivotif capsule for immunisation. On 15JAN2020, the consumer's wife took her fourth dose of Vivotif and then took her husband's fourth dose mistakenly right after her last dose. Thus, he was not able to take his last dose. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown. Company Comment: A consumer was not able to take his last Vivotif dose (missed dose) as his wife mistakenly took his Vivotif dose. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer was not able to take his last Vivotif dose (missed dose) as his wife mistakenly took his Vivotif dose. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.

Other Meds:

Current Illness:

ID: 1048653
Sex: U
Age:
State: OR

Vax Date: 01/13/2020
Onset Date: 01/15/2020
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Forgot to take the second dose; Spontaneous report received on 17JAN2020. A pharmacist reported that a consumer "forgot to take the second dose" (PT: Product dose omission) while being on Vivotif capsule for immunisation. The consumer took first dose of Vivotif on 13JAN2020 and then forgot to take the second dose, which was due on 15JAN2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown. Company Comment: A consumer forgot to take second dose of Vivotif (missed dose). Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer forgot to take second dose of Vivotif (missed dose). Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.

Other Meds:

Current Illness:

ID: 1048654
Sex: F
Age:
State: ID

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

Lab Data:

Allergies:

Symptoms: Took first dose of Vivotif and on the very next day took a second dose; Spontaneous report received on 20JAN2020. A nurse reported that a female consumer "took first dose of Vivotif and on the very next day took a second dose" (PT: Inappropriate schedule of product administration). The consumer was taking Vivotif for immunisation. The consumer took first dose of Vivotif on an unknown date and on the very next day, she took a second dose. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown. Company Comment: A consumer took first dose of Vivotif and on the very next day took a second dose (Inappropriate schedule of vaccine administered). Vivotif doses should be taken every alternate day, and the causality of the event is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took first dose of Vivotif and on the very next day took a second dose (Inappropriate schedule of vaccine administered). Vivotif doses should be taken every alternate day, and the causality of the event is assessed as not applicable to Vivotif.

Other Meds:

Current Illness:

ID: 1048655
Sex: F
Age: 42
State: UT

Vax Date: 01/14/2020
Onset Date:
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Missed second dose of Vivotif and did not take any other doses since then; Spontaneous report received on 21JAN2020. A nurse reported that a female consumer "missed second dose of Vivotif and did not take any other doses since then" (PT: Product dose omission). She was receiving Vivotif for immunisation. The consumer took first dose of Vivotif on 14JAN2020 at 10:00 pm and had not taken any other dose since then. The nurse reported that she would initiate the process for the consumer to restart the regimen of Vivotif but, she did not specify dates. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown. Company Comment: A consumer missed second dose of Vivotif and did not take any other doses since then (missed dose). Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer missed second dose of Vivotif and did not take any other doses since then (missed dose). Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.

Other Meds:

Current Illness:

ID: 1048656
Sex: U
Age:
State: MN

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

Lab Data:

Allergies:

Symptoms: Consumer took Vivotif on days 1, 4, 6, and 8; Spontaneous report received on 22JAN2020. A pharmacist reported that a consumer (unknown age and gender) who "took the Vivotif on days 1, 4, 6, and 8" (PT: Inappropriate schedule of product administration) for immunization. The action taken with Vivotif with respect to reported event was not applicable. The clinical outcome of the reported event was unknown. Company Comment: A consumer took Vivotif doses on days 1,4,6, and 8 (Inappropriate schedule of product administration) instead of taking it on alternate days. The causality of the event is assessed as not applicable with Vivotif.; Sender's Comments: A consumer took Vivotif doses on days 1,4,6, and 8 (Inappropriate schedule of product administration) instead of taking it on alternate days. The causality of the event is assessed as not applicable with Vivotif.

Other Meds:

Current Illness:

ID: 1048657
Sex: F
Age:
State:

Vax Date: 01/01/2020
Onset Date:
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: She had fallen ill; Spontaneous report received on 22JAN2020. A female consumer reported that "she had fallen ill" (PT: Ill-defined disorder), while being on Vivotif capsule for immunization. The consumer took only first dose of Vivotif a week and a day ago. She believes that she had fallen ill due to being close to other family members who were sick during that time. It was reported that she did not complete her Vivotif course. Action taken with Vivotif with respect to reported event was vaccine withdrawn. The outcome of the reported event was unknown. Company Comment: A consumer had fallen ill (Ill-defined disorder) after taking first dose of vivotif. The consumer was being around her family members who were sick during the time when she took the first dose of Vivotif and the consumer might have fallen ill as well. The consumer stopped taking further doses of Vivotif. Information on the type of family member's sickness and signs and symptoms of consumer's illness is limited. Considering the case information, the causality of ill-defined disorder is assessed as unlikely with Vivotif.; Sender's Comments: A consumer had fallen ill (Ill-defined disorder) after taking first dose of vivotif. The consumer was being around her family members who were sick during the time when she took the first dose of Vivotif and the consumer might have fallen ill as well. The consumer stopped taking further doses of Vivotif. Information on the type of family member's sickness and signs and symptoms of consumer's illness is limited. Considering the case information, the causality of ill-defined disorder is assessed as unlikely with Vivotif.

Other Meds:

Current Illness:

ID: 1048658
Sex: U
Age:
State: WA

Vax Date:
Onset Date: 01/22/2020
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Missed second dose of Vivotif; Spontaneous report received on 23JAN2020. A pharmacist reported that a consumer (unknown age and gender) who "missed second dose of Vivotif" (PT: Product dose omission), while being on Vivotif for immunization. The consumer missed the second dose of Vivotif, which was due on 22JAN2020. Action taken with Vivotif with respect to reported event was not applicable. At the time of report, the outcome of the reported event was unknown. Company Comment: A consumer missed second dose of Vivotif. Considering the nature of the event, the causality of missed dose is assessed as not applicable with Vivotif.; Sender's Comments: A consumer missed second dose of Vivotif. Considering the nature of the event, the causality of missed dose is assessed as not applicable with Vivotif.

Other Meds:

Current Illness:

ID: 1048659
Sex: F
Age: 76
State: IL

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Tired; Received another dose of the Moderna COVID-19 vaccine the next day; Sore arm; A spontaneous report was received from a consumer, concerning herself, a 76-year-old female patient, who accidently received first dose of Moderna's COVID-19 vaccine and experienced sore arm, received another dose of the Moderna COVID-19 vaccine the next day and was tired. The patient's medical history included sleep deprivation, short term memory loss, hyperparathyroidism, plaque in the artery, heart burn, ocular hypertension, irregular heartbeat, osteopenia, hypertension, cardiac arrhythmia, mitral valve prolapsed, aortic valve prolapsed, DVT, diverticulosis, IBS, rosacea, dry eye, osteoarthritis. Products known to have been used by the patient, within two weeks prior to the event, included Amlodipine, red yeast rice, ezetimibe, latanoprost, propranolol, Irbesartan, Flonase, N-Acetyl-L-Cysteine (NAC), heartburn essential and several supplements. The patient received their first of two planned doses of mRNA-1273 (Lot number:007M20A) intramuscularly in the left arm on 03 Feb 2021. On 04 Feb 2021 approximately 1 day prior to the onset of the events, patient received their second of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient received first dose of mRNA-1273 vaccine on 03 Feb 2021 and was accidently administered second dose of mRNA-1273 vaccine on 04 Feb 2021 from the same facility. Patient called poison center and was told the side effects may be intensified other than that patient should be fine. Patient stated of reading all the side effects and only thing she had was sore arm. Patient was tired because she only got 4.5 hours sleep on 04 Feb 2021 night. She was scared by the event. No treatment information was provided. Consent to follow up was given by her. Action taken with mRNA-1273 in response to the event sore arm was no change. Action taken with mRNA-1273 in response to the events received another dose of the Moderna COVID-19 vaccine the next day and tired were not applicable. The event received another dose of the Moderna COVID-19 vaccine the next day was considered resolved on 04-Feb-2021. The outcome of events, sore arm and tired were considered unknown at the time of this report.; Reporter's Comments: This case concerns a 76-year-old female patient who received their first and second of two planned doses of mRNA-1273 (Lot: 007M20A), reporting Inappropriate schedule of product administration and associated adverse events of vaccination site pain and fatigue. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.

Other Meds: AMLODIPINE; RED YEAST RICE WITH PLANT STEROLS; EZETIMIBE; LATANOPROST; PROPRANOLOL; IRBESARTAN; FLONASE ALLERGY RELIEF; NAC 500; heart burn essential

Current Illness: Memory loss (Short term memory loss for past six months)

ID: 1048660
Sex: M
Age:
State:

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

Lab Data:

Allergies:

Symptoms: took both of my Moderna shots 14 days apart; A spontaneous report was received from a consumer concerning a 90-year-old, male patient who experienced took both of my Moderna shots 14 days apart. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On unknown date, approximately fourteen days prior to the first dose, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. On unknown date, the patient reported he took both Moderna shots 14 days apart and he never had any reaction. Treatment information was not provided. The action taken with the drug in response to the event is not applicable. The outcome of the event took both of my Moderna shots 14 days apart was unknown.; Reporter's Comments: The reporter refers to a case of inappropriate schedule of product administration for mRNA-1273 vaccine, batch number not provided, with no associated AEs. Causality of this event is not applicable.

Other Meds:

Current Illness:

ID: 1048661
Sex: M
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Lost strength in his limbs, could not walk; Could not walk on his own; Arms and legs got swollen; Pain escalated; A spontaneous report was received from patient's daughter regarding her father who is a 92-year-old, male who experienced lost strength in his limbs and escalated pain to his chest, legs, shoulder, ankles, and hips/ MedDRA PT: [ Lost Strength in Limbs] The patient medical history included Hypertonic and Diabetes. Products known to have been used by the patient, within two weeks prior to the event, included Cephalexin 500 mg for skin infection. On 01 FEB 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID- 19 infection. Patient was hospitalized for two days at the Falmouth Hospital where he underwent a battery of test for Muscular Weakness, could not walk on his own, Arms and legs got swollen, escalated pain to his chest, legs, shoulder, ankles, and hips, not relieved with stronger pain relievers. Daughter stated that her father is getting better but very slowly. Treatment information was not provided/ unknown. Action taken with mRNA-1273 in response to the event was recovering. The Outcome of the events was not reported/unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Other Meds: CEPHALEXINE

Current Illness: Diabetes; Hypertonic bladder; Skin infection

ID: 1048662
Sex: F
Age:
State: NY

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Caused some vaccine to end up on the patient's arm and an incorrectly administered dose; Caused some vaccine to end up on the patient's arm and an incorrectly administered dose; When vaccine was being administered, the needle disconnected from the syringe; A spontaneous report was received from a healthcare professional concerning a 43-year-old female, White, patient that received Moderna's COVID-19 vaccine (mRNA-1273) and when the vaccine was being administered, the needle disconnected from the syringe/device connection issue. This caused some vaccine to end up on the patient's arm and an incorrectly administered dose/incomplete dose administered/exposure via skin contact. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 29 Jan 2021, the patient received their second dose of mRNA-1273 (Lot number: 029L20A) intramuscularly in left deltoid for prophylaxis of COVID-19 infection. On 29 Jan 2021, when the vaccine was being administered, the needle disconnected from the syringe. This caused some vaccine to end up on the patient's arm and an incorrectly administered dose. Treatment information was not provided. 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 for the events was considered resolved on 29 Jan 2021.; Reporter's Comments: This report refers to a case of Product administration error (Incorrect dose administered, Exposure via skin contact , Device connection issue) for mRNA-1273, lot # 029L20A with no associated AEs.

Other Meds:

Current Illness:

ID: 1048663
Sex: F
Age:
State: FL

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Passed out; Blood pressure dropped; Neck ache; Body ache; Dizziness; Nausea; Vomiting; Severe chills; Injection site swelling; A spontaneous report was received from a consumer, concerning a 86-year-old, female patient, who received Moderna's COVID-19 vaccine and experienced passed out, blood pressure dropped, neck, body ache, dizziness, nausea, vomiting, severe chills and injection site swelling. The patient's medical history was not provided. Concomitant product use was not provided. On 05 Feb 2021 at 10:00 am, prior to the onset of the events, patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 05 Feb 2021, initially patient had injection site swelling. Then 22 hours later on 06 Feb 2021, she passed out, her blood pressure dropped, had nausea, vomiting, severe chills, neck and body ache, and dizziness. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not reported. The outcome of the events, passed out, blood pressure dropped, neck, body ache, dizziness, nausea, vomiting, severe chills and injection site swelling were unknown 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 event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1048664
Sex: F
Age: 68
State: FL

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Passed out; Felt like two sticks in her stomach; Feeling of a warm flush; Fell on head; Sore arm; A spontaneous report was received from a consumer concerning a 68-years-old, female patient who experienced feeling of a warm flush, sore arm, felt like two sticks in her stomach, passed out and fell on head. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 15 Jan 2021, approximately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 01ZC207] intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 15 Jan 2021, the patient felt like two sticks were in her stomach and then a feeling of a warm flush going through her body. She also had a sore arm. Patient felt like she was going to pass out and did pass out and fell on her head. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The events feeling of a warm flush, sore arm, felt like two sticks in her stomach, passed out and fell on head were considered not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

Date Died:

ID: 1048665
Sex: M
Age:
State: NY

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

Lab Data:

Allergies:

Symptoms: Died; Internal bleeding and died; A spontaneous report was received from a nurse concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced internal bleeding and died. The patient's medical history was not provided. No concomitant product use was reported. On unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On unknown date, a nurse reported she read about a doctor who received the COVID-19 vaccine and died 3 days later. She stated she read that the doctor had internal bleeding. It started with bleeding in his hands and feet, then went to his brain and died 3 days later. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, internal bleeding and died, was considered fatal.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Reported Cause(s) of Death: Internal bleeding

Other Meds:

Current Illness:

ID: 1048666
Sex: F
Age: 74
State: FL

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Sore arm; Itchy rash on back; Swelling; Red blotches all over her arm; Fever; Worsening rheumatoid arthritis; Worsening fibromyalgia; Flu like symptoms; A spontaneous report (United States) was received from a consumer concerning herself, a 74-year-old, female patient who Moderna's COVID-19 Vaccine (mRNA-1273) and experienced worsening fibromyalgia, worsening rheumatoid arthritis, flu-like symptoms, sore arm, itchy rash on back, fever, swelling and red blotches all over her arm. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011L20A). On 05 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number:031L20A) intramuscularly in the arm for prophylaxis of COVID-19 infection. On 06 Jan 2021, after the first shot of vaccine, the patient experienced worsening fibromyalgia, worsening rheumatoid arthritis like her fingers were hurting so bad that she felt like they were going to fall off and flu like symptoms with fever. On 05 Feb 2021, after the second shot, patient experienced sore arm, swelling, red blotches all over her arm and itchy rash on her back. Treatment for event included acetaminophen and diphenhydramine which didn't seems to help events at all. Action taken with mRNA-1273 in response to the events were unknown. The outcome of the events, worsening fibromyalgia, worsening rheumatoid arthritis, flu-like symptoms, sore arm, itchy rash on back, fever, swelling and red blotches all over her arm were considered unknown at the time of this report.; Reporter's Comments: Based on the current available information, a temporal association between the use of the product and the onset of the reported events, and the known safety profile of mRNA-1273 a causal relationship cannot be excluded

Other Meds:

Current Illness:

ID: 1048667
Sex: F
Age: 46
State: FL

Vax Date: 02/04/2021
Onset Date: 02/05/2021
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Finally urinated and it was dark in color; Induration of erythema about 3 inches; Acute renal failure; Felt so dry and realized I did not urinate; Disoriented; Sustained tachycardia for about 26 hours straight; Couldn't lay on left side; Induration of erythema about 3 inches; chills/rigors; Chills and sweats, back and forth; Severe tremor, rigors/Chills; Temperature was 104.1/ Fever persisted; Significant headache/Worst headache of her life; Body aches; Nausea; Vomiting; A spontaneous report was received from a consumer who is a physician's assistant) concerning 46 year old female patient. Medical history included cystic fibrosis. No relevant concomitant medication was reported. On an unspecified date, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection. On 04Feb2021, the patient received the second dose of mRNA-1273 (lot number 028L20A) intramuscularly for prophylaxis of COVID-19 infection. On 05Feb2021, the patient experienced severe tremor, rigors, temperature of 104.1, significant headache (described as worst headache in her life), persistent fever, body aches, nausea vomiting, chills and sweats back and forth. The patient was in bad all day 04Feb2021 (Thursday) through Saturday until 2pm. She felt dry and did not urinate, until after a bag of unspecified intravenous fluids, when she finally urinated in was dark in color (the patient considered herself to have acute renal failure). The patient also experienced sustained tachycardia for 26 hours, was disoriented, had induration of erythema about three inches at the vaccination site, and could not lay on her left side. The patient treated herself with ibuprofen and Tylenol for fever and body aches. The patient reported she was fine on 08Feb2021. Action taken with the mRNA-1273 in response to the events was not reported. The outcome of the events of acute kidney injury, urinary retention, tremor, pyrexia, headache, pain, nausea, vomiting, hyperhidrosis, chromaturia, tachycardia, disorientation, vaccination site induration, vaccination site erythema, hypokinesia, and chills was considered resolved.; 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: Cystic fibrosis

ID: 1048668
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Immune thrombocytopenia; A spontaneous report was received from a consumer concerning a 72-year-old, female patient, who experienced bruises on her arm, legs and blisters that bled inside her mouth and severe immune thrombocytopenia. The patient's medical history was not provided. Concomitant product used was not provided by the reporter. On an unspecified date, one day prior to the onset of events, the patient received their first two planned doses of mRNA-1273 (Batch number: not provided) for the prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced bruises on her arm, legs and blisters that bled inside her mouth. On 19 Jan 2021, the patient was admitted in the hospital with a severe case of immune thrombocytopenia. The patient was given platelet transfusions along with steroids and immunoglobulins. On 02 Feb 2021, the patient's condition slightly improved and was sent home. Treatment for the events included platelet transfusion, steroids and immunoglobulins. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, bruises on her arm, legs and blisters that bled inside her mouth and severe immune thrombocytopenia, were considered resolved on an unspecified date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time.

Other Meds:

Current Illness:

ID: 1048669
Sex: M
Age:
State: NH

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

Lab Data:

Allergies:

Symptoms: Hallucinating; A spontaneous report was received from a Physician concerning a male individual (other health care professional and colleague) who received his 2nd dose of Covid-19 vaccine and have experienced hallucinations. The consumer's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, prior to the onset of events, the consumer received his 2nd of two planned doses of covid-19 vaccine for the prophylaxis of Covid-19 infection. According to physician, her colleague started hallucinating after his second shot. It is not known whether the patient had medical intervention or went to ER for treatment. Physician couldn't provide any further information as her head was fuzzy to answer any more questions. Action taken with doses of Moderna Covid-19 vaccine was not applicable as the patient received both the doses. The outcome of the event hallucinations was unknown.

Other Meds:

Current Illness:

ID: 1048670
Sex: F
Age: 59
State: PA

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Possibly injected using 1/2 inch needle; Sore Arm; A spontaneous report was received from a PA concerning a 60 year old, female patient who experienced injection site pain after possible wrong technique in device usage process. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the arm for prophylaxis of COVID-19 infection while using 1/2 inch needle. Treatment information was not provided. Action taken with mRNA-1273 in response to the event(s) was not provided. The outcome of the event, possible wrong technique in device usage process, was considered recovered/resolved on 05 Feb 2021. The outcome of the event, sore arm, was not reported.; Reporter's Comments: This report refers to a case of wrong technique in device usage process for mRNA-1273 (lot unknown) with reported listed non-serious event of vaccination site pain.

Other Meds:

Current Illness:

ID: 1048671
Sex: F
Age: 88
State: FL

Vax Date: 01/28/2021
Onset Date: 02/05/2021
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: not injected into the middle of the deltoid, but rather on the side of the arm; sore arm; swollen about 2-3 inch area, circle, red, and warm; Vaccination Site Red; A spontaneous report was received by a consumer regarding herself an 88-year-old female patient who experienced the vaccine not injected into the middle of the deltoid, but rather on the side of the arm/Incorrect route of product, sore arm/vaccination site pain, swollen about 2-3 inch area circle raised, red and warm/vaccination site swelling, and vaccination site red/vaccination site erythema. The patient's medical history was not provided. No concomitant medications provided. The patient received the first of two planned doses of mRNA-1273 (Batch number 030L20A) injected into the side of the left arm for prophylaxis of COVID-19 infection. On 28 Jan 2021, the patient received her vaccine, but noted that it was not given in the middle of the deltoid, but rather on the side of the arm. She also had a sore arm, swelling reported as about a 2-3 inch circle which was red and warm. Treatment information was not provided. Patient consented to be contacted. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, vaccine not injected into the middle of the deltoid, but rather in the side of the arm, sore arm, and a 2-3 inch circle that is raised, red and warm, was considered resolved.; Reporter's Comments: The events developed on same day after first dose of mRNA-1372. 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:

Date Died:

ID: 1048672
Sex: M
Age: 89
State:

Vax Date: 12/29/2020
Onset Date:
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Pass away; Got COVID; A spontaneous report was received on from a consumer, concerning an 87-year-old male patient, who received Moderna's COVID-19 (mRNA 1273) vaccine and experienced pass away (death) and COVID (COVID-19). The patient's medical history was not provided. No relevant concomitant medications were reported. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 injection for the prophylaxis of COVID-19 infection. Two days after mRNA-1273 injection, the patient's daughter was diagnosed with COVID-19 infection. The daughter states that her mother also got infected with COVID. On an unknown date, the patient got COVID. It was reported that he passed away. Treatment for the event was not provided. The cause of death was not provided. The plans for an autopsy were not provided. .; Reporter's Comments: Although the onset date of COVID-19 and the fatal outcome is lacking, Based on the natural history of COVID-19, the reported event, it is assessed as unlikely related with mRNA-1273. The actual cause of death cannot be ascertained but assessed as not related and most likely due to the COVID-19 infection.

Other Meds:

Current Illness:

ID: 1048673
Sex: M
Age: 84
State: CA

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: some of the vaccine spilled from the syringe; pain at the injection site; This spontaneous report was received from consumer on 04-feb-2021, concerning a 84 year old male patient who was administered Moderna COVID-19 vaccine ( mRNA-1273). The patient experienced pain at the injection site and reported some of the vaccine spilled from the syringe down his arm. The patient's medical history and Concomitant medication was not provided.. The patient received suspect product mRNA-1273 on 04-feb-2021, prior to the onset event, the patient received their first dose of mRNA-1273 (lot number:029L20A)intramuscularly on the right arm for prophylaxis of COVID-19 infection On 11-FEB-2021 to complete his adverse reaction form and to update Moderna on how he is going to proceed. Patient will get his second injection and will have antibodies after the second Moderna Covid-19 at the direction of his Physician Action taken with the second dose of mRNA-1273 in response to the event was not reported; Reporter's Comments: This case report concerns a 84 year old male patient who was administered mRNA-1273 vaccine Lot# 029L20A and experienced pain at the injection site and reported some of the vaccine spilled from the syringe down his arm. (incomplete dose administered). The event of pain at the injection site is consistent with the known safety profile of mRNA-1273 and temporarily associated with the product use and a causal association cannot be excluded. The event of incomplete dose administered is assessed as not applicable.

Other Meds:

Current Illness:

ID: 1048674
Sex: F
Age: 66
State: TX

Vax Date: 01/27/2021
Onset Date: 01/30/2021
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Possible kidney infection; Possible bladder infection; A spontaneous report received from a Consumer concerning, 66-year-old female patient who received first dose of the Moderna COVID-19 vaccine and experienced possible kidney infection and possible bladder infection (Cystitis) The patient's medical history was not included. Patient's concomitant medication was not included. On 27JAN2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection. Patient stated she received her first dose of the Moderna COVID-19 vaccine on 27Jan2021. Patient stated on 30Jan2021, she started to smell an odor and believes that she has a bladder or kidney infection. Patient stated that her doctor cannot see her for several days. Patient would like to have the doctor call in a ZPack or other antibiotic but wants to know if this will interfere with the Moderna COVID-19 vaccine. Patient stated that she does not have a fever. Treatment information was not provided/ unknown. Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the events was unknown/not reported.; Reporter's Comments: This report concerns a 66--year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # not provided, and experienced possible bladder and kidney infection. Very limited information regarding this event has been provided at this time. Further information has been requested

Other Meds:

Current Illness:

ID: 1048675
Sex: F
Age:
State: OH

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

Lab Data:

Allergies:

Symptoms: Chest tightening; moist non productive cough; tightening of the throat; facial flushing; hot flashes; This is a spontaneous report from a contactable nurse. A 56-year-old female patient received second dose of bnt162b2 (Brand: Pfizer, Formulation: solution for injection, Lot number: EL3302) via intramuscular, on right arm on 02Feb2021, 10.30 at single dose for COVID-19 immunization. The medical history included allergies to bees and nickel, GERD (Gastro-oesophageal reflux disease). The concomitant medication included diphenhydramine hydrochloride, paracetamol (TYLENOL PM) on an unknown date in 2021. The patient previously received historical vaccine, first dose of bnt162b2 (Brand: Pfizer, Lot number: EL0140) via intramuscularly on left arm at 9.30 on 12Jan2021 for COVID-19 immunization. It was reported that at 10.45 on 02Feb2021, the patient experienced chest tightening, moist non-productive cough, tightening of the throat, facial flushing, hot flashes. The patient was not pregnant at the time of vaccination. The patient received most recent COVID-19 vaccine at nursing home/senior living facility. The patient didn't receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient received Tylenol Pm within 2 weeks of vaccination. The patient visited emergency room for the events. Therapeutic measures were taken because of events via oral and subcutaneous. The patient had not diagnosed with COVID-19 prior to the vaccination and since the vaccination. The outcome of the events was recovered on an unknown date in 2021.; Sender's Comments: The association between the events chest tightening, moist non-productive cough, tightening of the throat, facial flushing, hot flashes with BNT162B2 use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: TYLENOL PM

Current Illness:

ID: 1048676
Sex: F
Age:
State: NE

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Severe eye pain evening after; drooping eyelid and eyeball on left side; This is a spontaneous report from a contactable consumer (patient herself). A 72-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number was not reported, Pfizer NTEC), via an unspecified route of administration in left arm on 05Feb2021 12:00 pm at single dose for COVID-19 immunization. The patient's medical history included thyroid issue, elevated cholesterol. Concomitant medications included ospemifene (OSPHENA), levothyroxine, meloxicam and ezetimibe. The patient was not diagnosed with COVID-19 prior to vaccination. The patient have not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe eye pain and drooping eyelid and eyeball on left side evening after (05Feb2021 20:00). Next day and still happening, drooping eyelid and eyeball on left side. The patient did not receive any treatment for the adverse events. The events were considered as non-serious by the consumer. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Other Meds: OSPHENA; LEVOTHYROXINE; MELOXICAM; EZETIMIBE

Current Illness:

ID: 1048677
Sex: F
Age:
State: MI

Vax Date: 01/19/2021
Onset Date: 02/01/2021
Rec V Date: 02/23/2021
Hospital:

Lab Data:

Allergies:

Symptoms: shingles; Bump on nose; It is painful; broke out in rash/rash under right eye; pretty sick; This is a spontaneous report from a contactable nurse (the patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left upper arm on 19Jan2021 at 11:15 to 11:30 (at the age of 58-years-old) as a single dose for Covid-19 immunization. Medical history included COVID-19 in Mar2020 and was reported as recovering (ongoing). The patient's concomitant medications were reported and none. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Feb2021, the patient experienced a bump on her nose and later got a rash under the right eye and broke out in a rash; on 08Feb2021, the patient was diagnosed with shingles; on an unknown date in Feb2021 she experienced she was pretty sick now; not feeling well and it was painful. The patient went to the emergency room about 3:40am on 08Feb2021. The events were considered serious per disabling since she was not able to return to work until blisters were crusted over. Has missed a couple days of work. Her only concern was that it was not in her eye and she was good. Treatment was given for the shingles which included Acyclovir. The clinical outcome of the events herpes zoster, rash, illness, skin disorder and pain was not recovered. The reporter stated she was supposed to get her second dose but cannot now. The reported considered the events herpes zoster, rash, illness, skin disorder and pain related to BNT162B2. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness: COVID-19 (Recovering)

ID: 1048678
Sex: M
Age:
State: NM

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

Lab Data:

Allergies:

Symptoms: polymyalgia rheumatica; mild headache; upper arm and hip flexor ache; upper arm and hip flexor ache; injection site induration; left arm muscle ache; malaise; This is a spontaneous report from a contactable physician reporting for self. A 72-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #EL3249), via an unspecified route of administration on 23Jan2021 12:00 at single dose for covid-19 immunisation. Medical history included hypertension, arthritis. Concomitant medication included losartan, hctz, dabigatran. On 23Jan2021, patient experienced injection site induration, left arm muscle ache, malaise; on 30Jan2021, patient experienced mild headache, upper arm and hip flexor ache relieved by aspirin or NSAIDs for three days, and polymyalgia rheumatica. Consistent with polymyalgia rheumatica. Still the same symptoms at day 12 the milder. Outcome of events was recovering.; Sender's Comments: The serious event reported as polymyalgia rheumatica is deemed as possibly related to BNT162B2 vaccine administration based on the plausible drug-event 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: LOSARTAN; HCTZ; DABIGATRAN

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm