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**
PLEASE CHECK BACK SOON
Download the files above while you wait.







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: 1037996
Sex: U
Age:
State: AZ

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:101

Allergies:

Symptoms: This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 15:22 at single dose for COVID-19 immunization. Medical history included compromising health issues. The patient already had COVID in Jul2021 and hospitalized, had an autoimmune disorder, had connective tissue disease, had a gamma globulin anemia and I do infusions once a week with Hizentra, so subQ' (not clarified further). Concomitant medications were unknown. The patient took the first vaccine, and had a reaction. And Tuesday the patient had a 101 fever and body ache, terrible headache on 26Jan2021. The patient kept taking Tylenol and then slept it off and then the next day the patient woke up, the fever broke. The patient still had like a little bit of headache and a little bit of the body aches but then as the day went on it had. So, the patient's question was because most people were not getting reactions to the first dose. The patient just wanted to know if it's safe to take the second dose. Outcome of the events was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1037997
Sex: F
Age:
State: IL

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

Lab Data:

Allergies:

Symptoms: This is a spontaneous report from a contactable nurse. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), other route on the right arm at the age of 60 years, on 02Feb2021 12:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included depression Depression, Hypothyroidism, High Cholesterol, Osteopenia, Occasional vertigo. Concomitant medication included simvastatin (SIMVASTATIN), duloxetine (DULOXETINE), raloxifene (RALOXIFENE), chlorthalidone (CHLORTHALIDONE), levothyroxine (LEVOTHYROXINE) , calcium (CALCIUM), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), folic acid (FOLIC ACID), fish oil (FISH OIL), vitamin b12 nos (VITAMIN B12 NOS) , calcium carbonate, colecalciferol (VITAMIN D 2000) and Tumeric. The patient had the first dose of vaccine on 12Jan2021. After the 2nd shot, the patient's arm didn't get heavy, just felt a weakness going from shoulders down to hands on Feb2021. She couldn't move or feel them for 15 min. Slowly she could move her fingers then hands then lift arms. The next day her brain felt kind of fuzzy and still a little "off kilter" on 2nd day (Feb2021). She did not have any anxiety about either shot, even with what happened with the first one. The outcome of the events was recovering.

Other Meds: SIMVASTATIN; DULOXETINE; RALOXIFENE; CHLORTHALIDONE; LEVOTHYROXINE; CALCIUM; VITAMIN D [VITAMIN D NOS]; FOLIC ACID; FISH OIL; VITAMIN B12 NOS; VITAMIN D 2000

Current Illness:

ID: 1037998
Sex: M
Age:
State: TX

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

Lab Data:

Allergies:

Symptoms: felt faint; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient felt faint for less than a minute after receiving the shot, on an unspecified date. Final outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1037999
Sex: F
Age:
State: ND

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

Lab Data: Test Date: 202102; Test Name: Blood creatinine; Result Unstructured Data: Test Result:more than double; Test Date: 202102; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Test Result:abnormal

Allergies:

Symptoms: Markers for ESR and CR were more than double what they should be; Markers for ESR and CR were more than double what they should be; This is a spontaneous report from a contactable nurse reporting for herself. A 71-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL9269), via an unspecified route of administration, on 02Feb2021, at single dose, for COVID-19 immunisation and methotrexate sodium (unknown manufacturer) (exp date 12Nov2021) tablet, via an unspecified route of administration, from 2014 and ongoing, at 7 DF weekly (it was 17.5 mg), for rheumatoid arthritis. Medical history included pain and ongoing rheumatoid arthritis. Concomitant medication included folic acid (unknown manufacturer). The patient experienced markers for ESR and CR were more than double what they should be (red blood cell sedimentation rate abnormal) in Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood creatinine: more than double in Feb2021, red blood cell sedimentation rate: abnormal in Feb2021. The action taken in response to the events for methotrexate sodium was unknown.

Other Meds: FOLIC ACID

Current Illness: Rheumatoid arthritis

ID: 1038000
Sex: F
Age:
State: PA

Vax Date: 09/21/2020
Onset Date: 09/01/2020
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: scratchy throat; Vomited; Chills; Entire body, even fingers and toes, ached; Welt at injection site; face was bright red/breasts were cherry red; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiry date unknown), via an unspecified route of administration on 21Sep2020 on the left arm at a single dose as a pneumonia shot. The patient had no medical history and there were no concomitant medications. The patient was trying to get a list of ingredients before she even thinks about getting the COVID shot (confirmed that she has not received the COVID shot) because she had a severe reaction to the pneumonia shot. On an unspecified date in Sep2020, in the evening, it started with scratchy throat. The patient's granddaughter suffers from anaphylaxis and her reactions begin with a scratchy throat. The patient's daughter left Children's Benadryl at the patient's house in case her granddaughter had a reaction. So the patient took Children's Benadryl after throat was scratchy because that is all she had. On an unspecified date in Sep2020 (reported as 'Thursday') at 06:00 in the morning the patient vomited and had chills. Her entire body even fingers and toes ached. She looked in mirror, her face was bright red. Her breasts were cherry red. The patient had a hug welt on her left arm at the site of the injection. The patient called doctor and was advised no more shots. The outcome of the events were unknown. It was also reported that approximately six weeks later the patient got the Fluzone shot and had a similar reaction, but not quite as severe, the patient was bright red, had a welt, she kind of chilly and not her usual self. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1038001
Sex: F
Age:
State: CT

Vax Date: 01/12/2021
Onset Date: 01/27/2021
Rec V Date: 02/18/2021
Hospital: Y

Lab Data: Test Date: 20210119; Test Name: COVID; Test Result: Negative ; Test Date: 20210127; Test Name: COVID; Test Result: Positive ; Test Date: 20210129; Test Name: COVID; Result Unstructured Data: Test Result:still positive

Allergies:

Symptoms: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable nurse reporting for the mother. A 92-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 12Jan2021 at single dose for Covid-19 immunisation . Medical history included dementia. The patient's concomitant medications were not reported. In Oct2020, the patient received the flu vaccine. The patient was tested positive for covid on 27Jan2021 with outcome of unknown. The patient was hospitalised because of the event on 29Jan2021. The patient got her first vaccine on 12Jan2021, she tested negative for COVID on 19Jan2021 but on 27Jan2021 she tested positive. The patient has been retested on 29Jan2021 and is still positive. Information of lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (tested positive for COVID after 15 days) with BNT162b2 can not be completely excluded.

Other Meds:

Current Illness:

ID: 1038002
Sex: M
Age:
State: FL

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration at the left deltoid on 26Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose of the Pfizer covid vaccine on 26Jan2021. When he came home that day his left arm swelled up and had a knot at the injection site. States he went right out, clarifies he went to sleep for hours. The next day (27Jan2021) when he woke up, he rubbed the area and it was sore. Three days ago (30Jan2021), he started running out of breath, he would walk to the mailbox and have to stop since he was out of breath. He never had that happen before. He was not sure what it was or if something else going on. He would have no breath whatsoever if he gets up to walk. When he was sitting still he was ok. If he gets up to walk to the bathroom, he was out of breath by the time he gets to the bathroom. States he was not short of breath as long as he was not doing anything. States it was crazy though when he starts walking and he gets out of breath. This has never happened to him before. He does not know if it was the vaccine or something else. He saw the shortness of breath was one of the side effects. He wants to find out what he should do and if he should go to the hospital. Advised to contact hcp. He asks if he was supposed to go back for the second shot. He has an appointment with his doctor in the next two weeks for all the medications he takes. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1038003
Sex: F
Age:
State: FL

Vax Date: 01/28/2021
Onset Date: 01/31/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Name: lab tests; Result Unstructured Data: Test Result:Normal; Test Name: neck x-ray; Result Unstructured Data: Test Result:showed no significant, it was normal; Comments: except for degeneration of C5-C6

Allergies:

Symptoms: redness; lumps on her head; swelling of the face/swelling on the side of her face; swelling of her eye; swelling of the back; rash/rash all over the body; itching; This is a spontaneous report from a contactable Physician. A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) at the age of 69 years via unspecified route of administration in the right arm on 28Jan2021 13:00 (lot number EL6982 and expiry date unknown) at single dose for Covid-19 immunization in a facility. Medical history included drug allergic to penicillin, liver problems 17 or 18 years ago and has fully recovered from the liver problems. The patient was admitted to the hospital because her liver enzymes were high; ongoing high blood pressure, ongoing cholesterol (blood cholesterol abnormal), ongoing blood pressure (blood pressure abnormal). Concomitant medication included ongoing atenolol for blood pressure, ongoing lovastatin for cholesterol, ongoing losartan for high blood pressure, ongoing vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) for unspecified indication, aminobenzoic acid, biotin, choline bitartrate, folic acid, inositol, nicotinamide, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, vitamin b12 nos (B COMPLEX [AMINOBENZOIC ACID;BIOTIN;CHOLINE BITARTRATE;FOLIC ACID;INOSITOL;NICOTINAMIDE;PANTOTHENIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;VITAMIN B12 NOS]) from unspecified date for unspecified indication. The patient received first dose of BNT162B2 at the age of 69 years on 07Jan2021 13:00 (lot number EL3246) in the right arm for Covid-19 immunization and had no side effects. The patient has no prior vaccinations within 4 weeks. On 31Jan2021, the patient experienced swelling of the face, swelling of her eye, swelling of the back, rash and itching. The reporter (a retired physician/husband) was calling regarding his wife who received the second dose on 28Jan2021 and on Sunday 31Jan2021 she got swelling of the face and eyes and went to the ER for 5 or 6 hours. The patient received cortisone and Benadryl and she was some improved. Today (unspecified date) she was still getting more swelling of the face and redness. The reporter clarified that the patient received the second dose on 28Jan2021 at 13:00 in the right arm. The patient noticed 31Jan2021 in the evening swelling of her face, swelling on the side of her face, swelling of the eyes and swelling on her back, also some lumps on her head. The patient was a little improved at the ER, but today there was more rash all over the body and itching and it was getting worse. The reporter added that the rash appears on one side and then disappears and went to another part of the body. The patient underwent lab tests and procedures which included lab tests: normal on unspecified date, neck x-ray: showed no significant, it was normal except for degeneration of C5-C6 on unspecified date. The patient received treatment with the events swelling of the face/swelling on the side of her face, swelling of her eye, swelling of the back, rash/rash all over the body, itching, lumps on her head. The outcome of the events was not recovered. The events swelling of the face/swelling on the side of her face, swelling of her eye, swelling of the back, rash/rash all over the body, itching was reported medically significant.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of all reported events cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. 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: ATENOLOL; LOVASTATIN; LOSARTAN; VITAMIN C [ASCORBIC ACID]; B COMPLEX [AMINOBENZOIC ACID;BIOTIN;CHOLINE BITARTRATE;FOLIC ACID;INOSITOL;NICOTINAMIDE;PANTOTHENIC

Current Illness: Blood cholesterol abnormal; Blood pressure abnormal; Blood pressure high

ID: 1038004
Sex: F
Age:
State: NM

Vax Date: 01/13/2021
Onset Date: 01/27/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Date: 20210118; Test Name: Nasal Swab covid test; Test Result: Negative

Allergies:

Symptoms: bladder infection/UTI/Antibiotics; blood in my urine; This is a spontaneous report from a contactable healthcare professional (patient). This healthcare professional reported similar events for two patients. This is the first of two reports. A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on the right arm on 13Jan2021 13:00 at a single dose for COVID-19 immunization. The patient has no medical history. The patient's concomitant medications were not reported. The patient reported that on 27Jan2021, exactly 2 weeks after the 1st dose of the vaccine, she came down with a UTI and bladder infection which caused her to have blood in her urine. This also happened to the patient's father who suffered the same thing 2 weeks after his first vaccine. Antibiotic was given as treatment for the patient. Lab data include nasal swab COVID test: negative on 18Jan2021. The outcome of the events was recovered in 2021. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : same product and event, different patient

Other Meds:

Current Illness:

ID: 1038005
Sex: U
Age:
State: NC

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/18/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: extremely sick; dizziness; This is a spontaneous report from a contactable consumer (patient). A 51-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318), via an unspecified route of administration on the left deltoid on 29Jan2021 at a single dose for COVID-19 immunization. Medical history included patient was asthmatic diagnosed around 8 or 9 years old. Concomitant medication included albuterol [salbutamol] for asthma. On 29Jan2021, the patient had first dose of the COVID vaccine and ended up getting extremely sick. The patient was taken by ambulance to the hospital on the same day. As reported, "so I was in ambulance dying just put me on there, but I got 2 doses of the "Aefrom" and I ended up of another dose of "hawdapil." The patient still had a little bit of dizziness which was not bad and has improved. The doctor instructed the patient to report and find out if patient was going to be able to get the second dose because they were saying not to. The patient got the vaccine at an hospital, in a line. Outcome of the event "extremely sick" was unknown and of dizziness was recovering.

Other Meds: ALBUTEROL [SALBUTAMOL]

Current Illness:

ID: 1038006
Sex: F
Age:
State: NY

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

Lab Data:

Allergies:

Symptoms: Chills; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 2nd of the two reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (at an unspecified age) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced chills. The clinical outcome of chills was unknown. same reporter/drug, different patient

Other Meds:

Current Illness:

ID: 1038007
Sex: F
Age:
State: PA

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

Lab Data:

Allergies:

Symptoms: a sore arm for a day; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 77-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN), lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for immunization. Medical history and concomitant medications were not reported. The patient experienced sore arm for a day on an unspecified date. Clinical outcome of the event was unknown. Information related to lot/batch has been requested.

Other Meds:

Current Illness:

ID: 1038008
Sex: F
Age: 49
State: MI

Vax Date: 02/11/2021
Onset Date: 02/12/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies: PCN,Keflex, Bactrim,Motrin,Morphine, Dermerol, Lisinopril

Symptoms: rash at injection site, redness, body aches, enlarge lymph nodes left arm pit. Large red rash left side with dark scaring

Other Meds:

Current Illness: None

ID: 1038009
Sex: F
Age: 44
State: MI

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies: Aspirin, Macrobid, Keflex, Levoquin

Symptoms: Arm burning, swelling of throat, facial numbness, dizziness, hives

Other Meds:

Current Illness:

ID: 1038020
Sex: U
Age:
State: NM

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

Lab Data:

Allergies:

Symptoms: shingles; other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the pt was treated by healthcare providers for shingles and other zoster-related conditions. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses and damages in the future. The outcome of the events shingles and other zoster-related conditions was not recovered. The causality assessment was considered as related by the lawyer.

Other Meds:

Current Illness:

ID: 1038021
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: After my first dose of Shingrix I became nauseous; This case was reported by a consumer and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea. On an unknown date, the outcome of the nausea was unknown. It was unknown if the reporter considered the nausea to be related to Shingrix. Additional details were reported as follows: This case was reported by patient him/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received 1st dose of Shingrix and became nauseous. The patient wanted to know was there any advice to minimize this side effect.

Other Meds:

Current Illness:

ID: 1038022
Sex: M
Age:
State:

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Date: 202101; Test Name: COVID 19 TEST; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 202101; Test Name: flu test; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:)

Allergies:

Symptoms: flu like symptoms; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 11th January 2021, the patient received the 1st dose of Shingrix. On 11th January 2021, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was not recovered/not resolved. The reporter considered the influenza-like symptoms to be possibly related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient started developing flu-like symptoms after the shot and thought it prudent to get tested for coronavirus, flu and anything else they were offering that day no matter how trivial. The patient tested for the flu and COVID-19, and both results came back negative. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1038023
Sex: F
Age:
State: PA

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

Lab Data:

Allergies:

Symptoms: allergic reaction; site where they injected me caused pain; my body had some aches; This case was reported by a consumer via other manufacturer and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergic reaction, injection site pain and general body pain. On an unknown date, the outcome of the allergic reaction, injection site pain and general body pain were unknown. It was unknown if the reporter considered the allergic reaction, injection site pain and general body pain to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received Shingle vaccination and the site where they injected her caused pain and her body had some aches, it was an allergic reaction to the vaccine. The reporter did not consent to follow-up to her and her prescribing healthcare professional.

Other Meds:

Current Illness:

ID: 1038024
Sex: M
Age: 79
State: PA

Vax Date: 01/06/2021
Onset Date: 01/01/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: rash over the chest, thighs, arms, and knee area; hives over the chest, thighs, arms, and knee area; being unable to sleep for the past 3 or 4 days due to the rash and hives; rash at the injection site; bruising at the injection site; This case was reported by a consumer and described the occurrence of injection site rash in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 6th January 2021, the patient received the 2nd dose of Shingrix. On 13th January 2021, 7 days after receiving Shingrix, the patient experienced rash and hives. In January 2021, the patient experienced injection site rash, injection site bruising and sleeplessness. The patient was treated with cortisone acetate and prednisone. On an unknown date, the outcome of the injection site rash, rash and hives were not recovered/not resolved and the outcome of the injection site bruising and sleeplessness were unknown. It was unknown if the reporter considered the injection site rash, injection site bruising, rash, hives and sleeplessness to be related to Shingrix. Additional details were provided as follows: The patient experienced bruising and rash at the injection site within 24 hours of vaccination The patient experienced rash and hives over the chest, thighs, arms, and knee area. The patient was unable to sleep for the past 3 or 4 days before the date of reporting due to the rash and hives. Cortisone and prednisone prescribed to treat the rash and hives was unsuccessful. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1038025
Sex: F
Age:
State: VA

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

Lab Data:

Allergies:

Symptoms: muscle aches; fatigue; did not feel well; This case was reported by a consumer and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain, fatigue and feeling unwell. On an unknown date, the outcome of the muscle pain, fatigue and feeling unwell were recovered/resolved. It was unknown if the reporter considered the muscle pain, fatigue and feeling unwell to be related to Shingrix. Additional details were provided as follows: The reporter was patient's brother. It was reported that the patient did not feel well after the vaccine, for either 3 or 5 days. The patient experienced fatigue and muscle aches, but there might have been other symptoms as well. The patient was not sure if she would receive the 2nd dose. The reporter spoke with patient about this about 2-3 weeks before the date of reporting. The reporter did not have additional information, but would ask his sister to call to provide more information.

Other Meds:

Current Illness:

ID: 1038026
Sex: M
Age: 57
State: NJ

Vax Date: 09/01/2020
Onset Date:
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Arm was sore at the injection site; This case was reported by a consumer and described the occurrence of injection site pain in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Flu vaccine with an associated reaction of injection site pain (received flu vaccine on an unknown date, refer case US2021AMR013295). In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be related to Shingrix. Additional details were provided as follows: The reporter was the patient The age at vaccination was not reported. The reporter did not have the lot/expiration date but did provide contact information for his pharmacy. The patient received Shingrix shot 1 in September 2020. The patient stated that his arm was sore at the injection site. For tolerance of 2nd dose refer case US2021AMR013283. This case is linked to the US2021AMR013295 same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR013283:Same reporter. US-GLAXOSMITHKLINE-US2021AMR013295:Same reporter.

Other Meds:

Current Illness:

ID: 1038027
Sex: F
Age: 56
State: TX

Vax Date: 10/13/2020
Onset Date: 10/13/2020
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: malaise; knot forming near the elbow, below the injection site; Limited ability to place her arm above her head / decreased mobility; swelling at injection site; arm is still painful; pain at injection site; Fatigue; This case was reported by a consumer and described the occurrence of injected limb mobility decreased in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number MT7C9, expiry date 15th April 2022) for prophylaxis. On 13th October 2020, the patient received the 1st dose of Shingrix. On 13th October 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling, pain in arm, injection site pain and fatigue. On 14th October 2020, the patient experienced injected limb mobility decreased, malaise and mass. On an unknown date, the outcome of the injected limb mobility decreased, mass and pain in arm were not recovered/not resolved and the outcome of the injection site swelling, malaise, injection site pain and fatigue were recovered/resolved. It was unknown if the reporter considered the injected limb mobility decreased, injection site swelling, malaise, mass, pain in arm, injection site pain and fatigue to be related to Shingrix. Additional details were provided as follows: The patient received 1st dose of Shingrix and the patient reported pain at injection site, swelling at injection site, fatigue, and malaise. The patient reported that the next day, she experienced a knot forming near the elbow, below the injection site. The patient reported that the arm was still painful and she had limited ability to place her arm above her head without the pain increasing. The soreness and the decreased mobility of the injected arm was still present, but all other events had resolved. The reporter did not consent to follow-up.

Other Meds:

Current Illness:

ID: 1038028
Sex: F
Age:
State: WA

Vax Date: 09/01/2020
Onset Date:
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Sore arm; This case was reported by a physician and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 1st September 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. The reporter considered the pain in arm to be related to Shingrix. Additional details were provided as follows: The case was reported via web form. The age at vaccination was not reported. The patient had sore arm that the patient related back to her second Shingrix vaccination which was given in Sept 2020. The patient denied any nodule or visible abnormality. The reporter did not agree nor denied follow-up.

Other Meds:

Current Illness:

ID: 1038029
Sex: F
Age: 55
State: IN

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: FAINTED; vision impairment (blackout); DIZZINESS; spinning; NAUSEA; VOMITED; over heating; chills; FATIGUE; CHILLS; over heating; A spontaneous report was received from a consumer concerning a female 55 years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fainted, vision impairment (blackout), spinning, chills, fever, fatigue, nausea, dizziness, and vomited. 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 (Lot # 026L20A), intramuscularly (IM) (site not provided), on 05 Jan 2021. On 02-Feb-2021, the patient received their second of two planned doses of mRNA-1273 (lot #013M20A), IM (site not provided) for prophylaxis of COVID-19 infection. On 05 Jan 2021, the patient received their first Moderna vaccine. On 06 Jan 2021, patient experienced chills and overheating. On 02 Feb 2021 the patient received second dose of Moderna vaccine and experienced chills and fatigue on same day. On 03 Feb 2021, the patient experienced overheating, nausea and vomited, dizziness, spinning, vision impairment (blackout), and fainted. Treatment was not administered. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. Action taken with second dose of mRNA-1273 in response to the event was not provided The outcome of all events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested. Chills, Pyrexia, nausea, vomiting and fatigue are listed events.

Other Meds:

Current Illness:

ID: 1038030
Sex: F
Age: 47
State: CA

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/18/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Appendicitis; Angioedema of the face; congestion; Joint pain; Nausea; Fatigue; fever; cardiac abnormalities; "blacked out"; Ulcers in/around the mouth; "zaps" all over her body and to her brain; overall body pain; Headaches; Chills; A spontaneous report was received from a healthcare professional concerning a 47-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced appendicitis, angioedema of the face, ulcer in/around the mouth, joint pain, zaps all over her body and to her brain, headaches, chills, nausea, fatigue, "blacked out" loss of consciousness, congestion, overall body pain, cardiac abnormalities. The patient's medical history included Covid-19. No relevant concomitant medications were reported. In March of 2020, the patient was first diagnosed with COVID-19. The patient reported she has since been considered a "long hauler" and has experienced various symptoms of the disease since that time. On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 ([LOT# 011J20A]) intramuscularly for prophylaxis of COVID-19 infection. After receiving the first dose of the vaccine the patient initially experienced joint pain and "zaps" all over her body and to her brain, headaches, chills and overall body pain. On an unspecified date, after visiting her doctor, the patient was diagnosed with angioedema of the face. Treatment medication included 2 different unspecified antihistamines. Once that condition was remedied (date unspecified), the patient still experienced fatigue, nausea and congestion. On 28 Jan 2021 the patient experienced swelling of the mouth and ulcers in and around the mouth. On 29 Jan 2021, the patient experienced severe stomach pain and cramping as well as a fever that worsened through the night. Treatment included oxycodone hydrochloride. On the morning of 29 Jan 2021, the patient was still experiencing abdominal pain and began vomiting. The pain was so much that the patient "blacked out" and was transported to the Emergency Room (ER). At the ER the patient experienced unspecified cardiac abnormalities. While in the ER, the patient was diagnosed with appendicitis and subsequently underwent an appendectomy. On 30 Jan 2021, the patient was discharged from the ER and was still experienced nausea, fatigue and fever. Action taken with mRNA-1273 in response to the events was not reported. The event of appendicitis was considered recovered/resolved on 30 Jan 2021, the event of angioedema and "blacked out" were considered recovered/resolved (dates not reported). The events of nausea, fatigue, and fever were considered not recovered/not resolved. The event outcome for ulcers in/around the mouth, joint pain, "zaps" all over her body and to her brain, headaches, chills, congestion, overall body pain, and cardiac abnormalities was considered unknown.; Reporter's Comments: This case concerns a 47-year-old, female subject, with medical history of COVID-19 (Mar-2020), who experienced serious events of angioedema, LOC, and appendicitis. 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. Based on the mechanism of action of mRNA-1273, the event of appendicitis is considered not related to the vaccine. Further information has been requested.

Other Meds:

Current Illness: COVID-19

ID: 1038031
Sex: F
Age: 17
State: NJ

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

Lab Data:

Allergies:

Symptoms: Administered Covid-19 vaccine to a 17 year old; A spontaneous report was received from a healthcare professional concerning a 17-year-old, female, who received Moderna's COVID-19 vaccine (mRNA-1273) at inappropriate age. The patient's medical history was not provided. No relevant concomitant medications were reported. On 02 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 026L20A) intramuscularly for prophylaxis of COVID-19 infection at the age of 17-year-old. Action taken with mRNA-1273 in response to the events was resolved. The outcome of the event was considered resolved.; Reporter's Comments: This report refers to a case of 17-year-old, female administered mRNA-1273 (lot # 026L20A) at inappropriate age (inappropriate age at vaccine administration). There were no associated adverse events with the event of inappropriate age at vaccine administration

Other Meds:

Current Illness:

ID: 1038032
Sex: M
Age: 77
State: CT

Vax Date: 01/22/2021
Onset Date: 01/24/2021
Rec V Date: 02/18/2021
Hospital: Y

Lab Data: Test Date: 20210124; Test Name: oxygen levels; Test Result: Inconclusive 60 %; Result Unstructured Data: Inconclusive; Test Date: 20210124; Test Name: PCR covid-19 tests; Test Result: Negative ; Result Unstructured Data: During hospitalization; Test Date: 2021; Test Name: PCR covid-19 tests; Test Result: Negative ; Result Unstructured Data: During hospitalization

Allergies:

Symptoms: Pneumonia; A spontaneous report was received from a physician concerning a 78 years-old, male patient, who received Moderna's COVID-19 Vaccine and who experienced pneumonia. The patient's medical history included chronic obstructive pulmonary disease (COPD) and pulmonary fibrosis. Products known to have been used by the patient, within two weeks prior to the event, included umeclidinium bromide/ vilanterol trifenatate, irbesartan, amlodipine besilate, metoprolol, glipizide, metformin, omeprazole, magnesium, and omega 3. The patient received their first of two planned doses of mRNA-1273 intramuscularly on 22 Jan 2021 for the prophylaxis of COVID-19 infection. On 22 Jan 2021 within a few hours of first dose, the patient developed fever, chills, weakness, and productive cough. On 24 Jan 2021, the patient was admitted to hospital due to oxygen levels in the 60s with productive cough, yellow sputum, and short of breath. He was diagnosed with pneumonia. During hospitalization, the patient had two negative PCR COVID-19 tests. Treatment information was not provided. The second dose of mRNA-1273 was discontinued in response to the events. The outcome of event pneumonia was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. Patient's medical history of COPD and pulmonary fibrosis may have been contributory.

Other Meds: ANORO; AVAPRO; NORVASC; METOPROLOL; GLUCOTROL; METFORMIN; PRILOSEC [OMEPRAZOLE]; MAGNESIUM; OMEGA-3 NOS

Current Illness: COPD (No medical history reported.); Pulmonary fibrosis

ID: 1038033
Sex: M
Age: 70
State: GA

Vax Date: 01/28/2021
Onset Date: 01/29/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: he has eaten almost nothing; Hot to the touch (Maybe had a fever); started shaking again; has neuropathy and felt extreme pain in his feet; A little bit of delirium; Shaking violently from chills and felt very, very cold/ Could not stop the shakes; has neuropathy and felt extreme pain in his feet; Nausea; A Spontaneous report was received from a consumer concerning her husband, a 70-year-old male who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced extreme pain in his feet (increased neuropathy), a little bit of delirium, nausea, shaking violently from chills and felt very, very cold/ could not stop the shakes, hot to the touch (maybe had a fever), started shaking again, and he has eaten almost nothing. The patient's medical history included neuropathy. Concomitant medications included fish oil, blood thinner, blood pressure medication, atorvastatin, Lyrica and baby aspirin. On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 29 Jan 2021, the patient started to experience side effects: nausea, shaking from chills, felt very cold and couldn't not stop the shakes. The patient has neuropathy and felt extreme pain in his feet which continued until 01 Feb 2021, when it got somewhat better. On 02 Feb 2021, the patient was good at first but then started shaking again. During the night, the patient shook violently from chills again and he was hot to the touch (maybe he had a fever but we didn't have a thermometer). The patient also had increased neuropathy and nausea and had eaten almost nothing. He also experienced a little bit of delirium. The patient's wife gave him acetaminophen that seemed to bring down the chills. Action taken with mRNA-1273 in response to the events was not reported. The events of has neuropathy and felt extreme pain in his feet, shaking violently from chills and felt very, very cold/couldn't not stop the shakes, and started shaking again were recovering/resolving on 01 Feb 2021. The outcome of the events of a little bit of delirium, nausea, hot to touch (maybe had a fever), has neuropathy and felt extreme pain in his feet, increased neuropathy and he has eaten almost nothing was considered unknown.; Reporter's Comments: This report concerns a 70-year-old male who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced non-serious events of extreme pain in his feet (increased neuropathy), delirium, nausea, shaking violently from chills and felt very, very cold/ could not stop the shakes, fever, and he has eaten almost nothing. 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: ATORVASTATIN; LYRICA; BABY ASPIRIN; FISH OIL

Current Illness: Neuropathy

ID: 1038034
Sex: F
Age: 31
State: CT

Vax Date: 01/10/2021
Onset Date: 01/10/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Date: 20210202; Test Name: ultrasound; Result Unstructured Data: No heartbeat at 15 weeks and 5 days

Allergies:

Symptoms: Pregnancy loss; Vaginal bleeding; Vaccine exposure during pregnancy; A spontaneous report was received from a nurse practitioner who was 31-year-old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine exposure during pregnancy, pregnancy loss (abortion spontaneous), and vaginal bleeding (vaginal hemorrhage). The patient's medical history was not provided. Concomitant medications reported as taken since conception included magnesium, prenatal vitamins, vitamin B and vitamin C. On 10 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011LZ0A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 10 Jan 2021, the pregnant patient was exposed to the mRNA-1273 vaccine. On 02 Feb 2021, the patient developed vaginal bleeding, so she went to her obstetrician and had an ultrasound exam. The patient reported that there was no heartbeat at fifteen weeks and five days. No treatment information was provided. The patient's prior positive pregnancy test, last menstrual period, conception and due dates were not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, pregnancy loss and vaccine exposure during pregnancy, was considered resolved. The outcome of the event, vaginal bleeding, was unknown.; Reporter's Comments: This case concerns a 31 year old, female subject, who experienced a spontaneous abortion and drug exposure before pregnancy. Very limited information has been provided at this time. Further information has been requested

Other Meds: MAGNESIUM; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS ; VITAMIN B [VITAMIN B NOS]; VITAMIN C [ASCORBIC ACID]

Current Illness:

ID: 1038035
Sex: M
Age: 73
State: FL

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

Lab Data: Test Date: 20210201; Test Name: ekg; Result Unstructured Data: normal

Allergies:

Symptoms: blacked out, passed out; could not move any part of the body; hard time breathing; sweating; A spontaneous report was received regarding a 73-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sweating, blacking out, passing out, inability to move any part of his body. The patient's medical history was not provided. Concomitant medications were not provided. On 01 Feb 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection. The injection took place in his car in a drive-in vaccination location. On 01 Feb 2021, approximately four minutes after the mRNA-1273 vaccine was given, the patient experienced sweating, blacking out, passing out, inability to move any part of his body. The patient reports that when he woke up he was out of his car on the grass and the emergency crew was working on him. They had given him a shot of an Epi-Pen. He had a hard time breathing and could not move any part of his body. He was placed in a wheelchair and taken into the emergency room. There, an EKG was done which had normal results. He was released from the emergency room approximately two hours later. Action taken with mRNA-1273 was not reported. The outcome of the events, sweating, blacking out, passing out, inability to move any part of his body, was considered resolved on 01 Feb 2021.; Reporter's Comments: Based on the current available information which indicates a strong temporal association between the use of the product and the onset of the reported events a causal relationship cannot be excluded

Other Meds:

Current Illness:

ID: 1038036
Sex: M
Age:
State: PA

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

Lab Data:

Allergies:

Symptoms: Patient with lyme disease received the second shot of the vaccine and ended at hospital; A spontaneous report was received from a consumer, concerning a male patient of unspecified age and, who received Moderna's COVID-19 vaccine (mRNA-1273) and where patient with lyme disease received the second shot of the vaccine and ended at hospital. The patient's medical history included lyme disease. Concomitant medications use was not provided On an unknown date, the patient received their second of two planned doses of mRNA-1273 (lot number: unknown) for prophylaxis of COVID-19 infection. The reporter stated that her physician advised her not to have the second shot of vaccine as on an unspecified date, other patient with lyme disease had ended up at hospital after the second shot of vaccine, Treatment of this event was not provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of event, patient with lyme disease received the second shot of the vaccine and ended at hospital was considered unknown at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time as the reason for hospitalization is lacking. Further information has been requested

Other Meds:

Current Illness: Lyme disease

ID: 1038037
Sex: F
Age: 76
State: AZ

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/18/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Symptoms of a bowel obstruction; Chest burning; Vomiting sensation; A spontaneous report was received from a consumer, concerning herself, a 76-years-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced symptoms of a bowel obstruction, burning sensation in chest and vomiting sensation. The patient's medical history was not provided. Concomitant medications reported included telmisartan, nebivolol hydrochloride, ezetimibe, valaciclovir, buspirone and alprazolam. On 21 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 [lot number 011L20A] intramuscularly for prophylaxis of COVID-19 infection. On 21 Jan 2021, following the administration of vaccine, the patient experienced a burning sensation in the chest, vomiting sensation and symptoms of a bowel obstruction. These side effects were worsened until the patient was admitted for bowel obstruction relief. Additionally, event symptoms of a bowel obstruction was considered life threatening. Treatment for the event included bowel obstruction removal. No side effects were existing at the time of this report. The second dose of mRNA-1273 was delayed in response to the events. The outcome of the events symptoms of a bowel obstruction, burning sensation in chest and vomiting sensation were considered resolved on an unspecified date in 2021.; 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: TELMISARTAN; BYSTOLIC; ZETIA; VALACICLOVIR; BUSPIRONE; ALPRAZOLAM

Current Illness:

ID: 1038038
Sex: U
Age:
State:

Vax Date: 10/01/2019
Onset Date: 01/01/2020
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: experienced lyme/co-infections; immune system collapsed; experienced lyme/co-infections; Initial information received on 30-Jan-2021 regarding an unsolicited valid serious case received from an other health professional. This case involves adult patient who experienced lyme/co-infections (Lyme disease and coinfection), and immune system collapsed (immune system disorder), while patient received DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [TDAP ]and while treated with PANCREATIN [CREON]. It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical history, medical treatment, vaccination and family history were not provided. On an unknown date, the patient started taking therapy of CREON (PANCREATIN) at dose and route unknown (with an unknown batch number) for unknown indication. On an unknown date in October 2019, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious experienced lyme/co-infections (lyme disease) unknown latency following the first dose intake and following the last dose intake of PANCREATIN and unknown latency following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. This event was assessed as medically significant. On an unknown date, the patient developed a non-serious immune system collapsed (immune system disorder) unknown latency following the first dose intake and following the last dose intake of PANCREATIN and unknown latency following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. On an unknown date in-Jan-2020, the patient developed a non-serious immune system collapsed (immune system disorder) and experienced lyme/co-infections (coinfection) unknown latency following the first dose intake and following the last dose intake of PANCREATIN and unknown latency following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. There were no lab data/results available. Action taken of PANCREATIN (CREON) was unknown with respect to all the events. It was not reported if the patient received any corrective treatment. At the time of reporting, the event outcome reported as unknown for events.; Sender's Comments: This case involves adult patient who presented with Lyme disease, coinfection and immune system disorder after vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [TDAP] from unknown manufacturer and while being treated with PANCREATIN. The time to onset is unknown. There is, however, no information regarding patient's condition at time of vaccination, past history and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of an individual suspect cannot be assessed.

Other Meds: CREON

Current Illness:

ID: 1038039
Sex: F
Age: 71
State: FL

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies: Niasin, B12

Symptoms: light headed Pt. in tent is felt lightheaded at 4:40pm after vaccine at observation site paramedics assessed pt. took vitals which were stable. Monitored until symptoms subsided. At 5:15pm pt. was released to go home.

Other Meds: Insulin

Current Illness:

ID: 1038040
Sex: F
Age: 66
State: CA

Vax Date: 02/06/2021
Onset Date: 02/07/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: None

Allergies: No ne

Symptoms: Nothing major, just Constant Itchy Palms in both hands Have taken Benadryl twice and that stops for a day or do Then it starts up again . My question is will it eventually stop? Or will it get worse after my second dose?

Other Meds: Hizentra infusion bi weekly for PI Advair for Emphysema Losartin 100 mg for Hypertension Vitamin D 5000 iu Multi vitamin

Current Illness: None

ID: 1038041
Sex: M
Age: 28
State:

Vax Date: 08/07/2008
Onset Date: 08/07/2008
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fever 102 F, severe body aches, extreme joint pain, sharp muscle/tissue pain, heavy fatigue, severe headache Outcome: constant joint pain throughout body and extreme fatigue and insomnia

Other Meds: none

Current Illness:

Date Died:

ID: 1038042
Sex: F
Age: 53
State: OH

Vax Date: 02/05/2021
Onset Date: 02/06/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: None.

Allergies:

Symptoms: Patient expired 02/06/2021. COD as ruled by Coroner "Hypertensive and Atherosclerotic Cardiovascular Disease."

Other Meds:

Current Illness:

ID: 1038043
Sex: F
Age: 89
State: FL

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

Lab Data: n/a

Allergies: NSaids

Symptoms: Client c/o numbness and tingling of lips 25 minutes after receiving Pfizer vaccine. Client seen and assessed by EMjS. V.S. are B/P 143/79, HR 79, O2 96. Client voiced that sensation had stopped after 5 minutes and was cleared to go home by EMS.

Other Meds: Sungulair, Losartan

Current Illness: no

ID: 1038044
Sex: F
Age: 35
State:

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

Lab Data:

Allergies: Penicillin and Sulfa drugs

Symptoms: Approx 6 hours post injection, a large, red, painful, hard, golf-ball sized swollen lump formed under the injection site apprx 3 inches in diameter. 12 hours post injection, the hard, red, painful blotch has increased to nearly 6 inches in diameter and is hot to the touch. Seems to be spreading down the arm. Pain radiates from the muscle in the arm at the injection site into the neck. Decreased strength in arm.

Other Meds: N/A

Current Illness: N/A

ID: 1038045
Sex: F
Age: 52
State: OH

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: required followup with primary care physician, no testing at this time, being monitored for the next month to determine if additional intervention will be needed.

Allergies: Feldene

Symptoms: Chills with shivering for 5 hours, mild body aches, extreme fatigue for 48 hours, swollen and sore lymph nodes in both axilla that resolved in 24 hours, headache that resolved in 96 hours, swollen and painful lymph node (size of a marble) above left clavicle that remains, required followup with primary care physician and is being monitored for the next month to determine if additional intervention will be needed.

Other Meds: Vitamin D, Multivitamin-Centrum

Current Illness: None

ID: 1038046
Sex: F
Age: 74
State: NY

Vax Date: 02/02/2021
Onset Date: 02/03/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: none I did notiify my urologist/surgeon

Allergies:

Symptoms: extremely bad cramp in inner right thigh at 6am the next morning

Other Meds:

Current Illness:

ID: 1038047
Sex: F
Age: 35
State: RI

Vax Date: 02/16/2021
Onset Date: 02/17/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies: NKDA

Symptoms: Moderna COVID?19 Vaccine EUA After 6 hours of the 2nd dose, the body aches started. 24 hours after vaccine, still joints, fatigue, and muscle soreness. My body left I was in a car accident. Overall aches. 30 hours after, bilateral swelling of under eyes. 36 hours after, under eye swelling spread to right upper and lower lip. 1 benadryl pill was taken

Other Meds: Adderall, Celexa

Current Illness: none

ID: 1038048
Sex: F
Age: 42
State: IN

Vax Date: 02/16/2021
Onset Date: 02/17/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies: xanax

Symptoms: Started feeling unwell and developed chills as afternoon progressed. Had fever 101, a 10/10 headache, my resting HR was anywhere from 122-140 bpm. Took 4 advil and went to bed. 12 hours later woke up and feel completely normal again

Other Meds: gabapentin

Current Illness: none

ID: 1038049
Sex: F
Age: 67
State: PA

Vax Date: 01/30/2021
Onset Date: 02/07/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: None

Allergies: Penicillin, Bactrim, Elavil

Symptoms: Left arm injection site became quite itchy and red which subsided on its own within 2-3 days. This happened about a week after the vaccine.

Other Meds: Irbesartan, clonidine, gabapentin, pantaprozole Lipitor, paroxetine Calcium, vit d, zinc

Current Illness: None

ID: 1038050
Sex: F
Age: 29
State: NY

Vax Date: 02/09/2021
Onset Date: 02/10/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Fever, chills, body aches, headache for 48 hours

Other Meds:

Current Illness:

ID: 1038051
Sex: F
Age: 25
State: VA

Vax Date: 02/16/2021
Onset Date: 02/18/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: Red, raised rash on R arm in the region of the injection site. Painful to touch but not itchy.

Other Meds: Bupropion 100mg; daily multivitamin; iron supplement 65mg; cetirizine 10mg; Mirena IUD

Current Illness: None

ID: 1038052
Sex: F
Age: 35
State: CT

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies: PCN

Symptoms: The vaccine leaked out between the connection of the needle and the syringe. That connection was found to be loose despite attempting to tighten it. Several other syringes within that same lot number had the same issues. Approximately 1/3 to 1/2 leaked out. Moderna was called and advised that at this time, the vaccine recipient should not be revaccinated.

Other Meds: Insulin pump. isosorbide, omeprazole, hydtoxizine, metoprolol,

Current Illness: T1DM, CAD s/p MI x2, Hyperlipidemia, Depression, Anxiety,

ID: 1038053
Sex: F
Age: 18
State: MN

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Experienced body aches, chills, fever nearly 12 hours after receiving the vaccine. Symptoms carried on for 36 hours but were resolved/reduced with ibuprofen.

Other Meds:

Current Illness:

ID: 1038054
Sex: F
Age: 84
State: MI

Vax Date: 02/13/2021
Onset Date: 02/14/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies: aldendronic acid, hydralazine, meperidine, fosamax, hydrocodone, ibuprofen, clopidogrel, propoxyphene

Symptoms: Found down - day after vaccination. Fall, potentially acute encephalopathy / confusion, hypertension (potential for non-compliance with antihypertensive medications?) - patient with known severe to advanced dementia / mild cognitive impairment. Likely related to hypertensive encephalopathy with post-COVID vaccine prodrome with underlying advanced dementia. Situation: hospitalization after a fall and hypertension emergency Background: Pt is an 84 y/o female pt with a log history of dementia, has been able to live alone safely until most recent illness/hospitalization. Assessment: Pt received her 2nd COVID vaccine on Saturday. On Sunday, pt's sister was unable to get a hold of her as her sister calls her daily due to her dementia. After several phone calls, her sister went to pt's home and found pt on her bedroom floor. There was some blood found, not sure from where. Sisiter was unable to get pt up so EMS was called and pt was taken to ED. She was evaluated, her BP was very elevated, she was admitted and testing was done. Head CT/MRI was unchanged. X-ray of her R shoulder shows a vertical non-displaced fracture of the greater tuberosity of the proximal humerous, no surgical intervention is recommended at this time, pt instructed to wear a sling for now. Pt is discharged home with Home Care and family support.

Other Meds: acetaminophen / aspirin PRN; atorvastatin; calcium carbonate; cyanocobalamin; folic acid; isosorbide mononitrate CR; memantine ER; metoprolol XL; revastigmine patch

Current Illness: NA

ID: 1038055
Sex: F
Age: 58
State: NH

Vax Date: 02/16/2021
Onset Date: 02/17/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: none

Allergies: penicillin, sulfa, codein

Symptoms: tenderness at injection site, chills, headache, low fever (99.3), tired. Lasted less than24 hours. Took 2 acetaminophen.

Other Meds: atorvstatin 20mg, calcium 1000mg, Vitamin D-3 2000IU , singulair allegra

Current Illness: none

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm