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: 1012082
Sex: M
Age: 91
State:

Vax Date: 12/22/2020
Onset Date: 12/27/2020
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Narrative: Symptoms: Myalgia & Fever Treatment:

Other Meds:

Current Illness:

ID: 1012256
Sex: F
Age: 64
State: TN

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

Lab Data:

Allergies: PCN years ago per patient.

Symptoms: Obtained 1st Moderna Covid Vaccine on 2/4/21, about 9 minutes c/o tingling all over and not feeling good. 2:24pm-Alert, HR 179, BP 170/78, O2 sat 97%. 2:25 p.m. - Benadryl 50mg Im given R deltoid. HR 94, 2:28pm-HR 98, O2 sat 94%. 2:29pm-HR 88. 2:31pm-HR 88, O2 sat 95%. Patient still c/o not feeling well. 2:33pm Epinephrine .5 IM given R deltoid. 911 called 2:34pm-HR 114, O2 sat 92%. 2:37pm-HR 106, O2 sat 98%. 2:38pm-HR 96, O2 sat 94%. 2:39pm-HR 97. 2:40pm-HR 92, O2 sat 98%, BS-clear. 2:41pm-HR 95, O2 sat 98%. 2:43pm-EMS here to transport and took over patient care.

Other Meds: Unknown

Current Illness: Unknown

ID: 1012363
Sex: U
Age:
State: MD

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: ROTATEQ administered after temperature excursion; No adittional AE/PQC identified; This spontaneous report as received from a nurse and refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 20-JAN-2021, the patient was vaccinated with a improperly store vaccine of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 0.5 milliliter, intramuscularly (IM), lot number reported and validated as 1688504, expiration date reported and validated as 19-NOV-2021 for an unknown indication. The vaccine underwent a temperature excursion of 9.6 degree Celsius (?C) for a period of 7 hours. The vaccine did not underwent a previous temperature excursion. The excursion was called by a digital data logger. The patient did not experience any adverse event.

Other Meds:

Current Illness:

ID: 1012364
Sex: M
Age:
State: WI

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

Lab Data:

Allergies:

Symptoms: Transplant; received 2 doses of Twinrix in 2010 / 2 doses of 3; This case was reported by a pharmacist via call center representative and described the occurrence of transplant in a male patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included Twinrix (received 1st dose in 2010). On an unknown date, the patient received the 2nd dose of Twinrix, Twinrix Pre-Filled Syringe Device, the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced transplant and incomplete course of vaccination. On an unknown date, the outcome of the transplant and incomplete course of vaccination were unknown. It was unknown if the reporter considered the transplant to be related to Twinrix and Twinrix Pre-Filled Syringe Device. This report is made without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported for 2nd dose and was not applicable for 3rd dose. The reporter stated that the patient might have received 2 doses of Twinrix in 2010. He was not sure if the patient received Twinrix or other vaccine (in the chart said the patient a Hepatitis combo vaccine and 2 doses of 3, so pharmacist thought that it was Twinrix). Till the time of reporting, the patient did not receive the 3rd dose of the vaccine, which led to incomplete course of vaccination. The patient received a transplant afterwards (reporter was not sure of which type of transplant). The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1012365
Sex: F
Age:
State:

Vax Date: 12/27/2020
Onset Date: 12/27/2020
Rec V Date: 02/08/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Hives; swelling; A spontaneous report was received from a pharmacist concerning a female patient participating who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the serious event of swelling and hives. The patient's medical history, as provided by the reporter, included an "extensive history of allergies" and history of taking diphenhydramine prior to influenza vaccination. No relevant concomitant medications were reported. On 27 Dec 2020, approximately 7 minutes prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 27 Dec 2020, the patient was admitted to the hospital with swelling and hives occurring 7 minutes after the injection. She was admitted to the intensive care unit (ICU) overnight and stayed approximately 24 hours. She did not require intubation. Treatment for the event included an epinephrine drip. On 30 Dec 2020, the hives and swelling returned. The patient planned to go to the hospital, but she was not sure if she would be admitted. Action taken with mRNA-1273 in response to the events was not reported. The events, swelling and hives, were considered not resolved. The reporter did not provide assessment for the events of swelling and hives.; Reporter's Comments: This case concerns a female patient with an extensive history of allergies, who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date -unknown), who experienced unexpected events of urticaria and swelling and hives on the same day, approximately 7 minutes after vaccination. The reporter did not provide the causality assessment for the events. Due to the temporal association between the events (urticaria and swelling) and the administration of the vaccine, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Allergy (Takes diphenhydramine prior to influenza vaccine)

ID: 1012366
Sex: U
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: We inadvertently administered the moderna vaccine past the 6 hours to a few clients of ours today; A spontaneous report was received from a nurse concerning two patients who were administered Moderna's COVID-19 vaccine inadvertently past the six hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On an undisclosed date, prior to the onset of the event, the two patients received their first of the two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. The patients were inadvertently administered the Moderna vaccine past the six hour window; the healthcare providers thought that it was a new vial that had just been opened. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, inadvertently administered the Moderna vaccine past the 6 hours, was resolved.; Reporter's Comments: This report refers to a case of a patients of unknown gender who experienced non-serious event of was administered vaccine inadvertently past the six hours (out of specification product use) for mRNA-1273, (Lot # unknown, expiration date-unknown). There were no reported AEs associated with this case of vaccine inadvertently administered past the six hours.

Other Meds:

Current Illness:

ID: 1012367
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: did not receive the full 2nd dose of the Moderna Covid-19 Vaccine; some vaccine was leaking out from the syringe; A spontaneous report was received from a pharmacist concerning a patient (unknown age, unknown gender) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some vaccine leaking out of the syringe (vaccine underdose/syringe connection issue) and did not receive the full 2nd dose of the Moderna Covid-19 Vaccine. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 29 Jan 2021 the pharmacist called to report that, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Batch number: not provided) for prophylaxis of COVID-19 infection. On 29 Jan 2021 the pharmacist called and stated that a patient may not have received the full second dose of the Moderna COVID-19 vaccine as some vaccine was leaking out from the syringe. Treatment for the event was unknown. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The event of some vaccine leaking out of the syringe (vaccine underdose/syringe connection issue) and did not receive the full 2nd dose of the Moderna Covid-19 Vaccine was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered and syringe issue for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of incorrect dose administered and syringe issue.

Other Meds:

Current Illness:

ID: 1012368
Sex: U
Age:
State: CO

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

Lab Data:

Allergies:

Symptoms: Administered the Moderna COVID-19 vaccine below the deltoid and more anterior towards the front; A spontaneous report was received from a healthcare professional concerning an unknown aged and unknown gender patient who received Moderna's COVID-19 vaccine (mRNA-1273) below the deltoid and more anterior towards the front. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unspecified date, the patient received a dose of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection. The patient was administered the mRNA-1273 below the deltoid and anterior towards the front. No treatment information was provided. Action taken with the mRNA-1273 was not reported. The event, product administered at inappropriate site, was considered resolved on an unspecified date.; Reporter's Comments: This report refers to a case of product administered at inappropriate site for mRNA-1273. There were no reported adverse events associated with this case.

Other Meds:

Current Illness:

ID: 1012369
Sex: F
Age: 79
State: NJ

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Developed rash a inch and a half diameter; Also Itchy; Also Itchy and warm; Injection was given in the tricepes area half way between the shoulder and elbow; A spontaneous report was received from a consumer concerning an 80-year-old, female patient who was administered Moderna's COVID-19 mRNA-1273 vaccine in the triceps area half way between the shoulder and elbow, later she developed a rash a inch and a half diameter, also itchy and warm . The patient's medical history was not provided. No relevant concomitant medications were reported. On 23 Jan 2021, patient received 1st dose of the Moderna vaccine mRNA-1273 (Lot number: 032L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. The patient was administered mRNA-1273 vaccine in right arm slightly lower than where she should receive it, she states it was given in the triceps area half way between the shoulder and elbow. On 31 Jan 2021, approximately 8 days after vaccine administration, patient developed a rash of an inch and a half diameter, which was also itchy and warm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The event, "vaccine in the triceps area half way between the shoulder and elbow" was considered resolved on 23 Jan 2021. The outcome of the events vaccine site rash, itchiness, and warmth was considered as unknown.; Reporter's Comments: This case concerns 80-year-old, female patient experienced non-serious events of Vaccine administered at inappropriate site (Injection was given in the triceps area half way between the shoulder and elbow) for 1st dose of the Moderna vaccine mRNA-1273 (Lot number: 032L20A).Additionally, eight days later patient experienced Vaccination site rash, Vaccination site pruritus and Vaccination site warmth. The events of Vaccine administered at inappropriate site and Vaccination site warmth are unexpected, Vaccination site rash is expected, and Vaccination site pruritus is expected for SmPC and Swiss SmPC. The company causality for reported event of Vaccine administered at inappropriate site is not applicable all other events were assessed as possibly related to Moderna vaccine mRNA-1273.

Other Meds:

Current Illness:

ID: 1012370
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: One of my coworkers gave a Moderna vaccine to someone under the age of 18; A spontaneous report was received from a healthcare professional concerning a 17-year-old patient, who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown) for prophylaxis of COVID-19 infection. On an unknown date, one of the reporter's coworkers gave a Moderna vaccine to someone who was under the age of 18. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, "one of my coworkers gave a Moderna vaccine to someone who is under the age of 18", was considered resolved on an unknown date.; Reporter's Comments: This case concerns a 17 year old patient who received their first of two planned doses of mRNA-1273 (lot number: unknown) for prophylaxis of COVID-19 infection. There were no reported adverse events after the vaccine was administered in the case of product administered to patient of inappropriate age.

Other Meds:

Current Illness:

ID: 1012371
Sex: M
Age:
State: VA

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

Lab Data:

Allergies:

Symptoms: 16 year old received vaccine; A spontaneous report was received from a Pharmacist concerning a 16-year-old, male patient with unknown race who was administered Moderna's COVID-19 mRNA-1273 vaccine. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, patient received a dose of the Moderna vaccine mRNA-1273 (Lot number: unknown) by injection for prophylaxis of COVID-19 infection. On unknown date, a minor patient received the mRNA-1273 vaccine at mass vaccination site. Action taken with mRNA-1273 in response to the event was not reported. The event, "16 year old received vaccine" was considered as resolved on an unknown date.; Reporter's Comments: This case concerns a 16-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot: unknown), reporting Product administered to patient of inappropriate age.

Other Meds:

Current Illness:

ID: 1012372
Sex: F
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: not properly injected, they've missed the deltoid; A spontaneous report was received from a physician concerning a 71-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) which was not injected properly and missed the deltoid. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for the prophylaxis of COVID-19 infection. The physician reported that a patient was not injected properly with the Moderna COVID-19 vaccine, and missed her muscle and the vaccine was injected nowhere near the deltoid. Treatment for the event was not provided. Action taken with mRNA-1273 in response to the events was not reported. The event, vaccine was not injected properly and missed the deltoid was considered resolved on an unknown date.; Reporter's Comments: This case concerns a 71-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: unknown), reporting Incorrect route of product administration.

Other Meds:

Current Illness:

ID: 1012373
Sex: F
Age:
State:

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Needle broke; Did not receive the full dose; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced did not receive full dose and needle broke. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. During vaccine administration, the needle broke, and the patient did not get the full dose. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The events, did not receive full dose and needle broke, were considered resolved on 22 Jan 2021.; Reporter's Comments: A spontaneous report from a consumer concerning a female patient who experienced non-serious events of did not receive full dose (Incomplete dose administered) and needle broke for administration of mRNA-1273 (Lot number: unknown expiration date-unknown). There were no reported AEs associated with this case of did not receive full dose and needle broke.

Other Meds:

Current Illness:

ID: 1012375
Sex: M
Age:
State: FL

Vax Date: 01/14/2021
Onset Date: 01/18/2021
Rec V Date: 02/08/2021
Hospital: Y

Lab Data: Test Date: 20210120; Test Name: Blood test; Test Result: Negative ; Test Date: 20210118; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: muscle weakness of both legs; exacerbation of the baseline numbness of many areas of my body; This is a spontaneous report from a contactable consumer (patient himself). A 62-year-old male 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, left arm, on 14Jan2021 11:00 at a single dose for covid-19 immunization. Medical history included multiple sclerosis. Concomitant medication included gabapentin, tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), oxybutynin and vitamin b12 [vitamin b12 nos] (VITAMIN B12 [VITAMIN B12 NOS]). The patient previously took diphenhydramine hydrochloride (BENADRYL) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 18Jan2021 at 11:00, the patient had muscle weakness of both legs to the extent that he could not stand. He had an exacerbation of the baseline numbness of many areas of his body. The event resulted in emergency room/department or urgent care visit and the patient was hospitalized for 2 days. The patient received intravenous antibiotics as treatment. The event was considered serious by the patient, requiring hospitalization. The patient's COVID test post vaccination via nasal swab on 18Jan2021 was negative then via blood test on 20Jan2021 was negative. The patient recovered from the events on an unspecified date. Information on the lot/batch number has been requested.

Other Meds: GABAPENTIN; FLOMAX [TAMSULOSIN HYDROCHLORIDE]; OXYBUTYNIN; VITAMIN B12 [VITAMIN B12 NOS]

Current Illness:

ID: 1012376
Sex: F
Age:
State: MO

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: her arm was red, swollen, and growing; her arm was red, swollen, and growing; She had numbness in parts of the ear and is now able to feel parts of the ear, but she is not sure if the numbness will go away; Caller mentioned that she can feel her ear "closing up" and by Saturday-Sunday had lost hearing on the right ear; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A 68-year-old female patient received her 1st bnt162b2 (Pfizer-Biontech Covid-19 Vaccine; Batch/lot number: EK9231) single dose on 22Jan2021 10:45 AM at right arm for COVID-19 immunization. Medical history included COVID on 05Nov2020 but was mild only and she was not hospitalized; No medications aside from over-the-counter drugs. The patient was given a Z-pack and vitamin C and immune stuff like Zinc. Concomitant drugs included high blood pressure medication. Around 6:00 PM on 22Jan2021, the patient can feel her ear "closing up" and by Saturday-Sunday had lost hearing on the right ear - the same side of her arm she received the vaccine. The patient stated it was better on 25Jan2021 but still not 100 percent. The patient tried calling the emergency room and has read up and no one can give her any answers. She made an appointment this morning with her doctor to see what was going on, states not being able to hear messes with her equilibrium. The patient was supposed to have another dose on 12Feb2021 and wanted to know if she should. The patient currently still had partial hearing loss and was prescribed a Prednisone that she took for 5 days. Her arm did not hurt Friday through Sunday, however, on Monday, her arm was red, swollen, and growing. She was able to get partial hearing back after taking Prednisone. She had numbness in parts of the ear and was now able to feel parts of the ear, but she was not sure if the numbness will go away. The outcome of hearing loss was resolving, of other events was unknown.

Other Meds:

Current Illness:

ID: 1012377
Sex: F
Age:
State: TX

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Delirium; headache; body chills; nausea; strong pressure felt in head and neck; strong pressure felt in head and neck; blurred vision; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL9261, expiry date not reported) via an unspecified route of administration at left arm, on 22Jan2021 10:45, single dose, for COVID-19 immunization. Medical history included neoplasm malignant and hypersensitivity. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccine in the last four weeks. It was unknown if the patient has COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medication included alprazolam (XANAX) and doxycycline hyclate. On 22Jan2021 14:00, the patient experienced delirium, headache, body chills, nausea, strong pressure felt in head and neck, and blurred vision. Outcome of the events was not recovered.

Other Meds: XANAX; DOXYCYCLINE HYCLATE

Current Illness:

ID: 1012378
Sex: F
Age:
State: IN

Vax Date: 01/21/2021
Onset Date: 01/01/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data: Test Name: Height; Result Unstructured Data: Test Result:she is shrinking monthly; Test Date: 20210121; Test Name: Heartbeat; Result Unstructured Data: Test Result:would accelerate for a few seconds

Allergies:

Symptoms: Dizzy; Headache; Joint pain; Fever; Injection site swelling; heartbeat would accelerate for a few seconds; Chills; off balance; throwing up; she could not drive and was half delirious; I am not feeling good; sneezing; has no energy; her bowel movement was little dab and then again another little dab; if she does not blow her nose, it feels like something is going down the back of her throat; She still has a punchy feeling; she does not have her peripheral vision right; Her arm felt like a boil where they gave her the shot.; Her arm is still is sore; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL8982, Expiry Date of Pfizer covid vaccine: May2021), intramuscular injection in left shoulder on 21Jan2021 13:00 at single dose as preventative, since she did not want to get COVID again/there was a new strain of COVID that was easier to catch. Medical history included ongoing high blood pressure diagnosed about 5 to 7 years ago, ongoing high cholesterol diagnosed about 5 to 7 years ago, thyroid disorder, Supplementation, for bones, COVID-19 from Nov2020 to Dec2020: She had COVID in Nov2020 till the end of Dec2020, and she was getting better. Concomitant medication included ongoing metoprolol tartrate for high blood pressure, ongoing simvastatin for cholesterol, ongoing levothyroxine for thyroid, ongoing colecalciferol (VITAMIN D) as Supplementation, for bones. The patient experienced chills, off balance, dizzy, headache, joint pain, fever, injection site swelling, heartbeat would accelerate for a few seconds on 21Jan2021, throwing up in Jan2021. The patient spent that whole night getting up and down and going to bathroom for bowel movement, and her bowel movement was little dab and then again another little dab. She was throwing up by 3am or 4am that night, she threw up twice and reports it was like bubbles. Her side effects started Thursday night. She experienced chills, joint pain, fever, injection site swelling, her heartbeat every so often would accelerate for a few seconds. She dizzy and off balance when she would get up to go the bathroom. Since then she still had sneezing and she was blowing her nose, and if she did not blow her nose, it felt like something was going down the back of her throat. She wanted to ask how long she would experience the side effects and how many people had a problem with the first dose. She still had a punchy feeling, had no energy. She could lay down and fall asleep at almost anytime. Height: about 5'2'', she jokingly stated she was shrinking monthly. Her chills started Thursday night and by Saturday morning they were completely gone. When she tried to turn a corner and reported she did not have her peripheral vision right since she kept running into door frames. She was a little better, sometimes she could walk a straight line and sometimes she veers. Headache was ongoing. She did not have it today, it was not a severe headache, it was more irritating than severe. Her arm felt like a boil where they gave her the shot. Her fever went away Saturday night or Sunday morning. She felt like she was not in her own mind, like she was drifting, so time lines for side effects are hard to recall. Her arm was still was sore. Heartbeat would accelerate for a few seconds was occasionally still happening, it happened last night. She called the hospital (facility where it was received) back the next morning and she was told she could come if she wanted to but it was suggested to stay home and sleep it off. She told them she could not drive and was half delirious, she was told she could call an ambulance to come get her. She confirms she did not call ambulance or go to the hospital. When querying indication, she was told there was a new strain of COVID that was easier to catch. The outcome of events chills was recovered on 23Jan2021, vomiting was recovered on 22Jan2021, joint pain was recovered on 24Jan2021, fever recovered in Jan2021. The outcome of events balance impaired NOS, dizzy, vaccination site swelling, Peripheral vision defective was recovering. The outcome of event headache, sneezing, feeling of total lack of energy, feeling abnormal, sleep excessive and pain in arm was not recovered. The outcome of rest events was unknown.

Other Meds: METOPROLOL TARTRATE; SIMVASTATIN; LEVOTHYROXINE; VITAMIN D [COLECALCIFEROL]

Current Illness: Blood pressure high (Verbatim: high blood pressure diagnosed about 5 to 7 years ago); High cholesterol (diagnosed about 5 to 7 years ago)

ID: 1012379
Sex: F
Age:
State: IL

Vax Date: 01/23/2021
Onset Date: 01/01/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Hallucinations; extremely tired/extremely lethargic; extremely tired/extremely lethargic; she wasn't making any sense; UTI; This is a spontaneous report from a contactable consumer. A 88-years-old female patient (mother) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunization. Medical history included dementia. The patient's concomitant medications were not reported. Reporter was asking if Hallucinations are a side effect of the vaccine. Her mother (patient) got the first dose of the covid vaccine on 23Jan2021. She reported that after getting the vaccine her mother was initially extremely tired but she was still able to carry on regular conversation until this morning when she wasn't making any sense. Reporter stated that this may be due to a possible UTI but she just wanted to see if older people with dementia were having hallucinations after getting the vaccine. It was reported that patient was extremely lethargic and having hallucinations. Reporter was wondering if this could be a reaction to the vaccine. All event from Jan2021. The outcome of the events was unknown. Information on batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to event hallucinations cannot be completely excluded. The case will be reevaluated 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:

Current Illness:

ID: 1012380
Sex: F
Age:
State:

Vax Date: 01/15/2021
Onset Date: 01/01/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:95.7 Fahrenheit

Allergies:

Symptoms: hypothermia; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age (reported as 48, unknown unit) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced hypothermia after receiving the 1st dose of the COVD-19 vaccine last 15Jan2021. She wanted to check if there are reported cases for hypothermia, coldness of hands and feet and recorded body temperature was 95.7 F; all on an unknown date in Jan2021 and unknown outcome. The patient was advised that there was no information available about hypothermia after getting the 1st dose. Information on Lot/Batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported hypothermia cannot be 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:

Current Illness:

ID: 1012381
Sex: F
Age:
State: MA

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:Low (50/20); Test Name: Blood pressure; Result Unstructured Data: Test Result:Rose; Comments: rose over the next 25 minutes; Test Name: Pulse; Result Unstructured Data: Test Result:Rose; Comments: rose over the next 25 minutes

Allergies:

Symptoms: felt herself losing consciousness; Low blood pressure following event (50/20); My vision went blurry first; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 25Jan2021 at 09:30 at a single dose in the workplace clinic for COVID-19 immunization. Medical history included asthma and history of vasovagal syncope following vaccinations; this adverse reaction to the vaccination directly aligns with other episodes that have occurred to her following vaccinations/interactions with needles (ie. blood draws). The patient had no COVID prior to vaccination. The patient is not pregnant. Concomitant medication included levonorgestrel (MIRENA). On 25Jan2021 at 09:30 (after getting the vaccine), the patient felt herself losing consciousness, her vision went blurry first and she was able to brace herself by lying down against a wall, and low blood pressure following event (50/20). Blood pressure and pulse rose over the next 25 minutes. 15 minutes more of observation was completed. The patient did not receive treatments for the events. The patient was not tested for COVID post vaccination. The patient recovered from the events. Information on the Batch/Lot number has been requested.

Other Meds: MIRENA

Current Illness:

ID: 1012382
Sex: M
Age:
State: PA

Vax Date: 01/20/2021
Onset Date: 01/25/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Belly's palsy, right side of face; This is a spontaneous report from a contactable physician. This physician reported for a 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient medical history included anxiety, cervical myofascial pain syndrome, gastrooesophageal reflux disease (GERD), known allergies: eggs, detergent. The patient's concomitant medications were not reported. The patient previously took salbutamol (ALBUTEROL), diphenhydramine hydrochloride (BENADRYL), esomeprazole (NEXIUM), prochlorperazine (COMPAZINE) and experienced allergies. The patient experienced Belly's palsy, right side of face on 25Jan2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included prednisone and valaciclovir (VALACYCLOVIR). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the reasonable temporal association and lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported Belly's palsy, right side of face and the administration of the COVID-19 vaccine, BNT162B2. 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:

Current Illness:

ID: 1012383
Sex: F
Age:
State: MI

Vax Date: 01/16/2021
Onset Date: 01/01/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: felt like she was having the onset of pneumonia; muscle and body aches; muscle and body aches; ongoing congestion in one nostril/stuffiness; felt tired and run down; feeling itchy/Her head, neck and back are very itchy; rash/like a fever type rash; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3249, unknown expiration), via an unspecified route of administration in the left shoulder area on 16Jan2021 at 11:15 AM at a single dose for COVID-19 immunization. Medical history included COPD (has it for lots of years) and nickel sensitivity. She does not have any reactions to her previous unspecified vaccines but had a normal reaction like sore arm. Concomitant medication included bimatoprost (LUMIGAN). The patient previously received flu vaccine and pneumonia vaccine, both for immunization in 2020 around the end of Sep or beginning of Oct. The patient reported side effects regarding the COVID vaccine and said she was a little confused and unsure if she was having a problem or if she should see a doctor. On 16Jan2021 at 11:15 AM, she had the first dose of the COVID vaccine and afterward she had a lot of effects which were mostly muscle and body aches in Jan2021. She also experienced some ongoing congestion in one nostril but saw this as just more congestion and that she was having to blow her nose more in Jan2021. She did the (app name) report but didn't report the stuffiness. She did report that in the first few days she felt like she was having the onset of pneumonia and felt tired and run down (Jan2021). Two days ago, she started feeling itchy (Jan2021) and she didn't know what it was, she didn't know if she ate something or what. Now she has developed a rash (Jan2021) which is ongoing until now. Her paperwork said the rash would happen right away if it was caused by the vaccine. The patient wanted to know if this is something she should be concerned about and if the rash could appear or started this long after she had the vaccine. Her second dose is due on 06Feb2021. The patient wanted to know if the vaccine contains nickel or any metal substances in it since she had compared her rash to her nickel sensitivity. The patient wanted to know if rash is a side effect from the vaccine and how long it will last. She didn't put rash down for the safety check either as she didn't know if it was caused by the vaccine. Today her rash, she is so itchy. She does have it on her neck and certain areas but not everywhere. It looks like what would happen after a bad fever. It is not raised but is like a fever type rash. She did note that she had an increase dose of a medication eye drops (Lumigan; Lot: T and a 0 or O followed by 544, and NDC: 0023320503. Expiry: Jan2022) around the time the rash started but after getting the vaccine. Her head, neck and back are very itchy. She mentioned that she waited 2 days and did not put this event in the (app name). She would have reported it yesterday, but she didn't get one yesterday. She also noted that it was very dry there and cold and a person is going to get dry skin. She does have an allergic to metal and wondered if that was in the product. In her neck area, it looks just like when she would wear a cheap necklace. No treatments received. The events did not require emergency room or physician office visit. The patient has no prior vaccination within four weeks. The patient had not yet recovered from events rash/like a fever type rash and congestion in one nostril/stuffiness; while unknown outcome for the remaining events.

Other Meds: LUMIGAN

Current Illness:

ID: 1012384
Sex: U
Age:
State: WI

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data: Test Date: 202101; Test Name: heart monitor; Result Unstructured Data: Test Result:atrial fibrillation

Allergies:

Symptoms: atrial fibrillation; heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 75-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3248) via an unspecified route of administration on 21Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included palpitations years ago. The patient's concomitant medications were not reported. Patient received the vaccine at 15:00 on 21Jan2021 and around 20:00, patient started getting heart palpitations. Years ago patient did have palpitations at times but had not had them like this that did not go away. Patient went to ER and the heart monitor showed patient had atrial fibrillation. Patient was sent home to follow up with primary care physician. Patient would be seeing her this coming Thursday. This was the fourth day after patient shot and patient was still bothered by them. No treatment received. Patient asked if it was the vaccine that started these palpitations up. No covid prior vaccination. No covid tested post vaccination. The patient underwent lab tests and procedures which included heart monitor showed atrial fibrillation in Jan2021. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1012385
Sex: F
Age:
State:

Vax Date: 01/09/2021
Onset Date:
Rec V Date: 02/08/2021
Hospital: Y

Lab Data: Test Date: 20210101; Test Name: Covid; Test Result: Negative

Allergies:

Symptoms: fluid on her heart caused by a virus; fluid on her heart caused by a virus; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration on (lot number and expiry date unknown) at single dose for Covid-19 immunization. Medical history included low fever from 01Jan2021 (negative for covid on 01Jan2021). The patient's concomitant medications were not reported. On 14Jan2021, the patient was hospitalized for fluid on her heart caused by a virus on unspecified date. The patient was scheduled to take her second dose of the vaccine on Saturday (unspecified date). The patient would like to know if she would be able to get her second dose of the Pfizer Covid vaccine after the side effects she experienced post-vaccination on the first dose. Her family doctor has told her to wait 90 days. She was also scheduled to visit her cardiologist tomorrow. The outcome of the events fluid on her heart caused by a virus was unknown. Follow-up activities are possible, information on the batch number has been requested.

Other Meds:

Current Illness:

ID: 1012386
Sex: M
Age:
State:

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

Lab Data:

Allergies:

Symptoms: ill with gas; can't walk; can't move arms; Initial information received on 14-Dec-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional via media. This case involves a 69-years-old male patient who experienced ill with gas (flatulence), can't walk (gait inability) and can't move arms (limb immobilisation), while he received vaccine INFLUENZA VACCINE. The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) lot number not reported via an unknown route at an unknown administration site for professional. On an unknown date, the patient was ill with gas (flatulence), can't walk (gait inability) and can't move arms (limb immobilisation) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized these events for duration of three months, rest home over a month. It is unknown if the patient experienced any additional symptoms/events. Medication details and reason for taking the medicine was unknown. Patient's wife took the low dose while husband got the double dose of the INFLUENZA VACCINE. There were no lab data/results available. It was not reported if the patient received a corrective treatment. The event outcome was unknown for gait inability and limb immobilisation. At the time of this report, outcome of the flatulence was not recovered (going on since 5-months). Batch number has been requested for suspect product for this case.; Sender's Comments: This poorly documented media case concerns a 69-years-old male who suffered from flatulence, gait inability and limb immobilisation after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset was unknown. However, patient's medical condition at the time of vaccination, lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 1012540
Sex: U
Age:
State: TX

Vax Date: 12/18/2020
Onset Date: 12/18/2020
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: no adverse event; incorrect product storage; This spontaneous report was received from an unspecified report and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 18-DEC-2020, the patient was vaccinated with improperly stored doses of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T007790 with expiration date 03-DEC-2021, 0.5 milliliter for prophylaxis. No other adverse event (AE) was reported. The vaccine experimented Temperature of 31.2 F for 30 minutes. No Previous temperature excursi?n. Digital data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007790; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability

Other Meds: PNEUMOVAX23 SYRINGE (DEVICE)

Current Illness:

ID: 1012541
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: headache; soreness; This case was reported by a consumer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache and pain. On an unknown date, the outcome of the headache and pain were unknown. The reporter considered the headache and pain to be related to Shingrix. Additional details were provide as follow: The case was reported by patient. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had headaches and soreness from Shinglrex vaccine also asked could the patient take Advil or Tylenol.

Other Meds:

Current Illness:

ID: 1012542
Sex: F
Age:
State: WA

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Inflammatory reaction; Pain in her shoulder; Tingling in fingers; Diarrhea; Headache; Nausea; Inflammatory reaction with swelling, redness and heat; Inflammatory reaction with swelling, redness and heat; Induration to her arm; Sub q injection; A spontaneous report was received from a physician assistant concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sub q injection, nausea, headache, diarrhea, significant swelling, redness and induration in her arm, inflammatory reaction, pain in her shoulder and tingling in her fingers. The patient's medical history was not provided. No concomitant product use was reported. On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) for prophylaxis of COVID-19 infection. On 13 Jan 2021, the patient was given the injection in the posterior lateral arm and it appeared to have been given subcutaneously. On 14 Jan 2021, the patient was nauseated, had a headache, diarrhea, and significant swelling with redness and induration to her arm. The skin reaction resolved on day 8, however it returned on day 9 at which point she visited her family practice. On 22 Jan 2021, she had an inflammatory reaction with swelling, redness and heat for which she was given diphenhydramine and loratadine. The patient also complained of pain in her shoulder and tingling in her fingers. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, sub q injection, was considered resolved on 13 Jan 2021. The outcome of the events, nausea, headache, diarrhea, significant swelling, redness and induration in her arm, inflammatory reaction, pain in her shoulder and tingling in her fingers, was unknown.; Reporter's Comments: This case concerns a female patient of unknown age. The medical history is not provided. The patient experienced non-serious unexpected events of Incorrect route of product administration, Paraesthesia, Diarrhea, Inflammation, and non-serious expected events of Injection site induration, Injection site swelling, Injection site erythema, Arthralgia, Headache and Nausea. The events of Injection site induration, Injection site swelling, Injection site erythema, Diarrhea, Headache and Nausea occurred approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot #041L20A). The events of Inflammation, Paresthesia and Arthralgia approximately nine days after receiving their first of two planned doses of mRNA-1273 (Lot #041L20A). Treatment included diphenhydramine and loratadine. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.

Other Meds:

Current Illness:

ID: 1012543
Sex: U
Age:
State: KS

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: syringe is leaking out some of the content in the syringe; did not get all that he suppose to get; A spontaneous report was received from a reporter concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced syringe leaking contents while administration and did not get all that he was supposed to. The patient's medical history was not provided. No relevant concomitant medications were reported. On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273(Lot number: 010M20A) intramuscularly for prophylaxis of COVID-19 infection. On 28 Jan 2021, while receiving the vaccine the patient experienced syringe leaking contents and did not get all that he was supposed to. Patient was referred to his health care professional. Action taken with mRNA-1273 in response to the events was not reported The events syringe leaking contents while administration and did not get all that he was supposed to, was considered resolved on 28 Jan 2021.; Reporter's Comments: This report refers to a case of Incorrect dose administered and syringe issue for mRNA-1273, lot # 010M20A. There were no reported AEs associated with this case of Incorrect dose administered and syringe issue.

Other Meds:

Current Illness:

ID: 1012544
Sex: F
Age:
State: MA

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

Lab Data:

Allergies:

Symptoms: liquid started dripping into patient's arm; A spontaneous report was received from a consumer concerning a 42-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced "liquid started dripping into patient's arm". The patient's medical history, as provided by the reporter included migraine, weight loss and cholesterol. No concomitant medications were reported. On 01 Feb 2021, the patient received her first dose of mRNA-1273 (Lot number 012M204) for prophylaxis of COVID-19 infection. The patient stated that while she was receiving her dose, the syringe broke while the nurse was pushing the needle into her arm. The liquid started dripping into her arm and made a puddle on the table. The nurse first told her that she administered half of the dose. The nurse called Moderna to ask if what occurred was fine, and she was told to send the patient home. Treatments of this event are unknown. Action taken with mRNA-1273 in response to the event was not reported. The event "liquid started dripping into patient's arm" considered as resolved on 01 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273. There were no reported adverse events associated with this case.

Other Meds:

Current Illness:

ID: 1012545
Sex: M
Age:
State: NY

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

Lab Data:

Allergies:

Symptoms: patient is 17 and got vaccinated; A spontaneous report was received from a consumer concerning a 17-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date, the patient received mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient, who was 17-years old, was vaccinated. Action taken with mRNA-1273 in response to the event was not reported. The event "patient is 17 and was vaccinated" was considered recovered / resolved on an unknown date.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product administered to patient of inappropriate age.

Other Meds:

Current Illness:

ID: 1012546
Sex: U
Age:
State: NJ

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

Lab Data:

Allergies:

Symptoms: Vaccine is mistakenly administered to a 16yo patient; A spontaneous report was received from a healthcare professional concerning a 16 year old unknown gender patient who received Moderna's COVID-19 vaccine (mRNA-1273) mistakenly at 16 year old. The patient's medical history was not provided. No relevant concomitant medication was reported. On an unspecified date, the patient was administered a dose of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection. The patient was 16 years old at the time of administration of the vaccine. No treatment information was provided. Action taken with the mRNA-1273 was not reported. The event, "vaccine is mistakenly administered to a 16yo patient", was considered resolved on an unspecified date.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273. There were no reported adverse events associated with this case.

Other Meds:

Current Illness:

ID: 1012547
Sex: F
Age:
State: UT

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

Lab Data:

Allergies:

Symptoms: 17 year old received vaccine; A spontaneous report was received from a consumer concerning a 17-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273). 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 intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, the reporter stated that the vaccine provider refused to administer the second dose since the patient was 17 years old. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, 17-year-old received vaccine, was considered resolved on 27 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female received vaccine) for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product administered to patient of inappropriate age. The reported event is unlisted and company causality was assessed s not applicable.

Other Meds:

Current Illness:

ID: 1012548
Sex: M
Age:
State: MS

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Body ache; Headache; Fatigue; Two doses; A spontaneous report was received from a consumer concerning a male patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced body ache, headache, fatigue and administered two doses of vaccine. The patient's medical history was not provided. No concomitant medications were reported. On 27 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch number: 09L20A), for prophylaxis of COVID-19 infection. On the same day, the patient was administered two doses of COVID-19 vaccine. On 28 Jan 2021, the patient experienced body aches, headache and fatigue after received the COVID-19 vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, body aches, headache and fatigue was not reported and that of extra dose administered was considered as recovered on 27 Jan 2021.; Reporter's Comments: This case concerns a male patient, who experienced an event of extra dose administered and non-serious expected events of Pain (body ache) , headache, fatigue . There were no AEs associated with event of extra dose administered (two doses on the same day).The events of Pain (body ache), headache, fatigue occurred 2 days after two doses of mRNA-1273, lot # 025L20A administered on the same day. Based on the current available information and temporal association between the use of the product and onset of the events , a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1012549
Sex: F
Age: 37
State: MS

Vax Date: 01/27/2021
Onset Date: 01/28/2020
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Joint Pain/Ankle Pain; Lower back pain; Fatigue; Received Two doses; pain ankle; A spontaneous report was received from an other health care professional concerning a 37-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an "extra dose administered", joint pain, ankle pain, lower back pain and fatigue. The patient's medical history was not provided. Concomitant product use was not provided. On 27 Jan 2021, the patient received her dose of mRNA-1273 (Lot number 09L20A) in the left arm for prophylaxis of COVID-19 infection. The patient stated that she received two doses on 27 Jan 2021. On 28 Jan 2021, the patient began experiencing joint pain, ankle pain, lower back pain and fatigue. Treatment of this event was not provided. Action taken with mRNA-1273 in response to the events was not reported. The event, extra dose administered was resolved on 27 Jan 2021. The outcome of the events, joint and ankle pain, lower back pain and fatigue were unknown.; Reporter's Comments: This case concerns a 37-year-old, female subject, who experienced non-serious unexpected event of Back pain, and non-serious expected events of Arthralgia (Joint pain and Ankle pain), and Fatigue. Arthralgia, Back pain and Fatigue occurred after the first dose of the mRNA-1273 administration on the next day. Very limited information regarding these events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events of Arthralgia, Back pain and Fatigue, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1012550
Sex: F
Age:
State: DE

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

Lab Data:

Allergies:

Symptoms: never pushed the plunger down while administering the vaccine; patient might not have received the vaccine; A Spontaneous report was received from a husband and wife, concerning the wife, a female consumer of unknown age who was participating in the mRNA-1273 Emergency Use Program and when they were administering the vaccine to her, they never pushed the plunger down, and the patient might have not received the vaccine The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, while administering the vaccine to the patient they never pushed the plunger down and the patient might have not received the vaccine (the reporter want to know if they received the vaccine). Action taken with mRNA-1273 in response to the events was not reported. The events, of when they were administering the vaccine to her, they never pushed the plunger down, and the patient might have not received the vaccine were considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of wrong technique in device usage process and incorrect dose administered for mRNA-1273. There were no reported adverse events associated with this case.

Other Meds:

Current Illness:

ID: 1012551
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: Recalled product administered; Red egg shaped mush on arm; A spontaneous report was received from a consumer who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, recalled product administered and red egg shaped mush on arm. The patient's medical history was not provided. Concomitant product use, within two weeks of vaccine administration included, pneumococcal vaccine polyvalent. On unknown date, the patient received their first of two planned doses of mRNA-1273(Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. Vaccine lot 041L20A was recalled. On 02 Feb, almost two weeks after vaccine administration, the patient reported a red egg shaped mush on her arm that was not painful. Patient believed this was due to her physician not waiting two weeks until administering her pneumococcal vaccine polyvalent. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, recalled product administered, was considered resolved. The outcome of event, red egg shaped mush on arm, was considered not resolved.; Reporter's Comments: This case concerns a female patient, who experienced a product administration error - recalled product administered and a non-serious unexpected event of rash on arm. There was no AEs associated with product administration error- recalled product administered . However, the event of rash on arm occurred 2 weeks after mRNA-1273 (Lot# 041L20A) administration. Based on the current available information and temporal association between the use of the product which is recalled vaccine and the start date of the event rash on arm , a causal relationship cannot be excluded, noting the concomitant use of pneumococcal polyvalent vaccine.

Other Meds: PNEUMOVAX 23

Current Illness:

ID: 1012552
Sex: F
Age: 57
State: OR

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data: none to date

Allergies: Sulfur, Crab, Latex

Symptoms: First Vaccination on 01/13/21 right arm - pain at injection site for several days following. Brain fog and some fatigue. Second vaccination on 02/3/21 left arm - approx. 3 hours later felt a little woosie and spacey. Pain at injection site. At approx. 3am the following morning experiencing chills and body jerks along with long deep breathing. Temperature 100.1. Also had a painful headache and full body aches along with some nausea and very fatigued and pain at injection site was growing in size and was also hot and red and swollen. Contacted primary care doctor about these side effects. On 2/5/21 the temperature reached 100.7 and the previous days aliments continued and fever came down to 99.6. Lots on pain in left side of neck and left arm. Let arm continues to be swollen, red and hot and is itchy. Fever finally broke on the night on Feb. 6th.

Other Meds: BuPROPion HCI ER (XL) 24HR 150mg

Current Illness: none

ID: 1012553
Sex: F
Age:
State: WI

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: bronchospasms; This is a spontaneous report from a non-contactable pharmacist. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248, expiry date: unknown), intramuscular on 21Jan2021 at a single dose for covid-19 immunization. The patient's medical history included chest pain in the past (has experienced this on and off unrelated to medication administration). Concomitant medications were not reported. The patient previously took first dose of bnt162b2 on unspecified date for covid-19 immunization. The patient is not pregnant. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 21Jan2021, the patient complained shortly after second dose of covid vaccine, having what she felt were bronchospasms. Medical Emergency Rapid Response call was made. RRT personnel arrived and administered 2 puffs of albuterol inhaler with subsequent improvement of status. No other complaints of chest pain, etc. It was reported that the event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of the event. Outcome of the event was recovered on unspecified date in Jan2021.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be 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:

Current Illness:

ID: 1012554
Sex: F
Age:
State:

Vax Date: 01/18/2021
Onset Date:
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: cataract; This is a spontaneous report from a non-contactable consumer (patient's daughter) via medical information team. An 84-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 18Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the COVID vaccine on 18Jan2021 and was scheduled for 08Feb2020 for the second dose. In between that she needed to have cataract surgery, if she can't make it to the second dose. The consumer wanted to know what would happen if she received the second dose outside of the 21 days and she wanted to know what was the timing of the second dose of PFIZER-BIONTECH COVID-19 VACCINE and can it be received earlier or later than 3 weeks. The event was considered non-serious by the reporter. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1012555
Sex: F
Age: 23
State:

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies: Omnicef, Zithromax, IV Contrast

Symptoms: 1) fatigue- began about 12 hours after dose, moderate/severe, still present 48 hours after dose 2) headache- began about 18 hours after dose, mild, resolved about 24 hours after onset 3) body aches- began about 18 hours after dose, moderate, still present 48 hours after dose 4) red painful, swollen patch on arm at injection site- began about 36 hours after dose, painful to the touch, painful when arm is at rest, still present 48 hours after dose 5) chest tightness- very mild, began 12 hours after dose, resolved within 24 hours 5) fever - began 12 hours after dose, 102 degrees on fever-reducing medication, shaking chills and fever sweats, fever still present after 48 hours, but not as high 6) sore throat - began 24 hours after dose, mild, still present 48 hours after dose

Other Meds: Vyvanse, Lamictal, Wellbutrin

Current Illness:

ID: 1012556
Sex: M
Age:
State: VA

Vax Date: 01/19/2021
Onset Date:
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Two episodes of delirium, vomited twice/two times now woke up delirious not knowing where he was; Two episodes of delirium, vomited twice; Got sick; Couldn't get up; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on the right arm on 19Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included liver cancer and chemo. There were no concomitant medications. It was reported that for two times, the patient woke up in the morning delirious, did not know where he was, hollering for his wife, couldn't get up, got sick and vomited, after he got up he felt pretty good. States he fell asleep on couch that night, toward morning he rolled onto floor, flopping around on floor like a wet seal, flopping arms around tried to roll over, pulled muscle in rib cage, after he got back up, got sick and had to vomit. Once he got up and went to the bathroom and all of that went away, wanted to know if this is this related to the Covid vaccine. This morning (unspecified date) he laid on the couch and he was about half scared to lay down because he was afraid something would happen again. The patient confirmed that he experienced this twice the day after or a couple days after the vaccine (unknown date). The patient stated that it has not happened again. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1012557
Sex: F
Age:
State: NC

Vax Date: 01/16/2021
Onset Date: 01/01/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Amyloidosis; felt a sweep over her stomach up her body and up to her head; Eyes swollen; hands hurt; sharp pings up and down legs; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on the left arm on 16Jan2021 13:45 at a single dose for COVID-19 immunization. Medical history included ongoing diabetic and previously took the flu shot one time and started having right arm pain across her chest over to the left side right after getting it. So she don't take it anymore and takes a bunch of herbs. The patient's concomitant medications were not reported. The patient reported that she has a disease, amyloidosis on an unspecified date, where there is a build up of protein in the body. She didn't know that there is protein in the shot and doesn't know the affects it has with her condition. She found out the day after getting the first Pfizer C-19 (clarified as COVID-19) shot that there was protein in it. The patient wanted to know the affects it has with her condition and if it will affect her getting the second dose and if it covers the new virus and booster shot. The patient got the vaccine on 16Jan2021 and found out about the protein in it the next day when it came across her phone. The patient received it at a school, where they vaccinated 1,169 residents. They text her to inform her she could get the vaccine. They also have the health department there. No other vaccines given that day or 4 weeks prior. On an unspecified date in Jan2021, the patient took 1 Tylenol about 15:00 that afternoon and seated herself in the chair about 17:45, then she felt a sweep over her stomach up her body and up to her head. She stood up and walked around to see if she was going to faint and she did not faint. She walked through the house and nothing else happened. The patient mentioned that her eyes have been swollen and her hands hurt, that's where the protein build up comes in the body. Has pings up and down her legs, they are sharp pings that lasted through on to Tuesday. She took 1 Advil to help and as of yesterday (as reported) no pings. Her hands still hurt, because this condition forms chains in the body and the chains are around the hands like carpel tunnel. The protein normally should leave the body and with this condition it doesn't and it leaves chains. When she was diagnosed with it they took a spot off the ankle to test it, the Dermatologist did and sent it off. No further details provided. Wants to know the affects of her getting the second shot. No further details provided. The outcome of the events amyloidosis and hands hurt was not recovered, the events felt a sweep over her stomach up her body and up to her head and sharp pings up and down legs was recovering, and the event eyes swollen was unknown.

Other Meds:

Current Illness: Diabetic

ID: 1012558
Sex: F
Age: 90
State: MA

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: at 11:50 pt c/o palpitations- O2 sat 100, HR 48-53, BP133/41. given gingerale and mask break w/ improvement. no lightheadedness or CP. palpitations intermittent. 12:05 vital signs unchanged. ER eval. Pt transported via stretcher for monitoring

Other Meds:

Current Illness:

ID: 1012559
Sex: F
Age: 73
State: IN

Vax Date: 01/29/2021
Onset Date: 02/06/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data: Applied ice & took Advil

Allergies: sulfa

Symptoms: 8 days after receiving vaccine my arm swelled up, got red, & itched around the site of the injection

Other Meds: none

Current Illness: none

ID: 1012560
Sex: F
Age: 41
State: TN

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

Lab Data:

Allergies:

Symptoms: The patient received dose 1 of the COVID Moderna vaccine at around 7:00 AM on 2/8/21 at her place of work The patient came back to the vaccine area around 10:00 AM saying she was experiencing shortness of breath, jaw pain, tingling in her left arm, and chest tightness. Her blood pressure was 188/120 mmHg at 10:05 AM with a heart rate of 105 bpm. The patient said she had had a heart attack a year prior. We called 911 at around 10:12 AM. EMS arrived and took a manual blood pressure of 178/118 mmHg, and took the patient to the hospital shortly after.

Other Meds:

Current Illness:

ID: 1012561
Sex: M
Age: 29
State: IN

Vax Date: 02/06/2021
Onset Date: 02/07/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Body/joints aches, headache, lethargy

Other Meds: Humira

Current Illness:

ID: 1012562
Sex: F
Age: 84
State: MO

Vax Date: 02/05/2021
Onset Date: 02/06/2021
Rec V Date: 02/08/2021
Hospital: Y

Lab Data: Blood work done was unremarkable. X-ray lungs consistent with recent COVID-19 infection.

Allergies: Unknown

Symptoms: C/o generalized weakness/dizziness/headache after receiving vaccine. Was seen in the ED on 1/6/21. Feeling weak and unable to stand up. ER labs unremarkable. Admitted to hospital. After received Azithromycin and Rocephin patientt reports feeling much better. Following day reports feeling symptom free.

Other Meds: Unknown

Current Illness: Previous infection with COVID-19. Diagnosed on 1/16/21. Released from quarantine on 1/27/21.

ID: 1012563
Sex: F
Age: 72
State: ME

Vax Date: 01/30/2021
Onset Date: 02/06/2021
Rec V Date: 02/08/2021
Hospital:

Lab Data: none

Allergies: sulfa drungs

Symptoms: One week after injection a 3-4 inch area around the injection site began to itch, became red, raised and tender. Also, that arm aches somewhat.

Other Meds: atorvastatin, 5 mg, calcium, multi-vitamin

Current Illness: none

ID: 1012564
Sex: F
Age: 52
State: MI

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

Lab Data: CBC, CMP 1/29/21 --essentially normal, Troponin 1/26/21 negative, CT scan of Head/Brain without contrast 1/29/21 = CT scan of the head does show a spot on the basal ganglia that is concerning for calcification rather than small hemorrhage. MD did recommend further follow-up on this, CTA of the head and neck is negative for vessel occlusion.

Allergies: cephalexin, codeine

Symptoms: 52-year-old female presents to the emergency department with complaints of left arm tingling sensation which is radiating up her neck to her jaw. She had just received the second dose of her Materna COVID-19 vaccine. She was resting in the 15-minute waiting area and only had a few minutes to go when she suddenly developed the symptoms. She then felt lightheaded and as if she was going to pass out. They did check her vital signs there and then decided to bring her to the emergency department for evaluation. On arrival here she states that the arm seems to get more tingling sensation into her fingertips now and she has some tingling on the left side of her face including the left side of her tongue. She denies any chest pain or shortness of breath. No cough fever or chills. No swelling of the lower extremities or calf pain. Patient received Diphenhydramine 25mg IV x1, Famotidine 20mg IV x1, Ondansetron 4mg IV x1, Acetaminophen 1000mg po x1, 1000 ml Normal Saline Bolus x 2 boluses Pt discharged from ER at 1800 1/29/21 MD note on discharge =MD went to the patient's room and discussed her work-up with her. MD discussed the finding on the CT scan. They also discussed the findings of the CTA head and neck. MD reexamined the patient, and she notes that she continues to have some numbness in her right upper extremity and in her mouth, but notes that the numbness in her tongue is improving. MD offered this patient observation admission, as well as evaluation by neurology with an MRI of the head, however the patient declined this, noting that she would prefer to be discharged home. Patient lives at home with her husband and child, she is a nurse by occupation, and overall is healthy. Given that she has understanding into the nature of her pathology, will have somebody at home to help her if she needs it, and will be reliable for follow-up, I am comfortable discharging the patient at her request. MD extensively discussed return precautions with her, and she verbalized understanding and agreement with the plan

Other Meds: none

Current Illness: none

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm