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: 1039550
Sex: F
Age: 67
State: CA

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

Lab Data:

Allergies:

Symptoms: Developed rash on left arm and torso. Also developed headache, fatigue, and body aches on 2/10-2/12/21.

Other Meds:

Current Illness:

ID: 1039551
Sex: F
Age: 57
State: LA

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies: Penicillin, ants, and latex

Symptoms: Patient received COVID-19 Moderna 2 or 2 in series yesterday; then neck pain began next morning. Neck and back stiff and tender with doll ache severe at 10 out of 10 associated symptoms nausea headache fatigue and malaise chills. Treatment includes 1000 mg of Tylenol every six hours PRN, nonpharmacological methods including heating pad, rest in adequate fluid intake, instructed to return to clinic if symptoms worsen or become stagnant, if not resolved in one week, obtain x-ray and refer to oncology for history of pleomorphic adenoma tumor in neck

Other Meds: PANTOPRAZOLE 40 mg daily; ONDANSETRON 8 mg every 8 hours as needed; levothyroxine 112 mcg twice daily METFORMIN 500 mg twice daily. ESCITALOPRAM 20 mg daily. BUSPIRONE 7.5 mg three times daily. POTASSIUM CHLORIDE 20 mEq daily

Current Illness: None

ID: 1039552
Sex: M
Age: 72
State: MA

Vax Date: 01/21/2021
Onset Date: 01/24/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: Body Rash

Other Meds: Amlodipine and Atorvastatin

Current Illness: None

ID: 1039553
Sex: F
Age: 61
State:

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

Lab Data: CT head normal

Allergies: Latex

Symptoms: Within 1 hour after 2nd dose of COVID vaccine had a strange sensation in R eye socket, but initially didn't think much of it. Then over next few hours, began having spreading Right sided face numbness, back of head, neck. Denies difficulty speaking or swallowing. Presented to ER. Resolved after a few hours. CT head unremarkable. Later that evening, severe chills, headache, arm soreness, fatigue. Fatigue persisting 6 days later.

Other Meds: Levothyroxine

Current Illness:

ID: 1039554
Sex: F
Age: 70
State: IL

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

Lab Data: None

Allergies: Kiwi, Codeine, environmental

Symptoms: Next day fever (102) chills headache. Gone by midday 2/13/21

Other Meds: Bedesinide, claritan, zertec, magnesium, vitamin D

Current Illness: None

ID: 1039555
Sex: F
Age: 31
State: KY

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

Lab Data:

Allergies: None

Symptoms: 6 hours after receiving the vaccine l went to shower and noticed chicken pox like blister on my torso from my underwear line to my bra line. They were mostly located on my sides are were in a vertical pattern. I have initial pictures I can share if needed.

Other Meds: None

Current Illness: None

Date Died: 02/14/2021

ID: 1039597
Sex: M
Age: 63
State:

Vax Date: 01/30/2021
Onset Date: 02/14/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Death Narrative: Patient received first dose of COVID vaccine on 1/30/21. Reported by his wife to agency that he passed away at an outside hospital on 2/14/21. By report of his wife: "due to sepsis (related to bed sores) and aspiration pneumonia"

Other Meds:

Current Illness:

ID: 1039869
Sex: U
Age:
State: OH

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

Lab Data:

Allergies:

Symptoms: No additional AEs; expired vaccine, PROQUAD, (lot# S02 l 73 2, expiration 10-JAN-2021) given to a patient; This spontaneous report was received from a nurse and refers to a patient of unknow age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 01-FEB-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), lot number S021732 with expiration date 10-JAN-2021 (dose, route and anatomical location were not reported) for prophylaxis. It was confirmed that there was no pervious temperature excursion. No additional adverse events were reported.

Other Meds:

Current Illness:

ID: 1039870
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: no adverse event; the second booster dose of V AQT A was given to a child 16 days before the sixth month mark from the first dose of V AQTA given to the child; This spontaneous report was received from a nurse and refers to a child patient of an unknown gender. Ni information regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date in 2020, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) (dose, route of administration, lot # and expiration date were unknown) for prophylaxis. On 03-FEB-2021, 16 days before the sixth month mark from the first dose, the patient was vaccinated with second dose of hepatitis a vaccine, inactivated (VAQTA), 0.5 milliliter (route of administration, lot # and expiration date were unknown) for prophylaxis. No adverse event was reported.

Other Meds:

Current Illness:

ID: 1039871
Sex: U
Age:
State: MO

Vax Date: 09/07/2016
Onset Date:
Rec V Date: 02/18/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: zoster related pneumonia; other zoster-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 07-SEP-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated Alternatively, on or about 07-SEP-2016, the patient's healthcare providers included but not limited to a healthcare provider, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects. On an unknown date, reported as subsequent to the inoculation, the patient was treated for zoster related pneumonia and other zoster-related conditions. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffered 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 include 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 varicella zoster pneumonia and ill-defined disorder were not recovered. The reporter considered varicella zoster pneumonia and ill-defined disorder to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, varicella zoster pneumonia was determined to be a medically significant event.

Other Meds:

Current Illness:

ID: 1039872
Sex: U
Age:
State: WV

Vax Date: 09/18/2017
Onset Date:
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: stroke; severe urinary tract infection; cardiovascular issues; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a currently 63-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 18-SEP-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequent, the patient was treated for the following injuries resulted from zoster vaccine live (ZOSTAVAX) used: severe urinary tract infection, cardiovascular issues and stroke. The outcome of cerebrovascular accident, urinary tract infection and cardiovascular disorder were not reported. The reporter considered cerebrovascular accident, urinary tract infection and cardiovascular disorder to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, cerebrovascular accident was determined to be a medically significant event.

Other Meds:

Current Illness:

ID: 1039873
Sex: F
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a 73-year-old 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, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were reported as follows: This case was reported by patient herself. In September or October 2020 (unsure for specific date), the patient received 1st dose of Shingirx and had experienced a sore arm. The patient stated that all the symptoms had resolved. The reporter gave permission to contact her healthcare professional. The reporter consented to follow-up. For tolerance of 2nd dose refer case US2020253841.; Sender's Comments: US-GLAXOSMITHKLINE-US2020253841:same reporter

Other Meds:

Current Illness:

ID: 1039874
Sex: U
Age: 81
State: FL

Vax Date: 12/21/2020
Onset Date: 12/01/2020
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: muscle ache; soreness st the injection site; chills; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 81-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. Concomitant products included Herpes zoster (Shingrix). On 21st December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced injection site pain and chills. On an unknown date, the patient experienced muscle pain. On an unknown date, the outcome of the injection site pain, chills and muscle pain were unknown. It was unknown if the reporter considered the injection site pain, chills and muscle pain to be related to Shingrix. Additional details were reported as follows: This case was reported by patient herself. The patient received 2nd dose of Shingix and had number of the side effects included chills, muscle ache, soreness at the injection site. The patient wanted to know how long these symptoms were expected to last. Shingrix package insert information was provided to patient and was advised to refer back to his/her physician or pharmacist for treatment options for these side effects.

Other Meds:

Current Illness:

ID: 1039875
Sex: U
Age:
State:

Vax Date: 12/01/2020
Onset Date: 12/01/2020
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: severe itching within the area of the injection; This case was reported by a other health professional and described the occurrence of injection site itching in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. In December 2020, the patient received Shingrix. In December 2020, less than a month after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was unknown. It was unknown if the reporter considered the injection site itching to be related to Shingrix. Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient received the vaccine 3 weeks before reporting and was complaining of severe itching within the area of the injection.

Other Meds:

Current Illness:

ID: 1039876
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: SEVERE HIVES; This case was reported by a consumer via interactive digital media and described the occurrence of hives 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 hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient asked, was it advisable to take 2nd dose after having had severe hives with 1st dose.

Other Meds:

Current Illness:

ID: 1039877
Sex: U
Age:
State:

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

Lab Data:

Allergies:

Symptoms: urine is darker than normal; This case was reported by a consumer via interactive digital media and described the occurrence of urine discoloration in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On 19th January 2021, the patient received Shingrix. In January 2021, less than a week after receiving Shingrix, the patient experienced urine discoloration. On an unknown date, the outcome of the urine discoloration was unknown. It was unknown if the reporter considered the urine discoloration to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient got the Shingrix shot 2 days ago from the day of reporting and since the patient's urine was darker than normal. The reporter asked was this a side effect of the vaccine.

Other Meds:

Current Illness:

ID: 1039878
Sex: U
Age:
State:

Vax Date: 01/20/2021
Onset Date: 01/01/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Date: 202101; Test Name: Body temperature; Result Unstructured Data: (Test Result:101,Unit:degree F,Normal Low:,Normal High:)

Allergies:

Symptoms: I have a 101 fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date). On 20th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported for this report. The age group was not reported but captured as adult as per vaccine indication. The patient got the 2nd shot last night from the day of reporting. They taken temperature and it was normal. The patient got the shot and now the patient had a 101 degree Fahrenheit fever. The patient did not have this kind of a reaction to the 1st shot. The patient also asked how long can expect the side effects to last.

Other Meds:

Current Illness:

ID: 1039879
Sex: U
Age:
State:

Vax Date: 01/20/2021
Onset Date: 01/01/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: bad arem pain / toes / were very painful/pain raidiated up my calve; toes / began to swell and itch and were very painful; toes / began to swell and itch; Numbness; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. On 20th January 2021, the patient received Shingrix. In January 2021, less than a day after receiving Shingrix, the patient experienced pain in arm, swelling of feet, pruritus and numbness. On an unknown date, the outcome of the pain in arm, swelling of feet, pruritus and numbness were unknown. It was unknown if the reporter considered the pain in arm, swelling of feet, pruritus and numbness to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported for this report. The age group was not reported but captured as adult as per vaccine indication. The patient received shingle vaccine Wednesday from the day of reporting, experienced bad arm pain tolerable but the next evening the toes on left foot began to swell and itch and were very painful. Numbness and pain radiated up to calve. The patient also asked was this a side effect.

Other Meds:

Current Illness:

ID: 1039880
Sex: F
Age:
State:

Vax Date:
Onset Date: 12/01/2020
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Date: 2020; Test Name: Mammogram; Result Unstructured Data: (Test Result:Breast tissue dense,Unit:unknown,Normal Low:,Normal High:)

Allergies:

Symptoms: immunodeficiency; Dry eyes aggravated; eye prosthesis insertion; eye pain; Plugs placed in eyes; mammogram abnormal; Head exploding; felt head exploding / headache was severe/ Headache aggravated; low grade fever; eye inflammation; Psoriasis flare-up/ hands Psoriasis / knee Psoriasis; stress; Psoriasis on nails; Butterfly rash; rosacea; This case was reported by a consumer via other manufacturer and described the occurrence of immunodeficiency in a 57-year-old female patient who received Flu Seasonal QIV Dresden (Flu Seasonal QIV Dresden) for prophylaxis. Co-suspect products included adalimumab (Humira) solution for injection in pre-filled pen for psoriatic arthritis and levothyroxine sodium (Synthroid) tablet for thyroidectomy. The subject's past medical history included thyroid operation (had Thyroid surgery in 1986), eye dryness (had dry eyes), headache (had headache), heart rate increased (had Heart rate increased), hypertension (had hypertension), asthma (had asthma), knee replacement (had Knee replacement), fatty liver (had fatty liver diseases), c-section (had C section), liver enzyme abnormal (had unstable liver enzyme), pain in hip (had hip pain), pruritus, crawling sensation of skin (had ants crawling on skin due to codeine allergy), breathing difficult (had breathing issue due to sulpha allergy), rash (hexachlorophene allergy manifested by rash) and eye burns (inveltys allergy manifested by burned eyes). Previously administered products included codeine (had codeine), Loteprednol etabonate (received inveltys(Loteprednol etabonate)), HEXACHLOROPHENE (received hexachlorophene), BACTRIM (had bactrim), FLAGYL (received flagyl) and PLAQUENIL. Concurrent medical conditions included drug allergy (had allergy to codeine, hexachlorophine, Bactrim, Flagyl and inveltys.) and sulfonamide allergy (had sulpha allergy). Concomitant products included salbutamol sulphate (Albuterol), fluticasone propionate (Flovent), carvedilol, amlodipine besilate (Norvasc), amlodipine, montelukast sodium (Singulair), piroxicam, caffeine + ergotamine tartrate (Cafergot), cefixime (Flexeril (Cefixime)) and hydrocodone bitartrate + paracetamol (Norco). On an unknown date, the patient received Flu Seasonal QIV Dresden, Humira (subcutaneous) 40 mg at an unknown dose and frequency and Synthroid (oral) at an unknown dose and frequency. In December 2020, unknown after receiving Flu Seasonal QIV Dresden and an unknown time after starting Albuterol and Flovent, the patient experienced eye inflammation (serious criteria other: Other Medically Imp Condition), butterfly rash (serious criteria other: Other Medically Imp Condition), rosacea (serious criteria other: Other Medically Imp Condition), psoriasis flare-up (serious criteria other: Other Medically Imp Condition), stress (serious criteria other: Other Medically Imp Condition) and nail psoriasis (serious criteria other: Other Medically Imp Condition). On 28th December 2020, the patient experienced low grade fever (serious criteria other: Other Medically Imp Condition). On 31st December 2020, the patient experienced headache (serious criteria other: Other Medically Imp Condition) and exploding head syndrome. On an unknown date, the patient experienced immunodeficiency (serious criteria GSK medically significant and other: Other Medically Imp Condition), mammogram abnormal (serious criteria other: Other Medically Imp Condition), dry eyes aggravated (serious criteria other: Other Medically Imp Condition), eye prosthesis insertion (serious criteria other: Other Medically Imp Condition), eye pain and punctal plug insertion. The subject was treated with excedrin (nos) (Excedrin), ibuprofen (Advil), ibuprofen, paracetamol (Tylenol) and macrogol + propylene glycol (Systane). The action taken with Humira was unknown. The action taken with Synthroid was unknown. On an unknown date, the outcome of the eye inflammation, butterfly rash, rosacea, psoriasis flare-up, stress, nail psoriasis, low grade fever, headache, exploding head syndrome, immunodeficiency, mammogram abnormal, dry eyes aggravated and eye pain were recovered/resolved and the outcome of the eye prosthesis insertion and punctal plug insertion were unknown. It was unknown if the reporter considered the immunodeficiency, eye inflammation, headache, low grade fever, mammogram abnormal, butterfly rash, rosacea, dry eyes aggravated, psoriasis flare-up, stress, nail psoriasis, eye prosthesis insertion, eye pain, punctal plug insertion and exploding head syndrome to be related to Flu Seasonal QIV Dresden. Additional details were provided as follows: The patient had medical history of left quad rupture with repair, partial total knee repalcement and ACL repair. The age at vaccination was not reported. The patient performed mammogram in 2020 with breast tissue dense and something was found in the right breast around the nipple or areolar. on an unknown date, the patient experienced low immunity. in 2019, the patient experienced plugs palced in eyes and worsened dry eyes. in 2020, the patient experienced abnormal mammogram. in December 2020, the patient experienced eye inflammation, stress out, butterfly symptom or rosacea to face and psoriasis flare on right knee and both hands and nails. on 28th December 2020, the patient experienced low grade fever. on 31st December 2020,the patient experienced worsened headache/felt head explode. The reporter's causality for the event(s) of plugs palced in eyes was not provided. The reporter's causality for the event(s)of abnormal mammogram, eye inflammation, low immunity, stress out, butterfly symptom or rosacea to face onset in december 2020, butterfly symptom or rosacea to face onset in December 2020, worsened dry eyes, low grade fever, psoriasis flare on right knee and both hands and nails and worsened headache or felt head explode with humira 40mg/0.8ml(adalimumab) was no reasonable possibility. The reporter stated that there was no reasonable possibility that the events of plugs palced in eyes, stress out, butterfly symptom or rosacea to face onset in December 2020, butterfly symptom or rosacea to face onset in december 2020, worsened dry eyes, low grade fever, psoriasis flare on right knee and both hands and nails and worsened headache/felt head explode are related to humira 40mg/0.8ml(adalimumab). The reporter stated that the events of abnormal mammogram and eye inflammation were not assessable. The reporter stated that there was a reasonable possibility that the event of low immunity is related to humira 40mg/0.8ml(adalimumab). The reporter's causality for the event(s) of plugs palced in eyes, abnormal mammogram, low immunity, stress out, butterfly symptom or rosacea to face onset in December 2020, butterfly symptom or rosacea to face onset in December 2020, worsened dry eyes, low grade fever, psoriasis flare on right knee and both hands and nails and worsened headache/felt head explode was not provided. The reporter's causality for the event(s) of eye inflammation with synthroid(levothyroxine) was no reasonable possibility. The reporter stated that there was no reasonable possibility that the events of plugs palced in eyes, abnormal mammogram, eye inflammation, low immunity, stress out, butterfly symptom or rosacea to face onset in December 2020, butterfly symptom or rosacea to face onset in December 2020, worsened dry eyes, low grade fever, psoriasis flare on right knee and both hands and nails and worsened headache/felt head explode were related to synthroid(levothyroxine).

Other Meds: Albuterol; Flovent; CARVEDILOL; NORVASC; AMLODIPINE; SINGULAIR; PIROXICAM; CAFERGOT; FLEXERIL (CEFIXIME); NORCO; HUMIRA; SYNTHROID

Current Illness: Drug allergy (had allergy to codeine, hexachlorophine, Bactrim, Flagyl and inveltys.)

ID: 1039881
Sex: F
Age: 71
State: FL

Vax Date: 01/13/2021
Onset Date: 01/19/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Angioedema; A spontaneous report was received from a physician concerning a 71-years-old, female patient who received Moderna's COVID-19 Vaccine and who experienced angioedema of lip, mostly upper, part of lower, and into cheeks. The patient's medical history included angioedema. Concomitant product use was not provided by the reporter. On 13 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 039K20A) intramuscularly for prophylaxis of COVID-19 infection. On 19 Jan 2021, the patient woke up with angioedema of the lip, mostly upper, part of lower, and it went into cheeks. Patient reported the same thing happened to her a fewyears ago with no known cause. Treatment for the event included a shot of prednisone and oral prednisone. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event angioedema of lip, mostly upper, part of lower and into cheeks was unknown.; Reporter's Comments: This case concerns a 71-year-old female patient with a significant medical history of angioedema, who experienced a serious unexpected event of angioedema. The event occurred approximately 6 days after first dose of mRNA-1273, lot # 039K20A. Treatment for the event included a shot of prednisone and oral prednisone. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. However, patient's prior medical history of angioedema may have been contributory.

Other Meds:

Current Illness:

ID: 1039882
Sex: F
Age: 34
State: WA

Vax Date: 01/14/2021
Onset Date: 02/04/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Patient received the second dose 1 week before due date; A spontaneous report was received from a nurse concerning a 34 year old, female patient who received Moderna's COVID-19 vaccine and the patient received the second dose 1 week before due date (21 days after first dosage). The patient's medical history was not provided. The patient received their first of two planned doses of mRNA-1273 (Batch number: 031K20A) on 14-Jan-2021 intramuscularly for prophylaxis of COVID-19 infection. The patient received their second dose of mRNA-1273 (Batch number: 042L20A) on 04-Feb-2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient received the second dose 1 week before due date (21 days after first dosage). Treatment information was not provided. Action taken with mRNA-1273 in response to the event(s) was not unknown. The outcome for the event Patient received the second dose 1 week before due date was considered resolved on 04-Feb-2021.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # 042L20A with no associated AEs.

Other Meds:

Current Illness:

ID: 1039883
Sex: F
Age:
State: NY

Vax Date: 01/06/2021
Onset Date: 02/03/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Needle was loose; vaccine drip on arm; vaccine drip on arm; A spontaneous report was received from a health care provider concerning a 30 year old, female patient who received less than 2nd dose of Moderna Vaccine on (03Feb2021) because syringe leaked a few drops. This HCP did not administer the doses. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on 06/Jan/2021. On 03Feb2021, approximately one month later, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. Nurse stated that needle was loose and full dose was not given because she noticed part of the vaccine that dripped out onto patients arm. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event, Needle was loose and vaccine drip on arm was considered resolved on an unreported date.; Reporter's Comments: This case concerns a 30 year old female patient who received second dose of the vaccine and experienced vaccine drip on arm due to needle being loose. There were no reported adverse events in this case of syringe issue and exposure via skin contact.

Other Meds:

Current Illness:

ID: 1039884
Sex: F
Age: 67
State: TX

Vax Date: 12/28/2020
Onset Date: 01/22/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Lost control of bladder; Could not walk; Paralyzed from the waist down for about 24 hours; Received the 2nd dose on 22Jan; Diarrhea; Vomiting; A spontaneous report was received from a consumer, concerning a 67-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced paralyzed from the waist down for about 24 hours/PT: Paralysis, received the 2nd dose on 22 Jan 2021/PT: inappropriate schedule of product administration, lost control of bladder/PT: urinary incontinence, could not walk/PT: gait inability, diarrhea/PT: diarrhoea, and vomiting/PT: vomiting. The patient's medical history was not provided. Concomitant medications included omeprazole, fluoxetine hydrochloride, propranolol, colestipol, acetylsalicylic acid, and calcium. The patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) on 28 Dec 2020. On 22 Jan 2021, the same day as the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, following the second vaccination, the patient experienced vomiting and diarrhea. On 23 Jan 2021, the patient could not walk, was paralyzed from the waist down for about 24 hours, and lost control of her bladder. Treatment information for the events was not provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events was not applicable. The outcome of the event, paralyzed from the waist down, was considered recovered/resolved on 24 Jan 2021. The outcome of the event, received second dose on 22 Jan 2021, was considered resolved on 22 Jan 2021. The outcome of the events, vomiting, diarrhea, could not walk, and lost control of bladder, was unknown.; Reporter's Comments: This case concerns a 67 year old female subject, who experienced a serious unexpected event of paralysis after second dose of mRNA1273 (Lot# 032L20A). Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds: ZEGERID [OMEPRAZOLE]; PROZAC; PROPRANOLOL; COLESTIPOL; BABY ASPIRIN; CALCIUM

Current Illness:

ID: 1039885
Sex: M
Age: 42
State: NY

Vax Date: 12/29/2020
Onset Date: 01/27/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Face was paralyzed; A spontaneous report was received from a consumer concerning a 42-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced facial paralysis. The patient's medical history was not reported. Concomitant medication history was not provided. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (lot number: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, the patient woke up to find that his face was paralyzed. The patient went to the urgent care center and they referred him to the emergency department at the hospital. After numerous tests they diagnosed him with Bell's Palsy. Treatment for this event included prednisone and doxycycline. Action taken with mRNA-1273 in response to this event was not reported. The outcome for the event, facial paralysis, 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

Other Meds:

Current Illness:

ID: 1039886
Sex: F
Age: 66
State: NY

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

Lab Data:

Allergies:

Symptoms: Showing signs of hyperthyroidism; A spontaneous report was received from a consumer concerning a 68-year-old, female patient who received Moderna's COVID-19 vaccine and developed signs of hyperthyroidism. The patient's medical history was hypothyroidism. No relevant concomitant medications were reported. On 06 Jan 2021, patient received their first of two planned doses of mRNA-1273 (Batch number 026L20A) injection for the prophylaxis of COVID-19 infection. On 02 Feb 2021, within 28 days of receiving vaccine, patient had a six-month checkup that showed signs of hyperthyroidism when patient has history of hypothyroidism. The patient's healthcare professional consent was obtained. Treatment for the event was not provided. Action taken with the event was not reported. The outcome of the event, signs of hyperthyroidism, was considered ongoing.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. However, the patient's history of hypothyroidism may confound causality assessment. Further information has been requested.

Other Meds:

Current Illness:

ID: 1039887
Sex: F
Age:
State: MA

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

Lab Data:

Allergies:

Symptoms: Anaphylactic reaction; Burning sensation in eyeballs; Wheezing; Rales; Airways were closing; Can't breathe; A spontaneous report was received from a consumer concerning a 22-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic reaction, burning sensation in eyeballs/abnormal sensation in eye, wheezing, rales, airways were closing/obstructive airways disorder, and can't breathe/dyspnoea. The patient's medical history was not provided. No relevant concomitant medications were reported. On 05 Feb 2021, within 5 minutes prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 05 Feb 2021, within 5 minutes after receiving her second dose of vaccine, the patient reported a burning sensation in her eyeballs, followed by wheezing and rales in her lungs. She was given epinephrine and taken to the emergency room via an ambulance. She was given a second dose of epinephrine. Her airways were closing and she could not breathe. She was given a steroid, diphenhydramine, H2 antagonist and albuterol. Consent given for follow up calls. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events, anaphylactic reaction, burning sensation in eyeballs, wheezing, rales, airways were closing, and can't breathe, was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1039888
Sex: U
Age:
State: FL

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

Lab Data:

Allergies:

Symptoms: three 16 year old patients received their first dose of the Moderna vaccine; A spontaneous report was received from a pharmacist concerning three 16 year old patients who were administered a COVID vaccine at an inappropriate age. The patient's medical histories were not provided. Concomitant medication details were not provided On an unreported date, the patients received their first of two planned doses of mRNA-1273 (Batch numbers: 039K20A, 011L20A, 013L20A) some time between 11/Jan/2021 and 21/Jan/2021 intramuscularly for prophylaxis of COVID-19 infection. On an unreported date, three 16 year old patients were administered a COVID vaccine at an inappropriate age. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. The event was considered resolved on an unreported date.; Reporter's Comments: This report refers to a case series of three (3) individual 16-year-old patients who each experienced the nonserious unexpected event of 'PT Product administered to patient of inappropriate age' for the first dose of mRNA-1273 (mRNA-1273 lots # 039K20A, 011L20A, 013L20A), with no associated adverse events in any patient. Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1039889
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: arm pain; sleepless night; This is a spontaneous report from a non-contactable adult female consumer reported for herself that: A adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient experienced arm pain and sleepless night. The patient received no treatment. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1039890
Sex: M
Age:
State: HI

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

Lab Data:

Allergies:

Symptoms: This is a spontaneous report from a contactable consumer. A 60-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot: unknown, brand: Pfizer), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown, Pfizer product) at single dose for COVID-19 immunisation. It was unknown whether the patient diagnosed with COVID-19 prior to vaccination or not. It was unknown whether the patient been tested for COVID-19 since the vaccination or not. It was reported that this was the second shot. The patient described muscle aches and a fever the night of the shot (on an unspecified date in Jan2021) and into the next day. It was unknown whether the patient received treatment for the adverse event or not. No seriousness criteria were reported for events. The outcome of the events was recovered on an unspecified date in 2021. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1039891
Sex: F
Age:
State: FL

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

Lab Data:

Allergies:

Symptoms: UTI; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on 26Jan2021 (at an unspecified age) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. In Jan2021, after the vaccination, the patient experienced a UTI (urinary tract infection). Treatment for the event UTI included sulfamethoxazole/trimethoprim (BACTRIM). The outcome of the event UTI was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1039892
Sex: M
Age:
State: MI

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

Lab Data:

Allergies:

Symptoms: headache; sore arm; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received on the left arm BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3248) via an unspecified route of administration on the left arm on 01Feb2021 09:30 at a single dose for COVID-19 immunization. The patient had no medical history. Concomitant medication included paracetamol (TYLENOL), ibuprofen (ADVIL [IBUPROFEN]) and pseudoephedrine hydrochloride (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]). On 02Feb2021 02:00 AM, the night following the vaccination patient had headache and sore arm. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a workplace clinic. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Outcome of the events was recovered on an unspecified date.

Other Meds: TYLENOL; ADVIL [IBUPROFEN]; SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]

Current Illness:

ID: 1039893
Sex: F
Age:
State: CT

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

Lab Data:

Allergies:

Symptoms: Soreness and tenderness near injection site; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 15:00 at single dose for COVID-19 immunization. The patient was vaccinated at a workplace clinic. Medical history was not reported. Concomitant medications included diphenhydramine hydrochloride (UNISOM), and diphenhydramine hydrochloride, ibuprofen (ADVIL PM). The patient was not pregnant at the time of vaccination. The patient experienced soreness and tenderness near injection site on 02Feb2021 20:00. No treatment was received for the adverse event. Clinical outcome of the event was not recovered.

Other Meds: UNISOM; ADVIL PM

Current Illness:

ID: 1039894
Sex: M
Age:
State: MI

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

Lab Data:

Allergies:

Symptoms: Chills; sweating; headache; body aches; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EL3248; expiry date: unknown) via an unspecified route of administration, in the right arm, on 02Feb2021 at 06:45, at a single dose, for COVID-19 immunization. The patient had no relevant medical history. The patient has no known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248) on an unspecified date at 13:30, in the right arm. for COVID-19 immunization. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the workplace clinic. On 02Feb2021, at 22:00, the patient experienced chills, sweating, headache and body aches. The events were considered non-serious. The patient did not receive treatment for the events. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1039895
Sex: M
Age:
State: CO

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

Lab Data: Test Name: CPK; Result Unstructured Data: Test Result:Unknown; Comments: Tentative diagnosis of myositis(CPK results pending); Test Name: Rib fracture; Test Result: Negative ; Comments: Negative evaluation for renal stone, rib fracture; Test Name: Evaluation for renal stone; Test Result: Negative ; Comments: Negative evaluation for renal stone, rib fracture

Allergies:

Symptoms: This is a spontaneous report from a contactable physician. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (deltoid injection) on 22Jan2021 09:30 at SINGLE DOSE for covid-19 immunization. Medical history included HBP (high blood pressure). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication included amlodipine, furosemide, lovastatin, losartan and niacin. On 24Jan2021 08:00, the patient experienced severe ipsilateral back pain extending to mid axillary line. Negative evaluation for renal stone, rib fracture. CPK pending. Symptoms started within 48 hrs of deltoid injection and have lasted for 13 days and have been severely activity restricting. Tentative diagnosis of myositis (CPK results pending). The patient underwent lab tests and procedures which included blood creatine phosphokinase: unknown on Tentative dx of myositis(CPK results pending) , chest scan: negative on Negative evaluation for renal stone, rib fracture , renal function test: negative on Negative evaluation for renal stone, rib fracture. The outcome of events was reported as 'recovering'. The patient did not receive treatment due to the events. Follow-up attempts are completed. The following information on the batch number has been requested.

Other Meds: AMLODIPINE; FUROSEMIDE; LOVASTATIN; LOSARTAN; NIACIN

Current Illness:

ID: 1039896
Sex: F
Age:
State: MI

Vax Date: 12/30/2020
Onset Date: 01/07/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Date: 202101; Test Name: CT scan; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptoms: hemifacial spasms on the right side of face; weird sound in the ear; pulsating in the neck; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 29-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the left arm on 30Dec2020 10:00 (lot number and expiry date unknown) at single dose for Covid-19 immunization in a workplace clinic. Medical history included hidradenitis suppurativa. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included unspecified other medication. The patient received first dose of hepatitis vaccine in the left arm on 15Dec2020 (29 years old) for immunization which was within 4 weeks prior to the COVID vaccine. On 07Jan2021 07:15, the patient experienced hemifacial spasms on the right side of face. The right side of face tightens to the point her eye closes, mouth pulls up and cheeks pulls up as well along with a weird sound in the ear and pulsating in the neck. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included CT scan: unknown results in Jan2021. The patient has not been tested for COVID-19 since the vaccination. The patient received treatment of muscle relaxer, medrol dose pack. The outcome of the events was not recovered. The reporter considered the events serious as disabling/incapacitating but did not results in death, not life threatening, did not cause/prolong hospitalization, no congenital anomaly/birth defect. Follow-up activities are possible, information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the hemifacial spasms and other reported events due to temporal relationship Additional information is needed to better assess the case, including complete medical history, diagnostics including results of Head CT scan, EMG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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: 1039897
Sex: F
Age:
State:

Vax Date: 02/03/2021
Onset Date: 02/01/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: This is a spontaneous report from a non-contactable consumer. A 47-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 03Feb2021, at a single dose on the arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Medical history and concomitant medications were not reported. The patient experienced arm injection site pain on an unspecified date in Feb2021. Since the vaccination, the patient has not been tested for COVID-19. It was unknown if treatment was received for the adverse event. Outcome of the event was unknown. The reporter assessed the event as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1039898
Sex: F
Age:
State: OH

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

Lab Data:

Allergies:

Symptoms: This is a spontaneous report from a contactable consumer. A 44-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9269) on her left arm, via an unspecified route of administration on 03Feb2021 12:30 at a single dose for covid-19 immunization. Medical history included PCN allergies. The patient's concomitant medications were not reported. It was reported that the patient's left arm and the left side of her left hand has felt weak since having her shot yesterday. She can close her hand, but it feels weak. Took place at 03Feb2021 01:15PM. No treatment was received for the event. The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 1039899
Sex: F
Age:
State: SC

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

Lab Data:

Allergies:

Symptoms: it took her 6-8 months to recover and walk again; she had pneumonia shot and experienced muscle and joint pain and all kind of side effects.; she had pneumonia shot and experienced muscle and joint pain and all kind of side effects.; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A female patient (age: 80, unit: unknown) of an unspecified age started to receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient stated that it took her 6-8 months to recover and walk again and she had pneumonia shot and experienced muscle and joint pain and all kind of side effects. Outcome of the event Walking difficulty was recovered on an unspecified date while outcome of the remaining events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1039900
Sex: M
Age:
State: MA

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

Lab Data: Test Name: Labs; Result Unstructured Data: Test Result:He does not have any infection; Test Name: X-ray of his legs; Result Unstructured Data: Test Result:Fracture ruled-out

Allergies:

Symptoms: groin started to hurt; tired; This is a spontaneous report from a contactable consumer. A 85-years-old male patient (reporter's grandfather) received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Batch/lot number: EL9262, via an unspecified route of administration in right arm, on 01Feb2021 (at 85 years of age) at single dose for COVID-19 immunization. Medical history included diabetes from an unknown date. There were no concomitant medications. On 01Feb2021 the patient felt great; on 02Feb2021 he felt ok but was tired; on 03Feb2021 his groin started to hurt, it hurt even to touch it, his leg started to bother him from his groin down and then was unable to be touched; the reporter asked if that could be swollen lymph nodes from the vaccine. At 3 o'clock the patient rushed to the hospital and, on 04Feb2021, he was admitted to hospital due to pain in groin. They thought he had broken something but that was ruled out. The patient underwent an X-ray of his leg and labs. He does not have any infection. At the time of the report the patient was still in hospital and the events "groin started to hurt" had not resolved yet and outcome of the event "tired" was unknown.

Other Meds:

Current Illness:

ID: 1039901
Sex: F
Age:
State: WV

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

Lab Data: Test Name: x-rays; Result Unstructured Data: Test Result:Unknonwn results; Test Name: x-rays; Result Unstructured Data: Test Result:Unknonwn results

Allergies:

Symptoms: smelled something like cigarette smoke; stomach cramps; left arm was in pain, more pain that it had been/pain was in her scapula, her left arm, all of her joints; pain was in her scapula, her left arm, all of her joints; could feel her blood surging through her body; she couldn't get comfortable; Crying; Allergic reaction; body aches; dizziness; hallucinations; up all night; exhausted/ fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL9261), via an unspecified route of administration at the right arm on 22Jan2021 14:58 at a single dose for COVID-19 vaccination and ketorolac tromethamine (TORADOL), via an unspecified route of administration on 22Jan2021 16:30 at an unknown dose, single for pain. The patient medical history includes low iron anemia from Oct2020 and allergy to eggs, pecans, walnuts and latex. Also on 15Jan2021, she fell down the stairs and thought she broke her arm and was in severe pain. The has been taking iron supplements as concomitant medications. The patient reported having hallucinations, body aches, fatigue and dizziness on Jan2021. On 22Jan2021 09:00PM, she started smelling smoke, like cigarette smoke, like her home was filling with cigarette smoke, and no one in her house even smokes. On 22Jan2021, she also had severe stomach cramps like she was going to have diarrhea, but she never did. She says she was bowed over with the worst cramps like menstrual cramps, and her left arm was in pain, more pain that it had been. She says she could feel blood surging in her legs, it was almost surreal, she could feel the blood going through her body, which she never had felt something like that before. She says that the pain was in her scapula, her left arm, all of her joints. She says she could not get comfortable, and she was crying she was in that much pain. She says she does not typically cry and has a pretty good pain tolerance. She says she was getting freaked about that, and the next morning she was exhausted (Jan2021), she would assume since she was up all night in pain (Jan2021). The following day she laid around and felt extremely fatigued and dizzy, then by Sunday she was feeling better. For pain treatment she took Ibuprofen though her doctor also prescribed her another pain pill for her arm, she was scared to take it, so she took Ibuprofen 600mg which was also prescribed to her. The patient said that she did not think it was an allergic reaction but her doctor thought it might have been. The action taken in response to the events for ketorolac tromethamine was unknown. The outcome of the events was unknown.

Other Meds: TORADOL

Current Illness:

ID: 1039902
Sex: F
Age:
State:

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

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:blood pressure was up; Test Name: heart rate; Result Unstructured Data: Test Result:heart rate was up

Allergies:

Symptoms: feeling flushed and faint; her blood pressure went up as well as her heart rate; her blood pressure went up as well as her heart rate; brain fog; slurring her words; lethargy/ lethargic for 2-3 hours; hands were so cold it was like they were stuck in a snow bank and wasn't able to get them warm; feeling flushed and faint; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on unspecified date as a SINGLE DOSE for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The consumer reported her daughter had a bad reaction and is concerned about getting the second dose since it is said people could have more severe reactions. The patient's heart rate was up, blood pressure was up, feeling flushed and faint. Since her daughter works at the hospital and was next to the emergency room they kept an eye on her and everything. When she was okay to go back to her department she had brain fog, lethargy/ lethargic for 2-3 hours, and slurring of her words and that lasted 2-3 more hours. A few days later her hands were so cold it was like they were stuck in a snow bank and she wasn't able to get them warm. Not sure if that was a late reaction since it has never happened before. The patient underwent lab tests and procedures which included blood pressure: blood pressure was up on unknown date, heart rate: heart rate was up on unknown date. Outcome of the feeling flushed and faint, her blood pressure went up as well as her heart rate, brain fog, slurring her words, lethargy/ lethargic for 2-3 hours were unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1039903
Sex: M
Age:
State: GA

Vax Date: 12/27/2020
Onset Date: 12/28/2020
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: lethargy; Fever; chills; body aches; This is a spontaneous report from a non-contactable consumer. A 36-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on his left arm, via an unspecified route of administration on 27Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced Fever, chills, body aches, lethargy; all on 28Dec2020. No treatment was received for the events. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1039904
Sex: F
Age:
State: FL

Vax Date: 12/26/2020
Onset Date:
Rec V Date: 02/18/2021
Hospital:

Lab Data: Test Date: 20210204; Test Name: COVID Spike IgG antibodies protein; Result Unstructured Data: Test Result:Negative; Test Date: 20210204; Test Name: COVID Spike IgG antibodies protein; Result Unstructured Data: Test Result:Negative

Allergies:

Symptoms: negative COVID Spike IgG antibodies protein/failed to achieve immunity/patient had no response to the vaccine/vaccine did not work for her; relationship between Ocrevus and lack of response to the vaccine; This is a spontaneous report from a contactable physician (rheumatologist) reporting for his wife and a contactable consumer (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL1284/expiration date: 30Apr2021), via intramuscular route of administration, on 16Jan2021 12:00 (at the age of 62 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number:EH9899/expiration date: 30Mar2021), via intramuscular route of administration, on 26Dec2020 (at the age of 62 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Co-suspect medication included ocrelizumab (OCREVUS) from an unknown date with her last dose on 11Jun2020, (7 months prior to first dose of vaccination) via intravenous route of administration for multiple sclerosis. Relevant medical history included multiple sclerosis, sulfa allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Feb2021, the patient had a COVID Spike IgG antibodies protein drawn to assess response. The results were negative on two occasions, even after sending the test to a different lab. The patient seems to have failed to achieve immunity. The patient reported that she had no response to the vaccine, as she had no antibody so the vaccine did not work for her. Action taken in response to the event with ocrelizumab was unknown. Treatment was not received for the event. The outcome of the event negative COVID Spike IgG antibodies protein/failed to achieve immunity/patient had no response to the vaccine/vaccine did not work for her was unknown. Since the vaccination, the patient had not been tested for COVID-19. The physician reported that he thinks there is a relationship between Ocrevus and lack of response to the vaccine.

Other Meds: Pfizer, Inc. EUA 027034; OCREVUS; SYNTHROID

Current Illness:

ID: 1039905
Sex: M
Age:
State: CT

Vax Date: 01/19/2021
Onset Date: 02/04/2021
Rec V Date: 02/18/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: a possible transient ischaemic attack; the patient began retaining water; This is a spontaneous report from a non-contactable consumer (patient). An 87-year-old male patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 19Jan2021 for Covid-19 immunisation. Medical history included mitral valve replacement, pacemaker. The patient had not experienced Covid-19 prior vaccination. Concomitant medication included blood thinner, atorvastatin calcium (STATIN), lisinopril (manufacturer unknown), warfarin (manufacturer unknown). No other vaccine received in four weeks. In 2021 a few days after 1st vaccination the patient began retaining water. On 04Feb2021 the patient was hospitalized for a possible transient ischemic attack. The patient was hospitalized for a possible transient ischaemic attack and began retaining water from 04Feb2021 to an unknown date. Therapeutic measures were taken as a result of events. The outcome of unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: STATIN [ATORVASTATIN CALCIUM]; LISINOPRIL; WARFARIN

Current Illness:

ID: 1039906
Sex: M
Age:
State:

Vax Date: 12/28/2020
Onset Date: 01/11/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: systematic allergic reaction that is still on going; Exactly two weeks after taking the first shot my body broke out in systematic rash; welts with swelling of face.; welts with swelling of face.; This is a spontaneous report from a contactable Other HCP (patient himself). A 38-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. EH9899, expiration date not reported) intramuscular on left arm on 28Dec2020 at a single dose, then second dose (lot no. EK9231, expiry date not reported), intramuscular on right arm on 18Jan2021 at a single dose for covid-19 immunization. Medical history included known allergies: penicillin. (no major history of allergic reactions except penicillin as a baby). The patient's concomitant medications were not reported. The patient reported that on 11Jan2021 15:00 (03:00 PM) "exactly two weeks after taking the first shot, my body broke out in systematic rash and welts with swelling of face. My doctor thought two weeks was two long of a delay for the reaction to be from the vaccine. My doctor thought it might have been some antibiotics I had been on and they gave me prednisone. The prednisone cleared up the reaction before the second shot. I received the second shot (on 18Jan2021 with lot no. EK9231, intramuscular on right arm) and within two hours I had an even worse systematic allergic reaction that is still on going as of today 04Feb2021. The Prednisone is not clearing up the reaction. I am going to have to take short term disability." The adverse events resulted to patient had clinic visit, disability or permanent damage. Patient took prednisone, famotidine, hydroxyzine, and XANAX (because of the prednisone) as treatments. The vaccine was given in the hospital. No other vaccines were given in four weeks. Outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported allergic reaction manifested with "systematic rash and welts with swelling 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: 1039907
Sex: F
Age:
State: TN

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

Lab Data: Test Name: CT Scan; Result Unstructured Data: Test Result:Negative; Test Name: cardiac work up; Result Unstructured Data: Test Result:negative

Allergies:

Symptoms: red to blue rash on thigh; short of breath; headache; could hardly walk; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable 75-year-old female consumer (Patient) received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME) (lot number/expiration date: unknown), via unknown route of administration, on 25Jan2021 as a single dose for COVID-19 immunization. Relevant medical history was unknown. Concomitant medications was unknown. On 26Jan2021 patient was admitted to hospital for red to blue rash on thigh and short of breath. She stated she got headache after injection and 2 hrs later she could hardly walk. She was in the hospital for 3 days. Complete cardiac work up and CT scans performed which were all negative. The patient inquired if she should take the second covax. The outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1039908
Sex: F
Age:
State: MA

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Syncope; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received 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 15Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included Crohns disease which is in remission (No immunosuppressants in 5 years) and shellfish sensitivity. The patient is not pregnant. Concomitant medication included duloxetine hydrochloride (CYMBALTA), trazodone, buspirone hydrochloride (BUSPAR), lisdexamfetamine mesilate (VYVANSE) and methylfolate. The patient experienced syncope on 15Jan2021. The event was assessed as serious (medically significant). The outcome of the event was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: CYMBALTA; TRAZODONE; BUSPAR; VYVANSE; METHYLFOLATE

Current Illness:

ID: 1039909
Sex: F
Age:
State: TX

Vax Date: 02/02/2021
Onset Date: 02/04/2021
Rec V Date: 02/18/2021
Hospital:

Lab Data:

Allergies:

Symptoms: left armpit in arm tender swollen; left armpit in arm tender swollen; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received her first doe of bnt162b2 (BNT162B2 reported as PFIZER -BIONTECH COVID-19 VACCINE; lot number: Em9810; expiration date: unknown), via an unspecified route of administration left arm on 02Feb2021 10:30 at a single dose for covid-19 immunization. The patient has no medical history and known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included clarithromycin (CLARITIN), zinc, ergocalciferol (VIT D) and vitamins nos (MULTIVITAMINS reported as mtv). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Feb2021 12:00 AM, the patient had left armpit in arm tender swollen. The events were non-serious, and no treatment was received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was recovering.

Other Meds: CLARITIN [CLARITHROMYCIN]; ZINC; VIT D; MULTIVITAMINS [VITAMINS NOS]

Current Illness:

ID: 1039910
Sex: F
Age:
State:

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

Lab Data:

Allergies:

Symptoms: muscle aches; Nausea/vomiting; Nausea/vomiting; general malaise; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received bnt162b2 (BNT162B2 reported as COVID-19 vaccine; unknown lot number and expiration date), via an unspecified route of administration on 03Feb2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced muscle aches, nausea/vomiting and general malaise on an unspecified date. The events were non-serious, and it was unknown if the patient received treatment for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1039911
Sex: F
Age:
State: VA

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

Lab Data:

Allergies:

Symptoms: one of vials was accidentally diluted with 2mL of diluent. Instead of 1.8mL; one of vials was accidentally diluted with 2mL of diluent/2 people were vaccinated with it; one of vials was accidentally diluted with 2mL of diluent/2 people were vaccinated with it/received vaccine that was diluted with 2mL instead of 1.8mL; This is a spontaneous report from a contactable pharmacist reported similar events for 2 patients. This is 1st of 2 reports. This Pharmacist reported for a 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported NDC number of COVID-19 Vaccine: 59267100001) , via an unspecified route of administration on 03Feb2021 at a single dose (diluted the COVID-19 vaccine with 2mL instead of 1.8mL) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had her first dose of BNT162B2 intramuscular (hopefully it was in the arm) as covid-19 immunization. On 03Feb2021, one of vials was accidentally diluted with 2mL of diluent. Instead of 1.8mL, he used a whole 2mL. 2 people were vaccinated with it. Patients received vaccine that was diluted with 2mL instead of 1.8mL. The caller explained she was calling because one of her pharmacists diluted the COVID-19 vaccine with 2mL instead of 1.8mL. The pharmacist did inject two patients and it was their second dose. Caller is calling because she wants to know what the next steps are with the patients. Should they get another dose or what? Prior vaccinations were reported as unknown. The vaccine was given in a Pharmacy. Information on the lot/batch number has been requested.; Sender's Comments: The company deems there is not a reasonable possibility that the reported event is related to suspect product BNT162b2. The impacts 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.,Linked Report(s) : US-PFIZER INC-2021126750 same drug/reporter, different patient/AE

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm