VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1299250
Sex: F
Age:
State: CO

Vax Date: 04/24/2021
Onset Date: 04/25/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; Not sleeping at night; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Had to call 911.; This is a spontaneous report from contactable consumer. A 41year old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8735), via an unspecified route of administration administered on Left arm at 24Apr2021 12:30 PM (at the age of 41 years) as a single dose for covid-19 immunisation. The patient was not pregnant. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8734), via an unspecified route of administration administered on Left arm at 03Apr2021 04:30 PM as a single dose for covid-19 immunisation. The patient's medical history included asthma and premature ventricular contractions. Patient's past drug included aspirin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Zyrtec, Lexapro 5mg, sprintec (birth c) and Vit C. On 25-APR-2021 02:30 Patient stated that not sleeping at night, 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Treatment was received for the adverse event Ems came checked pulse and blood pressure gave plan. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events were resolving. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds: ZYRTEC R; LEXAPRO; SPRINTEC; VIT C

Current Illness:

ID: 1299251
Sex: F
Age:
State: NY

Vax Date: 04/17/2021
Onset Date: 04/18/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: started scratching and now the holes are open on areas to her chest; stated that the left side of her face is hard as a rock; Has rash on left side of face down to chest with blistery spots; could not breathe/cannot catch her breath every now and then; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 60-year-old, dose 1 via an unspecified route of administration, administered in right arm on 17Apr2021 (Lot Number: EW0171) as single dose for COVID-19 immunisation. Medical history included high blood pressure; and bad feet since 2004. The patient's concomitant medications were not reported. The patient had first vaccine on 17Apr2021. On 18Apr2021, she had a reaction, could not breathe. She cannot catch her breath every now and then and had to use the Epipen. Has been using nebulizer. Has more Epipens in case something else happened. Stated that she has a rash on the left side of her face down to her chest with blistery spots and that the left side of face was hard as a rock on 19Apr2021. Stated that the rash was worst on her chest. Has put some cream on the rash but it burns. Had a pain cream called Volten that she put on it because the rash was painful but that made it worst. Stated that she started scratching and now the holes are open on areas to her chest on 21Apr2021. Stated that she had to wear low shirts because her shirts were rubbing her chest. Stated that she was told by her doctor not to take the second shot that was scheduled for 17May2021. Stated that she has scheduled doctor's appointments that were fine. The patient wanted to know if she could get something in writing to submit with her passport stating the she could not have the second shot. The outcome of the event could not breathe/cannot catch her breath every now and then was recovered with sequel, and for the rest of the events was not recovered.

Other Meds:

Current Illness:

ID: 1299252
Sex: F
Age:
State: WI

Vax Date: 04/10/2021
Onset Date:
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: blood clot it is from my hip all the way down to my left leg to my ankle; blood clot but it is the big one from my hip all the way down to my foot; foot going down the swelling went up to my leg/foot and my leg is swelled my toes all over up to my leg swelled; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0162), via an unspecified route of administration, administered in left upper arm on 10Apr2021 at the age of 85-years-old as single dose for COVID-19 immunization. The patient's medical history included ongoing arthritis and ongoing chronic obstructive pulmonary disease (COPD). The patient reported that she was not taking anything for arthritis, just some Tylenol once in a while over the counter (it was not prescription). The patient was taking an inhaler for COPD. The patient was taking unspecified concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER2613), administered in left upper arm on 20Mar2021 at the age of 85-years-old for COVID-19 immunization and experienced bladder infection and viral infection. The patient got the first Pfizer vaccine on 20Mar2021 and was alright for a few days afterwards. Then all of a sudden, she started getting infections on 28Mar2021, 8 days after she had the first vaccine. She got a real bad bladder infection then she went to the doctor and she got medication for that. She was with bladder infection then she came down with the viral infection. The patient reported that she has not even been going anywhere because of the virus and she has been staying home. She just goes to the grocery store and clinic to the doctor, that was it. The patient had an antibiotic for the bladder infection. Sulfamethoxazole was the name of the medication that was for bladder infection. They didn't give the medication for the viral infection. The patient reported that it was just a viral infection, it was not the Covid. Since then, she had her second dose of the vaccine on 10Apr2021 and from an unspecified date in 2021, her foot started, her foot swelled up and she didn't know. She takes lot of retention pills, so she thought maybe it was that. So she took her pills and everything and washed and start getting but the next day instead of the foot going down, the swelling went up to her leg and then the next day it went all away up to her hip. The swelling on the left side from the foot all away up to the hip. She went to urgent care on 21Apr2021 (reported as "21st") and saw a doctor and she was tested and she had blood clots. Regarding lab test, the patient reported she had two infections and then she got the blood clot that was from her hip all the way down to her left leg to her ankle. She could not figure out that they called the test and what they tested. But they had a lab work done then one has a test, veins, and everything. She can't remember. The patient reported that her foot and her leg was swelled, her toes all over up to her leg swelled. She had a fat foot and a fat leg just one side. She would say since she has started taking medicines for that, she took the first dose at the evening of 21st (21Apr2021), the day she went to the urgent care, and she would say it was not any worse. The medication was supposed to break up the blood clot, but it was the big one from her hip all the way down to her foot. Just a little bit better. The outcome of the events was recovering.

Other Meds:

Current Illness: Arthritis (not taking anything for arthritis may be just some Tylenol once in a while over the counter); COPD (taking an inhaler for COPD)

ID: 1299253
Sex: F
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Delirium; mumbling unintelligbly; shaking uncontrollably; not recognizing family members; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 24-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive other vaccine in four weeks. The patient did have COVID prior vaccination and the patient did not test for COVID post vaccination. On an unspecified date, the patient experienced delirium at night of given dose in the morning. The patient was not feverish, but she was mumbling unintelligibly, shaking uncontrollably and not recognizing family members. The patient received ibuprofen and acetaminophen as the treatment for the events. the outcome of events, delirium, mumbling unintelligibly, shaking uncontrollably and not recognizing family members was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between event delirium and BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) 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: 1299255
Sex: F
Age:
State: AL

Vax Date: 04/19/2021
Onset Date:
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: High fever of 107.5 degree Fahrenheit; Dizziness; Nausea; Headache; Fatigue; Joint and muscle pain; Joint and muscle pain; Blurred vision; Persistent cough; My glands started hurting; My ears hurt specially on the right where the shot was given everything is the worse; Sore throat; Jaw pain; my neck under my chin is swollen and painful; my neck under my chin is swollen and painful; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; This is a spontaneous report from a contactable consumer(patient). A 60-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EW016) via an unspecified route of administration in right arm on 19Apr2021 at 17:15 as SINGLE DOSE for covid-19 immunization. Patient was 60 years old at the time of vaccination. Medical history included rheumatoid arthritis, COPD, chronic empyema, asthma, chronic bronchitis, gastritis, irritable bowel syndrome, blood pressure high and digestive disorder, all from an unknown date and unknown if ongoing. Concomitant medications included quetiapine fumarate (SEROQUEL), POTASSIUM CHLORIDE, albuterol sulfate (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT), FLUNISOLIDE, FLUOXETINE, HYDROCHLOROTHIAZIDE, IPRATROPIN, METOPROLOL, MONTELUKAST, PANTOPRAZOLE, FAMOTIDINE and LOSARTAN, all taken on unspecified date for unknown indication. In Apr20, the patient had high fever of 107.5 degree fahrenheit, dizziness, nausea, headache, fatigue, joint and muscle pain, blurred vision, persistent cough, my glands started hurting, my ears hurt specially on the right where the shot was given everything was the worse, sore throat, jaw pain and neck pain, my neck under my chin is swollen and painful, abscess in my gum and swelling and blisters in my mouth. On unspecified date, the patient underwent lab tests and procedures which included body temperature 107.5 degree F, blood test which she does every year and she had a follow up every 6 months. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: SEROQUEL; POTASSIUM CHLORIDE; ALBUTEROL; SYMBICORT; FLUNISOLIDE; FLUOXETINE; HYDROCHLOROTHIAZIDE; IPRATROPIUM; METOPROLOL; MONTELUKAST; PANTOPRAZOLE; FAMOTIDINE; LOSARTAN

Current Illness:

ID: 1299256
Sex: M
Age:
State: MA

Vax Date: 04/21/2021
Onset Date: 04/21/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: Rash is getting worse; severe rash on lower right leg with blistering and swelling; burning sensation to the touch; burning sensation to the touch; severe rash on lower right leg with blistering and swelling; severe rash on lower right leg with blistering and swelling; extreme chills est 3hrs; body ache all over; nausea; This is a spontaneous report received a contactable consumer, the patient. A 63-year-old adult male received the second dose of BNT162b2 (solution for injection; Lot ER8731 and expiry information not provided) as a single dose via unspecified route in the left arm on 21Apr2021 at 10:15 (at 63-years-old) for COVID-19 immunisation. Relevant medical history included Diabetes and High Blood Pressure. Concomitant medications sans indications, posology and therapy dates included carvedilol; losartan potassium; and levothyroxine sodium. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (Lot ER8735) in the left arm on 30Mar2021 at 11:45 (at 63-years-old). The patient denied any known allergies or any COVID-19 prior to the vaccine. The patient denied receiving any other vaccine within four weeks prior to this vaccine. On 21Apr2021 at 23:30, reported as twelve hours after receiving the vaccine, the patient began to experience extreme chills est 3 hrs, body aches all over, and nausea. On 22Apr2021 at 10:15, reported as twenty-four hours after receiving the vaccine, the patient developed a severe rash on lower right leg with blistering and swelling. The patient described the rash as going from ankle to knee, and no itchiness just a burning sensation to the touch. The patient reported that he had not yet sought medical attention though planned to go to the emergency room (ER) for the rash as it was getting worse. The patient denied any COVID testing since receiving the vaccine. It was reported unknown if any treatment was received. The outcome of the events extreme chills est 3 hrs, body aches all over, nausea, severe rash on lower right leg with blistering, burning sensation to the touch, and getting worse, was not recovered.

Other Meds: CARVEDILOL; LOSARTAN POTASSIUM; LEVOTHYROXINE SODIUM

Current Illness:

ID: 1299257
Sex: F
Age:
State: MI

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: was exposed to Covid, tested postive; was exposed to Covid, tested postive; This is a spontaneous report from a contactable consumer female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history included exposed to covid-19 on an unknown date. The patient's concomitant medications were not reported. The patient was exposed to covid and was tested positive on an unknown date. It was further reported that patient received the first dose of Covid Vaccine and was due to receive second dose Tuesday. As she was exposed to Covid, tested positive wants to know if she should still get second dose. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1299258
Sex: M
Age:
State: AZ

Vax Date: 04/09/2021
Onset Date:
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: I don't know it is stroke or something; heart burn something; its like I am having a heart attack; feeling crappy/ feeling funny/ I can feel like the drug was inside me like something was changing/ something happening with my body; Headache/ slight headache; Chest pain/ I can feel a pain where my heart is; arm was sore; heart burn; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 09Apr2021 at a single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of BNT162B2 on 18Mar2021 for COVID-19 immunisation (left arm). Patient stated, "the second was really bad my arm was sore for like over a week I mean it was sore. I don't know I have not felt the same since. I can feel like the drug was inside me like something was changing and I never had no problem for anything but now its been like at the last when I got the shot was 9th of April of this month, its been like 2 weeks now almost and it is like I feel crappy. I have headache I have like a chest pain u know in my chest. I have like my heart is I don't know its like I am having a heart attack or something I don't know it is stroke or something. I do not know it is feeling funny. I have no problem I do, may be I have may be heart burn something. I don't know because on every single day everyday I have chest pain my heart, headache I have slight headache now. I don't know why I can feel a pain where my heart is on left side now I got the pain on right side you know I have the pain there and I wondering what's going on so I don't know". Consumer stated, "First its both side that is what I am saying now right now so as I am talking to I have pain in my heart and like it feels the heart u know I don't know there is a weird thing in my heart. I feel like you have a heart attack or so, I you feel like a chest pain or you had a heart burn or something and then on my right side has started it is like something happening with my body you know now its the right side. I don't really know, I can feel me liver, my kidneys are like something is like I can feel something is going I don't know what's going on with my body. You know after getting the shot right now I have the slight headache. I took a quite couple of Tylenol as stuff but that seems like no. This every single day you know that you I thought it will go away but it did not go away". Consumer stated, "Yes, it is the first time. Like I said I thought it will go away but it is not getting any better. I am getting concerned. I do not know I have to be admitted to hospital. I do not have no insurance or anything. I am really worried." The patient hasn't been to the doctor, he was calling first for help. He has no insurance so he cannot just go to the doctor. Consumer stated, "It never improved no. Persisting." Outcome of the events was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1299259
Sex: F
Age:
State: NH

Vax Date: 03/17/2021
Onset Date: 03/01/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Shingles on face; I could get acne breakout with that/it is gonna around the eyes was only the eyelid and it was on region on my eyelid; it started down my forehead and blistered.; top of my scalp near the crown there is little tenderness still. It was really tender.; She touched my hair and I didn't jump out if my skin but it hurts.; This is a spontaneous report for herself. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included pulmonary hypertension from an unknown date, arthritis from an unknown date, and rosacea from an unknown date. Concomitant medications included atenolol taken for an unspecified indication, start and stop date were not reported; enalapril maleate (LOTRIAL [ENALAPRIL MALEATE]) taken for an unspecified indication, start and stop date were not reported; guanidine taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for hypothyroidism, start and stop date were not reported, and other vitamins over the counter start and stop date were not reported. The patient experienced shingles on face; I could get acne breakout with that/it is gonna around the eyes was only the eyelid and it was on region on my eyelid on Mar2021 with outcome of unknown, it started down her forehead and blistered on Mar2021 with outcome of unknown, top of her scalp near the crown there is little tenderness still. it was really tender on Mar2021 with outcome of unknown, and she touched her hair and she didn't jump out if her skin but it hurts on Mar2021 with outcome of unknown. As treatment, the patient received valacyclovir, that is for 7 days, 1000mg Once a day. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the available information the reported events more likely represent intercurrent medical conditions which were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). 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 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 Investigators, as appropriate.

Other Meds: ATENOLOL; LOTRIAL [ENALAPRIL MALEATE]; GUANIDINE; SYNTHROID

Current Illness:

ID: 1299260
Sex: F
Age:
State: MN

Vax Date: 03/03/2021
Onset Date: 04/10/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: some hearing loss; Severe Tinnitus after the second which has not gone away; This is a spontaneous report from a contactable consumer, patient. A 63-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0151) via an unspecified route of administration, in the left arm on 03Mar2021 as a single dose for COVID-19 immunisation. The patient medical history was not reported. Since the vaccination, the patient has not been tested for COVID-19. Concomitant drugs were not provided. The patient previously received the first dose of BNT162b2 in the left arm on 03Mar2021 at 15:00 (Lot Number: EN6199) for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 10Apr2021 at 03:15, the patient experienced some hearing loss and severe tinnitus after the second which has not gone away. The patient reported, she noticed ringing in the ears (tinnitus) after the first one then went away. Severe tinnitus after the second which has not gone away. Doc sent me for hearing test. Which I've had some hearing loss. No treatment was provided for the events. The patient had not recovered from the events, some hearing loss and severe tinnitus after the second which has not gone away.

Other Meds:

Current Illness:

ID: 1299261
Sex: F
Age:
State: IL

Vax Date: 02/18/2021
Onset Date: 04/17/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient's husband). This is the 2nd of 2 reports. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) dose 1 (lot number: EL9262) on 28Jan2021 at 15:30 and dose 2 (lot number: EN6201) on 18Feb2021 at 15:30, both via an unspecified route of administration and both as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies and was not diagnosed with COVID-19 prior to vaccination. Concomitant medications (other medications in two weeks) were reported as yes. The patient did not receive another vaccine within 4 weeks prior to the COVID-19 vaccination. The patient experienced COVID-19 confirmed by positive COVID-19 test on 17Apr2021 at 14:00 (as reported). The clinical course was reported as follows: "My wife and I have both been fully vaccinated since 18Feb2021 at 3:30 pm. We both have since tested positive with COVID-19 on 22Apr2021. Our 15month old daughter and her daycare provider are the people who exposed us." It was reported that the event required a physician office visit and no treatment was received for the event. The patient tested positive for COVID-19 via nasal swab, COVID test name: Innovative care, on 22Apr2021. The clinical outcome of the event COVID-19 confirmed by positive COVID-19 test was recovering/resolving.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021456777 same reporter/drug/AE, different patients.

Other Meds:

Current Illness:

ID: 1299262
Sex: F
Age:
State: CA

Vax Date: 03/18/2021
Onset Date: 03/01/2021
Rec V Date: 05/08/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Butterflies in the chest that went to quivering; quivering; A-Fib/Arterial fibrillation with rapid ventricular response; Arterial fibrillation with rapid ventricular response; cannot rule out anterior infarct and abnormal EKG; cannot rule out anterior infarct and abnormal EKG; trouble breathing; Her heart rate is screwed up; she feels so weak; irregular heart beat; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 18Mar2021 (lot number: EP7534) as SINGLE DOSE for COVID-19 immunization. Medical history included asthma, chronic obstructive pulmonary disease (COPD), irritable bowel syndrome described as a condition where you're in the bathroom a lot, fibromyalgia, little depression, heartburn, upset stomach, heart fluttering issues, congestion spray (nasal congestion), and had part of a lung taken out. Family medical history included heart issues (dad and uncle). Concomitant medications included salbutamol (VENTOLINE [SALBUTAMOL]) for asthma; venlafaxine hydrochloride (EFFEXOR) for little depression; pantoprazole for heartburn and upset stomach; fluticasone propionate (lot number: AA47468, expiration date: Aug2020) for congestion spray (nasal congestion); fluticasone propionate, salmeterol xinafoate (ADVAIR) for heart fluttering issues. The patient previously took SHINGRIX (also reported as shingles vaccine, for clarification) for immunization and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) on 25Feb2021 (age: 76 years) in the left shoulder for COVID-19 immunization. On 18Mar2021, right after taking the vaccine, patient started to experience quivering inside. Initially it felt like butterflies in the chest and then to quivering, it was then quivering the whole week. She knew she was going in for a test , an endoscopy, where they go down the throat. So she waited, the quivering did not go away for a whole week. It lasted until Friday before her endoscopy. When they found out, they sent her to ER at the hospital. They did not do the endoscopy. They said they might have to shock her heart or something. They wanted her to see the cardiologist right away. From the ER, she had 2 IVs, 1 in each arm. They were also taking blood every 4 hours (unknown results). The provided diagnosis was arterial fibrillation with rapid ventricular response and cannot rule out anterior infarct and abnormal EKG (Mar2021). The events cannot rule out anterior infarct and abnormal EKG, butterflies in the chest that went to quivering, A-Fib/Arterial fibrillation with rapid ventricular response resulted in emergency room visit and physician office visit and let to hospitalization. The patient was hospitalized from 2021 to an unknown date (also reported for 2 days, for clarification). It also gave her A-Fib, trouble breathing and now her heart rate is screwed up (Mar2021). On an unspecified date in 2021, she feels so weak and has irregular heartbeat. Therapeutic measures were taken as a result of the events which included Eliquis, Atorvastatin, Diltiazem, and other unspecified medications. The outcome of cannot rule out anterior infarct and abnormal EKG, butterflies in the chest that went to quivering, arterial fibrillation with rapid ventricular response, she feels so weak was not recovered; while the other events was unknown.

Other Meds: VENTOLINE [SALBUTAMOL]; EFFEXOR; PANTOPRAZOLE; FLUTICASONE PROPIONATE; ADVAIR

Current Illness:

ID: 1299263
Sex: M
Age:
State: NY

Vax Date: 02/11/2021
Onset Date: 02/14/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Ventricular arrhythmia; Heart palpitations - ventricular arritmia; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: 92EL9267) via unspecified route of administration on left arm on 11Feb2021 at 12:00 (at the age of 43 years) as single dose for COVID-19 immunisation. The patient had no medical history and allergy. The concomitant medications the patient received within 2 weeks of vaccination included Vitamin C and D. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not tested for COVID-19 since the vaccination. On 14Feb2021 at 00:00, the patient experienced heart palpita-tions - ventricular arrhythmia. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received amioadoron as treatment. The outcome of the events was unknown.

Other Meds: VITAMIN C; VITAMIN D NOS

Current Illness:

ID: 1299264
Sex: M
Age:
State: IN

Vax Date: 03/18/2021
Onset Date:
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: COVID tested and had COVID; COVID tested and had COVID; Didn't feel well; Upset stomach; Chills; The worst headache of his life; no energy; This is a spontaneous report from a contactable consumer (patient's spouse) under the same suspect products for 2 patients. This is one of the 2 reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the shot on 18Mar2021 and didn't feel well from it over the weekend. The patient started to feel worse and worse. On an unspecified date, the patient got COVID tested and had COVID. Somewhere around the time the patient got his first shot he had been exposed to COVID. He had COVID for 2 weeks. He didn't have to be hospitalized and his oxygen levels were fine. He had all other symptoms except fever, diarrhea, and oxygen depletion. The vaccine was scheduled out far enough and he was past COVID so he could come and get second dose. With the first dose, it is hard to tell what a reaction to the shot was when it was actually coming down with COVID. He did have an upset stomach and chills and the worst headache of his life on an unspecified date. He also had no energy on an unspecified date. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021461372 same reporter, drug , event; different patient

Other Meds:

Current Illness:

ID: 1299265
Sex: F
Age:
State: NC

Vax Date: 01/19/2021
Onset Date: 04/20/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: Shortness of breath/Shortness of breath on exertion; with chest pressure, on exertion; Headache with sinus congestion; Headache with sinus congestion; Body aches; Diagnosed with Covid-19 virus after taking both vaccines; Diagnosed with Covid-19 virus after taking both vaccines; Tachycardic; This is a spontaneous report from a contactable nurse (patient) reported that a 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiration date: 31Mar2021) on 29Dec2020 20:00 (at the age of 29-years-old) then received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date: 30Apr2021) on 19Jan2021 09:00 (at the age of 29-years-old) both via an unspecified route of administration, administered in deltoid left as 0.3 mL, single for covid-19 immunisation. The vaccine was administered at the hospital. The patient medical history included Factor V Leiden from Mar or Apr of 2017, while she was pregnant; migraine from 2011; exercise induced asthma from 2007 or 2008; all were ongoing. The patient's other family members have tested positive for Covid-19 last summer but specifies that they were not vaccinated. The patient was taking medications routinely prior to the event being reported which included Vyvanse at 20 mg by mouth once a day. She added that she does not take it every day because she works at night; and amitriptyline at 10 mg by mouth daily. On 20Apr2021, the patient was diagnosed with Covid-19 virus after taking both vaccines, tachycardic, loss of taste and smell; then at 3:00 am of 20Apr2021, the patient had body aches, headache with sinus congestion and cough. On 21Apr2021, the patient experienced fever. On 22Apr2021, the patient experienced shortness of breath, with chest pressure, on exertion. It was also reported that the patient's loss of taste and smell was worsened 21Apr2021 described as very noticeable. It was further reported as the patient got her first vaccine on 29Dec2020 and second vaccine on 19Jan2021 then she was diagnosed with Covid-19 on 20Apr2021. The patient stated that when she moves around, she gets short of breath and her heart rate elevates. She went to the emergency room. She had to go to the hospital because she was tachycardic described as when she came home from work, it felt like her chest was pounding; and had chest pressure from being short of breath. She was not admitted, she went to the emergency room, and was released. She cannot walk without getting short of breath. She called her primary care provider, who told her to go to the emergency room, because of her history with a clotting disorder, Factor V Leiden. The patient confirmed she has no history of having clots. Her heart rate baseline was 50 to 70 beats a minute. Shortness of breath on exertion. Loss of taste and smell started in the evening on the 20Apr2021 as her drink did not taste right, and the next day, the event was very noticeable, on the 21Apr2021. She had fever, and took Tylenol for her headache and reclarified, that it somewhat helped the headache. She also had body aches, headache with sinus congestion and cough; all on 20Apr2021 at 3:00 am. The events shortness of breath and tachycardia resulted in emergency room visit. The patient did receive additional therapies for COVID-19 which included albuterol started on 20Apr2021 as patient will take it when she was sick or has allergies; and Lovenox started on 20Apr2021 at 0.7 ml once a day, subcutaneous injection, due to her history of clotting condition. The patient underwent lab tests and procedures on 20Apr2021 which included rapid Covid-19 test: positive, no reference range provided; CBC, BMP, D-dimer: all results were normal, reference ranges not provided; Chest X-ray in emergency room: no infiltrates were noted. The events diagnosed with Covid-19 virus after taking both vaccines, tachycardic; shortness of breath, with chest pressure, on exertion; fever and headache with sinus congestion were all considered as medically significant by the reporter/patient. The outcome of the events body aches and cough was recovering while the rest of the events was not recovered. Relatedness of drug to reactions/events. Reactions assessed were diagnosed with Covid-19 virus after taking both vaccines, tachycardic, loss of taste and smell, fever, body aches, headache with sinus congestion and cough: Source of assessment was the primary source reporter and the method of assessment was global introspection then the drug results were unknown.; Sender's Comments: The association between the event lack of effect (COVID-19) and the other events with BNt162b2 can not be fully excluded based on the temporal relationship. 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: VYVANSE; AMITRIPTYLINE [AMITRIPTYLINE HYDROCHLORIDE]

Current Illness: Exercise induced asthma (from 2007 or 2008.); Factor V Leiden carrier (Mar or Apr of 2017, while she was pregnant; clotting disorder); Migraine

ID: 1299266
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: This is a spontaneous report from a contactable pharmacist. This pharmacist reported same events for 2 patients. This is the second of two reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that two patients who have been testing positive for Covid-19 after they got their first dose of the vaccine. The outcome of the events was unknown. Information about the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021455895 same reporter/drug/event, different patient

Other Meds:

Current Illness:

ID: 1299267
Sex: M
Age:
State: CA

Vax Date: 04/23/2021
Onset Date: 04/23/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: extreme hallucinations; not feeling well; chills; aches and pains; headaches; slight numbness in his extremities; difficulty walking; he did not get much sleep; fever; This is a spontaneous report from contactable consumer (parent). An 18-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 23Apr2021 at 12:45 (Lot Number: Ew0153) at the age of 18 years, as a single dose for COVID-19 immunization. Medical history included autism spectrum disorder, ADHD (Attention deficit hyperactivity disorder) combined, learning disabilities. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included alfetamine aspartate/alfetamine sulfate/dexamphetamine saccharate/dexamphetamine sulfate (ADDERALL) taken for an unspecified indication. Historical vaccine included BNT162B2, dose 1 in left arm, on 02Apr2021, lot # EK5730. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 21:00 the patient experienced extreme hallucinations, not feeling well, chills, aches and pains, headaches, slight numbness in his extremities, difficulty walking, he did not get much sleep, fever. The clinical course of events was reported as follows: My son reported to me at bedtime last night, the night of his second Pfizer vaccine dose, that he was not feeling well. I told him to take some Advil and go to bed. He had a very bad night with chills and aches and pains but most distressing was his description of having had extreme hallucinations. He said that he was aware they were hallucinations and not real during and after the experience, but it was nonetheless concerning. It is also concerning that he didn't wake me for help. At any rate, he did not get much sleep and I have to assume his fever went pretty high before morning. He described to me the need to hydrate during the night. He also relayed to me this morning an experience of headaches and slight numbness in his extremities, difficulty walking, but he is now feeling much better. He is dressed, has eaten, and is playing games on the computer. I am keeping a close eye on him today and should we return to that level of concern, we will take him to urgent care. The clinical outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Other Meds: ADDERALL

Current Illness:

ID: 1299268
Sex: M
Age:
State: FL

Vax Date: 04/02/2021
Onset Date: 04/01/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Tested positive last week for COVID; Tested positive last week for COVID; This is a spontaneous report from a Pfizer-sponsored programt. A contactable consumer (patient) reported that a 53-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 02Apr2021 (Batch/Lot number was not reported) (at the age of 53 years old) as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient got his first shot of the vaccine and he was scheduled to get his second dose but he tested positive last week for COVID (Apr2021) and he wanted to know if he can get his second dose. He wanted to make sure about what he had to do because his second shot is supposed to be tomorrow but he was positive now, he was tested positive. The patient did his COVID test on Friday and Saturday night he was positive. Tomorrow is going to be his second shot on 23Apr2021 at 4:15 PM. No treatment for the event. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1299269
Sex: F
Age:
State: NJ

Vax Date: 04/06/2021
Onset Date: 04/01/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: severe allergic reaction; Swollen lymph nodes; unable to move her left side of her body; muscle and joint pain; muscle and joint pain; total numbness of her body; severe migraine; Headache / head pain; Injection site redness; Injection site swelling; arm was hurting a lot; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, first dose) solution for injection intramuscular in the left arm on 06Apr2021 at 13:30 (at the age of 89-years-old) as a single dose for COVID-19 vaccination. Medical history included seizures from 1970, serious migraines (would guess this was diagnosed about the same time as the seizures) from 1970, broken leg and ankle (diagnosed 4-5 years ago, she can't walk), severe arthritis (this was diagnosed about 5 years ago), Blood pressure high, and uses a walker and a wheelchair (prior to getting the vaccine). There were no concomitant medications. On 07Apr2021, the patient experienced severe allergic reaction, swollen lymph nodes, unable to move her left side of her body, muscle and joint pain, total numbness of her body, severe migraine, headache, injection site redness, and injection site swelling. In Apr2021, the patient experienced arm was hurting a lot. The patient went to the emergency room because she couldn't move the left side of her body, had a really bad migraine, and her head started hurting, but she didn't stay in the hospital. Treatment for the event migraine included acetaminophen (TYLENOL) but that was not doing anything. Shots of prednisone was offered for migraine but the patient refused. The outcome of the events allergic reaction, swollen lymph nodes, muscle and joint pain, total numbness of her body, severe migraine, headache, injection site redness, and arm was hurting was unknown. The outcome of the events unable to move her left side of her body and injection site swelling was recovering. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1299270
Sex: F
Age:
State: FL

Vax Date: 04/10/2021
Onset Date: 04/10/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: Eleven days later, she got another allergic reaction with blister on her arm, water filled blister; She got blister on the opposite arm of the injection, on her right arm; Diagnosed her with a skin disease that happens when your immune system is under attack; Her arm is now swollen around the blister; bullous pemphigoid; cellulitis; Had an allergic reaction; Itchiness; They gave her a high dose/received a higher dose of the vaccine; This is a spontaneous report from a contactable consumer. A 17-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 10Apr2021 at 12:00 (Batch/Lot Number: ew0153) as a single dose for COVID-19 immunisation. Medical history included asthma seasonal only during allergy season. No episodes this year. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Multivitamin/women's one a day gummies. The parent reported that her daughter had the vaccine done on 10Apr2021 and she had an allergic reaction that evening, she had itchiness. So, I contacted the pharmacist that she had an allergic reaction and she told me that they gave her a high dose and there were few patients who got the high dose. So, eleven days later, she got another allergic reaction with blister on her arm, water filled blister, I took her to an urgent care and they referred me to a dermatologist that diagnosed her with a skin disease that happens when your immune system is under attack (event captured as per verbatim). So, I went to her primary doctor and her primary doctor has put her on antibiotic because her arm is now swollen around the blister, so now, she is on ointment, antibiotic and vitamin d (treatment) to bring up her immune system and also she has to get her blood work done to check her immune system. She also stated that the reaction my daughter is now having and how her primary doctor is suggesting not to take her second dose because she highly thinks it is an allergic reaction to the vaccine." The outcome of the events was not recovered. Reported Event: Four hours after the injection on 10Apr2021 (Name) entire body began to itch and the top of mouth. The pharmacist was notified and at the time and further explained that (Name) was one of the patients that day who received a higher dose of the vaccine at the time of injection. The pharmacist did not notify me of how high the dosage was. So I cannot put the exact details on this report because I was not given that information by the pharmacist. I suggest the pharmacist be contacted for the exact mistaken dosage. The second side effect was on 21Apr2021 (Name) woke up with a water filled blister on her right arm which ruptured with a yellow liquid. We seeked medical attention on 21Apr2021 and 23Apr2021 from 3 different facilities. The outcome was (Name) being diagnosed with bullous pemphigoid and cellulitis. (Name) was placed on cephalexin 500mg, vitamin d 50mcg/2000 units, mupirocin 2%, and fluconazole 150 mg to build her immune system back up. Did the adverse event result in any of the following?: Doctor or other healthcare professional office/clinic visit Did the adverse event result in any of the following?: Emergency room/department or urgent care What treatment received for the adverse event? Antibiotics oral and ointment as well as vitamin D Prior to vaccination, was the patient diagnosed with COVID- 19?:No Since the vaccination, has the patient been tested for COVID-19?:No Device Date: 24Apr2021 Language: En Report about covid vaccine: Yes Reporting type: AE Reporter type: Patient Age group: Adolescent (12-17 Years) Current age: 17 Current age unit: Years Is pregnant: No Patient occupation: None of the above Covid vaccine details: [{product=COVID 19, brand=Pfizer biontech ew0153, lot unknown=True, lot unknown reason=other, lot unknown reason other=unsure of above question, administration date=10Apr2021, administration time=12:00 PM, dose number=1, vaccine location=Left arm}] Other vaccine same date details: [{other vaccine same date vaccine date=10Apr2021}] Facility type vaccine: Pharmacy or Drug Store If other vaccine in four weeks: No Other medications in two weeks: Multivitamin/women's one a day gummies Adverse event: Four hours after the injection on 10Apr2021 (Name) entire body began to itch and the top of mouth. The pharmacist was notified and at the time and further explained that (Name) was one of the patients that day who received a higher dose of the vaccine at the time of injection. The pharmacist did not notify me of how high the dosage was. So I cannot put the exact details on this report because I was not given that information by the pharmacist. I suggest the pharmacist be contacted for the exact mistaken dosage. The second side effect was on 21Apr2021 (Name) woke up with a water filled blister on her right arm which ruptured with a yellow liquid. We seeked medical attention on 21Apr2021 and 23Apr2021 from 3 different facilities. The outcome was (Name) being diagnosed with bullous pemphigoid and cellulitis. (Name) was placed on cephalexin 500mg, vitamin d 50mcg/2000 units, mupirocin 2%, and fluconazole 150 mg to build her immune system back up. Adverse event start date: 10Apr2021 Adverse event start time: 05:00 PM AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care] If patient recovered: Not recovered If treatment ae: Yes AE treatment: Antibiotics oral and ointment as well as vitamin D If covid prior vaccination: No If covid tested post vaccination: No Known allergies: No Other medical history: asthma seasonal only during allergy season. No episodes this year

Other Meds:

Current Illness:

ID: 1299271
Sex: F
Age:
State: IN

Vax Date: 03/18/2021
Onset Date:
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: got COVID tested and they had COVID; got COVID tested and they had COVID; sore arm; stuffy nose; sinus infection; upset stomach and chills; chills/was so cold teeth were chattering; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the second of two reports. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 53-year-old, via an unspecified route of administration, administered in left arm on 18Mar2021 (Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included she had colonoscopy and anaesthesia. Concomitant medication included daily vitamins. The patient previously took oxytocin (PITOCIN) and experienced uncontrollable shaking. The patient got chills, was so cold teeth were chattering, sore arm, muscle aches, tired, and stuffy nose after the first dose on an unspecified date in 2021. She got it late in the day, but she didn't noticed symptoms until the next morning. It was complicated because her and her husband got the shot on 18Mar2021 and didn't feel well from it over the weekend. She thinks 18Mar2021 was on a Thursday. They knew they would be down for the weekend. They started to feel worse and worse. She went to a (institution name) because she thought she had a sinus infection on an unspecified date in 2021. She got some medication. The next day she lost the sense of smell and taste. Then her husband and her got COVID tested and they had COVID on an unspecified date in 2021. Somewhere around the time she got the first shot she had been exposed to COVID. She had COVID for 2 weeks. She didn't have to be hospitalized and her oxygen levels were fine on an unspecified date in 2021. She had all other symptoms except fever, diarrhea, and oxygen depletion. She called and the vaccine was scheduled out far enough and she was past COVID so she could come and get second dose. With the first dose, it was hard to tell what was a reaction to the shot when it was actually her coming down with COVID. She did have an upset stomach and chills and the worst headache of her life, she had no energy on an unspecified date in 2021. The sore arm was obviously was from the shot. The sore arm was clearly a side effect, but it was hard to tell when the side effects were ending and when it was COVID. It was a weird coincidence that they got exposed and she feels that it was not related to shot. The events got COVID tested and they had COVID and sinus infection resulted in physician office visit. The outcome of the event got COVID tested and they had COVID was recovered on an unspecified date in 2021 after two weeks and for the rest of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021460871 same reporter, drug , event; different patient

Other Meds: VITAMINS NOS

Current Illness:

ID: 1299272
Sex: F
Age:
State: PA

Vax Date: 04/08/2021
Onset Date: 04/20/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Myalgia; Fatigue; Chills; The reporter did not know if this is due to another infection or a viral infection; The reporter did not know if this is due to another infection or a viral infection; This is a spontaneous report from a contactable physician (patient's husband). A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right deltoid on 08Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history and concomitant medications reported as none. The patient also received first dose of BNT162B2 via intramuscular injection in right deltoid on 11Mar2021 (unknown lot number and expiration) for COVID-19 immunization. The patient experienced myalgia, fatigue and chills on 20Apr2021. The reporter asked if there have been any reports of delayed adverse events after receiving the second dose of the COVID vaccine. Clarified that by delayed adverse events he meant 12 days after receiving the second dose of the COVID vaccine, versus a few days after. The patient had a negative PCR COVID test on 22Apr2021. The reporter did not know if patient's myalgia, fatigue and chills is related to the COVID vaccine. That is why reporter called to find out if there have been any reports or delayed adverse reactions. The reporter did not know if this is due to another infection or a viral infection. The patient recovered from the events on 23Apr2021. The events were assessed as serious (medically significant). Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events myalgia, fatigue and chills cannot be excluded. The events infection and viral infection are most likely intercurrent medical conditions and are assessed as unrelated to the suspect drug. 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:

Current Illness:

ID: 1299273
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had the first shot of the Pfizer vaccine and after three days, patient developed a very bad eye infection and got pus, bleeding out of the eyes. Also, in the last 24 hours, it has started turning in, patient thought he/she was getting an upper respiratory infection. Patient got this vaccine on Friday and by Monday, patient started noticing swelling in right eye and then it got worse and worse until patient finally ran down to the doctor on Tuesday because had a yellow pus leaking all out of the eyes. The doctor said that he/she have some kind of viral or bacterial conjunctivitis and got infected so he wanted patient to be on antibiotic (treatment) and started that. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1299274
Sex: F
Age:
State: NY

Vax Date: 04/20/2021
Onset Date:
Rec V Date: 05/08/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: legs were heavy and numb; weakness in legs; bladder was now the problem/brain doesn't tell the body to go to the bathroom she is leaking because the bladder is filling up filling over; reason for hospitalization;her kidneys; totally became paralyzed from the waist down; legs were heavy and numb; Patient was a little nervous; painful tingling feeling she have that kind of feeling in her legs; This is a spontaneous report from a contactable consumer (patient's mother) from a Pfizer-sponsored program,. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 20Apr2021 at 19:30 (Batch/Lot number was not reported) as single dose for covid-19 immunization and pregabalin (LYRICA), via an unspecified route of administration from an unspecified date at 100 mg, 3x/day for neuropathy. Medical history included neuropathy from 2020 and ongoing. The patient's concomitant medications were not reported. It was reported that the patient got the vaccine and she was taking pregabalin as well and after vaccination, she experienced an adverse event, her legs were heavy and numb and also her bladder was now the problem she was actually now at the emergency room. Patient was a little nervous. The patient was still in the hospital and she was not getting any care. What happened at the beginning was that she totally became paralyzed from the waist down, when your foot fall asleep you get painful tingling feeling she have that kind of feeling in her legs not able to move any part of her anywhere from her waist down later on that night, after she took pregabalin, went to sleep about an hour she was able to move her left toes and able to drag one leg a little bit. She was supposed to take pregabalin 3 times a day and they were giving her a difficult time about it, she took one at 12 O' clock on Wednesday and the hospital they did not give another one until 11 o clock that evening because she was supposed to take 3 times a day. After she no longer feel from the waist down, she took a pregabalin and it didn't help her it didn't work and her physician told her to take 3 times a day and then at 10 O' clock yesterday morning she was still asking the hospital to give her another one. When asked to repeat the concern, patient stated "weakness in her legs that felt very heavy like she was dragging. The date of hospitalization was reported as 21Apr2021. The reason for hospitalization was reported as numbness in her legs and weakness in legs, became paralyzed from the waist down, and her kidneys. So her brain doesn't tell the body to go to the bathroom she is leaking because the bladder is filling up filling over and the body doesn't know to get it out its leaking because it is filling up it is so full. The patient underwent lab test in the hospital. The action taken with pregabalin in response to the events was unknown. Outcome of the events was unknown.

Other Meds:

Current Illness: Neuropathy

ID: 1299275
Sex: M
Age:
State: CA

Vax Date: 04/15/2021
Onset Date: 04/16/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Left arm sore improved after first shot as well as after second shot; He had 101.1 degree fever; Exhaustion and extremely tired; His stomach was hurting a lot; lungs felt like someone reach inside inside and punched him in the lungs; Achiness in joint in any place he had problems in the past in his body; nauseated; came right up on Pulmonary oil micro embolism or POEM; This is a spontaneous report from a contactable consumer, reporting for himself. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscular, administered in the left arm on 15Apr2021 at 12:00 (Batch/Lot Number: EN6204) as 2ND DOSE, SINGLE (at the age of 48 years old) for covid-19 immunisation; and testosterone cipionate (Perrigio manufacturer), via an unspecified route of administration from 2018 (Batch/Lot Number: 2005126.1; Expiration Date: Jul2023), at 200mg/ml. 100mg injected weekly for secondary hypogonadism . Medical history included hypogonadism from 2018, diagnosed allergies from an unknown date, compromised immune status from an unknown date, respiratory illness from an unknown date, genetic /chromosomal abnormalities from an unknown date, endocrine abnormalities from an unknown date, diabetes from an unknown date, and obesity from an unknown date. The patient's concomitant medications were not reported. Historical vaccine included flu vaccine over a year ago, and the first dose of BNT162B2 on 24Mar2021 at 12:30 injected intramuscularly in left arm for which he had a mild sore left arm. The patient experienced came right up on pulmonary oil micro embolism or poem on 16Apr2021 with outcome of unknown, left arm sore improved after first shot as well as after second shot on 16Apr2021 at 13:30 with outcome of unknown, exhaustion and extremely tired on 16Apr2021 at 00:30 with outcome of recovering, his stomach was hurting a lot on 16Apr2021 with outcome of recovering, lungs felt like someone reach inside inside and punched him in the lungs on 16Apr2021 with outcome of recovering, he had 101.1 degree fever on 16Apr2021 at 01:00 with outcome of recovering, achiness in joint in any place he had problems in the past in his body on 16Apr2021 with outcome of recovering, and nauseated on 16Apr2021 with outcome of recovered on 18Apr2021. Details were reported as follows: 16Apr2021 at 8-9 am he gave himself the testosterone injection and he felt that tickling, rough feeling in his wind pipe like he just had to cough hard. Caller states, "yesterday, 22Apr21, I gave myself the testosterone injection like I have always done, my wind pipe started feeling like I had to cough, it tickled and felt just like it did on 16Apr21 following the 2nd vaccine dose. I looked my symptoms up on line and found pome-(pulmonary oil micro embolism)." The patient underwent lab tests and procedures which included pyrexia: 101.1 fahrenheit on 16Apr2021. The action taken in response to the event(s) for bnt162b2 was not applicable, and for testosterone cipionate was unknown.

Other Meds:

Current Illness:

ID: 1299276
Sex: F
Age:
State:

Vax Date: 01/08/2021
Onset Date: 01/15/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: sore arm; positive COVID-19 test; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 08Jan2021 as a single dose for COVID-19 immunization. Medical history included arthritis and the patient could hardly walk because of the knee and body, in Jul2020 had the upper lung removed due to lung cancer, exposed to COVID-19 in Jan2021 (prior to the vaccination). Concomitant medications were not reported. The patient received the first vaccination on 08Jan2021 and prior in the week was exposed to COVID-19. On 15Jan2021, the patient tested positive for COVID-19. Per the patient, this was not from the vaccine. On 20Jan2021, the patient received an infusion of monoclonal antibodies as treatment for COVID-19. On an unspecified date after the first vaccination, the patient experienced a little sore arm. The clinical outcome of positive COVID-19 test and sore arm was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of COVID-19. The reported event likely represent intercurrent medical condition. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. 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.,Linked Report(s) : US-PFIZER INC-2021461792 same patient/reporter/drug, different dose

Other Meds:

Current Illness:

ID: 1299277
Sex: F
Age:
State: IL

Vax Date: 03/16/2021
Onset Date: 03/28/2021
Rec V Date: 05/08/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Ischemic stroke; Ischemic stroke causing car accident; This is a spontaneous report received a contactable consumer, the patient. This patient/consumer reported different events for different doses of the same product; this case refers to dose 2.An 84-year-old elderly [non-pregnant] female received the second dose of intramuscular BNT162b2 (solution for injection; Lot ER8731 and expiry information not provided) as a single dose in the left shoulder (deltoid) on 16Mar2021 at 12:00 (at 84-years-old) for COVID-19 immunization. Relevant medical history included ongoing atrial fibrillation, penicillin allergy, fractured tibia (09May2020; surgery to repair fractured tibia, plate and screws installed). The patient has a family history of strokes in maternal grandmother. Concomitant medications included oral rivaroxaban (XARELTO) 20mg once daily for atrial fibrillation ongoing from an unspecified date. The patient previously received COVID-19 immunization with the first dose of intramuscular BNT162b2 (Lot EN6200) in the left shoulder (deltoid) on 23Feb2021 at 12:10 (at 84-years-old) and experienced periods of dizziness like atrial fibrillation was acting up every few minutes all day, both days, left arm was sore for a day, and was fatigued and took two naps each day. The patient denied any COVID-19 prior to the vaccine and the patient was not pregnant at the time of vaccination. The patient denied receiving any other vaccine within four weeks prior to this vaccine. On 28Mar2021 the patient experienced an Ischemic stroke and car accident. The patient reported that the events resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient explained that she was hospitalized for thirty-two days, including seven days in the Intensive Care Unit. The patient assessed the events serious (life-threatening, hospitalization / prolongation of hosp., persistent / significant disability / incapacity, Important medical event). The patient was tested for COVID-19 post-vaccination via nasal swab PCR on 28Mar2021 which was negative. The patient received multiple treatments for the events including occupational therapy (OT), Speech/Swallowing therapy (ST) , Physical therapy (PT), gabapentin, acetaminophen (TYLENOL) twice daily (BID) and tramadol BID. The outcome of the events Ischemic stroke and car accident was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021216108 PFIZER (Same reporter/patient/product, different dose/events)

Other Meds: XARELTO

Current Illness: Atrial fibrillation

ID: 1299278
Sex: M
Age:
State: NC

Vax Date: 04/21/2021
Onset Date: 04/21/2021
Rec V Date: 05/08/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: stroke like symptoms; on his left side he had face droop; he had a speech slur; he couldn't move his left arm/couldn't lift his left arm; low blood pressure; his face was numb; his lip was twitching; bad headache; brain fog; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 21Apr2021 14:00 (Batch/Lot Number: EW0169) as single dose (at the age of 57-years-old) for COVID-19 immunisation. Medical history included stroke from 02Feb2020 to 02May2020 (not ongoing). The patient had 3 stroked last year and he was put on ELIQUIS and baby aspirin and a regimen for his strokes. The last one he had was 02May2020 and he has had no problems since then. Last year when he had strokes it wasn't because of his heart it was because of an artery in his brain that went 90 degrees. In Jun2020 they found out that the problem was an artery and that's when the doctor to do the double dose baby aspirin and then everything was fine and he had no episodes at all. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), lot number: P116218, expiration date: Jan2022 taken for stroke from 02Feb2020 to an unspecified stop date; and apixaban (ELIQUIS), lot number: 1796050, expiration date: Sep2023 taken for stroke from 02Feb2020 to an unspecified stop date. The patient had no additional vaccines on the same date as Pfizer vaccine and had no prior vaccine within 4 weeks. The patient had his first shot of the Pfizer COVID vaccine on 21Apr2021 at 14:00 and stated that they made him go wait for 15 minutes in his car. 10 minutes into waiting after the COVID vaccine, he had to call over the EMT because he had stroke like symptoms. On his left side he had face droop, he had a speech slur and he couldn't move his left arm. The patient was transferred to the hospital and was hospitalized. His CT scan was fine, the CT scan with dye was fine, his MRI was fine, and his heart was fine. The patient wanted to know if he should get the second COVID vaccine because of the reaction that he had from the first COVID vaccine. The patient got the COVID vaccine on 21Apr2021 and on 23Apr2021 he was still having a bad headache, brain fog and there was a deficit on his left side. He can't grab and hold something in his left hand and he has a slight deficit on the left side corner of his mouth. The patient was planning on seeing the provider in the first week of May2021. The patient added that he was told to wait 15 minutes and then 10 minutes in he could feel his face was numb and his lip was twitching and he couldn't lift his left arm. He laid on the horn and the EMS came over and they said that he had stroke like symptoms so they transferred him out of his car and into an ambulance where he had vitals taken and he had another episode of stroke like symptoms. They took him into a different ambulance and had another episode in that ambulance when they were on the way to the hospital. He didn't have anything after that except a bad headache and a slight deficit on his left side, according to them, and just a brain fog like when he was trying to figure out how to put things together and he was still having those at the time of the report. The patient was discharged from the hospital on 22Apr2021. The patient stated that his last stroke was on 02May2020 and he has had no headaches since until he had the COVID vaccine on 21Apr2021. According to the doctors and the neurologist at the hospital he could've had a stroke, he could've had low blood pressure from the vaccine or he could've had a multitude of other things but they recommended him to call Pfizer and CDC for the report. While in the hospital, he had a CT scan without contrast, a CT with contrast on 21Apr2021; an MRI without contrast on 21Apr2021; an echocardiogram without dye and with dye on 22Apr2021 and they did another MRI but of his neck on 22Apr2021; all were normal. The patient was hospitalized for stroke like symptoms, on his left side he had face droop, he had a speech slur and he couldn't move his left arm from 21Apr2021. The event stroke like symptoms resolved with sequel on 22Apr2021. The patient recovered from on his left side he had face droop, he had a speech slur, and he couldn't move his left arm on 22Apr2021. The patient has not recovered from bad headache, brain fog. The outcome of his face was numb was unknown, his lip was twitching and low blood pressure was unknown.

Other Meds: BABY ASPIRIN; ELIQUIS

Current Illness:

ID: 1299279
Sex: F
Age:
State: OR

Vax Date: 04/05/2021
Onset Date: 04/05/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: almost passed out; Dizzy; heart started racing; Dry mouth; metal taste; hard to swallow; itchy on arm it is little bit blotchy; itchy on arm it is little bit blotchy; Migraine; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180), dose 1 via an unspecified route of administration, administered in left arm on 05Apr2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient had unspecified concomitant medications; unspecified allergy medicine and unspecified vitamins. On 05Apr2021, the patient experienced the following events: almost passed out, dizzy, heart started racing, dry mouth, metal taste, hard to swallow, itchy on arm it is little bit blotchy, migraine. Details were as follows: patient had a reaction after the vaccination. She got really dizzy, almost passed out. Then her heart started racing. It took about 10 minutes to go normal and then she got like a super dry mouth and a metal taste after that, elaborated as like she had penny or something in her mouth like metal. After that, it was little more hard to swallow and just started to get itchy on arm, it is little bit blotchy. Therapeutic measures were taken as a result of migraine, and included treatment with sumatriptan (MANUFACTURER UNKNOWN), at 100 mg ( take half every time). The outcome of events, almost passed out, dizzy, heart started racing, dry mouth, metal taste, hard to swallow, itchy on arm it is little bit blotchy, migraine was unknown.

Other Meds:

Current Illness:

ID: 1299280
Sex: F
Age:
State: WA

Vax Date: 04/22/2021
Onset Date: 04/01/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: little heart palpitations; felt really warm; felt like she was on fire; Nauseous; she was white as a ghost; felt cold; Dizzy; bruised her tailbone; Passed out; from when she fell she has a knot on the back of her head, and her back has a kink; from when she fell she has a knot on the back of her head, and her back has a kink; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in left arm on 22Apr2021 17:36 (Lot Number: EW0161) (at age 59 years old) as single dose for covid-19 immunisation. Medical history included diabetic from an unknown date and unknown if ongoing diagnosed in 2001-2002. The patient's concomitant medications were not reported. She did not get any other vaccinations yesterday or in the last four weeks. She says she has started no other new meds recently. The patient stated she got her first dose on 22Apr2021 and was perfectly fine, she didn't feel anything. She says when she went to bed a few hours later, she felt really really warm like she was sunburnt or something. She says she slept, then woke up around midnight and got up and thought maybe she had to go to the bathroom. She says she felt nauseous and thought she was going to be sick so she went back to the bathroom and she was white as a ghost, and felt cold and dizzy. She says she was feeling like she was gonna pass out, so she thought her sugar levels had dropped really low, so she went downstairs to check them then woke up on the floor, she had passed out. She says she came to, and checked her sugar and it was normal, 110, so she is assuming she passed out due to the shot. She says her first dose was injected around 17:36, and it was a few hours later when she went to bed around 09:00-9:30PM and got into bed when she kind of felt like she was on fire. She says she did no treatment; she went to sleep. She says from when she fell she has a knot on the back of her head, and her back has a kink in it. She says she is sure she has also bruised her tailbone. As of 23Apr2021, she doesn't feel warm or anything now, she just has little heart palpitations that is all, and those have stayed about the same. Outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1299281
Sex: U
Age:
State: PA

Vax Date: 04/15/2021
Onset Date:
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: bad pain in the leg, near the calf/ confirmed the patient had blood clot in the leg; hurting in the arm; chills; This is a spontaneous report from a contactable consumer (patient). A 54-year-old patient of an unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 15Apr2021 (batch/lot number and expiration date were unknown) as a single dose for COVID-19 immunization. The patient had no medical history. The patient was taking other unspecified medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Mar2021 at the age of 54 years old for COVID-19 immunization. The patient reported having the normal side effect like the hurting in the arm, chills, and stuff on an unspecified date, but after that the patient got a really bad pain in the leg, near the calf and left it go for a week maybe, thinking it would go away, but didn't go away, so the patient went in to the emergency room and the emergency room work on it. That's what they did something to come up wrong with one of the blood test, so then they did an ultrasound and they confirmed the patient had blood clot in the leg, for which the patient was currently on a blood thinner. The patient didn't know if this was going to fix the problem or this was not going to fix the problem. The patient knew that some of the other vaccine caused blood clots, but the patient's doctor won't give any kind of pain medicine, and all they do was to give paracetamol (TYLENOL). They did start the patient on a pill called apixaban (ELIQUIS) taken at 25 mg tablet in the morning and 25 mg in the evening, and this was the thing the patient had never had; anything like this had never happened with the patient before, since the patient had been healthy in all his/her life, so the patient called to ask if there would be any relief as the patient didn't want this. Before the patient went into the emergency room, the patient had taken TYLENOL as treatment for all the events. The patient underwent lab tests and procedures on an unspecified date, which included blood test and chest x-ray with unknown results and an ultrasound, which revealed blood clot in the leg. The outcome of the events was unknown. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1299282
Sex: F
Age:
State: IL

Vax Date: 02/15/2021
Onset Date: 03/29/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: spontaneous abortion; This is spontaneous report from a contactable nurse. A 27 year old female patient who was not pregnant at the time of vaccination received bnt162b2 (BNT162B2 Formulation: Solution for injection, Batch/Lot Number: EL3247) dose 1 intramuscular administered on Arm left on 15Feb2021 as single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. Seriousness criteria was reported by the patient that it was not serious, no death life-threatening or cause of prolonged hospitalisation. It was not disabling and did not have any congenital birth defect. COVID-19 vaccine was administered at the hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive medications within 2 weeks of vaccination. 12Mar2021, the patient underwent lab tests and procedures which included sars-cov-2 test negative. On 29Mar2021, the patient had spontaneous abortion and was taken to emergency room in hospital. On 25Apr2021, the device date given. vaccine facility, race and ethnicity information was available. The outcome of the event was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, spontaneous abortion cannot be completely ruled out. The impact of this report on 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, Ethic committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-2021458221 mother/baby case

Other Meds:

Current Illness:

ID: 1299283
Sex: F
Age:
State: CA

Vax Date: 03/19/2021
Onset Date: 03/22/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: This is a spontaneous report from a contactable consumer reporting for self. A 45-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm, on 19Mar2021 13:15 (Batch/Lot Number: EP7534) as a single dose (at the age for 45-years-old) for COVID-19 immunisation. Medical history included asthma and allergies. The patient did not receive other vaccines in the 4 weeks prior. She received an unspecified concomitant medication for allergy in the two weeks prior. The patient had not experienced COVID prior to vaccination. On22Mar2021, chills and headache started. On 23Mar2021, chills and headache continued and the patient experienced 102 fever with a little cough. She went to the Urgent Care and they diagnosed it as a side effect of the vaccine. On 01Apr2021, the coughing got worse and it turned into pneumonia. On 10Apr2021, she was admitted to the ER for over 103F fever, chills, cough, and shortness of breath. "Low immune from pneumonia developed or flared up the Valley Fever." The events were treated with steroid shot, antibiotic IVs, fluid IV, and more. The patient was COVID-tested post vaccination with Rapid COVID test (nasal swab) on 25Mar2021 with Negative result, and with PCR test (nasal swab) on 10Apr2021 with negative result. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1299284
Sex: F
Age:
State: PA

Vax Date: 04/12/2021
Onset Date: 04/16/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in the right arm on 12Apr2021 at 15:00 (batch/lot number: EW0153) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient was not pregnant. The patient has no known allergies. There were no concomitant medications. Historical vaccine included BNT162B2 first dose on 22Mar2021 at 01:30 PM (batch/lot number: EP7534) administered in the right arm for COVID-19 immunisation. No other vaccine in four weeks. No Covid prior to vaccination and was not Covid tested post vaccination. The patient experienced urinary tract infection: group B strep on 16Apr2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of urinary tract infection: group B strep which included antibiotic, Macrobid. The outcome of the event was recovering.

Other Meds:

Current Illness:

ID: 1299285
Sex: F
Age:
State:

Vax Date: 04/24/2021
Onset Date: 04/01/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: My temperature went up to 109.9 to 102 F; I felt drained, and tired; Coughing; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 24Apr2021 at single dose for COVID-19 immunization. Medical history included ongoing smoker. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported) administered via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization and experienced coughing. In Apr2021, the patient temperature went up to 109.9 Fahrenheit to 102 Fahrenheit and the patient felt drained and tired. The patient asked whether she could catch COVID-19 in between the doses since she had been coughing even though she was a smoker. The patient took Tylenol throughout the last day (as of 26Apr2021) and the body temperature dropped to 98.6 Fahrenheit, but the patient's normal temperature usually runs in the 96 Fahrenheit. The patient asked whether these events were side effects of the vaccine. The outcome of the event temperature went up to 109.9 to 102 Fahrenheit was recovering and outcome of other events was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness: Smoker

ID: 1299286
Sex: F
Age:
State: TN

Vax Date: 04/03/2021
Onset Date: 04/07/2021
Rec V Date: 05/08/2021
Hospital: Y

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: tested positive for Covid 19; pneumonia; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 03Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient had her 1st dose of Covid 19 Vaccine on 03Apr21 and was tested positive for Covid 19 on 07Apr21. She had been hospitalized and just got release from the hospital (19Apr21), she had pneumonia now and wanted to know if she will still get her 2nd dose and if it was still possible to get it on (24Apr21). The patient was hospitalized for tested positive for covid 19 (covid-19) from 07Apr2021 to 19Apr2021. The outcome of the events was unknown. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1299287
Sex: F
Age:
State:

Vax Date: 04/21/2021
Onset Date: 04/22/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: I got super nauseous.; I really wasn't feeling well; Then I got super hot and sweaty; Then I got super hot and sweaty; I passed out.; I had a fever of up to 103.5; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 21Apr2021 08:45 (Batch/Lot number was not reported) (at the age of 23 years old) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medication included ibuprofen. The patient previously took septra and experienced allergies (known allergies); and first dose of BNT162B2 on 31Mar2021 08:45 at right arm for COVID-19 immunization. No other vaccine in four weeks. On 22Apr2021, the patient had a fever of up to 103.5 and was down to around 102 by the time of the incident (around 4:00). The patient woke up and was standing for about 3 minutes to refill water when she got super nauseous. She was making her way to the bathroom to throw up, and the next thing she knew she was on the floor. The patient was not sure how long she was passed out for though she had no reason to believe it was long. She tried to sit up, but she really wasn't feeling well, so she laid back down and closed her eyes for a bit. Then she got super hot and sweaty. Once that passed (maybe a few more minutes), she was able to check her temperature and she was down to around 101 and was able to get back to bed. No treatment for the events. No COVID prior vaccination. The patient had not been COVID tested post vaccination. The outcome of the events was recovered in Apr2021. Information about Batch/Lot number has been requested.

Other Meds: IBUPROFEN

Current Illness:

ID: 1299288
Sex: M
Age:
State: TX

Vax Date: 04/14/2021
Onset Date: 04/15/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: passed out; no energy; Tired/exhausted; Blurred vision; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 14Apr2021 09:00 (Lot Number: RW0150) as SINGLE DOSE for COVID-19 immunization. The patient previously took BNT162B2 (lot number: EN6207) dose 1 in the right arm on 24Mar2021 for COVID-19 immunization. Medical history included ongoing hormones are low. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hormone from an unspecified start date and ongoing; hydrocortisone taken for hormone from an unspecified start date and ongoing. The patient took the second dose of the COVID-19 vaccine, the next day he was tired on 15Apr2021. The patient had never been tired in his life like that. The patient was completely passed out. His wife wanted to call an ambulance and the caller told her no ambulance please. He knew the tiredness would eventually go away. The patient had no energy, zero, for 4 days or so. He has blurred vision for some reason on 15Apr2021. He thinks that the vaccine was no good. The patient has never had blurred vision before that that he is still experiencing some blurred vision. The blurred vision is what concerns him. His vision is not right and his side effects were severe. The tired disappeared, but the blurred vision is still there at time of call on 23Apr2021. The patient was wearing his reading glasses but that something has happened with his vision. He had 20/20 vision and now something is not right. The patient was exhausted, passing out, and not polite. The patient has to go to the doctor for the doctor to check his eyes. The outcome of tired was recovering. The outcome of the event blurred vision was not recovered and the outcome of the rest of the events was unknown.

Other Meds: SYNTHROID; HYDROCORTISONE

Current Illness: Hormone level abnormal

ID: 1299289
Sex: F
Age:
State: MD

Vax Date: 04/24/2021
Onset Date: 04/25/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Woke up with extreme nausea in middle of the night (2:30 AM) and passed out/fainted in the restroom. Unsure of how long episode lasted.; Woke up with extreme nausea in middle of the night (2:30 AM) and passed out/fainted in the restroom. Unsure of how long episode lasted.; Woke up with extreme nausea in middle of the night (2:30 AM) and passed out/fainted in the restroom. Unsure of how long episode lasted.; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 24Apr2021 at 09:00 (Batch/Lot Number: EW0164) at 27-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient did not have COVID prior to the vaccination. Medical history included Ehler-Danlos Syndrome, migraine, gastroparesis, and fibromyalgia; all from an unknown date and unknown if ongoing. Concomitant medications included colecalciferol (VITAMIN D); gabapentin (MANUFACTURER UNKNOWN); promethazine (MANUFACTURER UNKNOWN); ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS); all taken for an unspecified indication, start and stop date were not reported; received within two weeks of the suspect vaccine.. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization (Lot number: RE8732; Anatomical Location: Arm Left; Dose Number: 1) on 03Apr2021 at 27-years-old. On 25Apr2021 at 02:30, the patient experienced: woke up with extreme nausea in middle of the night (2:30 am) and passed out/fainted in the restroom. Unsure of how long episode lasted. (medically significant); with no treatment taken. The clinical outcome of the events was recovered on an unspecified date. The patient was not tested for COVID post vaccination. No follow-up attempts are possible. No further information is expected.

Other Meds: VITAMIN D [COLECALCIFEROL]; GABAPENTIN; PROMETHAZINE; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS

Current Illness:

ID: 1299290
Sex: F
Age:
State: MA

Vax Date: 03/25/2021
Onset Date:
Rec V Date: 05/08/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: received 1st dose of vaccine on 25Mar2021 and then contracted COVID-19; received 1st dose of vaccine on 25Mar2021 and then contracted COVID-19; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 25Mar2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received her first dose of the vaccine on 25Mar2021 and then contracted COVID-19 on an unspecified date in 2021. She was taken out of ICU the day before her second dose was due to be given on 15Apr2021 and she was released from the hospital shortly after. She was hospitalized from an unspecified date in 2021 to Apr2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1299291
Sex: F
Age:
State:

Vax Date: 01/01/2020
Onset Date: 04/01/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Pneumonia; Cold; Fatigue; Pain in arm/Sore arm; This is a solicited report from the based on the information received by Pfizer from (Mfr. Control No. : 21K-163-3861208-00). A contactable consumer (patient) reported that a 39-year-old female patient received bnt162b2 (Pfizer Covid-19 Vaccine), intramuscular in Apr2021 (lot number unknown, expiration date unknown because the packaging was discarded) as single dose for Covid-19 Vaccination; adalimumab (HUMIRA), subcutaneous from 01Jan2020 (Batch/Lot number was not reported) to Apr2021, at unspecified dose for Moderate To Severe Rheumatoid Arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date with outcome of recovered, fatigue and pain in arm/sore arm in Apr2021 with outcome of recovered in Apr2021, and cold on an unspecified date (reported as 2020/2021) with outcome of recovered. The last action taken in response to the events for adalimumab was permanently withdrawn in Apr2021. COVID-19 Vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (Adalimumab): The reporter's causality for the events with Humira (Adalimumab) was no reasonable possibility. Causality for bnt162b2 (Pfizer Covid-19 Vaccine): Not Reported The reporter's assessment of the causal relationship of the events with the Pfizer suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on a compatible temporal association and known product safety profile, there was a reasonable possibility that the reported events of fatigue and pain in arm were related to BNT162B2 vaccine. The events pneumonia and cold are attributed to intercurrent medical conditions that were not related to BNT162B2 vaccine.

Other Meds:

Current Illness:

ID: 1299292
Sex: M
Age:
State: UT

Vax Date: 04/01/2021
Onset Date: 04/04/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: This is a spontaneous report from a contactable consumer (patient's husband). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscular, administered in Arm Right on 01Apr2021 14:00 (Lot Number: ER8727) as SINGLE DOSE for COVID-19 immunization. The patient previously took BNT162B2 (lot number: EN6198) in the right arm via intramuscular dose 1 on 10Mar2021 14:00 for COVID-19 immunization at 52 years old and experienced passed out, fell to floor and was unresponsive for multiple minutes, syncope, feeling of nausea and lightheadedness before passing out and mild sore arm. The patient's medical history and concomitant medications were not reported. Three days post vaccination, the patient experienced dizzy potential syncope on 04Apr2021 20:00, BP was 115/70 and heart rate: 48 bpm. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1299293
Sex: U
Age:
State: UT

Vax Date: 04/05/2021
Onset Date: 04/01/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: bloodclots in my leg and lungs; bloodclots in my leg and lungs; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose, dose 2 via an unspecified route of administration on 05Apr2021 for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient experienced blood clots in the leg and lungs in Apr2021 within days of receiving the second dose. The clinical outcome of blood clots in the leg and lungs were unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1299294
Sex: F
Age:
State:

Vax Date: 04/09/2021
Onset Date:
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: blacked out; fatigue; dizziness; nausea/vomiting; nausea/vomiting; symptoms like food poisoning; Hit a pole while driving; This is spontaneous report based on the information received by Pfizer. A contactable consumer reported for herself. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient was blacked out on an unspecified date with outcome of unknown , had fatigue on an unspecified date with outcome of unknown , dizziness on an unspecified date with outcome of unknown , nausea/vomiting on an unspecified date with outcome of unknown , symptoms like food poisoning on an unspecified date with outcome of unknown , hit a pole while driving on an unspecified date with outcome of unknown. The event blacked out was considered an Important Medical Event. Course of the event: Patient stated she got her Covid (Pfizer) vaccine on 09Apr2021 she experienced fatigue, dizziness, nausea/vomiting, symptoms like food poisoning was able to move around few days later but she got very dizzy, blacked out and hit a pole while driving. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1299295
Sex: F
Age:
State: FL

Vax Date: 04/09/2021
Onset Date: 04/09/2021
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the back kind of by the lungs; She has been sick; Her mental status was also affected; What scared her was not feeling like she was getting enough oxygen; Nausea; Body pain/flu-like body pain in her muscles over her shoulders; Out of it; Pain in her back where her lungs are; Problems breathing/Her breathing still almost feels labored; Hot and cold sweats; Dizzy; Shaky; Weak; Tired; Headache; Anxious; Fever; Itchy; Arm hurt; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A 61-year-old female patient received first dose BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:00 (Batch/Lot Number: TW0151) as SINGLE DOSE for covid-19 immunization. Medical history included cancer, pneumonia, pain in her lungs, smoker and arthritis. The patient's concomitant medications were not reported. The patient experienced what scared her was not feeling like she was getting enough oxygen on an unspecified date, problems breathing/her breathing still almost feels labored on 11Apr2021, arm hurt on 09Apr2021, pain in her back where her lungs are on 11Apr2021, hot and cold sweats on 10Apr2021, dizzy on 10Apr2021, shaky on 10Apr2021, nausea on 13Apr2021, body pain/flu-like body pain in her muscles over her shoulders on 11Apr2021, out of it on 11Apr2021, weak on 10Apr2021, tired on 10Apr2021, headache on 10Apr2021, anxious on 10Apr2021, fever on 10Apr2021, itchy on 09Apr2021, feeling like maybe there is something wrong with her spleen on an unspecified date, the pain is in the left side of the back kind of by the lungs on an unspecified date, she has been sick on an unspecified date, her mental status was also affected on an unspecified date. Patient had the first dose of the Covid Vaccine on 09Apr2021 and gradually her arm hurt, she had hot sweats, she felt dizzy, was shaky, had nausea, and had body pain. The one thing she is concerned about was she had pain in her back where her lungs are and she was having problems breathing. She has a little bit of that still. She has also been out of it. Her breathing still almost feels labored, and this past weekend she thought she would go to the emergency room. Her main concern is this awful pain in her back while she was having problems breathing and getting enough oxygen. She felt weak, dizzy, and shaky. She got scared. She has been sick, she had cancer a long time ago. What scared her was not feeling like she was getting enough oxygen. The pain is in the left side of the back kind of by the lungs. It goes directly from the front to the back. On Monday it started feeling better. Today it is so much better. She will feel like she is not getting enough oxygen or giving a full breath and then this in her back. She remembers having pneumonia years ago and having pain in her lungs. That's why she knows the pain is in the back of her lungs. She has to say she is a smoker. She slowed down and couldn't smoke this week or during that. She kind of quit, that's her reality now. The pain comes and goes throughout the day but it is not as bad. She didn't have this shortness of breath and other things until a couple days after she got the vaccine. It gradually came up on her. She was not having trouble breathing, it was more slightly labored. It was not profound, just there. Sometimes when she is speaking after a while she gets tired and will have to take a moment and take a deep breath. It is so much better. She called her primary care physician and was anxious, and all he said was she would feel effects for 2 weeks. He wasn't very helpful. Her arm hurt the day that she had the shot. Even today there are little bits of pain but very light. 09Apr2021 through 11Apr2021 was when everything really hit. It was hard to lift up her arm. It was a little pain, it was no big deal. She would have the AC on and blast it when she had the hot and cold sweats. She was using napkins because she was sweating profusely. It felt like she obviously had a reaction to the vaccine. It's normal she guesses. She didn't expect it for the first dose. The 11th, 12th, 13th, and 14th it was really bad. Her whole body was sweating and would get wet. She'd be hot and then cold. She was anxious because she was having problems breathing. She still gets a little bit of hot and cold sweats, but nothing compared to what she went through. As the days go on she is slowly getting better. She was dizzy not just during the day, at night she couldn't sleep because of it. She has gradually gotten better. Yesterday she tried to do some gardening but felt so weak she had to come back inside. When she gets up she feels weak and a little bit of lack of air. She has labored breathing. She was real itchy. The shakiness, dizziness, and anxiety all came on and were horrible. She doesn't know if the nausea was because she couldn't eat and had to take her regular medication. It was very light nausea. She had flu-like body pain in her muscles over her shoulders. Her headache was major too during all of this. The headache is something that comes and goes still. It is a weird kind of headache. She had a fever and got like flu all over body pain. She doesn't know how to explain how she felt out of it. She doesn't know if it was the fact she was so sick. She had a feeling of did she do that. She couldn't make decisions. She would need to take the garbage out and go back to the garbage and think what did she come here for. Her mental status was also affected. The weakness gradually got really bad, and she still hasn't recovered from it. She still feels weak and tired when trying to do things. She was tired the day after she got the vaccine. The first day she thought it was nothing and she was fine. Gradually it got real bad when she was sick. She didn't feel that flu-ish feeling but was weak and tired. She got dizzy and she had the brain fog thing. She was having really bad headaches during the same time. The weakness and tiredness go hand in hand. She takes a mineral for her thoracic spine, but she takes that more for elderly arthritis. She doesn't have any conditions that she thinks played a role. She has been feeling like maybe there is something wrong with her spleen. Took Tylenol for her fever. Mentioned fever would go away and come back. The patient underwent lab tests and procedures which included body temperature: 102, 99 and 100.1 (unit unspecified) all on unspecified dates. Therapeutic measures were taken as a result of fever and itchy. Outcome of the event problems breathing/her breathing still almost feels labored, arm hurt, pain in her back where her lungs are, hot and cold sweats, dizzy, out of it and headache was recovering. Outcome of the event fever was recovered on 13Apr2021, itchy was recovered with sequelae on 14Apr2021, body pain/flu-like body pain in her muscles over her shoulders was recovered on 16Apr2021, nausea was recovered on 16Apr2021, shaky was recovered on 19Apr2021. Outcome of the event weak and tired was not recovered. Outcome of all the other events was unknown.

Other Meds:

Current Illness:

ID: 1299296
Sex: M
Age:
State: GA

Vax Date: 04/05/2021
Onset Date: 04/19/2021
Rec V Date: 05/08/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: got Bell's palsy, On the right side of his face; This is a spontaneous report from a non-contactable consumer. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0150, first dose) solution for injection intramuscular on 05Apr2021 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient got Bell's palsy, on the right side of his face on 19Apr2021 with seriousness criteria of hospitalization. Treatment for the event Bell's palsy included prednisone at 20 mg tablet, 3 tablets by mouth daily; and acyclovir 800 mg tablet, orally one tablet by mouth 5 times daily for 10 days from 19Apr2021. The outcome of the event Bell's palsy was not recovered.

Other Meds:

Current Illness:

ID: 1299297
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 04/05/2021
Rec V Date: 05/08/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Guillain Barre Like syndrome; bilateral lower extremity weakness with foot drop; bilateral lower extremity weakness with foot drop; This is a spontaneous report received from a contactable physician. A 70-year-old male patient received first dose of BNT162B2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown) via unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient had no past drugs, and no concomitant medications were reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 05-Apr-2021, patient was hospitalized due to Guillian Barre Like syndrome, stroke work up negative, bilateral lower extremity weakness with foot drop and LP was noncontributory. Patient was being treated with Corticosteroids for the events and was improving. Outcome of all the reported events were resolving. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Gullain Barre syndrome, muscular weakness and peroneal nerve palsy and the suspect drug. 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: 1299298
Sex: F
Age:
State: TX

Vax Date: 03/18/2021
Onset Date: 03/20/2021
Rec V Date: 05/08/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP7534 and expiration date was not reported), via an unspecified route of administration in right arm on 18Mar2021 at 17:00 (at the age of 56 years) at single dose for COVID-19 immunization at pharmacy or drug store facility. Medical history included arthritis. Concomitant medications included ibuprofen, vitamin D, magnesium and DoTerra Bone Heal from an unknown date for an unknown indication. The patient was not a pregnant. 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 and since the vaccination, the patient was not tested for COVID-19. The patient experienced subarachnoid hemorrhage-aneurysm on 20Mar2021 at 08:00. The patient was hospitalized for this event on an unspecified date in 2021 and discharged within 16 days. It was unknown whether the patient received the treatment or not for this event. The outcome was recovering at the reporting time.

Other Meds: IBUPROFEN; VITAMIN D NOS; MAGNESIUM

Current Illness:

ID: 1299299
Sex: F
Age:
State: FL

Vax Date: 03/16/2021
Onset Date:
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Pneumonia; Heart attack; Cancer; COPD; Got sick; Headache; This is a spontaneous report from a contactable consumer received via Pfizer sponsored program support. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose on 16Mar2021 and she got sick, heart attack, cancer, chronic obstructive pulmonary disease (COPD), and pneumonia. At the time of report the patient has a headache. The 2nd dose schedule will be on 27Apr2021 and wanted to know if she should go and take the 2nd shot because the doctor's office she went to was unsure if they are open. The outcome of the events was unknown. Information on the lot/ batch number has been requested

Other Meds:

Current Illness:

ID: 1299300
Sex: M
Age:
State: FL

Vax Date: 04/15/2021
Onset Date:
Rec V Date: 05/08/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: His eyes didn't look good and could not see after his first dose.; His eyes didn't look good and could not see after his first dose.; This is a spontaneous report from a Pfizer- sponsored program received from a contactable consumer (patient's wife) reported for a male patient (reporter's husband). A male patient of an unspecified age received first dose of BNT162B2 (BNT162B2), via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced his eyes didn't look good and could not see after his first dose. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm