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: 1191765
Sex: M
Age: 61
State: IN

Vax Date: 04/01/2021
Onset Date: 04/09/2021
Rec V Date: 04/10/2021
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: Fist day,Headache,dizziness, fatigue,soar throat an coughing. Second day Headache,soar throat an coughing.

Other Meds:

Current Illness:

ID: 1191766
Sex: F
Age: 71
State: CO

Vax Date: 03/01/2021
Onset Date: 03/22/2021
Rec V Date: 04/10/2021
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: none

Symptom List: Anxiety, Dyspnoea

Symptoms: Exactly 3 weeks after my first shot (2/9/21) I had severe arthritis pain and was unable to walk for a number of days. Exactly 3 weeks after my second shot (3/1/21) I had a reaction of being dizzy and nauseous and unable to get out of bed for 3 days. Both times I just waited it out.

Other Meds: No prescription drugs supplements: Omega 3 turmeric-curcumin red yeast rice

Current Illness:

ID: 1191767
Sex: F
Age: 36
State: OR

Vax Date: 04/08/2021
Onset Date: 04/08/2021
Rec V Date: 04/10/2021
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: Not that I am aware of

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

Symptoms: At 15 mins I was released. As I drove away from the clinic, 20 mins, I was flooded but a wave. My heart started pounding, my throat and mouth were tingling and tightening, my face and ears turned red and flushed. At about 45 mins, I became extremely dizzy like I was intoxicated . My mouth and throat kept tightening and tingling in waves. My skin was itchy and red in patches. I felt like I was having a stroke on the right side of my face. My right eye and face felt odd. Over the night and next days, my chest was tight on the left side and pain in my left arm and sharp stabbing pain in my left back and side. The next day I had heavy chest and shortness of breath and remained dizzy.

Other Meds: Multi vitamin

Current Illness: Not that I am aware of

ID: 1191768
Sex: M
Age: 34
State: CA

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

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

Lab Data:

Allergies: nkda

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: shortly after receiving moderna had clamminess and dizziness. resolved after laying supine and receiving water

Other Meds:

Current Illness:

ID: 1191769
Sex: F
Age: 56
State: CA

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 04/10/2021
Hospital:

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

Lab Data:

Allergies: none

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

Symptoms: I was vaccinated with the first dose of the Pfizer vaccine on March 25. I am typically a very fit and healthy individual . I am 57 years old. After receiving my shot I was sick for over 12 days with exhaustion, runny nose, shortness of breath, coughing, headaches, nausea. I finally started feeling somewhat better about 2 days ago but I am still experiencing a great deal of exhaustion and shortness of breath. I am scheduled for the second dose on April 15th next week. I am extremely concerned about what this second shot will do to me. Should I skip the second shot?

Other Meds: none

Current Illness: no

ID: 1191770
Sex: F
Age: 64
State: AL

Vax Date: 04/07/2021
Onset Date: 04/07/2021
Rec V Date: 04/10/2021
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: Boniva Sudafed

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

Symptoms: Nausea, Headache, Weakness, Dizziness, Sweating, chills, skin sensitivity, sound sensitivity, smell sensitivity, hypotension, reduced appetite, nose bleed, pain in right eye, difficulty speaking, sore arm.

Other Meds: none

Current Illness:

ID: 1191771
Sex: F
Age: 29
State: WA

Vax Date: 04/08/2021
Onset Date: 04/08/2021
Rec V Date: 04/10/2021
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: N/A

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: A pt came in to get a second dose of COVID-19 vaccine. I usually verify the pt?s DOB and name then ask when and what kind of vaccines he/she received to be sure. But I got distracted because, when I verified her DOB, she got upset since the tech who helped her didn?t fix her DOB. I had to fix it myself. Then when I came back, she told me she had a dental appointment. I totally forgot to ask her what she had as her first dose and gave her Moderna since I only had the Moderna with me at that time. When I tried to sign the COVID-19 Vaccination Record Card, I noticed that she received Pfizer-BioNTech. I explained to her that she received Moderna by mistake. I also told her that since both mRNA vaccine products are engineered with the same technology, she might not need to repeat the second dose. And I observed her for about 30 minutes. I told her that I would find out if she needed to repeat it. I contacted the Immunization Action Coalition and they told me that as long as the pt had received mRNA COVID-19 vaccine products, pt would not need to repeat a dose. They also sent me the CDC info on this recommendation. But the CDC guideline is not clear to me since she received the two doses 21 days apart, not 28 days. So I emailed a vaccine expert at the CDC, who I usually email whenever I have an immunization question. I called the pt around 2 pm (two hours after vaccination) and she seemed to be doing fine at that time. I gave her my cell phone number and told her to call me if she had any concerns. I talked to her today and she told me that she called out since she was very tired. I will follow up with her again.

Other Meds: N/A

Current Illness: N/A

ID: 1191772
Sex: F
Age: 66
State: AR

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

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

Lab Data:

Allergies: n/a

Symptom List: Pharyngeal swelling

Symptoms: After getting vaccine, I walked to the waiting area and sat down. After a few minutes my vision started getting strange and got worse for several minutes. In my peripheral vision I could see colors and patterns seeming to move and melt. Psychedelic. Very bad in my right eye, but also could see it in my left eye. Didn't check them by closing one, I was just trying to figure out what was happening to me. I could still read straight ahead. I stayed 10 minutes past my 15 min waiting period & felt well enough to leave. It probably took 1-2 hrs total before my vision seemed back to normal. No other symptoms after that. Researching on the internet I found kaleidoscope vision which seemed to describe it perfectly. Second dose did not produce any problems.

Other Meds: n/a

Current Illness: none

ID: 1191773
Sex: F
Age:
State: AZ

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 04/10/2021
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: my gums were slightly inflamed or puffy, particularly the upper gums; Left side of face slightly swollen/left side of face was slightly puffy; full muscular control of my face; Polyneuropathy symptoms were stirred up; Throat felt slightly itchy; Left upper forearm pain; Pain upper arm; This was a spontaneous report from a contactable consumer, the patient. A 57-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6205), via an unspecified route of administration in left arm on 06Mar2021 at 08:11 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing seasonal allergy, asthma (very mild), polyneuropathy from Aug2020 and ongoing, anxiety, and sinusitis. Patient was tested positive for Covid in Jan, she tested positive on 14Jan2021. This was a mild case and antibodies were confirmed afterwards. It was 7 weeks after she tested positive that there were confirmed positive antibodies. Concomitant medications included bupropion (MANUFACTURER UNKNOWN); gabapentin (MANUFATURER UNKNOWN), guaifenesin, pseudoephedrine hydrochloride (SUDAFED) (MANUFACTURER UNKNOWN) and Wilson's Wash (MANUFACTURER UNKNOWN). The patient previously took theophylline for asthma and experienced swelling face and pharyngeal swelling. On 06Mar2021, the patient experienced throat felt slightly itchy, left upper forearm pain, pain upper arm. On 09Mar2021, the patient experienced polyneuropathy symptoms were stirred up. On 12Mar2021, the patient experienced full muscular control of my face, at 05:30 she experienced left side of face slightly swollen/left side of face was slightly puffy. On 14Mar202, the patient experienced my gums were slightly inflamed or puffy, particularly the upper gums. It was reported that patient received the 1st dose on 06Mar2021 and Friday on 12Mar2021, when woke up, the left side of face was slightly puffy, face looked normal and had full muscular control of face, but it just went form the jaw all the way to the eyelid only on the left side. On 14Mar2021, gums were slightly inflamed or puffy, particularly the upper gums. Patient called neurologist the next day, 15Mar2021, went to see him on Thursday to have him take a look. He confirmed there was no muscular damage, but the left side of my face when poked was duller than the right side. It started 2 weeks ago today, it hasn't gotten worse and hasn't gotten better. Patient was scheduled to get 2nd dose this Sunday but going to hold off because she was concerned about this side effect. Patient tried using Claritin and Benadryl to see if that might make it go away, but it didn't. Her face does not look disfigured in any way. It's not getting worse or better. Just staying the same. She also has polyneuropathy. She got it in Aug2020 from a needle biopsy of the lymph node in her left breast. It was supposed to decrease over time over one or two years. Prior to having Covid she didn't think about it most days. When she got Covid it stirred up the symptoms. When she got the vaccine it also stirred up the polyneuropathy symptoms. She started to notice it being stirred up 09Mar2021. Her neurologist said it was her immune system working and it was aggravating it. On 12Mar2021, she had the left face thing, which was completely new, she never had symptoms like that. It has been 2 weeks and hasn't gotten worse, hasn't gotten better. She was super healthy. She doesn't drink, doesn't smoke, and exercises every day. On the needle biopsy last year by the radiologist in Aug2020. She got small fiber polyneuropathy, which causes tingling prickly sensations in different parts of the body. It was acute form and will go away in a year or two. By Jan it had minimized, but Covid stirred up the symptoms. The neurologist said any illness can cause polyneuropathy symptoms to increase. Then they started to subside. When she got the vaccine, by that Tuesday the polyneuropathy symptoms were greatly aggravated, by the 09. She was confident that they would resolve and have lessen in severity. The clinical outcomes of the left side of face slightly swollen, throat felt slightly itchy was not resolved, for the throat felt slightly itchy, left upper forearm pain was resolved on 06Mar2021, for the pain upper arm was resolved on 07Mar2021 and for event Polyneuropathy symptoms were stirred outcome was resolving. No follow-up attempts are possible. No further information was expected.

Other Meds: BUPROPION; GABAPENTIN; SUDAFED [GUAIFENESIN;PSEUDOEPHEDRINE HYDROCHLORIDE]

Current Illness: Asthma (asthma (very mild)); Polyneuropathy; Seasonal allergy

ID: 1191774
Sex: M
Age:
State: TX

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 04/10/2021
Hospital: Y

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: Weakness; dizziness; cold; seizure; This is a spontaneous report from a contactable consumer reporting for himself. A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 22Mar2021 10:45 (Lot Number: EN6205) as single dose for COVID-19 immunisation. Medical history included Heart stent. There were no known allergies to medications, food, or other products. Concomitant medications included atorvastatin; cyanocobalamine; loratadine (LORADINE); metoprolol, all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Weakness, dizziness, cold, seizure on 22Mar2021 16:45. The events resulted in Emergency room/department or urgent care and hospitalization. The patient was hospitalized for Weakness, dizziness, cold, seizure for 2 days. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included COVID test Nasal Swab post vaccination: negative on 25Mar2021. Therapeutic measures were taken as a result of events which included Anti seizure meds.

Other Meds: ATORVASTATIN; CYANOCOBALAMINE; LORADINE; METOPROLOL

Current Illness:

ID: 1191775
Sex: M
Age:
State: NC

Vax Date: 03/25/2021
Onset Date: 03/26/2021
Rec V Date: 04/10/2021
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: I cannot urinate although I feel I need to / painful and no urine; I cannot urinate although I feel I need to / painful and no urine; This is a spontaneous report from a contactable consumer (patient himself). A 56-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported) via an unspecified route of administration in right arm on 25Mar2021 13:30 as a single dose for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. He did not have allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but received other medications (unspecified) within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient stated "I cannot urinate although I feel I need to. Very painful and no urine" on 26Mar2021 14:00. No treatment was received for the events. Outcome of the events was not recovered. The patient had not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1191776
Sex: F
Age:
State: FL

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 04/10/2021
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: ringing in her ears; Blood pressure went up; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown) at the age of 84-years-old, via an unspecified route of administration on 19Feb2021 at 11:30 at single dose for COVID-19 immunization. Medical history included high blood pressure diagnosed 3-5 years ago and ongoing and blood clots (reported as blood thinner) from an unspecified date and ongoing. Concomitant medications included rivaroxaban (XARELTO) from 2020 and ongoing as blood thinner, metoprolol from 2018 and ongoing for high blood pressure, amiodarone from 2020 and ongoing for high blood pressure, and ongoing normal supplement. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263) at the age of 84-years-old, via an unspecified route of administration in left arm on 22Jan2021 at single dose for COVID-19 immunization. On 19Feb2021 at 15:30, four hours after the second dose of the COVID vaccine, the patient started having ringing in her ears and it has not gone away. It was like a truck in her head, she felt like she was losing her mind, it was driving her insane. She could not live like this; it was the worst thing in the world. Her blood pressure went up. She went to the ER for the ringing in ears and had to stay for 2 days at the hospital because they saw a blip on her EKG and it turned out to be nothing. She was hospitalized from 19Feb2021 to 21Feb2021. She has seen 3 doctors. One of them recommend a stress test which was done on 2021 and it was ok. She went to the doctor's office and they thought she had fluid, but it was not there; the neurologist said there was nothing they could do. With regards to treatment for ringing in hears, first, she stated nothing, she did not know what to do. She has gone to 3 doctors and one of them prescribed prednisone but that did not help. She had to take an MRI yesterday (25Mar2021) because they wanted to make sure her brain was okay, and it was all normal. The outcome of the event ear ringing was not recovered and unknown for all other events. Information on the lot/batch number has been requested.

Other Meds: XARELTO; METOPROLOL; AMIODARONE

Current Illness: Blood pressure increased (diagnosed 3-5 years ago); Clot blood

ID: 1191777
Sex: F
Age:
State: NY

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 04/10/2021
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: Weight: Gained 25lbs; Arm is slightly tender; arm might get a little stiff; excruciating leg cramping going from her buttock down behind her knee and rolling to the inside of her thigh/the same pain occurred on the opposite leg around noon and lasted for 15 minutes; excruciating leg cramping going from her buttock down behind her knee and rolling to the inside of her thigh/the same pain occurred on the opposite leg around noon and lasted for 15 minutes; the inside of her thighs were a little red on the side, both legs from her thighs to her knees; the shot is already fogging her mind; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of NT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 08:30 (Lot Number: ER8727; Expiration Date: 31Jul2021, at age of 69 years old) at a single dose for covid-19 immunization. Medical history included allergies: Penicillin, Ampicillin, hair color product. The patient's concomitant medications were not reported. She was allergic to Penicillin, and Ampicillin. As a child, always reacted strongly to any vaccination she was given with a fever and flu like symptoms for a couple of days. With Ampicillin, she thought she was having a heart attack. Was told to stop Ampicillin immediately because she could get a heart attack. This was when she was 25 years old and she never went to the ER. She was allergic to a hair color product in the 1990s and it made her scalp itch really badly. Was given a cortisone shot, which she reacted immediately breaking out head to toe in hives. Has no NDC/LOT/EXP for the vaccinations she reacted strongly to as a child. Stated this was in the 1950s or early 1960s. Clarified she did not have a heart attack with Ampicillin, but it felt like she was having one. Has had cardiograms per her request and her heart and heart walls are perfect. The patient received the first dose of the Covid vaccine at 8:30 a.m. this morning on 26Mar2021. Caller reports around 11 a.m., she experienced excruciating leg cramping going from her buttock down behind her knee and rolling to the inside of her thigh, states that the pain lasted 15 minutes. The patient reports the same pain occurred on the opposite leg around noon and lasted for 15 minutes, states that "the pain was so excruciating that she could barely stand up and it was so agonizing it was unbelievable." The patient noticed that the inside of her thighs were a little red on the side, both legs from her thighs to her knees. The patient states that she has not been in the sun, and didn't think it was anything alarming, but this is abnormal for her, states that she received the vaccine in the right arm and her upper torso is fine and her head is clear, asked if anyone else had reported this reaction. She was planned to received the second dose on 16thApr in the early afternoon. The patient stated the COVID shot was already fogging her mind. The patient felt pretty good after first shot. Felt nothing. Fifteen minutes before leaving the diner she got a leg cramp. Was sitting in a booth and didn't think much of it. Attributed it to the way she was sitting. Around 11AM when she got back to her garage, she was in agony. It hurt from the top of her rear all the way down the side to the back of her knee and rolled to the inside of her thigh. She was in such agony and didn't know if she could get out of her chair and walk. By the time she reached her apartment it has subsided. An hour later, same thing happened in the left leg. She was laying in bed and texting because she didn't' know if she would get any other reaction. This leg cramp was even worse. She was in tears. Got off bed to try and walk it off. Initial leg cramp happened in right leg. Was excruciating. Both times it lasted for 15 minutes. Both cramps were from her buttocks, all down to her knees, and rolled over into her thigh. Didn't know if that was a reaction. It is not typical of anything written on Pfizer's information or that she had heard. She was concerned. Heard about blood clots, but not with this particular product. Stated second leg cramp subsided. If it hadn't, she wouldn't have gone to the ER. Leg cramps was so excruciating. Originally thought it was coincidental and stated she will be 70 on (Date withheld). To say she has never had leg cramps before would be a lie. The way the leg cramps were timed was kind of weird. It was absolutely the same kind of cramp and location just on the a different leg. Weight: Gained 25lbs. Doesn't have COVID or any symptoms. Tested three to four months ago and was negative. Received first dose COVID-19 Vaccine today, 26Mar2021, at 08:30AM. First leg cramp began 11:00AM in right leg. Second leg cramp began Noon in left leg. Each time lasted 15 minutes. Not having leg cramps right now. Could barely talk when having leg cramps. Was worried about getting clots in legs. Otherwise she would think it was because she was getting older. She doesn't get leg cramps very often. Doesn't know when the last time she had leg cramps prior to today. Nurse technician at vaccine faculty stated caller's allergy history wouldn't be a problem and she only had to sit for 15 minutes. Received the COVID-19 Vaccine and hardly felt it. Waited for 15 minutes. She was fine until 11AM. She was fine now, but her arm might get a little stiff tomorrow. Arm was slightly tender. Surprised she felt something in her legs. Doesn't know whether to associate it with COVID-19 Vaccine or not. Has nothing to complain about in the upper torso or from the waist up. Wants to know if this is a reaction or coincidence. Stated she expected to have a stiff arm. The outcome of the event "Cramps in legs" and "pain" was recovered on 26Mar2021. The outcome of other events was unknown.

Other Meds:

Current Illness:

ID: 1191778
Sex: F
Age:
State: MA

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 04/10/2021
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: Very difficult to fall asleep that evening; Passed out in bed; nausea/queasy; simultaneously had diarrhea and vomiting (several times in a row).; simultaneously had diarrhea and vomiting (several times in a row).; headache; Slept all day; sore arm; chills; very tired; Fever about 100.5/temp now almost 101; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613) via unspecified route of administration in left arm on 23Mar2021 09:30 AM at single dose for COVID-19 immunization. Medical history included prone to bronchitis with bad cold. Known allergies included strong reactions to oxycodone hydrochloride;paracetamol (PERCOCET), zolpidem tartrate (AMBIEN) and some anesthesias. Patient did not have COVID prior vaccination, did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. Concomitant medications included rosuvastatin, loratadine, ergocalciferol (VIT D) and multi-vitamin. The patient previously received first dose of BNT162B2 (lot number: EN6205) in left arm on 01Mar2021 09:30 AM for COVID-19 immunization. Evening of the shot on 23Mar2021 07:30 PM, patient experienced sore arm, chills, later and very tired. Fever about 100.5. Middle of night, about 16-17 hrs after shot (24Mar2021) awoke with nausea. Rose to go to bathroom and simultaneously had diarrhea and vomiting (several times in a row). Extreme tiredness and nausea. About 4:30 took 2 paracetamol (TYLENOL) and anti-nausea med. Passed out in bed on 24Mar2021. Woke about 11:30 AM. temp now almost 101, headache, paracetamol and more anti-nausea med. Slept all day until 10:45 PM 24Mar2021 fever normal, nausea gone, quite tired still. On 25Mar2021, patient was able to get up, still tired but so much better, stomach still queasy. Ate bit of toast, later, rice and applesauce. Bit of headache took paracetamol. Very difficult to fall asleep that evening (25Mar2021), awoke 26Mar2021 and fell so much better although stomach still a bit queasy. Treatment was received for all events. Patient had not tested COVID post vaccination. The outcome of events was recovering.

Other Meds: ROSUVASTATIN; LORATADINE; VIT D

Current Illness:

ID: 1191779
Sex: M
Age:
State:

Vax Date: 03/05/2021
Onset Date: 03/01/2021
Rec V Date: 04/10/2021
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: got covid; got covid; This is a spontaneous report from a contactable consumer (patient's daughter). Same reporter reported similar events for two patients (father and Mother). This case is for her father. A 88-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 05Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient's daughter stated that her dad received the first dose of the vaccine on 05Mar2021. After the first dose he got covid on an unknown date in Mar2021. The patient's daughter wanted to know when they can get the second dose. The outcome of the events was unknown. Information related lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021345764 same drug/event, different patients

Other Meds:

Current Illness:

ID: 1191780
Sex: F
Age:
State: AZ

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 04/10/2021
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: Blurred vision/focus issues/can't focus visually/couldn't see right; floaters; left arm and leg went numb; Both arms and legs tingly; felt disoriented; cold chills; Legs and arm felt heavy; my eyes are now having esophoria convergence Excess or vergance dysfunction; my eyes are now having esophoria convergence Excess or vergance dysfunction; my eyes are now having esophoria convergence Excess or vergance dysfunction; This is a spontaneous report from a contactable consumer (patient). A 38-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 18Mar2021 11:45 (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included allergies to Penicillin and no other medical history. The patient had no COVID prior vaccination. The patient was no pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID); cetirizine hydrochloride (ALLERTEC); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); ascorbic acid (VITAMIN C); ergocalciferol (VITAMIN D). There was no vaccine in four weeks. The patient stated that right after she drove off, Blurred vision/floaters, left arm and leg went numb. Both arms and legs tingly, felt disoriented, cold chills, had to pull the car over because she couldn't see right. Legs and arm felt heavy. Blurred vision & focus issues had continued and the eye doctor said her eyes were now having esophoria convergence Excess or vergance dysfunction. She still can't focus visually since she drove off from the vaccine. She had to go to the doctor today & they were going to schedule a neurologist appointment to make sure she didn't have a mini stroke. It had been extremely scary since she received it. All events occurred on 18Mar2021 12:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Treatment received for the events and she needed glasses with a prism and neurologist appointment. The patient had no COVID tested post vaccination. The outcome of the events was not recovered.

Other Meds: SYNTHROID; ALLERTEC; ADDERALL; VITAMIN C [ASCORBIC ACID]; VITAMIN D [ERGOCALCIFEROL]

Current Illness:

ID: 1191781
Sex: M
Age:
State: FL

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 04/10/2021
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: passed out/unconscious; feel weak; dizzy; not normal; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in arm left on 26Mar2021 09:45AM (Lot Number: ER8730) as single dose for COVID-19 immunisation. The patient had COVID prior vaccination. The patient had no other medical history or known allergies. The patient's concomitant medications were reported as none. The patient did not have COVID test post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After taking the vaccine the patient waited for 15 minutes prior to departing the facility in order to make sure there was no adverse reactions. At approximately 10:15 10:30 AM the patient drove back home. After driving for about five minutes while stopped at a traffic light the patient completely passed out at 10:45, he was unconscious for approximately 2 to 3 minutes, almost crashed his car and EMT support had to be called. The patient regained his conscience but it took him over a half hour to feel 50% better. Until 8:30 PM 26Mar2021, the patient still felt weak and dizzy and not normal. No treatment was received for events. The outcome of events was recovering.

Other Meds:

Current Illness:

ID: 1191782
Sex: F
Age:
State: OR

Vax Date: 03/24/2021
Onset Date: 03/24/2021
Rec V Date: 04/10/2021
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: Seizure like events; Began sputtering; My shoulder and neck seized up; Eyes rolled back in her head and she had no control over it; Did not remember some of it; Confused; Unable to focus with her eyes; Extreme fatigue; Walking is unsteady; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 59267-1000-03), via an unspecified route of administration, administered in left arm on 24Mar2021 16:45 as single dose for COVID-19 immunization. Medical history included asthma, bronchitis, anxiety, allergy to Aspirin, NSAIDs, agave, soy, and dairy. The patient has no history of COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not COVID tested post vaccination. Concomitant medications included venlafaxine and progesterone taken for an unspecified indication. On 24Mar2021, 19:30, the patient experienced seizure like events. She began sputtering, her shoulder and neck seized up, eyes rolled back in her head and she had no control over it and did not remember some of it. It happened twice in a row. She had been confused, unable to focus with her eyes, extreme fatigue, and her walking was unsteady. The adverse event resulted in Emergency room/department or urgent care. The patient received treatment for the events. The patient was requested for testing and referral for neurologist for MRI. The patient has not recovered from the events. Follow up attempts are possible. Further information is expected.

Other Meds: VENLAFAXINE; PROGESTERONE

Current Illness:

ID: 1191784
Sex: M
Age:
State:

Vax Date: 03/23/2021
Onset Date: 03/24/2021
Rec V Date: 04/10/2021
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: Dizziness; upset stomach; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 23Mar2021 at 07:30 (at the age of 40-years-old) at a single dose for COVID-19 immunization. Medical history included hypertension. Concomitant medications included losartan, metoprolol, omeprazole (PROTONIX) and citalopram. The patient previously received Keflex and experienced allergies. Patient didn't 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 has not been tested for COVID-19. The patient experienced dizziness and upset stomach on 24Mar2021 at 06:00. No treatment was given for the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: LOSARTAN; METOPROLOL; PROTONIX [OMEPRAZOLE]; CITALOPRAM

Current Illness:

ID: 1191785
Sex: M
Age:
State: NY

Vax Date: 03/21/2021
Onset Date: 03/21/2021
Rec V Date: 04/10/2021
Hospital: Y

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: Bell's Palsy; administered in the left leg; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727, expiry date: unknown), via an unspecified route of administration, administered in the left leg, on 21Mar2021 09:45, as single dose, for COVID-19 immunization. The patient medical history was not reported. The patient did not have COVID-19 prior to vaccination. There were no concomitant medications (no other medications in two weeks). The patient did not receive other vaccines in four weeks. On 22Mar2021, the patient experienced Bell's palsy. This event required hospitalization for 2 days (unspecified dates). Treatment included steroids. The patient underwent COVID Nasal Swab and tested negative on 22Mar2021. The outcome of the event Bell's palsy was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1191786
Sex: F
Age:
State: AK

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 04/10/2021
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: decreased hearing; Allergic reaction which included hives; Mild vasovagal reaction; itchy throat; Allergic reaction which included hives, itchy throat, eyes, nose, and ears, and hives; fast heart rate; flushing; lightheaded; itchy throat, eyes, nose, and ears; itchy throat, eyes, nose, and ears; itchy throat, eyes, nose, and ears; This is a spontaneous report from a contactable other HCP (patient). A 39-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 39-year-old via an unspecified route of administration, administered in Arm Left on 26Mar2021 17:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included asthma, allergies, inflammatory bowel disease. There was no COVID prior vaccination, no other vaccine within 4 weeks prior to the COVID vaccine, and no COVID tested post vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA); lisdexamfetamine mesilate (VYVANSE); breo all within 2 weeks of vaccination. The patient experienced allergic reaction which included hives, itchy throat, eyes, nose, and ears; mild vasovagal reaction which included flushing, fast heart rate, lightheaded, and decreased hearing all on 26Mar2021 17:15 and resulted in Doctor or other healthcare professional office/clinic visit. Treatments included antihistamines and steroids. The events outcome was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association and profile of the product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the contributory role of the suspect product is possible.

Other Meds: ALLEGRA; VYVANSE

Current Illness:

ID: 1191787
Sex: M
Age:
State: KY

Vax Date: 03/08/2021
Onset Date: 03/15/2021
Rec V Date: 04/10/2021
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: Tested positive; This is a spontaneous report received from contactable consumer. A 66-years old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch EN6198 and expiry date: Unknown) via an unspecified route of administration on 08Mar2021 for covid-19 immunisation. Relevant medical history and concurrent conditions included Pre-diabetic and Blood pressure high from unknown date and ongoing is unknown. Concomitant medication included proprietary medicinal product name: Unspecified medication for Blood pressure. On 15Mar2021 patient tested positive for covid after taking the first shot of the Covid19 vaccine. Reporter wanted to know whether the next dose cane be taken or not as per scheduled date which was on the 28 of March. The events outcome was unknown. Follow up letter has been generated information on batch/lot number was available.

Other Meds:

Current Illness:

ID: 1191788
Sex: F
Age:
State: NY

Vax Date: 03/23/2021
Onset Date: 03/26/2021
Rec V Date: 04/10/2021
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: Woke up on 3rd morning with excruciating hip pain, unable to bend; Woke up on 3rd morning with excruciating hip pain, unable to bend; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 2) via an unspecified route of administration, administered in left arm on 23Mar2021,15:00 (batch/lot number: unknown) at 62 years old as SINGLE DOSE for COVID-19 immunization. The vaccine was administered in Other vaccination facility. The patient's medical history included MGUS (Monoclonal gammopathy of undetermined significance), Ehlers Danlis syndrome 3, and iodine allergy; all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Concomitant medications included clarithromycin (CLARI), estradiol (ESTROGEN), progesterone (PROGESTERONE), methylphenidate hydrochloride (RITALIN), and testosterone (TESTOSTERONE); therapy dates and indications for all were unspecified. The patient previously received the first dose of the BNT162B2 via an unspecified route of administration, administered in left arm on 02Mar2021 17:00 (batch/lot number: unknown) at 62 years old as single dose for COVID-19 immunization. Patient did not receive other vaccination within 4 weeks prior to the BNT162B2. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 26Mar2021 07:00, the patient woke up on 3rd morning with excruciating hip pain, unable to bend. It was unknown if patient received treatment as a result of the event. The patient has not recovered from the event. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: CLARI; ESTROGEN; PROGESTERONE; RITALIN; TESTOSTERONE

Current Illness:

ID: 1191789
Sex: F
Age:
State:

Vax Date: 01/17/2021
Onset Date:
Rec V Date: 04/10/2021
Hospital:

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: got COVID after first dose of the vaccine; got COVID after first dose of the vaccine; This is a spontaneous report received from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on 17Jan2021 (Batch/Lot Number: EM0477) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer COVID-19 vaccine on 17Jan2021, then she got COVID on an unspecified date after the vaccine and has not received second dose at this time. She wanted to know where she can get the second dose, she knows she is over due for the second dose, was supposed to be received on 15Mar2021. Patient wanted to know if she can have her second dose after 6 weeks, local system is impossible because she got her first dose abroad. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1191790
Sex: F
Age:
State: KY

Vax Date: 03/08/2021
Onset Date: 03/17/2021
Rec V Date: 04/10/2021
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: Coronavirus test positive; This is a spontaneous report received from a contactable consumer (reported for herself) via the Pfizer sponsored program. A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6198, expiry date not reported), via an unspecified route of administration on 08Mar2021 as single dose for covid-19 immunization. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient's concomitant medications included unspecified medication; patient mentioned as taking concomitant products as yes, as patient have hypothyroidism. The patient was tested positive after taking the first shot of the Covid19 vaccine. Patient was just wondering if she will get the next dose on 28Mar2021. Patient was tested positive (Covid test) on the 17Mar2021; also reported as Coronavirus test positive. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1191791
Sex: M
Age:
State: VA

Vax Date: 01/29/2021
Onset Date: 02/06/2021
Rec V Date: 04/10/2021
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: Metastatic melanoma most likely a recurrence from the 2014; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration, administered in left arm on 29Jan2021 13:00 (at 37-year-old) at single dose for COVID-19 immunization. The vaccine was administered at military base. Medical history included stage 1b malignant melanoma lesion removed from right shoulder in 2014. The patient was not diagnosed with COVID-19 prior to vaccination. None known allergies to medications, food, or other products. Concomitant medications included multivitamins [VITAMINS NOS]; fish oil. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had a stage 1b malignant melanoma lesion removed from his right shoulder in 2014 and had completed all required follow-up. On 06Feb2021 06:00 PM, about a week after receiving the first dose (left arm), patient noticed a small marble-sized lump in his right armpit. The lump continued to grow rapidly, and he went to the doctor, after a biopsy and scans it was confirmed to be metastatic melanoma, most likely a recurrence from the 2014 melanoma. The patient received the second dose on 18Feb2021 (left arm) and noticed the lump in his right armpit grew much faster and he had a reaction (swollen nodes) in his left armpit as well. The melanoma was limited to his right armpit. They were reporting the event because of the timing of the melanoma recurrence in conjunction with the vaccination and because they are investigating the biopsy/pathology of the tumor in the right axilla as there were features, they had never seen before in melanoma. The event was reported as non-serious. It resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event included immunotherapy. The outcome of the event was not recovered. Since the vaccination, the patient has not been tested for COVID-19.

Other Meds: MULTIVITAMINS [VITAMINS NOS]; FISH OIL

Current Illness:

ID: 1191792
Sex: F
Age:
State: CA

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 04/10/2021
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: Blood pressure went up; Heart Rate exceeded 100 beats a minute five minutes after the injection; This is a spontaneous report from a contactable other hcp (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included asthmatic from an unknown date and unknown if ongoing. The patient don't have heart problems or blood pressure problems. The patient's concomitant medications were not reported. The patient experienced heart rate exceeded 100 beats a minute five minutes after the injection and blood pressure went up on an unspecified date in Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was hospitalized for 1 day due to the events. Therapeutic measures were taken as a result of the events which included Heart monitor/ IV for flushing. The patient did not recover from the events. Information about lot/batch has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events "Blood pressure went up" and "Heart Rate exceeded 100 beats a minute five minutes after the injection" cannot be completely excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1191793
Sex: F
Age:
State: CT

Vax Date: 03/15/2021
Onset Date: 03/01/2021
Rec V Date: 04/10/2021
Hospital:

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: chest heaviness; having a hard time breathing; throat very scratchy; due to her allergies; lips swollen; "windpipe is shutting off" and "esophagus is closing; "windpipe is shutting off" and "esophagus is closing; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received bnt162b2 (BNT162B2), second dose via an unspecified route of administration on 15Mar2021 at single dose for COVID-19 immunization. Medical history included bronchitis in the past. The patient's concomitant medications were not reported. The patient stated she "felt good" from that 15Mar2021 to 17Mar2021. She stated on 18Mar2021 she started experiencing heaviness in her chest and stated she was having a hard time breathing, and stated that on 26Mar2021 it was the same thing. She stated that her chest felt "Almost like bronchitis" as she stated she had bronchitis in the past. She reported that her throat was "very scratchy" and that it felt like her "windpipe was shutting off" and "esophagus was closing." The patient made a noise like she was clearing her throat and stated that that "helps it go away." She also reported that her lips are a little swollen, but stated this may be due to her allergies and stated she had taken a loratadine (CLARITIN) in the morning of 27Mar2021 for that. She reported that her head was fine, her temperature was 97.2, and her blood pressure was fine. She would like to know how long these side effects are expected to last. She spoke with her son who told her that these were side effects of the vaccine. She really did not want to go to the emergency room and reported she had tried to call her doctor but was on hold for a while. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1191794
Sex: F
Age:
State: NY

Vax Date: 01/26/2021
Onset Date: 02/01/2021
Rec V Date: 04/10/2021
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: losing hair pretty rapidly/ hair loss/ Telogen Effluvium; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), dose 1,on 26Jan2021 14:15 (Batch/Lot number was not reported), dose 2 on 16Feb2021 (Batch/Lot number was not reported); both via an unspecified route of administration, administered in left arm at the age of 48 years old as single dose for covid-19 immunization. The facility type vaccine: Home/Facility. The patient medical history includes borderline HPB and borderline high blood sugar due to PCOS. The patient was not pregnant. No vaccines were given 4 weeks prior. The patient has no COVID-19 prior to vaccination. Concomitant medication included losartan and metformin. On 01Feb2021, the patient noticed that she was losing hair pretty rapidly. She went to her primary care physician and had bloodwork completed which all came back normal. She then went to a dermatologist who felt there may have been a link between the vaccine and her hair loss. The dermatologist diagnosed her with Telogen Effluvium on 25Mar2021. The event resulted to doctor or other healthcare professional office/clinic visit and no treatment was given. The event was reported to have caused disability or permanent damage. The patient had COVID-19 test PCR nasal swab on 23Mar2021 and the result was negative. The outcome of the event was recovering. Information on about lot/batch number has been requested.

Other Meds: LOSARTAN; METFORMIN

Current Illness:

ID: 1191795
Sex: F
Age:
State: TX

Vax Date: 03/24/2021
Onset Date: 03/25/2021
Rec V Date: 04/10/2021
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: eye had a hemorrhage - it got worse the next day; I feel light headed; head/face is tingly/cold; head/face is tingly/cold; eye had a hemorrhage - it got worse the next day; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female non-pregnant patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Mar2021 at 08:30 AM (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included gastric bypass from Jul2018, high blood pressure prior to gastric bypass but has had regular BP (blood pressure) since then, and allergy to penicillin. The patient's concomitant medications were not reported. The patient previously received the first dose of the same vaccine in left arm on 03Mar2021 at 08:30 AM for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 05:00 PM, a day after she received the Pfizer vaccine (2nd dose), her eye had a hemorrhage - it got worse the next day (26Mar2021). She felt light headed and head/face was tingly/cold. Took her blood pressure and it's in a normal range (109/77 111/77). She spoke with a relative that was a nurse practitioner and was advised hemorrhage could be related to vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the events. The outcome of the events was not resolved. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination. Information about batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 1191797
Sex: M
Age:
State:

Vax Date: 03/09/2021
Onset Date:
Rec V Date: 04/10/2021
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: peripheral neuropathy; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced peripheral neuropathy on an unspecified date with outcome of unknown. The patient received the 1st dose of the vaccine on 09Mar2021. He mentioned that he had peripheral neuropathy and had read on a website that people experienced new or worsened neuropathy after getting 2nd dose of the vaccine. He was scheduled for his 2nd dose on 30Mar2021 but was considering to not get it because of the articles he had read. He was asking for any live documentation on Neuropathy outside of the clinical trials. The case was assessed as non-serious. No follow up attempts needed. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1191798
Sex: F
Age:
State:

Vax Date: 02/25/2021
Onset Date:
Rec V Date: 04/10/2021
Hospital: Y

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: neck pain; arm pain; 3 troponin levels at 200/203/204; chronic LBBB; PAF; This is a spontaneous report from a contactable nurse (reporting for mother). A 92-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) dose 2 via an unspecified route of administration on 25Feb2021 as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 taken for COVID-19 immunisation. The patient was admitted to the hospital with neck/arm pain with 3 troponin levels at 200/203/204. Echo did not show wall motion abnormalities. Could she have had a delayed inflammatory process causing her symptoms? Myocarditis. There was no indication of an acute MI: EKG showed chronic left bundle branch block (LBBB). She did develop paroxysmal atrial fibrillation (PAF) on day 2, lasting only 12 hours. The outcome of events was unknown. Events were reported as non-serious. Information about the Lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1191799
Sex: F
Age:
State:

Vax Date: 03/18/2021
Onset Date: 03/01/2021
Rec V Date: 04/10/2021
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: pressure in her ears; right ear was burning; almost passed out; dizzy; hot; couldn't hear everything sounded really far away; had impaired thinking, couldn't think straight; no concentration for two days straight; had buzzing in her ears and heightened sounds; pins and needles sensation in her feet that went up to her legs/on day 9 the pins and needles sensation seems to be in her hands and arms as well; This is a spontaneous report received from a contactable consumer (patient). A 35-year-old female patient received 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on 18Mar2021 at age of 35-year-old at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated she received the first dose of the Pfizer COVID vaccine on 18MAR 2021. She stated ten minutes after the vaccine on 18Mar2021 she became dizzy, hot, almost passed out, couldn't hear everything sounded really far away. Patient stated this lasted for 20 minutes. Patient stated she also had impaired thinking, couldn't think straight and no concentration for two days straight. She stated she also had buzzing in her ears and heightened sounds for three days. She stated she had pins and needles sensation in her feet that went up to her legs. She stated on day 9 the pins and needles sensation seems to be in her hands and arms as well. Patient stated yesterday (26Mar2021) her right ear was burning and today (27Mar2021) she has pressure in her ears in addition to the pins and needles sensation. Events were reported as non-serious. Patient would like to know if her symptoms have been reported or are normal. She would like to know how long will her symptoms last and if they are permanent. She would like to know if she should receive the second dose of the vaccine. She would like to know what treatment she should have for her symptoms. She would like to know if there were any reports of autoimmune diseases being diagnosed after receiving the vaccine. She would like for someone to notify her if any information or data becomes available regarding the side effects she has mentioned that were not mentioned in the FactSheet. No information in PI regarding impaired thinking, loss of hearing, heightened hearing, pins and needles in extremities, and burning and pressure in ears. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. No information in PI regarding autoimmune disorders being diagnosed after receiving Pfizer COVID vaccine. Outcome of dizzy, hot, almost passed out, couldn't hear everything sounded really far away was recovered on 18Mar2021, of had impaired thinking, couldn't think straight, no concentration for two days straight, buzzing in her ears and heightened sounds for three days was recovered in Mar2021, of the other events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1191800
Sex: M
Age:
State: CO

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 04/10/2021
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: nasal and chest congestion; nasal and chest congestion; Severe dyspnea; tiredness; wheezing; coughing; headache; fever-like symptoms; injection site soreness; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient received 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration at arm left on 20Mar2021 at 14:00 at age of 25-year-old at single dose for COVID-19 immunisation. Medical history included severe asthma, rhinitis, allergies to grapseed, beans and legumes. Concomitant medications included budesonide, fluticasone propionate (FLOVENT), omeprazole, tiotropium bromide (SPIRIVA), levosalbutamol hydrochloride (XOPENEX). There was no other vaccine in four weeks. Patient experienced severe dyspnea, nasal and chest congestion, tiredness, wheezing, coughing, headache, fever-like symptoms, injection site soreness; all on 20Mar2021 at 02:45 PM. The events were reported as resulting in doctor or other healthcare professional office/clinic visit and disability or permanent damage. There was unspecified treatment for the events. Patient didn't have COVID prior vaccination. Patient was not tested COVID post vaccination. Outcome of the events was not recovered. Information on batch/lot number was requested.

Other Meds: BUDESONIDE; FLOVENT; OMEPRAZOLE; SPIRIVA; XOPENEX

Current Illness:

ID: 1191802
Sex: M
Age:
State: GA

Vax Date: 03/25/2021
Onset Date: 03/27/2021
Rec V Date: 04/10/2021
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: injection site pain; joint pain; headache; dizziness; This is a spontaneous report from a contactable consumer (patient). A 52-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm Left on 25Mar2021 09:30 (Lot Number: EN6207) as single dose for covid-19 immunization. Medical history included overweight. There were no concomitant medications. The patient did not receive other medications within 2 weeks of vaccination and 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. The patient experienced injection site pain, joint pain, headache, dizziness on 27Mar2021 12:00. No treatment received for the events. The report was non-serious. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1191803
Sex: F
Age:
State: NY

Vax Date: 03/23/2021
Onset Date: 03/24/2021
Rec V Date: 04/10/2021
Hospital:

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: I fainted and my heart rate was 144 which is extremely high; I fainted and my heart rate was 144 which is extremely high; I had woken up in a sweat, had 103.6 fever.; I had woken up in a sweat, had 103.6 fever.; After fainting I threw up and continue to not feel good; After fainting I threw up and continue to not feel good; I also had a bad headache; This is a spontaneous report from a contactable consumer (patient). A 23-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated that, "The 24th, the day after my shot. I had woken up in a sweat, had 103.6 fever. I fainted and my heart rate was 144 which is extremely high. After fainting I threw up and continue to not feel good. I also had a bad headache and continue to have one." The adverse event result in Doctor or other healthcare professional office/clinic visit. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was not resolved. No follow-up attempts are needed. No further information is expected; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1191804
Sex: M
Age:
State: LA

Vax Date: 02/01/2021
Onset Date: 02/04/2021
Rec V Date: 04/10/2021
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: Central Retinal Vein Occlusion; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: El9261), via an unspecified route of administration administered in left arm on 01Feb2021 (at the age of 71-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Medical history included high blood pressure, premature ventricular contractions (PVC's), and cholesterol. The patient has a known allergy with meclizine. Concomitant medications included acebutolol, aspirin [acetylsalicylic acid] (ASPIRIN), atorvastatin, valsartan, and unspecified vitamin. On 04Feb2021, the patient experienced central retinal vein occlusion. Therapeutic measures were taken as a result of central retinal vein occlusion which included intravitreal avastin injection. The patient had not yet recovered from the event.

Other Meds: ACEBUTOLOL; ASPIRIN; ATORVASTATIN; VALSARTAN

Current Illness:

ID: 1191805
Sex: U
Age:
State: NJ

Vax Date: 02/02/2021
Onset Date: 03/18/2021
Rec V Date: 04/10/2021
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: interval between two doses were 18 days; interval between two doses were 18 days; Tested Positive for COVID; Covid-19 test result was positive; Taste of coffee was different; Stuffy nose; This is a spontaneous report from a contactable consumer. A 49-year-old patient of an unspecified gender received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, formulation: solution for injection) via an unspecified route of administration on 02Feb2021 (Lot Number: EL9264) as single dose for covid-19 immunisation. Historical vaccination included patient received first dose of BNT162B2, Lot Number: EL8982 on 15Jan2021 for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included Covid-19 test result was positive on 20Mar2021. On an unspecified date, the patient tested positive for covid, interval between two doses were 18 days, stuffy nose on 18Mar2021 and taste of coffee was different on 19Mar2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1191806
Sex: M
Age:
State: VA

Vax Date: 03/27/2021
Onset Date: 03/27/2021
Rec V Date: 04/10/2021
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: Red blood in stool after 2nd dose of vaccine; This is a spontaneous report from a contactable consumer (patient himself). A 51-year-old male gender patient started to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: ER8732) via an unspecified route of administration in the left arm on 27Mar2021 at 15:00 (at the age of 51-years-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took BNT162B2(lot number: EN6955) via an unspecified route of administration in the left arm on 06Mar2021 15:00 at single dose for COVID-19 immunization. The patient experienced Red blood in stool after 2nd dose of vaccine on 27Mar2021. Patient did not receive any treatment. The outcome of event was recovering.

Other Meds:

Current Illness:

ID: 1191807
Sex: M
Age:
State: FL

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 04/10/2021
Hospital:

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: fever; Feeling Unwell; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient's wife) reported a male patient of an unspecified age received first and second dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: unknown, Expiry Date: unknown), via an unspecified route of administration on 01Mar2021 and 22Mar2021 respectively at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fever and feeling unwell. The reporter stated her husband got both of the doses for COVID 19 vaccine and he was experiencing an adverse event like fever and feeling unwell. His first dose was taken last 01Mar2021 and the second dose took last 22Mar2021. She also mentioned that if her husband can take Tylenol. The outcome of event was unknown. Follow-up activities have been completed and Information related to lot/batch no. has been requested.

Other Meds:

Current Illness:

ID: 1191808
Sex: F
Age:
State: FL

Vax Date: 03/22/2021
Onset Date: 03/26/2021
Rec V Date: 04/10/2021
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: Very heavy menstrual bleeding; lots of blood clotting; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 22Mar2021 at 05:45 PM (17:45), at a single dose, for COVID-19 immunization. The patient's medical history included allergies to penicillin. The patient's concomitant medications included collagen, krill oil, and ethinylestradiol/ etonogestrel (NUVARING). 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 most recent COVID-19 vaccine was administered in a pharmacy or drug store. On 26Mar2021, the patient had a very heavy menstrual bleeding which she had never experienced prior; there was no cramping but lots of blood clotting. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the event. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

Other Meds: COLLAGEN; KRILL OIL; NUVARING

Current Illness:

ID: 1191809
Sex: M
Age:
State: NC

Vax Date: 03/21/2021
Onset Date: 03/23/2021
Rec V Date: 04/10/2021
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: numbness of the left heel within two days of the shot; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 21Mar2021 08:45 (Batch/Lot Number: EP7534), at the age of 67-years at vaccination, as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received dose 1 of the vaccine on Feb2021 on left arm (lot number: EN6202). It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. On 23Mar2021 10:00, the patient experienced numbness of the left heel within two days of the shot (disability). The patient underwent lab tests and procedures which included blood work: unknown result on 26Mar2021. The outcome of the evet was not recovered. Therapeutic measures were taken as a result of the event. Since the vaccination, the patient has not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 1191810
Sex: M
Age:
State: MI

Vax Date: 03/18/2021
Onset Date: 03/19/2021
Rec V Date: 04/10/2021
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: they had a ultrasound done and found out I had a number of clots in that position; a sore Leg, Upper part of the left calf 2 inches below the knee on the backside; This is a spontaneous report from a contactable consumer. A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 15:00 (Batch/Lot Number: En6207) as SINGLE DOSE for covid-19 immunisation. Medical history included Treatable Acid reflex, anxiety and mild depression. Concomitant medications included omeprazole, buspirone and alprazolam for unspecified indication. Patient had the Covid shot on 18Mar2021 at about 3 PM the next morning (on 19Mar2021 06:00) patient woke up with a sore Leg, Upper part of the left calf 2 inches below the knee on the backside. After it did not go away, he went to the doctor then they had a ultrasound done and found out he had a number of clots in that position. Treatment received for the adverse event includes they put patient on a blood thinner. Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, the patient has been tested for COVID-19. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Mar2021. Covid test post vaccination done via nasal Swab, They had the results in 15 minutes, covid test result Negative, ultrasound scan: clots in that position on 19Mar2021 found out, had a number of clots in that position. Outcome of the events was recovering.

Other Meds: OMEPRAZOLE; BUSPIRONE; ALPRAZOLAM

Current Illness:

ID: 1191811
Sex: F
Age:
State: CO

Vax Date: 03/18/2021
Onset Date: 03/19/2021
Rec V Date: 04/10/2021
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: feeling almost to pass out; lightheaded/dizzy; extreme confusion; cognitive issues (more than 'brain fog'); cognitive issues (more than 'brain fog'); nausea; weak to the point of needing to sit down often; break out in sweat a couple of times daily; arm hurt; I am not confident to drive and am having difficulty performing my dailing routine; This is a spontaneous report from a contactable consumer (patient). This 64-year-old female patient (Patient was not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown), via an unknown route on 18Mar2021 at 13:30 PM (at the age of 64-years-old) at single dose on the left arm for COVID-19 immunization. Relevant medical history included neutropenia. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient was perfectly well prior to vaccine administration. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She did not receive any other medications within 2 weeks of vaccination. On 19Mar2021 at 14:30 PM, she has been lightheaded and dizzy to the point of feeling almost to pass out. She had extreme confusion/cognitive issues (more than brain fog) and nausea. She was weak to the point of needing to sit down often and break out in sweat a couple of times daily. Her arm hurt for a couple of days but that has resolved. She was not confident to drive and having difficulty performing her dailing routine. The patient was concerned about ever recovering and receiving the second dose. No treatments were given for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The outcome of the event arm hurt was recovered in Mar2021 while the outcome of the remaining events was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1191812
Sex: M
Age:
State: FL

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 04/10/2021
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: Evening of second shot, developed fever of 101/I had a low grade fever; body aches/body aches during the entire time.; overall feeling ill; dry cough; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number was en6202) via an unspecified route of administration, administered in left arm on 06Mar2021 at 15:45 (at the age of 56-years-old) at a single dose for COVID-19 immunization. Medical history included glaucoma and hypertension. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received any other medications within 2 weeks of vaccination. Patient had no allergies to medications, food or other products; Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was en601) administered on left arm on 13Feb2021 at 15:45, single dose for COVID-19 immunization. The patient reported that on the evening of second shot, on 06Mar2021, he developed fever of 101, body aches, and overall feeling ill. This went on for two weeks. He had a low grade fever and body aches during the entire time. There were days that he spent in bed. The patient also mentioned that he developed a dry cough. No treatment was received for the events. The outcome of the events was recovered with lasting effects (recovered with sequel).

Other Meds:

Current Illness:

ID: 1191813
Sex: F
Age:
State: SC

Vax Date: 03/03/2021
Onset Date: 03/01/2021
Rec V Date: 04/10/2021
Hospital:

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: pain over her heart area; pain in the right shoulder where she got the shot; Pain in the right shoulder; pain in the right shoulder travels down the right arm. It goes down the shoulder and down the arm; tooth ache; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EN6198, via an unspecified route of administration administered in right arm (shoulder) on 03Mar2021 10:00 at single dose for COVID-19 immunisation. Medical history included diabetes, blood pressure abnormal, thyroid problems, fall (fell a couple of years ago), and trouble with her shoulder (prior to getting the vaccine). She reported that she did have some trouble with her shoulder prior to getting the vaccine. She fell a couple of years ago and the doctor's x-rayed it and thought it was pulling away from the bone. They didn't have to do surgery. She was completely over that and it had resolved before getting the vaccine. Patient has no additional vaccines administered on same date of the Pfizer suspect. Patient has no prior vaccinations within 4 weeks. Concomitant medications included metformin hydrochloride, sitagliptin (JANUMET) taken for diabetes from an unspecified start date and ongoing (been taking it a long time over 20 years); glipizide taken for diabetes, start and stop date were not reported (been taking it a long time over 20 years); losartan taken for blood pressure from an unspecified start date and ongoing (been on it about 10 years, her blood pressure is in between and it doesn't bother her a lot, it is not really high or low); and thiamazole (METHIMAZOLE) taken for thyroid problem from an unspecified start date and ongoing (been on it about ten years). Patient was calling because she had her first Pfizer shot about three weeks ago. About three days after on 06Mar2021, she developed pain in the right shoulder where she got the shot. It has been bothering her up until this time. She also had a pain over her heart area. The pain over her heart area occurred when she was breathing it. That has gone away. She had her second shot today and she was trying to explain to the doctor what happen to the right shoulder. He said the shot had to be in the other shoulder and he put it in the left shoulder in the bone. It hit the bone. She hollered because it hurt so bad. He said no one ever jumped like that before. She jumped because it hurt. She still has the pain in the right shoulder, but she doesn't feel anything in the left where she got it today. She clarified Pfizer shot as COVID19 vaccine. The pain in the right shoulder travels down the right arm. It goes down the shoulder and down the arm in Mar2021. She got first and second dose. She got the first dose of COVID19 vaccine on 03Mar2021. Pain in the right shoulder: it felt like her toothache has something to do with the pain in the shoulder. The toothache came on a little later (Mar2021) than the pain in the shoulder. The tooth ache is still ongoing, but it has improved. Pain over heart area: It started at the same time as with the pain in the right shoulder. The pain over the heart stopped about a week ago. She thinks she has recovered completely. She didn't have anything done for the heart pain. She got the second dose today, 25Mar2021, lot number: ER8733, Expiry date: unknown. The outcome of the events 'pain over her heart area and pain in the right shoulder travels down the right arm/it goes down the shoulder and down the arm' was recovered, event tooth ache was recovering, and events 'pain in the right shoulder where she got the shot (vaccination site pain) and pain in the right shoulder' was not recovered.

Other Meds: JANUMET [METFORMIN HYDROCHLORIDE;SITAGLIPTIN]; GLIPIZIDE; LOSARTAN; METHIMAZOLE

Current Illness:

ID: 1191814
Sex: F
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 04/10/2021
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: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable female consumer(patient) via Pfizer Sponsored Program. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included asthma. The patient's concomitant medications were not reported. The patient tested positive for covid-19 on an unspecified date and experienced drug ineffective. She was wondering if she should still take the Covid-19 vaccine 2nd shot scheduled next day. She had her 1st dose of the vaccine 3 weeks ago. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unknown date. Outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1191815
Sex: F
Age:
State: NE

Vax Date: 03/18/2021
Onset Date: 03/19/2021
Rec V Date: 04/10/2021
Hospital:

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: it's 10 times worse than when I normally used to have periods.; it's way heavier than ever and I just noticed the little lump on my collar bone this morning; I don't normally get my period because I continuously take my pills and I have been bleeding ever since the next day; I have been bleeding ever since the next day and I found a lump on my collar bone, I found a marble sized lump on my collar bone that keeps moving around; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 46-years-old via an unspecified route of administration, administered in arm left on 18Mar2021 (Batch/Lot Number: ER2613) as single dose for covid-19 immunisation. Medical history included allergy from an unknown date. Concomitant medications included montelukast taken for hypersensitivity, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for hypersensitivity, start and stop date were not reported; birth control pills and multivitamins. The patient reported that she got her first shot of the Pfizer Covid vaccine on 18Mar2021 and since then she don't normally get my period because she continuously take her pills and she have been bleeding ever since the next day and she found a lump on her collar bone, she found a marble sized lump on her collar bone that keeps moving around. The period started on 19Mar2021 still goin and it's way heavier than ever and she just noticed the little lump on her collar bone this morning. Her birth control was either Drospire /Ethestr /Lev tab (for further clarification) and she takes it one pill a day. She called her gynecologists yesterday since she was bleeding and they told her to stop taking it the birth control until Sunday and then restart it that's the only thing. She was still experiencing the event and it's 10 times worse than when she normally used to have periods. The patient did not recover from menstrual cycle abnormal and bleeding menstrual heavy while unknown for the other events.

Other Meds: MONTELUKAST; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1191816
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 03/08/2021
Rec V Date: 04/10/2021
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: I got the first shot, I had COVID and I got like a severe reaction almost like COVID again; I got the first shot, I had COVID and I got like a severe reaction almost like COVID again; This is a spontaneous report from a contactable consumer reporting for herself. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6204, expiry date Jun2021), via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history included Blood pressure high, diagnosed with COVID-19 earlier since 23Dec2020. Concomitant medications were not reported. Patient stated, "I just have a question I do not sure you could even answer, I got the first shot, I had COVID and I got like a severe reaction almost like COVID again (on 08Mar2021), I was wondering you know I have been reading maybe you do not need second vaccination if you had a strong antibody reaction." Due date of second shot was reported as 29Mar2021. Treatment for the event included taking Tylenol at 325mg. The outcome of the event was resolved in Mar2021.

Other Meds:

Current Illness:

ID: 1191817
Sex: M
Age:
State:

Vax Date: 03/24/2021
Onset Date: 03/25/2021
Rec V Date: 04/10/2021
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: Developed Left lower extremity DVT 24 hours after vaccine; This is a spontaneous report from a non-contactable Physician. A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unknown route, on 24Mar2021 (at the age of 59-year-old) at a single dose for COVID-19 immunisation. Relevant medical history included hypertension (HTN), diabetes mellitus (DM) and hyperlipidemia (HLD). The patient did not have history of deep vein thrombosis (DVT) and no other risk factors. The patient was not diagnosed with COVID-19 before vaccination. No relevant concomitant medications were provided. She developed left lower extremity DVT 24 hours after vaccine, on 25Mar2021. The event required emergency room visit. The patient was treated with an anticoagulation therapy. Post vaccination COVID-19 test was not done. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information currently available, the event deep vein thrombosis was most likely due to the patient's underlying hypertension, diabetes mellitus and hyperlipidemia. However a possible contributory role of vaccine BNT162B2 to the event can not be totally excluded. Case will be re-assessed upon the additional information provided. 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:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm