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

Incidents per State

State Total
85,681
AK1,780
AL6,016
AR3,913
AS44
AZ14,319
CA63,635
CO11,967
CT8,616
DC1,723
DE1,837
FL40,797
FM3
GA15,402
GU91
HI2,419
IA4,681
ID2,699
IL21,155
IN23,471
KS4,751
KY8,153
LA5,236
MA15,083
MD12,927
ME3,231
MH8
MI19,788
MN12,591
MO9,898
MP30
MS3,026
MT2,348
NC17,122
ND1,417
NE2,985
NH3,091
NJ19,175
NM4,038
NV4,534
NY35,950
OH19,815
OK6,429
OR8,778
PA24,615
PR2,423
QM2
RI2,066
SC6,830
SD1,223
TN9,807
TX38,110
UT4,421
VA15,249
VI61
VT1,764
WA15,227
WI11,389
WV2,412
WY880
XB5
XL1
XV2

ID: 1320072
Sex: M
Age:
State: MI

Vax Date: 03/08/2021
Onset Date: 04/19/2021
Rec V Date: 05/15/2021
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Symptoms: Tested Positive for Covid19 on 19APR2021, after receiving his second dose of the Covid Vaccine on 8MAR2021.; Tested Positive for Covid19 on 19APR2021, after receiving his second dose of the Covid Vaccine on 8MAR2021.; 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), via an unspecified route of administration, administered in Deltoid Left on 08Mar2021 (Lot Number: EL9269, at age of 65 years old) and first dose on 15Feb2021 (Lot: EN6200), both as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first vaccine dose of BNT162B2 on 15Feb2021 for COVID-19 immunisation, LOT: EN6200. The patient Tested Positive for Covid-19 on 19Apr2021, was diagnosed with Covid19. The patient stated that was going to require glasses he thought when asked to read the numbers off of the vaccine card. Treatment: None. The outcome of events was recovered on 27Apr2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021484060 same drug/reporter/event, different patient

Other Meds:

Current Illness:

ID: 1320073
Sex: U
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 05/15/2021
Hospital: Y

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Symptoms: more numbness in their body after the second COVID-19 vaccine; This is a spontaneous report received from a contactable other non-HCP (healthcare professional). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation and experienced numbness in their limbs. On an unspecified date the patient experienced more numbness in their body after the second COVID-19 vaccine, which was serious for hospitalization. One of the reporter's friends was a primary care doctor, and the doctor saw the same type of reaction that the reporter had, in another patient. The caller's friend, who was a doctor, mentioned someone that had numbness in their limbs after receiving the first COVID-19 vaccine. When this person had the second COVID-19 vaccine they had more numbness in their body and now they were hospitalized. That person was having a bad reaction. The reporter did not know anything else about this patient. The clinical outcome of the event more numbness in their body after the second COVID-19 vaccine was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1320074
Sex: F
Age:
State: CA

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 05/15/2021
Hospital: Y

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Symptoms: Second blood clot that traveled to her brain which caused her to have a stroke; Blood clot in her right leg; Weight Loss from 258 pounds, down to 208 pounds, back up to 214 pounds.; She has to learn how to walk again, she is in a wheelchair now; Having Problems Swallowing from the Stoke; Speech went down to 25% and now she is at 50%, because of the Stroke; high blood pressure; slept five days; Arm was Sore; Body was Sore; Diarrhea; Slept and was Totally Exhausted; This is a spontaneous report received from a contactable consumer (husband of the patient) and a contactable other healthcare professional. This consumer reported similar events with different doses of the same product; this case refers to dose 2; only this case is serious. A 61-year-old adult female received the second dose of BNT162B2 (solution for injection, Lot EL3246 expiry information not provided) as a single dose via an unspecified route on 30Jan2021 at 13:45 (at 61-years-old) for COVID-19 immunization. Relevant medical history included ongoing seizures (1964; began at 5 years old, minor seizures; under control in 1984, possibility configuration it is the right cocktail), and wound on her left leg (that was being treated by a wound doctor for the last 7 years). Concomitant medications included gabapentin; 300mg three times a day by mouth (6am, 2pm and bedtime) ongoing from 2014 for nerves; valproate semisodium (DIVALPROEX; 500mg two tablets in the morning and one tablet at 6pm ongoing from 2010 for seizures furosemide 20mg every 48 hours (odd days); States she takes it to reduce swelling (diuresis)on the leg wound leg; states he gives it to her on the odd day of the month from an unspecified date; metoprolol (50mg) one tablet twice a day (6am and 6pm), for Blood pressure management; ascorbic acid, zinc (VITAMIN C WITH ZINC; 500mg/50mg) once daily from an unspecified date for an unspecified indication; acetylsalicylic acid (ASPIRIN) 81mg once daily from an unspecified date for an unspecified indication; and pramipexole 0.5mg once daily at 6pm ongoing from an unspecified date for seizures. The patient previously received COVID-19 immunization with the first dose of BNT162B2 (solution for injection; Lot EL1284) on 09Jan2021 (at 61-years-old) and experienced arm was sore, slept for two to three-days, body was sore, and diarrhea. The consumer reported that on 30Jan2021, the patient experienced her arm was sore, her whole body was sore for about five days, she had diarrhea for five days, and she for slept five days and was totally exhausted. The consumer then reported that on 22Feb2021, she developed a blood clot in her right leg. The reporter explained that her leg swelled up and turned dark blue, almost black. The consumer reported that the patient was immediately rushed to the hospital. Caller states they did all sorts of tests and confirmed she had a blood clot in her right leg. States she was hospitalized from 22Feb2021 through 26Feb2021, so for five days. Caller states the leg went back to normal color, the swelling went down and she felt good. Caller states they came home on 26Feb2021, and she was up moving around, and everything was wonderful. On an unspecified date in Feb2021, around the time of the first blood clot, the patient was diagnosed with high blood pressure. Caller states on 12Mar2021 she had a second blood clot that traveled to her brain which caused her to have a stroke. Caller states when they got to the hospital they said she had a stroke from a blood clot that was somewhere in her system and it traveled to her brain. Caller states she was hospitalized from 12Mar2021 through 16Mar2021 when she was released from the hospital. Caller states she was too sick to go home so she was transferred to Rehab Center. She was there from 16Mar2021-27Apr2021. Caller states on 27Apr2021, she was transferred for rehab. Caller states at the center they only give rehab once a day for 30 minutes and he only works five days a week. Now she gets three hours of physical therapy a day and it is seven days a week. States they are working to get her to walk again and she is receiving speech therapy. States she has to learn how to walk again. Caller states her lowest weight was 208lbs, and they weighed her in yesterday and she was at 214lbs. Caller states with the stroke when she was at the hospital, they put her on baby food because she was having problems swallowing. While at rehab center she went from baby food to mechanical food. On 27Apr2021 she went to regular food. Speech because of the stroke went down to 25% and now she is at 50% and she is also getting one hour of speech therapy at hospital. Caller states they recognized it is important to get as much therapy as possible in the first 90 days, they call it a boot camp and patients are limited to 90 days to repair the damage. After 90 days, that is it. States that is why it was important to transfer her to hospital to heal and get back to normal. Caller states she is in a wheelchair and they are trying to get her to stand up. Caller states at the hospital they were able to get her to take 2 steps. At Hospital they were able to get her to do special training and he was able to get her to take 4 steps. Caller states he has no idea where she is with the walking right now. States she did not do anything on the 27Apr2021, because that was arrival date. Therapy started yesterday on 28Apr2021 at Hospital. The consumer also reported that the patient's current weight is 214 pounds, from 258 when she took the shot and down to 208 pounds on an unspecified date in 2021. Treatment for the events included occupational, physical and speech therapies, as well as apixaban (ELIQUIS), rivaroxaban (XARELTO), and spironolactone 25mg once a day; takes in the evening at 6:00p.m. ongoing from 12Mar2021 for hypertension. The outcome of the events arm was sore, body was sore, diarrhea, and slept and was totally exhausted and slept five days was recovered on 04Feb2021. The outcome of the event blood clot in right leg was recovered on 26Feb2021. The outcome of the event second blood clot that traveled to her brain which caused her to have a stroke was recovered with sequelae on an unspecified date in 2021. The outcome of the event Having Problems Swallowing from the Stoke was recovered on 27Apr2021. The outcome of the events speech went down to 25%, back up to 50%, and weight loss from 258 pounds, down to 208 pounds, back up to 214 pounds was recovering. The outcome of the event high blood pressure was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021484454 PFIZER (Same reporter/patient/different doses/events)

Other Meds: GABAPENTIN; DIVALPROEX; FUROSEMIDE; METOPROLOL; VITAMIN C WITH ZINC; ASPIRIN [ACETYLSALICYLIC ACID]; PRAMIPEXOLE

Current Illness: Lower limb wound; Seizures

ID: 1320075
Sex: M
Age:
State: CA

Vax Date: 03/17/2021
Onset Date:
Rec V Date: 05/15/2021
Hospital: Y

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Symptoms: developed Covid after receiving the first dose; developed Covid after receiving the first dose; This is a spontaneous report from a contactable 71 year old male consumer (patient) who reported that: Dates for developed Covid after receiving the first dose: (From: Unspecified To: Unspecified) Reporter seriousness for developed Covid after receiving the first dose: Hospitalization Dates when patient was in hospital for developed Covid after receiving the first dose: Unspecified to Unspecified Additional Context: Caller received the first dose of the Covid-19 vaccine on 17Mar2021. He was supposed to have received the second dose on 02Apr2021. After receiving the first dose he developed Covid and was in the hospital. He is now negative. He is asking when can he get the second dose? Declines to provide email address. Declines to provide further details. initially provided date of birth but then requested that his birthdate be eliminated. Communication: PC filed. Is there a Product Complaint: Yes Description of Product Complaint: Description of complaint: developed Covid after receiving the first dose Product strength and count size dispensed: Covid 19 vaccine

Other Meds:

Current Illness:

ID: 1320076
Sex: F
Age:
State: MI

Vax Date: 02/05/2021
Onset Date: 04/23/2021
Rec V Date: 05/15/2021
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Symptoms: tested positive for COVID-19 but she was asymptomatic; tested positive for COVID-19 but she was asymptomatic; This is a spontaneous report from a contactable consumer (patient's husband). A 65 year old female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 15Jan2021 at 20:30 (at the age of 64 years old) (Batch/Lot Number: EL3249) as a single dose, and dose 2 via an unspecified route of administration on 05Feb2021 at 13:00 (at the age of 64 years old) (Batch/Lot Number: EL9269) as a single dose, dose 2 for COVID-19 immunisation. Relevant medical history and concomitant medication were not provided. On 23Apr2021, the patient tested positive for COVID-19 but she was asymptomatic. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 23Apr2021. The patient did not receive treatment for the event. The outcome of the event tested positive for COVID-19 but she was asymptomatic was unknown. ; Sender's Comments: Linked Report(s) : PFIZER INC-2021483900 same drug/reporter/event, different patient

Other Meds:

Current Illness:

ID: 1320077
Sex: F
Age:
State: MO

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 05/15/2021
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Symptoms: Left calf pain started around 4/12; went to Total Access Urgent Care on 4/28 as pain had increased with minor swelling and Ultrasound showed DVT.; swelling; Ultrasound showed DVT; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 01Apr2021 (Lot Number: er8733, at age of 41 years old) as single dose for COVID-19 immunisation. The patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications included: Levonorgestrel; Pravastatin. The patient previously received Penicillin, dairy products. Left calf pain started around 12Apr2021; went to Total Access Urgent Care on 28Apr2021 as pain had increased with minor swelling and Ultrasound showed DVT (Deep vein thrombosis) in Apr2021. The adverse event result in Emergency room/department or urgent care. The patient received treatment for the adverse event: On Eliquis blood thinner for 3 months. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contribution of the suspect drug administration to the event deep vein thrombosis cannot be excluded, due to a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: LEVONORGESTREL; PRAVASTATIN

Current Illness:

ID: 1320078
Sex: F
Age:
State: CA

Vax Date: 04/03/2021
Onset Date: 04/03/2021
Rec V Date: 05/15/2021
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Symptoms: high blood pressure; chest pains; cold sore; dizzy / lightheaded; vision is blurry; tingling in hands and feet; Memory loss; experienced early period with clotting which stopped in 2-3 days then started faint spotting; Throat closure sensations; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 03Apr2021 (Batch/Lot Number: Er8734) as single dose at the age of 40-year-old for covid-19 immunisation. Medical history included allergy to amoxicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. No other medications the patient received within 2 weeks of vaccination. The patient had not received other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date the patient experienced early period with clotting which stopped in 2-3 days then started faint spotting again a day later, high blood pressure, cold sore, dizzy / lightheaded, vision is blurry, chest pains, tingling in hands and feet, memory loss. On 03Apr2021 18:00 the patient experienced throat closure sensations. The course of events was as follows: Throat closure sensations, high blood pressure, chest pains, cold sore, dizzy / lightheaded, early period with clotting which stopped in 2-3 days then started faint spotting again a day later. After 25 days, I am still dizzy and have tingling in hands and feet. Memory loss, and vision is blurry. The adverse events resulted in Doctor visit, Emergency room/department or urgent care. The events early period with clotting and started faint spotting again a day later, throat closure sensations were considered medically significant. No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.

Other Meds:

Current Illness:

ID: 1320079
Sex: F
Age:
State: NC

Vax Date: 04/26/2021
Onset Date: 04/28/2021
Rec V Date: 05/15/2021
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Symptoms: Spotting/bleeding 2 days after 2nd dose.; Spotting/bleeding 2 days after 2nd dose.; This is a spontaneous report from a non-contactable consumer (patient). A 54-year-old female patient received the second dose of BNT162B2, via an unspecified route of administration in left arm on 26Apr2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 diagnosed prior to vaccination and menopause for 2 years. Concomitant medications received within 2 weeks of vaccination included vitamins. Patient previously received the first dose of BNT162B2 for COVID-19 immunisation. Patient experienced spotting/bleeding 2 days after the second dose on 28Apr2021. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received. Outcome of the events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1320081
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date: 04/25/2021
Rec V Date: 05/15/2021
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Symptoms: blood clots, Clots were going down the back of her throat; currently feels very weak; nose bleed; This is a spontaneous report from a non-contactable consumer. This report was received via a sales representative. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose via an unspecified route of administration in Apr2021 for covid-19 immunization. The patient's medical history was not reported. The patient has been on icosapent ethyl (VESCEPA) and ibuprofen for years and currently feels very weak on 25Apr2021. Concomitant medications were unknown. The patient experienced nose bleed blood clots throughout the week on 25Apr2021. Clots were going down the back of her throat. The patient had to seek medical attention. and currently feels very weak on 25Apr2021, two weeks after vaccination. The outcome of nose bleed blood clots and weak was unknown. No follow-up attempts are possible. No further information expected.

Other Meds:

Current Illness:

ID: 1320082
Sex: F
Age:
State: FL

Vax Date: 04/23/2021
Onset Date: 04/01/2021
Rec V Date: 05/15/2021
Hospital: Y

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Symptoms: difficulty walking; difficulty with speech / slurred speech; fingers are going numb holding the phone; feels like she is coming down with a respiratory illness; nausea; vomiting; cough; sweating; headache; body pain, achy and uncomfortable; body pain, achy and uncomfortable; overall feeling badly; cognition was not there; Problems with breathing; aspirating; sleepiness; fatigue; stomach pain; her nerve response is strong/affected; swelling in hands and feet; had arm soreness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EW0162), via an unspecified route of administration in the left arm, on 23Apr2021 at 15:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing neuropathy (few years ago, at least since 2015 or 2016), seizures or epilepsy (had focal/absence seizures since a kid; not on any seizure medication, do have a neurologist), hard time with her vision, cancer from an unspecified date to an unspecified date (cancer as a teenager but has been cancer-free for a very long time), and glaucoma. The patient had a family history of cancer and heart problem. Concomitant medications included latanoprost (MANUFACTURER UNKNOWN) taken for glaucoma from Apr2021 and ongoing and gabapentin (MANUFACTURER UNKNOWN) taken for neuropathy from an unspecified start date and ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: ER8730), intramuscularly in the left arm, on 02Apr2021 for COVID-19 immunisation and experienced not very many side effects with first dose, not enough to be a problem; influenza vaccine (MANUFACTURER UNKNOWN) in 2021 (maybe) for immunisation; and polio vaccine (MANUFACTURER UNKNOWN) as a child for immunisation and experienced severe pain in her legs and she had trouble walking because of pain. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced difficulty walking and difficulty with speech / slurred speech on 23Apr2021, which required hospitalization from Apr2021 to 26Apr2021. The patient also experienced body pain, achy and uncomfortable, overall feeling badly, cognition was not there, and problems with breathing on 23Apr2021; sweating and headache on 26Apr2021; vomiting and cough on 27Apr2021; feels like she is coming down with a respiratory illness and nausea on 28Apr2021; sleepiness, fatigue, stomach pain, her nerve response is strong/affected, swelling in hands and feet, aspirating, and had arm soreness in Apr2021; and fingers are going numb holding the phone on 29Apr2021. The clinical course was reported as follows: The patient stated that she works in healthcare support and she is a first responder; she identifies as a person with a disability (unspecified). She stated that she did not have very many side effects with first dose, not enough to be a problem. By dinnertime, closer to 18:00-19:00 on 23Apr2021, she started experiencing difficulty walking and with her speech. She was concerned about having a stroke but that she is active and generally healthy. This was unusual for her and she started feeling pain through her body and overall feeling like crap. She did not expect the neurological stuff. By the end of the night on 23Apr2021, she realized she was not feeling good and went to the hospital either that night on 23Apr2021 or early the next day on 24Apr2021 and was admitted to the hospital. The patient stated that her cognition was not there, and her speech was kind of slurry, she felt like everything was slowing, and did not feel like herself. She could not get up unassisted, could not get up out of the bed, chair, or go to bathroom, and still requires the use of a walker and bedside commode, but now with the walker and assistance caller can make it to the bathroom. She also had problems with breathing, but she had a negative COVID-19 PCR test in Apr2021 both arriving to and leaving from the hospital; she did not believe them to be COVID-19 symptoms. At the hospital they did an x-ray or computerized tomography (CT) scan and a magnetic resonance imaging (MRI) on her brain in Apr2021 with unknown results. They gave her 3 or 4 intravenous (IV) unspecified medications and she had her complete blood count (CBC) labs done in Apr2021 with unknown results. There was an issue with her lungs, and she is currently waiting for her doctor to read report to see if there is an issue there. The patient stated that she never experienced anything like this after a vaccine. She cannot even get up and move around it is pretty serious. Caller states that at first when she had the symptoms, she thought she was going to wait it out, maybe her immune system is overresponding, give it a chance to resolve. She reported that she could not stand up, legs were shaking and that she had pain that was from her breasts down; felt like a ton of bricks. The patient stated that she is cognitively alert now, speaking normal. There are times it goes in waves where she feels like she can walk with walker but then a few hours later that is not the case. On Tuesday, 27Apr2021 night, the patient had a light dinner but then she was vomiting. Caller states that the pain was throughout her body and felt like someone lighting firecrackers. The patient initially stated 28Apr2021 was when the cough started, but later clarified she first noticed it on 27Apr2021, but at that time she was vomiting and thought it was due to that. However, the next day 28Apr2021, she still had this cough and that the cough was getting worse. She felt like she has a respiratory issue and has been coughing. She was not able to stay awake, even without taking any medications. She does take medications regularly but did not take the medications those days and not having medications would not cause sleepiness. She thought the doctor gave her sedative, but they did not. She states she had fatigue to the point where she was dead asleep, and nurse would come in to take vitals or do whatever and she would wake up suddenly with someone in front of her. She was sitting up with the nurse trying to read the discharge instructions and she fell asleep sitting up. She also complained of stomach pain. The patient had not been to work and not been having to use her brain and talking like she would for 8+ hours a day. She stated that the cough hurts, it feels like somebody is lighting firecrackers in her body. It also feels like this when she sneezes; the nerve response is strong. She reported that it is not a constant hacking cough, not really a dry cough; the cough is in-between productive and dry cough and cough is a bit better now and worse towards the evening. She still has swelling in her feet and hands. It looks like it has gone down a bit. She has a history of neuropathy and that her fingers are going numb holding the phone now. She got the shot in her left arm and those fingers are going numb. She was so tired and feels like did not get enough sleep. The fatigue had a slight improvement. She is more awake than when she was in the hospital. However, it depends as the day goes on, she is wiped out and has to go lay down. She stated that her nerve response is affected, and she had a difficult time with the neuro exam in Apr2021 with unknown results in the hospital. She was having an issue with her arms. She can't say anything about whether it affected her vision because she already has a hard time with her vision. She stated that she was throwing up pretty bad; the pain was really severe through her whole body while vomiting. After the vomiting stopped, the coughing got worse and she was coughing a little bit before the vomiting, but during the vomiting it was to the point she felt like she was drowning. She reported that she was vomiting through her nose and aspirating. After her MRI she started to get a really bad headache. Then when the nurse was coming to read the discharge information, she started to get sweats. She is not menopausal so she cannot blame the sweatin

Other Meds: LATANOPROST; GABAPENTIN

Current Illness: Neuropathy (few years ago, at least since 2015 or 2016)

ID: 1320083
Sex: F
Age:
State: PA

Vax Date: 03/27/2021
Onset Date: 04/11/2021
Rec V Date: 05/15/2021
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Symptoms: tested positive with few symptoms; tested positive with few symptoms/I had a mouth taste away; This is a spontaneous report from the Pfizer-sponsored program, via a contactable consumer (who reported for herself). A female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number ER8730) on 27Mar2021, via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. Medical history and concomitant medications were not reported. The On 11Apr2021, the patient experienced she got the 1st dose of the vaccine, but she stated that after 2 weeks she got tested positive with few symptoms, I had a mouth taste away. Right now she wants to ask when she will be getting the 2nd dose of the vaccine, upon probing she mentioned that on the 01May she will be getting it. The clinical outcome of the events was unknown. Information on lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1320084
Sex: F
Age:
State: CA

Vax Date: 04/28/2021
Onset Date: 04/28/2021
Rec V Date: 05/15/2021
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Symptoms: this time she began to pass out; tingly sensation in her left arm and left hand; numbing feeling; brain has a swooshy feeling; she was in a position of where she might pass out; did not feel so great; she felt weird; like she is groggy; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0170) via an unspecified route of administration on 28Apr2021 at 14:00 (at the age of 56-years-old) as a single dose in the right arm for COVID-19 immunisation. Medical history included car accident in 2019 (two years ago; she slammed her hand into the steering wheel and she was not sure if that was the injury that caused her hand to hurt like arthritis), arthritis from an unspecified date and unspecified if ongoing and history of passing when she gets shot or blood drawn as a young girl from an unspecified date and unspecified if ongoing. Medical history (including any illness at time of vaccination) and family history relevant to the adverse event were both reported as no. The patient stated that she had never had symptoms or adverse events after prior vaccinations. Concomitant (other) products were reported as no. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine or on the same date as the COVID-19 vaccine. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8737) via an unspecified route of administration on 06Apr2021 at 12:15 (at the age of 56-years-old) as a single dose in the right shoulder upper arm for COVID-19 immunisation and experienced she felt high, inflamed bursitis in the knees, could not walk, felt a little depressed, could not form words very well, she felt sleepy and her arm and her hand was hurting. On 28Apr2021 the patient experienced this time she began to pass out, tingly sensation in her left arm and left hand, numbing feeling, brain has a swooshy feeling, she was in a position of where she might pass out, did not feel so great, she felt weird and like she is groggy. The clinical course was reported as follows: The patient stated that she was supposed to wait 15 minutes after getting the second dose of the vaccine and within a few minutes she had a tingly sensation in her left arm and left hand that was more so towards the pinky and her ring finger area. She used to have a history of passing when she got a shot or blood drawn as a young girl, but as her brain had experienced this over and over again she had been fine; however, this time she began to pass out. Since she knew it was coming with the tingling, she knew it was not normal, so she immediately went and told the employees that she was in a position of where she might pass out. So, she laid down and did not feel so great, but probably 20 minutes went by and she felt weird. It took her 45 minutes to decide to sit up and then 15 minutes later she left. The tingly sensation in her left arm and left hand was gone, but she had a left-over numbing feeling. The patient also reported that her brain had a swooshy feeling, like she was groggy, and she did not want to turn her head too fast because she felt like she would not like it. Relevant tests were reported as no. The clinical outcomes of the events this time she began to pass out, tingly sensation in her left arm and left hand, she was in a position of where she might pass out, did not feel so great and she felt weird were recovered/resolved on 28Apr2021 while the clinical outcomes of the events numbing feeling, brain has a swooshy feeling and like she is groggy were not recovered/not resolved.

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Current Illness:

ID: 1320085
Sex: F
Age:
State: MT

Vax Date: 04/20/2021
Onset Date: 04/01/2021
Rec V Date: 05/15/2021
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Symptoms: tested positive for Covid; This is a spontaneous report from a contactable consumer, the patient, via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown if the patient was pregnant. On an unspecified date in Apr2021, the patient tested positive for COVID-19. Her second dose was scheduled for 11May2021 and the patient queried if she needed to reschedule her second dose. The clinical outcome of "tested positive for COVID" was unknown. Information on lot number has been requested.

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Current Illness:

ID: 1320086
Sex: F
Age:
State: NJ

Vax Date: 03/26/2021
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Rec V Date: 05/15/2021
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Symptoms: patient had aggravated the sesamoid bones in her right big toe/ Diagnosed with sesamoiditis of right foot; Pain in right big toe after first vaccine/It was stinging and burning and painful.; Pain in right big toe after first vaccine/It was stinging and burning and painful.; This is a spontaneous report from a contactable consumer (patient's mother) who reported for her daughter (patient) that a 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP6955) via an unspecified route of administration, administered in arm on 26Mar2021 as 1st dose, single for covid-19 immunisation. Medical history included having the COVID virus in Feb2021, her symptoms were mild, she lost her sense of taste and smell; patient started her period before the shots (HPV vaccine) they weren't regulated yet. Family history included cancer (patient's father). No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. Concomitant medication included unspecified pill to help regulate periods. Patient previously received first dose of HPV vaccine vlp rl1 4v (yeast) (GARDASIL) in May2011 (Lot Number: 0087Y), second dose in Jul2011 (Lot Number: 0087Z), third dose in Nov2011 (Lot Number: 06918A), all for immunization at the age of 13 years. The mother reported that she believes her daughter had an adverse reaction to the HPV vaccine. Stated that the following year they were going on a family vacation in Jun2012. She took the kids to get their annual blood work and her daughter's (patient) came back abnormal. Patient was retested and was told that she had Hashimoto's Thyroiditis in Jul2012. When patient went to high school she had a lot of problems with her menstrual cycle, her period stopped. They thought maybe it was because she was thin and played a lot of sports. Then patient was diagnosed with premature ovarian failure. Patient had started her period before the shots so they weren't regulated yet; but after the Gardasil vaccines it was worse. Stated that patient does not produce estrogen and has to take a pill; also takes a pill to help regulate her periods. No further information provided about these pills. The mother said they are worried she will have a hard time having children. Patient has periodic ultrasounds of her ovaries and has been told they look normal. The mother stated she did not want patient to get the COVID Vaccine after this experience, they believe was related to the HPV Vaccine. Stated patient was very anxious about COVID-19; worried she would give it to her parents, especially her father who has cancer. Patient had the COVID virus in Feb2021, her symptoms were mild, she lost her sense of taste and smell. The mother consulted with their family doctor who said it didn't make a difference how long patient waited after the Covid Virus to get the Covid Vaccine. Patient became eligible to receive the vaccine in Mar2021. Patient got the vaccine and about 9 days later, the mother thought she had hurt her right big toe. It was stinging and burning and painful. The patient was seen at an urgent care and at an institute. The doctor at the Institute said patient had aggravated the sesamoid bones in her right big toe and was diagnosed with sesamoiditis of right foot on an unspecified date in 2021. The patient was given a walking boot to wear. The events did not require a visit to emergency room (discrepancy noted), but they visited physician office due to pain in right big toe after first vaccine. Outcome of the events was not recovered. No follow up attempts are needed. No further information expected.

Other Meds:

Current Illness:

ID: 1320087
Sex: M
Age:
State: SC

Vax Date: 04/29/2021
Onset Date: 04/30/2021
Rec V Date: 05/15/2021
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Symptoms: This is a spontaneous report received from a contactable physician (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, lot number EW0169), via unspecified route of administration in left arm on 29Apr2021 05:00 PM (at the age of 36-year-old) as 2nd dose, single for COVID-19 immunisation. The patient had no medical history. Prior to vaccination the patient was not diagnosed with COVID-19. No concomitant medications were reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, lot number EW0150), via unspecified route of administration in left arm on 05Apr2021 04:00 PM (at the age of 36-year-old) as 1st dose, single for COVID-19 immunisation. On 30Apr2021 09:00 the patient experienced encephalopathy, vertigo, dizziness, fever, chills, nausea, myalgia, fatigue, cold sweats, headache, neck pain, injection site pain. The reporter stated that he was a doctor, he treated himself symptomatically. Patient had not been tested for COVID-19 since the vaccination. The outcome of the events was resolved with sequel.; Sender's Comments: The etiology for the reported event could be multifactorial however.Based on a temporal association a causal relationship between the reported event and suspect drug is assessed as possible. 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.

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Current Illness:

ID: 1320088
Sex: M
Age:
State: NJ

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 05/15/2021
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Symptoms: Light headedness; Feeling of wanting to pass out; Fatigue; Muscle and joint soreness; Muscle and joint soreness; Extreme warm feeling; Hot and cold flashes; Hot and cold flashes; Chills; Some twitching in my left hand; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8732) via an unspecified route of administration on 26Mar2021 at 13:30 (at the age of 64-years-old) as a single dose in the left arm for COVID-19 immunisation. Medical history included high blood pressure from an unspecified date and unspecified if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (received within wo weeks of the vaccination) included lisinopril, rosuvastatin and doxycycline, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EN6205) via an unspecified route of administration on 05Mar2021 at 13:30 (at the age of 64-years-old) as a single dose in the left arm for COVID-19 immunisation. On 26Mar2021 at 18:00 the patient experienced lightheadedness, feeling of wanting to pass out, fatigue, muscle and joint soreness, extreme warm feeling, hot and cold flashes, chills, and some twitching in my left hand. The clinical course was reported as follows: "The patient reported that all symptoms occurred between 3 to 5 hours after the second injection. Fatigue, light headedness, muscle and joint soreness, extreme warm feeling over his entire body, hot and cold flashes that lasted several minutes at a time, chills; however, no fever. All the symptoms subsided after three days from the second injection. Several side effects continued for over a month now. Fatigue, muscle and joint soreness as well as the light headedness with the feeling of wanting to pass out. Some twitching in the left hand intermittently throughout the day skipping days at a time." The adverse events resulted in a doctor or other healthcare professional office/clinic visit. The clinical outcomes of the events lightheadedness, feeling of wanting to pass out, fatigue, muscle and joint soreness, extreme warm feeling, hot and cold flashes, chills, and some twitching in my left hand were recovered/resolved with sequel (recovered with lasting effects). Since the vaccination, the patient had not been tested for COVID-19. Follow up needed, further information has been requested.

Other Meds: LISINOPRIL; ROSUVASTATIN; DOXYCYCLINE

Current Illness:

ID: 1320089
Sex: F
Age:
State: NJ

Vax Date: 12/29/2020
Onset Date: 03/15/2021
Rec V Date: 05/15/2021
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Symptoms: DVT to right popliteal vein; This is a spontaneous report from a contactable physician (patient). A 68-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscularly, administered in left arm, on 29Dec2020 (at the age of 68-years-old) at 1st dose, single for COVID-19 immunisation. Medical history included type II diabetes and hypertension. The patient was not pregnant. No COVID prior vaccination and no COVID tested post vaccination. The patient had no known allergies. Other medications in two weeks included metoprolol, ramipril and metformin. No other vaccines were received in four weeks. The patient experienced deep vein thrombosis (DVT) to right popliteal vein on 15Mar2021. The event resulted in doctor or other healthcare professional office/clinic visit. Treatments were administered as a result of the event and included ELIQUIS, bed rest, legs elevated. The patient was recovering from the event.; Sender's Comments: Based on the temporal relationship, the association between the event deep vein thrombosis with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: METOPROLOL; RAMIPRIL; METFORMIN

Current Illness:

ID: 1320090
Sex: M
Age:
State: MN

Vax Date: 04/27/2021
Onset Date: 04/27/2021
Rec V Date: 05/15/2021
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Symptoms: This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 27Apr2021 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing tremors and prostate issue. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included clonazepam, tamsulosin, oxybutynin. The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 27Apr2021 (the first day), the patient was a little tired. On 28Apr2021 (the second day), the patient experienced joint pain, felt very tired and weak. By 19:00-20:00, the patient realized he was going to have a tremor attack, but quickly turned into what would be called a seizure. The patient lost motor skills, speaking and breathing issues accrued. The symptoms where coming and going. With the help of his wife, the patient managed to take one 0.5 mg clonazepam. The situation lasted for around an hour, after which the patient went to bed. The next morning, 29Apr2021, the patient still had a lot of joint and muscle pain. As soon as he tried to start some minor work around the house, the tremors started again, but this time the patient took clonazepam and rested in bed all day. Today, 30Apr2021, the patient was tired from the situation and will be resting also. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of seizure, " tremor attack / tremors started again", joint pain, tired, weak, lost motor skills, speaking and breathing issues accrued and muscle pain was resolving. Information about lot/batch number requested.

Other Meds: CLONAZEPAM; TAMSULOSIN; OXYBUTYNIN

Current Illness: Tremor

ID: 1320091
Sex: M
Age:
State: AL

Vax Date: 02/18/2021
Onset Date: 02/20/2021
Rec V Date: 05/15/2021
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Symptoms: massive stroke; coded six times at the hospital; a pacemaker lead possibly dislodged during vigorous CPR; This is a spontaneous report from a contactable nurse (patient's son) communicated to a Pfizer sales representative. An 81-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on 18Feb2021 as single dose for COVID-19 immunization. Medical history included diffuse atherosclerotic disease including single vessel coronary artery disease, two prior carotid endarterectomy surgeries, an abdominal aortic aneurysm and iliac disease, and cardiac pacemaker insertion. The patient's concomitant medications were not reported. On 20Feb2021, the patient experienced massive stroke less than 48 hours after receiving his second dose of vaccine. On 20Feb2021, the patient coded six times at the hospital and one his pacemaker leads appeared to not be working properly, possibly dislodged during vigorous CPR (Cardiopulmonary resuscitation). The patient's son, a RN (registered nurse) in a cardiology practice for more than 20 years was the reporter. The clinical course was as follows: The stroke happened on 20Feb2021. The patient was taken to Hospital. The patient coded six times at the hospital. One his pacemaker leads appeared to not be working properly, possibly dislodged during vigorous CPR. The clinical outcomes of the events massive stroke, coded six times at the hospital, and a pacemaker lead possibly dislodged during vigorous CPR were not reported. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the preexisting complicated cardiovascular conditions including diffuse atherosclerotic disease, two carotid endarterectomy surgeries, abdominal aortic aneurysm and cardiac pacemaker user, the events massive stoke, coded six times (cardiac arrest transient) and pacemaker dislocation in this 81 years old elderly patient are considered most likely intercurrent medical conditions and not related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1320092
Sex: F
Age:
State: CA

Vax Date: 04/14/2021
Onset Date: 04/15/2021
Rec V Date: 05/15/2021
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Symptoms: This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EWO151) via an unspecified route in the left arm on 14Apr2021 at 11:30 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes mellitus. 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. Concomitant medications the patient received within 2 weeks of vaccination included insulin and metformin. On 15Apr2021 at 06:00 (reported as18 hours later), the patient had a "gran map seizure" and had to be taken to the hospital via ambulance. The event resulted in visit to emergency room/department or urgent care. The patient was not treated for "gran map seizure". The clinical outcome of "gran map seizure" was unknown. Since the vaccination, the patient has not been tested for COVID-19.

Other Meds: INSULIN; METFORMIN

Current Illness:

ID: 1320093
Sex: M
Age:
State: IN

Vax Date: 04/15/2021
Onset Date: 04/01/2021
Rec V Date: 05/15/2021
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Symptoms: currently asymptomatic but he tested positive on his polymerase chain reaction (PCR) shortly after received the BNT162b2; currently asymptomatic but he tested positive on his polymerase chain reaction (PCR) shortly after received the BNT162b2; This is a spontaneous report from a contactable pharmacist reporting on her son. A 22-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was currently asymptomatic but he tested positive on his polymerase chain reaction (PCR) shortly after received the BNT162b2 on an unspecified date in Apr2021. The patient underwent lab tests and procedures which included PCR test: positive in Apr2021. The outcome of event was unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: The contribution of the suspect drug to the onset of event drug ineffective cannot be ruled out since drug efficacy varies from one patient to another and affected by different factors.

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Current Illness:

ID: 1320094
Sex: M
Age:
State: MI

Vax Date: 04/13/2021
Onset Date: 04/13/2021
Rec V Date: 05/15/2021
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Symptoms: Allergic reaction on April 13th, 2021 after 2nd Pfizer shot. Took 2 Naproxen and had reaction 6 hours later. Allergic reaction again 4-29-2021 after taking Naproxen again. Never had allergic reactions; This is a spontaneous report received from a contactable consumer, the patient. A 51-year-old adult male received the second dose of BNT162B2 (solution for injection, batch/lot and expiry information not provided) as a single dose via an unspecified route in the left arm on 13Apr2021 at 14:30 (2:30pm; at 51-years-old) for COVID-19 immunization. The patient also started to receive naproxen (unspecified formulation) unspecified dose at an unspecified frequency via an unspecified route from an unspecified date for an unspecified indication. There was no medical history or concomitant medications reported. The patient previously received COVID-19 immunization with the first dose of BNT162B2 (solution for injection; lot unknown) in the left arm on an unspecified date in Mar2021 at 14:30 (2:30pm; at 51-years-old). The patient denied being diagnosed with COVID prior to the vaccine. The patient denied receiving any other vaccinations within four weeks of this vaccine. The patient also denied receiving any other medications within two weeks of the vaccination. The patient reported that on 13Apr2021 at 20:30 (8:30pm) six hours after getting the second Pfizer shot, she had an allergic reaction. The patient reported that she took two naproxen and had a reaction six hours later. The patient reported that she had an allergic reaction again on 29Apr2021, after taking naproxen again. The patient reported that she has never had allergic reactions to naproxen prior to the vaccination shots. The patient reported that the events did not result in any visit to an Emergency room or doctor's office. The patient denied being tested for COVID-19 since receiving the vaccine. Treatment for the event included diphenhydramine HCL (BENADRYL). The outcome of the event allergic reaction was recovered on an unspecified date in Apr2021. Information on the batch/lot number has been requested.

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Current Illness:

ID: 1320095
Sex: M
Age:
State: IL

Vax Date: 04/16/2021
Onset Date: 04/18/2021
Rec V Date: 05/15/2021
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Symptoms: This is a spontaneous report received from a contactable consumer (patient). A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER8731, on 16Apr2021 13:30 at single dose in left arm for COVID-19 immunization. Medical history included high blood pressure. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed Bell's Palsy confirmed in ER on 18Apr2021 14:30. The event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the event included steroids & antivirals. The outcome of the event was resolving.

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Current Illness:

ID: 1320096
Sex: F
Age:
State: FL

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 05/15/2021
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Symptoms: loosing urine; mind would 'go off' for a couple of seconds and she would just urinate.; seizure; she would just urinate.; This is a spontaneous report received from a contactable consumer (patient). A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number and Expiration date were not reported), via an unspecified route of administration, administered in Arm Left on 24Feb2021 10:00 (at age of 68 years old) as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included omeprazole (PROTONIX). No Prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number and Expiration date were not reported), via an unspecified route of administration, administered in Arm Left on 03Feb2021 (at 68 years old) as single dose for COVID-19 immunisation. Caller stated she received Pfizer's COVID vaccine and shortly afterwards (on 24Feb2021), her mind would 'go off' for a couple of seconds and she would just urinate. She stated, "I never had this issue before. It happened one day, then 2 days later, then 2 days later. My mind would just go off for a second and I would just stand there and urinate. And it went on for 10 days every other day. Now it just happened. I just unloaded yesterday (29Apr2021). It all just started happening after the 2nd vaccine. It may be related or may not. The urologist said that's strange and they said there's nothing they can do about it. I will be seeing the neurologist on 07Jun2021." Caller calling about the Pfizer COVID vaccine. She states that 2 days after getting the second shot every now and then her mind would go off, like a mini seizure and then she would loose her urine. She states that she has never had this issue before. It has been going on for almost over a month now, but it has been going down a little less, but it's still happening. She is going to a neurologist, but the neurologist can't see her until June. She is wondering has anyone else had an issue with this? She states she has been to a urologist, but they say they can't do anything for her and that she needs to see a neurologist. She states that it is very strange. She does state that it is becoming less and less, and it is like every 4 days now. She states she did have a 6 day stretch where she didn't have any incidence of the mini seizure or loosing her urine. She states she has never had anything happen to her like this, not even close. It happens out of the blue, and she doesn't even feel the sensation to urinate. She states she could be talking to someone, or in a store talking to someone and her mind goes out for just a second and then she just pees. She states that she is aware of what is going on. Caller states that she doesn't know what a mini seizure is like and does not know how to describe this event. However, it is usually when she is talking to someone, her mind might go off for a second then she just pees. She states it's weird. She states that it is usually when she is out, and that it doesn't happen at home. She states that she doesn't have the sensation of having to go to the bathroom she just goes. She says it's weird, nothing like this has ever happened before. She doesn't have a problem with fizzing out for a couple seconds. Caller states she doesn't want to use mini-seizure because then that marks her of having epilepsy. She also states that her doctor told her not to describe it as a seizure because they are not sure what it is yet. She wants to use the term fizz out for a min. Fizzing out for a minute: She clarified and states that the last two times this happened she did not fizz out, but she still just peed out of nowhere, without even having a sensation of having to pee. The last time she fizzed out was 10Apr2021. She doesn't know what to do and she is hoping that it gets figured out. She went four days without anything happening and then she was waiting in line and it just happened. She states she just urinated but doesn't recall fizzing out. She states it is not every day but every four days now, the urine. She states that it happened after the second vaccine. Dates for loosing urine was 04Mar2021. Physician Office visit for all events (went to the doctor after this happened. She states that the events might of happened before the second vaccine, she is not sure, but she started righting it down shortly after receiving the second vaccine). The outcome of the event loosing urine was not recovered, for other events was unknown. information on the lot/batch number has been requested.

Other Meds: PROTONIX [OMEPRAZOLE]

Current Illness:

ID: 1320097
Sex: M
Age:
State: TX

Vax Date: 04/28/2021
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Rec V Date: 05/15/2021
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Symptoms: blood in stool; headache; This is a spontaneous report from a contactable consumer (patient's wife) from Pfizer sponsored program Pfizer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Apr2021 (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. Patient received vaccine yesterday (unspecified) and now had blood in stool and headache. The event outcome for events was unknown. Information about Lot/Batch number has been requested.

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Current Illness:

ID: 1320098
Sex: F
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State:

Vax Date: 02/21/2021
Onset Date: 02/24/2021
Rec V Date: 05/15/2021
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Symptoms: she was diagnosed with Covid; This is a spontaneous report from a contactable consumer (patient's daughter). A 93-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient was diagnosed with COVID on 24Feb2021. She had an antibody infusion and her doctor said that she should wait 90 days to get the second dose. The event was considered serious as medically significant. The outcome of the event was unknown. The information on the batch number has been requested.

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Current Illness:

ID: 1320099
Sex: M
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State:

Vax Date: 04/20/2021
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Rec V Date: 05/15/2021
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Symptoms: convulsions; Fever (up to 103 F degrees); chills; confusion; dizziness for first 48 hours; body aches for 96 hours.; This is a spontaneous report from a non-contactable consumer who reported for himself. A 54-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0172), via an unspecified route of administration, in Arm Left on 20Apr2021 at 13:30 (at 54 years) at single dose for covid-19 immunisation . Medical history included known allergies penicillin. Previously, on 29Mar2021, patient took the first dose of the vaccine (lot Number: EQ0150) administered in Arm Left for covid-19 immunisation. The patient's concomitant medications were not reported. Patient had no COVID prior vaccination and was not covid tested post vaccination. On an unspecified date in 2021 patient experienced fever (up to 103 F degrees), chills, convulsions, confusion, dizziness for first 48 hours, body aches for 96 hours. No treatment given. Patient recovered from all the events on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.

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ID: 1320100
Sex: M
Age:
State: TX

Vax Date: 04/20/2021
Onset Date: 04/24/2021
Rec V Date: 05/15/2021
Hospital: Y

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Symptoms: Shortness of breath after second vaccine at 4-5 days after vaccine requiring oxygen and hospitalization; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received second dose bnt162b2 (PFIZER COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Left on 20Apr2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. Medical history included lung cancer from an unknown date and unknown if ongoing. Concomitant medications included lorlatinib, alprazolam, rosuvastatin calcium (CRESTOR), lisinopril and steroid, all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose bnt162b2 (PFIZER COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Mar2021 (Batch/Lot number was not reported) for COVID-19 immunisation. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. On 24Apr2021, the patient experienced shortness of breath after second vaccine at 4-5 days after vaccine requiring oxygen and hospitalization. The patient was hospitalized for this event for 1 days. This event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the adverse event included oxygen and home oxygen, albuterol nebulizer, vento. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19: negative. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: LORLATINIB; ALPRAZOLAM; CRESTOR; LISINOPRIL

Current Illness:

ID: 1320101
Sex: M
Age:
State: PA

Vax Date: 04/06/2021
Onset Date: 04/27/2021
Rec V Date: 05/15/2021
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Symptoms: left eye tingling and not able to close with Left side mouth not able to close; left eye tingling and not able to close with Left side mouth not able to close; loss of taste of left side of tongue; Bell's palsy symptoms; Cold with light sneezing; Cold with light sneezing; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737), dose 2 via an unspecified route of administration, administered in left arm on 06Apr2021 15:00 as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955) administered in left arm on 16Mar2021 18:30 for COVID-19 Immunization. Cold with light sneezing developed on 27Apr2021 and Bell's palsy symptoms developed from 28Apr2021 around night before bed (22:45). On 29Apr2021, left eye tingling and not able to close with Left side mouth not able to close and loss of taste of left side of tongue. Doctor diagnosed on 30Apr2021 that it is early stages of Bell's palsy could be due to vaccine or shingles. No symptoms of shingles. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient received treatment (Bell's Palsy along with Shingles) for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There is no COVID prior vaccination, no COVID tested post vaccination, no known allergies. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

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ID: 1320102
Sex: M
Age:
State: MN

Vax Date: 04/02/2021
Onset Date: 04/13/2021
Rec V Date: 05/15/2021
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Symptoms: Scattered petechial spots in both legs with thrombocytopenia with platelets count of 91000.; Scattered petechial spots in both legs with thrombocytopenia with platelets count of 91000.; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER8737, on 02Apr2021 13:00 at single dose in left arm for COVID-19 immunization. Medical history included myocardial infarction, hyperthyroidism, allergy to Contrast agent. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)), clopidogrel bisulfate (PLAVIX), atorvastatin, pantoprazole sodium sesquihydrate (CONORAN), sertraline. The patient experienced Scattered petechial spots in both legs with thrombocytopenia with platelets count of 91000 on 13Apr2021. The outcome of the events was unknown.

Other Meds: ASPIRIN (E.C.); PLAVIX; ATORVASTATIN; CONORAN; SERTRALINE

Current Illness:

ID: 1320103
Sex: F
Age:
State: CA

Vax Date: 04/28/2021
Onset Date: 04/29/2021
Rec V Date: 05/15/2021
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Symptoms: diarrhea; Vomiting; sore throat; sore shoulder; sore neck; blood in her diarrhea; feeling icky; This is a spontaneous report from a contactable consumer (patient's mother). A 20-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8735), administered in left arm, on 28Apr2021 at 13:00 (at the age of 20-years-old) at 1st dose, single for COVID-19 immunisation. Medical history included bipolar disorder, bipolar depression, anxiety and depression. Family medical history relevant to the adverse events was reported as none. Concomitant medications included ongoing citalopram (provided as CELEXA, clarified that she took the generic citalopram) taken from an unspecified date (has been taking for about 4 years, as reported) at 40mg orally daily for anxiety and depression, ongoing lamotrigine (provided as LAMICTAL, clarified that she took the generic lamotrigine) taken orally from an unspecified date (had been taking for 2-3 years, as reported) at 150mg twice daily for bipolar disorder, ongoing lithium taken orally at 300mg twice daily for bipolar depression. No prior vaccinations (within 4 weeks) were received, no history of all previous immunization with the Pfizer vaccine was considered as suspect, no additional vaccines administered on same date of the Pfizer suspect. The patient experienced blood in diarrhea and sore neck on 30Apr2021, diarrhea, vomiting, sore throat, sore shoulder on 30Apr2021 at 01:00, feeling icky on 29Apr2021 at 18:00. The events did not require emergency room and/or physician office visit. The reporter stated that the patient was fine until 29Apr2021 around 6 pm when she started feeling icky. She woke up at 1 am with diarrhea and vomiting, sore throat and sore shoulder. The patient was having blood in her diarrhea. The last time she threw up was around 7:30. Her daughter developed a sore throat and sore shoulder late last night of the reporting day or early the morning of the reporting day. Reporter added that her daughter also had a sore neck that started late last night of the reporting day or early the morning of the reporting day. No relevant tests were performed. The patient had not recovered from diarrhea, sore throat, sore shoulder and sore neck, had recovered from vomiting on 30Apr2021 at 07:30, the outcome of the other events was unknown.

Other Meds: CITALOPRAM; LAMOTRIGINE; LITHIUM

Current Illness:

Date Died:

ID: 1320104
Sex: U
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Symptoms: dropped dead; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a patient of unspecified gender in 20s received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter reported that someone in town in their 20s that had the Pfizer vaccine in the morning and dropped dead in the afternoon for no reason. Between all 3, there have been quite a bit of deaths in the last few months. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: dropped dead

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ID: 1320105
Sex: M
Age:
State: NC

Vax Date: 04/28/2021
Onset Date: 04/29/2021
Rec V Date: 05/15/2021
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Symptoms: a potential false blood pressure readings/The readings were over 200/140/took it on his wrist and measured at 215/147; the pain at the location of the lower arm got near tremble; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 28Apr2021 16:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included blood pressure abnormal, blood cholesterol abnormal, deafness. The patient's concomitant medications included unspecified products received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 on 06Apr2021 01:15 PM at arm left for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, he has not been tested for COVID-19. The patient reported a potential false blood pressure readings on 29Apr2021, a day after administered 2nd dose. The readings were over 200/140 and he took it at home using a blood pressure reading device. He took it on his wrist and measured at 215/147. In his recent doctors visit prior to administer the 2nd dose, the accurate readings was 183/136 (estimated). With the false blood pressure readings, the pain at the location of the lower arm got near tremble due to the fact of the false readings has been taken. The events outcome was unknown. Information on the Lot/Batch number has been requested.

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ID: 1320106
Sex: M
Age:
State: IL

Vax Date: 04/27/2021
Onset Date: 04/27/2021
Rec V Date: 05/15/2021
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Symptoms: fever spiked to 103.7 from a normal of about 97.3; Sore left arm, armpit/ache in forearm; Sore left arm, armpit; Numbness/ache in forearm, slight numbness in hand; bad chills; lot of sweating starting that evening and continuing; runny nose; nausea; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 15:00 (Lot Number: EW0170) as 2nd dose, single for COVID-19 immunisation. Medical history included chronic lymphocitic leukemia, Known allergies to environmental. Concomitant medications included atorvastatin; azelastine; fluticasone propionate (FLONASE ALLERGY RELIEF); metformin, 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 previously received the first dose of BNT162B2 (lot number: EW0150) for Covid-19 immunisation on 06Apr2021 in left arm at the age of 59-year-old. The patient experienced sore left arm, armpit, numbness/ache in forearm, slight numbness in hand. bad chills, lot of sweating starting that evening and continuing, a runny nose, nausea, fever spiked to 103.7 from a normal of about 97.3 at about the 23 hour mark, since 27Apr2021 21:00. As of right now 30Apr21 14:21, 3 days later, the patient was still a little sweaty, armpit and arm sore, forearm still ache and hand still a little numb. Since the vaccination, the patient has not been tested for COVID-19. There was no treatment received. Adverse events resulted in Emergency room/department or urgent care. The outcome of events was recovering.

Other Meds: ATORVASTATIN; AZELASTINE; FLONASE ALLERGY RELIEF; METFORMIN

Current Illness:

ID: 1320107
Sex: F
Age:
State: NC

Vax Date: 04/17/2021
Onset Date: 04/27/2021
Rec V Date: 05/15/2021
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Symptoms: Measle-like rash; itchy; This is a spontaneous report received from a contactable consumer (patient). A 49-years-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 17Apr2021 12:30 (Lot Number: EW0162) at single dose for COVID-19 immunization. Medical history included the patient had elevated liver enzymes until late 2020, but those have been reduced; just on the cusp of overweight/obese; intolerant of opiods/opiates (itching); allergy to Pollen; allergy to Z-pack antibiotic. The patient was not pregnant. On 27Apr2021, the patient experienced measle-like rash (fine, small, red distinct spots) on tops of hands and feet. More prevalent on feet, from just above ankles to toes. Not on soles (or palms). Rash was not up the legs or up the arms. Itchy, rough. No swelling or fever in the affected areas. The adverse events result in visit to emergency room/department or urgent care. The patient was hospitalized for the events. Treatment received for the adverse event included steroid cream prescribed and the patient was told to take Benadryl. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was Hospital. The outcome of the events was not recovered.

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ID: 1320108
Sex: F
Age:
State: MO

Vax Date:
Onset Date: 04/25/2021
Rec V Date: 05/15/2021
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Symptoms: This is a spontaneous report from a contactable other hcp (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Er8731), dose 2 via an unspecified route of administration, administered in arm right on an unspecified date as 2nd dose, single for covid-19 immunisation. Concomitant medications included metformin; insulin glargine (TOUJEO); lisinopril; atorvastatin calcium; piroxicam (FARXICAN). Medical history included ongoing diabetes mellitus. The patient previously took Ibuprofen and experienced allergy to Ibuprofen. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ep7534,) administered in right arm on 24Mar2021 10:30 for COVID-19 Immunization. The patient had a mini stroke on 25Apr2021 20:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.; Sender's Comments: Based on the limited available information, the reported event I had a mini stroke is assessed as unlikely related to the suspect product BNT 162b2 (PFIZER-BIONTECH COVID-19 VACCINE). 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: METFORMIN; TOUJEO; LISINOPRIL; ATORVASTATIN CALCIUM; FARXICAN

Current Illness: Diabetic

ID: 1320109
Sex: M
Age:
State: NY

Vax Date: 03/11/2021
Onset Date: 03/01/2021
Rec V Date: 05/15/2021
Hospital: Y

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Symptoms: Blood clots; Delirious; Oxygen was down to 80%; Sepsis; E. coli/sepsis with cultures of E. coli; C-diff; sick; Shaking uncontrollably; Achy; Extremely high fever/a high fever of 103 F; Chills; Aneurysm in his leg; Bleeding from somewhere; weak; missed his second dose of the Pfizer COVID-19 vaccine; Caller says her husband's kidney was failing too while he was in the hospital; This is a spontaneous report from a contactable consumer reported for her husband. A 69-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 11Mar2021 18:00 (Lot Number: EV6206) as single dose for covid-19 immunization. Medical history included Kidney transplant from 1998, same kidney all these years, on immune medication, polycystic kidney disease from 1998, the transplant saved him in 1998, blood pressure high went along with the polycystic kidney disease, had it for a while, Type 2 diabetes mellitus this was diagnosed probably about four years ago and immunocompromised. There were no concomitant medications. The patient had the first dose of the Pfizer vaccine on 11Mar2021, "he felt okay first evening, Friday was okay, Saturday 13Mar2021 achy, Sunday running a high fever of 103 F, he started to get chills. Then Around 3am (Early Monday on the 15Mar2021) called the ambulance, oxygen was down to 80% he was shaking uncontrollably, temperature was still 103 F when they took it and even at the hospital was the same temperature. He was delirious on 15Mar2021. When he got to Emergency Room he was in critical section, had to put on BiPAP with 100% oxygen, When in the ambulance they tested for covid and was negative each time he was tested for covid he was negative. He was in the hospital from 15Mar2021 to 24Mar2021, in critical care unit. He Turned out having sepsis, E.coli, had to put him on strong antibiotics. He developed CDIFF on 15Mar2021, and an aneurysm in his leg in Mar2021 and needed a blood transfusion. They were trying to rule out blood clots and did sonogram and found it. His blood was going down, he was bleeding from somewhere and had to have a transfusion. They did a procedure on the leg to break up the aneurysm twice. On BiPAP for a few days and then did the medium one and then able to take off oxygen when he went home. He came home on antibiotics and tons of medication. Should he get the second vaccine? Is it related? Is it to late to get the second vaccine? following Sunday he had an extremely high fever and was shaking uncontrollably on 14Mar2021. He was told to get the shot by his provider. She had to call an ambulance, he almost died, and she didn't know if it is related to her husband getting the vaccine. They put her husband on a BiPAP with 100% O2 when he went to the hospital by ambulance and was admitted on 15Mar2021, which he was on the BiPAP a couple days then went on to the second level, then right before he came home he was weaned off of oxygen. They kept testing him for COVID every day, because the symptoms were similar but they tests kept coming up negative. On 15Mar2021, the patient had sepsis, with cultures of E. Coli, and very contagious C-diff, he was sick from the 15th to the 24th for all those things. She didn't know if the vaccine brought it on if it was brewing in him before that, or if it had to nothing to do with vaccine. He also had an aneurysm in his leg and had a medical procedure where they had to go in and take care of it to break up the aneurysm. The patient's kidney was failing too while he was in the hospital. The patient missed his second dose of the Pfizer COVID-19 vaccine due to his hospitalization from 15Mar2021 to 24Mar2021. She would like to know if it would still be recommended for the patient to get the second shot of his COVID-19 vaccination since he is past the deadline to get it, is it going to be too late for him to get the second dose to be fully vaccinated and effective to get it after waiting this long? His first dose was injected about 06:00PM in unknown arm. The patient had a fever Saturday evening, clarified to being 13Mar2021, which was higher the next day on 14Mar2021 and reached 103 degrees Fahrenheit, and he went to the hospital by ambulance at 03:00AM 15Mar2021. His fever started getting higher late Saturday to Sunday and he got progressively worse. The patient had had serious complications before related to his health problems, but she had never had to call an ambulance before this. The patient had chills on Saturday 13Mar2021 and then Sunday evening he was shaking and it wouldn't stop so she gave him Tylenol, then she called the ambulance Monday morning. The patient can't take anything more than Tylenol, and he never usually takes anything. The patient's kidney function was getting bad while he was in the hospital, his Creatinine went high and was 3.8, which is high for someone with a transplant. The patient was doing better, he was still very weak, he was under a doctor's care, he was on very strong antibiotics for a month, Vancomycin and other medications which also make him weak. The patient was on IV antibiotics at the hospital and then came home on oral. The 3.8 for the Creatinine was probably at the beginning when he went into the hospital. The outcome of the event Sepsis was Resolved with Sequel and the outcome of the other events was unknown.

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ID: 1320110
Sex: F
Age:
State: WV

Vax Date: 04/21/2021
Onset Date: 04/21/2021
Rec V Date: 05/15/2021
Hospital: Y

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Symptoms: This is a spontaneous report received from a contactable consumer (patient) . A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot ER8735), in Arm Left on 21Apr2021 at 15:15 (at 48 years) at single dose for covid-19 immunisation. Medical history included urinary tract infection (UTI) and history of low blood pressure (not ongoing). She biked and hiked and eat healthy. Family history included high blood pressure in her dad and in her sister.Previously on 24Mar2021 (at 48 years) the patient received the first dose of the vaccine (lot ER8730) in right arm for covid-19 immunisation. Concomitant medication included ciprofloxacin taken for urinary tract infection from 10Apr2021 to 16Apr2021 (She just came off antibiotic a week prior to the second shot). On 21Apr2021 at 10:05 PM her heart rate was "extremely accelerated" (had accelerated heart rate) and patient stated that her chest, neck, and head felt "super hot" (her chest, neck, and head were hot) and also stated that she was feeling "weird" and "floaty". She stated these symptoms lasted about 15 seconds and went away but had another episode right after that she stated was "not as intense but pretty intense still."She had a couple of those situations and she kept getting a wave of like this floating feeling or sensation all over her body.She reported going to the emergency room (ER) on 21Apr2021 where she had a few more incidents like this and stated that she also got "real hot" and had a "sensation" all over her body all at once that she cannot describe (she states that it's different than a "pins and needles" feeling) that made her dizzy and caused her heart to race. She stated these symptoms continued for a couple of days. She reported that on 24Apr2021 she woke up and felt fine but on 24Apr2021 at night stated that the symptoms returned but worse, her muscles started "trembling and jerking" and reported having a hard time talking and walking; she got that all over sensation again all over her body, her heart was racing, her chest was tight and hot and her muscles were tremoring and her leg muscles started jerking and she had trouble talking and walking, her throat and neck were feeling tight and closing.She reported she took 2 Benadryl and drank some sugar 2 teaspoons of sugar water but her symptoms worsened so she went back to the ER. She stated that by the time she got to the emergency room, her symptoms had subsided except her legs were "still trembling"/ her legs were just shaky. At the ER they checked her heart and did a blood panel. They said everything was good, they sent her home. On 25Apr2021 and on 26Apr2021 she was dizzy, weak, shaky, and had other incidents of her heart racing that she stated weren't extreme and then started to feel better on 27Apr2021. She reported that on 27Apr2021 night she woke up and her chest was tight again, it was hot and tight on the left side, she had that floaty feeling again all over. She had left side chest pain from 23:00 until 5:40 in the morning then it stopped, everything stopped and she was fine all day.On 29Apr2021 afternoon she felt better but still had some slight dizziness "almost like vertigo" but on 29Apr2021 night she was back at the ER, she had that all over feeling again, that sensation all over, her leg muscles were jerking, she couldn't talk again, she took Benadryl and drank sugar water again because it worked before she really does not know if that was what worked but it calmed down after that the time before. She went back to the ER they checked her in and this time the sensation, the feeling that was all over stayed in the right arm and leg but it subside on left side, her heart was racing a couple more times. It was right when her legs muscles started tremoring, they were having minor jerks, not as bad but every time that happened her heart rate would go up, her resting was 59 or 61 and it got up to 101. Her neck and chest would get hot. On 29Apr2021 night she was in the ER for quite a while, it subsided they sent her home with some Ativan for tremors and palpitations and told her to follow up with a cardiologist. Patient went to the cardiologist, she had blood and labs done and she had 2 conferences on the phone with her doctor.On 30Apr2021 morning she was super dizzy and weak and shaky and light headed and nauseous. She went to a cardiologist on 30Apr2021 and has been hooked up to a 7 day heart monitor. She reported that she still felt "real trembly" she has started feeling a little dizzy and floaty feeling. Event accelerated heart rate was ongoing, it just popped up whenever on and off. Dizziness was ongoing, patient said it was on and off but it was more on than off; she said sometimes it was worse or it was less but it had never left. Chest pain recovered on 28Apr2021 at 05:40.Outcome of the other events was unknown.Events heart rate increased , feeling hot, floating sensation and dizziness are reported as serious per hospitalization in 2021.

Other Meds: CIPROFLOXACIN

Current Illness:

ID: 1320111
Sex: F
Age:
State:

Vax Date: 02/06/2021
Onset Date:
Rec V Date: 05/15/2021
Hospital: Y

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Symptoms: tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable other HCP. A 5-decade-old female patient (in her 40's) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated they have a female patient in her 40s who received the first dose of the Pfizer covid vaccine on 06Feb2021 and tested positive for Covid, she was in the hospital for it. The reporter wanted to know about the second dose, can she still get Pfizer covid vaccine; if not, can she get J&J vaccine. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unknown date. The outcome of the event was unknown. The information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported COVID-19 cannot be ruled out in terms of drug ineffective.

Other Meds:

Current Illness:

ID: 1320112
Sex: F
Age:
State: NJ

Vax Date: 03/21/2021
Onset Date: 03/21/2021
Rec V Date: 05/15/2021
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Symptoms: states she cant sleep; cant concentrate; tinnitus, ringing of ears; Ear fullness; Tingling in right side of face, around eye and cheeks and everything; This is a spontaneous report from /Medical Information received from a contactable nurse reporting for herself A 46 year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6206) on 21Mar2021 at single dose via an unspecified route of administration on right deltoid for COVID-19 immunization. Relevant medical history included ongoing autoimmune disease from 2016 (diagnosed about 5 years ago). Concomitant medications were not reported. On 21Mar2021 the patient experienced Tingling in right side of face, around eye and cheeks and everything, started little bit the day of vaccination and then just kept going and got gradually a little bit worse. The events was considered as medically significant. On 23Mar2021 the patient started complaining ear fullness, started to get full like feeling in ear, like plugged under water kind of thing described as ongoing as improved slightly but it comes and goes (as such). The event was considered medically significant. On 27Mar2021 the patient also started experiencing tinnitus, clogged/plugged ears and ringing in the ears. The event was considered medically significant. This was not going away, she also mentioned can' t sleep and can' t concentrate. Patient also informed that she is part of a huge online Support group (1500-2000) for people who have developed tinnitus after covid vaccination with either of Pfizer, Moderna or Jansen and Jansen Covid vaccine. Patient declined to provide information on the persons other people who were experiencing the same symptoms, hopefully, those persons call Pfizer on their own. She also informed that was not be getting her second dose (as such). The patient recovered from 'Tingling in right side of face, around eye and cheeks and everything' on an unspecified date in Mar2021, was recovering from ear fullness, while have not yet recovered from tinnitus, ringing of ears. At the time of the reporting outcome of other events was unknown.; Sender's Comments: Based on the close temporal relationship, the association between the event "tingling in right side of face" with BNT162b2 can not be fully excluded. The association between the events "ear fullness" and "tinnitus" with BNT162b2 can not be fully excluded based on the temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness: Autoimmune disorder (Diagnosed with about 5 years ago, caller would say 2016.)

ID: 1320113
Sex: M
Age:
State: TX

Vax Date: 04/13/2021
Onset Date: 04/26/2021
Rec V Date: 05/15/2021
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Symptoms: Diagnosed with Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 15:00 (Lot Number: ER8737) as single dose for covid-19 immunisation. Medical history included ongoing high blood pressure. There were no known allergies. Concomitant medications included omeprazole; tizanidine; meloxicam and metoprolol all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient was diagnosed with bells palsy on 26Apr2021 08:00 with outcome of recovering. The event resulted in Doctor or other healthcare professional office/clinic visit.

Other Meds: OMEPRAZOLE; TIZANIDINE; MELOXICAM; METOPROLOL

Current Illness: Blood pressure high

ID: 1320114
Sex: M
Age:
State: WI

Vax Date: 04/21/2021
Onset Date: 04/23/2021
Rec V Date: 05/15/2021
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Symptoms: 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm.; 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm; 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm.; diagnosed Vestibular Neuritis; 23Apr2021 at 4pm sudden onset severe dizziness 4:15pm SEVERE Vertigo, Nausea, Vomiting until 7pm.; unable to work for more than a few minutes without nystagmus; extreme fatigue and continued vertigo; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration, administered in the arm right on 21Apr2021 at 10:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing , sarcoidosis from an unknown date and unknown if ongoing , obesity from an unknown date and unknown if ongoing , seasonal allergy from an unknown date and unknown if ongoing , allergy to horse and cat dander from an unknown date and unknown if ongoing. 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's concomitant medications were not reported. The patient previously received the first dose of BNT162b2 on 31Mar2021 at 10:45 (Lot Number: EW0150) via an unspecified route of administration in the right arm for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 23Apr2021 at 16:00, the patient experienced vestibular neuritis (medically significant), 23apr2021 at 4pm sudden onset severe dizziness, 4:15pm severe vertigo, nausea, vomiting until 7pm, unable to work for more than a few minutes without nystagmus, and extreme fatigue. Clinical course: on 23Apr2021 at 4pm sudden onset severe dizziness. At 4:15pm severe vertigo, nausea, vomiting until 7pm. At 7pm, wife took patient to ER and received a CT and MRI to rule out a blood clot. Vomiting has resolved with medication. On 26Apr2021, patient was diagnosed vestibular neuritis. Symptoms are slightly better but patient have been unable to drive, walk without increase in symptoms, unable to work for more than a few minutes without nystagmus, extreme fatigue and continued vertigo. Treatment received for the events included diphenhydramine (BENADRYL), droperidol,meclizine, and methylprednisone. The patient recovered from the event, vomiting. The patient had not recovered from the events, vestibular neuritis, 23apr2021 at 4pm sudden onset severe dizziness, 4:15pm severe vertigo, nausea until 7pm, unable to work for more than a few minutes without nystagmus, and extreme fatigue. No follow-up attempts are needed. No further information is expected.

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Current Illness:

ID: 1320115
Sex: M
Age:
State: VT

Vax Date: 04/01/2021
Onset Date: 04/16/2021
Rec V Date: 05/15/2021
Hospital: Y

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Symptoms: Slow cap refill in feet, knees, inside ankle -L/R sides; Numbness, starting in toes, ascending to knees, thighs.; Mottling on feet, interior ankles, kneecaps; Bilateral decreased sensation from the toes up to the hip, with intact strength, with 2-3 beats of clonus bilaterally.; Mottling on feet, interior ankles, kneecaps, along with blanching redness.; Mottling on feet, interior ankles, kneecaps, along with blanching redness.; with 2-3 beats of clonus bilaterally; This is a spontaneous report from a contactable consumer (patient). A 22-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 09:30 (Lot Number: ER8734) as 1st dose, single for COVID-19 immunisation. There was no medical history and no known allergies. Concomitant medications included paroxetine taken for an unspecified indication, within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Slow cap refill in feet, knees, inside ankle - L/R sides; Numbness, starting in toes, ascending to knees, thighs; Mottling on feet, interior ankles, kneecaps, along with blanching redness; Bilateral decreased sensation from the toes up to the hip, with intact strength, with 2-3 beats of clonus bilaterally, 2+ reflexes in lower extremities, No cold sensation below the ankles bilaterally. Adverse events started on 16Apr2021. The adverse events result in Emergency room/department or urgent care. The patient was hospitalized for the reported events for 3 days. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included COVID-19 PCR-Nasal Swab: negative on 13Apr2021, COVID-19 rt-PCR-Nasal Swab: negative on 27Apr2021. There was no treatment received. The outcome of events was not recovered.

Other Meds: PAROXETINE

Current Illness:

ID: 1320116
Sex: F
Age:
State: OR

Vax Date: 04/28/2021
Onset Date: 04/29/2021
Rec V Date: 05/15/2021
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Symptoms: passed out/Loss of consciousness resulted in concussion; concussion; became dizzy; Was experiencing body aches; increased thirst following vaccination; This is a spontaneous report from a contactable physician for a patient. A 20-year-old female patient received second dose bnt162b2 (PFIZER COVID-19 VACCINE), intramuscular, administered in Arm Right on 28Apr2021 08:30 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient previously received first dose bnt162b2 (PFIZER COVID-19 VACCINE), on an unknown date (Batch/Lot number was not reported) for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at time of vaccination. Concomitant medications (received within 2 weeks of vaccination) included celecoxib (CELEXA), trazodone, oral contraceptive nos (reported as oral birth control) taken for an unspecified indication, start and stop date were not reported. The patient got up at 2am 29Apr2021 to use restroom, became dizzy and passed out. She was experiencing body aches and increased thirst following vaccination. Loss of consciousness resulted in concussion. The adverse events result in: Doctor or other healthcare professional office/clinic visit. The events did not result in death, cause/prolonged hospitalization, was not life threatening, disabling/incapacitating, congenital anomaly/birth defect. The patient was not diagnosed COVID-19 prior to vaccination. Since the vaccination, the patient had not the patient been tested for COVID-19. The patient did not receive treatment for the events. The outcome of the event was recovering. Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, the event Loss of consciousness is considered most likely associated with intercurrent or underlying medical conditions, appears unrelated to the suspect drug.

Other Meds: CELEXA [CELECOXIB]; TRAZODONE; ORAL CONTRACEPTIVE NOS

Current Illness:

ID: 1320117
Sex: F
Age:
State: CA

Vax Date: 02/22/2021
Onset Date: 03/31/2021
Rec V Date: 05/15/2021
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Symptoms: This is a spontaneous report from a contactable consumer. A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), dose 2 via an unspecified route of administration, administered in right arm on 22Feb2021 14:15 as 2nd dose, single for covid-19 immunisation. Medical history included hyper/hypothyroid, cardiac arrhythmia. Concomitant medications included metoprolol; acetylsalicylic acid (ECOTRIN); atorvastatin (LIPITOR); levothyroxine sodium (SYNTHROID); cetirizine hydrochloride (ZYRTEC). The patient previously took codeine, compezine, sulfa medication, adhesives, all experienced allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261) administered in right arm on 01Feb2021 14:15 for COVID-19 Immunization. On 31Mar2021 (20:00), the patient awakened by upper abdominal pain, rapid pulse, and sweating, experienced diarrhea. On 01Apr2021 the patient awakened with same symptoms, plus tachycardia, shortness of breath, clammy skin, lightheadedness, what felt like acid reflux/upper abdominal pain, and diarrhea. Upon walking, almost fainted. On 01Apr2021 17:00, the patient went to Urgent Care. She had abnormal bloodwork, rapid heart beat and shortness of breath/wheezing. EKG showed irregularities. Was told to proceed to the ER for more tests. On 01Apr2021 19:00, the patient went to Hospital. She completed ultrasound of abdomen, EKG, CT Scan, and other testing. Found evidence of cardiomegaly (1st time ever), elevated blood pressure, inflammation around the heart, liver, pancreas, and stomach. Also noted pulmonary edema. Told I could travel back to CA with compression socks and pain medication and Zofran. 05Apr2021, they ordered additional tests and referral to the Cardiologist. Still experiencing extreme fatigue. Events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment (pain medication, zofran, referral to GI and cardio) for adverse event. There is no covid prior vaccination. The patient received covid tested post vaccination with Nasal Swab on 01Apr2021, result was negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not resolved.

Other Meds: ECOTRIN; LIPITOR [ATORVASTATIN]; SYNTHROID; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; METOPROLOL

Current Illness:

ID: 1320118
Sex: M
Age:
State: MN

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Rec V Date: 05/15/2021
Hospital: Y

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Symptoms: he is in the hospital with Encephalitis due to the Pfizer vaccine; dementia like symptoms; sudden loss of hearing; Can't walk; losing his voice; urinary incontinence; trouble swallowing; loss of personality flat affect; shaking of hands/full body tremor; weakness; fatigue; loss of interest; kind of in a "stupor state",; can't stay warm; trouble responding in conversations; confusion; falling asleep constantly; This is a spontaneous report from a contactable consumer reported for her father. An 80-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient had received both doses of the Pfizer Covid 19 vaccine. He was in the hospital with Encephalitis due to the Pfizer vaccine per his doctors. His symptoms were as follows: Can't walk, losing his voice, dementia like symptoms, urinary incontinence, trouble swallowing, loss of personality flat affect, shaking of hands, full body tremor, weakness, fatigue, loss of interest, kind of in a "stupor state", sudden loss of hearing, can't stay warm, trouble responding in conversations, confusion, falling asleep constantly. He had tons and tons of new symptoms and he had never had any of these problems. It had been reported to the CDC by the doctors. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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Current Illness:

ID: 1320119
Sex: F
Age:
State: AZ

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 05/15/2021
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Symptoms: Her stool has not been normal; couldn't eat, nothing was appetizing; messed with her stomach, it's off balance/stomach does not feel balanced; tired/exhausted; Feels like she is starving; nauseated/stomach is so nauseous; diarrhea; throwing up; Can't eat normal portions; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0162), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 09:00 as 1st dose, single (Not sure of the dose, but the injection was very fast) for covid-19 immunisation. Medical history included hiv from 2015 and ongoing (diagnosed in 2015, and has undetectable, CD4 count has been great. Ongoing but, undetectable). Concomitant medications included abacavir sulfate, dolutegravir sodium, lamivudine (TRIUMEQ) taking for over 6 years, still currently taking. States there is only one dosage, there's no milligram or anything, and she has to take it; estradiol valerate (ESTRADIOL VALERATE) this medication not injected into the same site as the COVID vaccine. She has been taking for the past 8 months and is still taking it.. The patient stated he had the first dose of the Pfizer covid 19 vaccine on 15Apr2021. Since the she has been starving because she can't eat. The patient stated she was HIV undetectable, takes Triumeq, had monoclonal antibody treatment and had covid. She stated she did not know if her side effects are related to the vaccine, an interaction between the vaccine and his medication or because she had covid and/or took monoclonal antibody treatment. The patient stated her stomach does not feel balanced. She stated she took one or two bites then she felt like she can not eat anymore. The patient stated she was eating a quarter of the normal portions. The patient stated she is nauseated and having diarrhea. The patient stated it was affecting her daily life noting she feels cranky and tired because he was not getting enough food in her system. The patient stated she we starving when she ate stating the food goes right through her. The patient stated she was going through horrible side effects. She cannot eat. The patient stated that she saw his PCP, an immediate care and the ER. The patient stated that none of them have any information on how to treat her symptoms. Her stomach is so nauseous and when she eats it goes right through her. She has been to the ER and to her doctor about this, and everyone says they just know much about the vaccine, which is scary to her, that no one can treat her, they don't know if this is a side effect or anything and she doesn't know what to do. She reports she is trying to stay awake but, she does not feel like she is getting the proper nutrition. She is very tired and she can force herself to stay up but she's hungry, and does not want to eat because, if she does, she has got to be in the restroom with in 10 minutes. Her stool has not been normal since the vaccine. It's messed up, the day she got the vaccine, she ate beforehand, just toast, and after getting it she wasn't hungry she could drink fluids but she would throw it up, even if it was just water. The next day she couldn't eat at all, she reports having a fruit smoothie but couldn't keep it down, had diarrhea all day. That day she was in bed all day. She reports she can't eat normal portions because she feels full after a few bite and the is right back in the restroom again. The patient wants to know if this is a normal side effect of the vaccine and if it has been reported? Also, she wants to know what she can do to soothe her stomach she wonders? She isn't looking for something to boost her appetite, because it's there, but wondering if something with the vaccine has messed with her stomach, it's off balance. She got the vaccine at 9 am (15Apr2021 09:00) at 3 o'clock (15Apr2021 15:00) she started feeling nauseous and couldn't eat, nothing was appetizing, so she got a smoothie and it went on from there. She is questioning if she should get the second dose, it is scheduled on 06May021. About 5 years ago, after her HIV diagnosis she stopped getting flu vaccine because of a horrible reaction to it, she was sick for 2 weeks, she felt like she was dying, couldn't eat, she couldn't keep anything down, she was exhausted. She could at least keep something down at that time like the brat diet. Right now she can't eat anything and nothing is absorbing. She doesn't think she is getting the proper nutrition in because everything is coming out liquid, she knows that is disgusting but, that is how it. Her husband had the vaccine the same day she did and he was fine, she doesn't understand. On 16Apr2021, she is very tired and trying to stay awak and feels like she is starving. Can't eat anything because of feeling nauseous and when she eats it goes right through. Has been throwing up and having diarrhea. The AEs require a visit to Emergency Room and Physician Office. There is prior Vaccinations (within 4 weeks). AEs following prior vaccinations was Flu vaccine. The outcoem of the events was not resolved.

Other Meds: TRIUMEQ; ESTRADIOL VALERATE

Current Illness: HIV infection (Pertinent Details: Caller reports it is undetectable, her CD4 count has been great. She is on ART.)

ID: 1320120
Sex: F
Age:
State: IL

Vax Date: 04/23/2021
Onset Date: 04/23/2021
Rec V Date: 05/15/2021
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Symptoms: throat felt swollen ,and soar my lungs felt raw like when you have bad congestion; throat felt swollen; Arm swollen muscles very painful through neck into jaw down my left side into my leg ,down to ankle, jaw felt numb at times; Arm swollen muscles very painful through neck into jaw down my left side into my leg ,down to ankle; shoulder pain; nausea; chills; Jaw felt numb at times; extremely tired; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 23Apr2021 10:45 AM at the age of 52-years-old (Batch/Lot Number: ER8735) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included cardiomyopathy from an unknown date. The patient did not have known allergies. Concomitant medications included metoprolol and lisinopril, taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Apr2021 02:00 PM, the patient experienced arm swollen, muscles very painful through neck into jaw down my left side into my leg ,down to ankle, jaw felt numb at times ,shoulder pain went on for 7 days ,nausea ,chills ,extremely tired ,her throat felt swollen ,and soar her lungs felt raw like when you have bad congestion ,hard to function tired all week. The patient did not want to take 2nd dose too many side effects. Therapeutic measures were taken included Tylenol, Asprin, loratadine famotidine tums. The outcome of the events was resolving.

Other Meds: METOPROLOL; LISINOPRIL

Current Illness:

ID: 1320121
Sex: F
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Symptoms: received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. However, she tested positive for Covid; received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. However, she tested positive for Covid; This is a spontaneous report from Medical Information. A non-contactable pharmacist reported that a female patient of unspecified age received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. The patient who received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. However, she tested positive for Covid and now wants to know how long she had to wait before she can receive the 2nd dose. The outcome of the events was unknown. No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and SARS-CoV-2 test positive cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.

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ID: 1320122
Sex: F
Age:
State: CO

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Rec V Date: 05/15/2021
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Symptoms: when it was administered her arm bled profusely, the lady who did it said she hit a blood vessel./significant amount of blood came out of her arm.,; when it was administered her arm bled profusely, the lady who did it said she hit a blood vessel.; when it was administered her arm bled profusely, the lady who did it said she hit a blood vessel.; This is a spontaneous report from a contactable consumer (patient) A 49-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced when it was administered her arm bled profusely, the lady who did it said she hit a blood vessel on an unspecified date. Caller just received second dose of covid vaccine. When it was administered her arm bled profusely. A significant amount of blood came out of her arm., the lady (person administering the vaccine) who did it said she hit a blood vessel. Caller wants to know if it will still be effective and if there will be any problems if it went into her blood stream. Caller would like to know if a blood vessel was hit inadvertently does it mean it hit the muscle if she would need to be revaccinated. The clinical outcome of the events was unknown.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 667,192

Page last modified: 03 October 2021 5:28pm