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
72,296
AK1,638
AL5,339
AR3,412
AS44
AZ13,316
CA58,147
CO11,002
CT7,824
DC1,626
DE1,670
FL36,235
FM3
GA13,429
GU82
HI2,195
IA4,332
ID2,473
IL19,261
IN22,568
KS4,284
KY6,945
LA4,714
MA13,886
MD11,901
ME2,997
MH8
MI17,865
MN11,345
MO8,919
MP30
MS2,676
MT2,147
NC15,401
ND1,273
NE2,732
NH2,859
NJ17,232
NM3,702
NV4,071
NY32,763
OH18,072
OK5,940
OR7,954
PA22,457
PR2,104
QM2
RI1,911
SC6,055
SD1,133
TN8,691
TX34,122
UT4,023
VA13,944
VI49
VT1,661
WA13,811
WI10,395
WV2,220
WY805
XB5
XL1
XV2

ID: 1419893
Sex: F
Age:
State: VT

Vax Date: 04/21/2021
Onset Date: 05/20/2021
Rec V Date: 06/23/2021
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Symptoms: I felt fatigue for about four weeks after second dose,; outbreak of Herpes ll; genital outbreak; blistering/itchy blistering on her finger; redness; itching/itchy blistering on her finger; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the right arm on 21Apr2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included herpes II from 1991, reported as 30 years ago. The patient had no known allergies and prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in four weeks. Concomitant medications included propranolol from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number unknown) on 31Mar2021 (at the age of 59-years-old) in the right arm for COVID-19 immunisation. The patient reported she felt fatigued for about four weeks after the second dose, especially when having to exert herself, "walking up a hill for example." The patient stated that she seemed better after four weeks and about one week later she got "what seemed to be" an outbreak of herpes II. She stated she had herpes thirty years ago with no additional outbreaks until now. She stated her symptoms where genital outbreak, some blistering, redness, itching and an itchy blistering on her finger. No treatment was received for the events. The clinical outcomes of fatigue for about four weeks after second dose, outbreak of herpes II, genital outbreak, blistering/itchy blistering on her finger, redness, itching/itchy blistering on her finger were recovering. It was also reported the patient had not been tested for COVID-19 since vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds: PROPANOLOL [PROPRANOLOL]

Current Illness:

ID: 1419894
Sex: F
Age:
State: VA

Vax Date: 04/22/2021
Onset Date: 04/29/2021
Rec V Date: 06/23/2021
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Symptoms: my lower jaw and teeth began to hurt; my lower jaw and teeth began to hurt; my legs got hives for a couple of days; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0171) via an unspecified route of administration in the left arm on 22Apr2021 at 11:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included having her jaw rewired in 2001, reported as 20 years ago. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in four weeks. The patient received unspecified concomitant medications in two weeks. The patient reported she had her jaw rewired 20 years ago and after she got her first dose, her lower jaw and lower teeth began to hurt. She also reported that her legs got hives for a couple of days. It was reported no treatment was received for the events. The patient received her second dose of BNT162B2 (lot EW0168) on 14May2021 at 09:15. The clinical outcomes of her lower jaw and lower teeth began to hurt, and her legs got hives for a couple of days were not recovered. It was also reported the patient had not been tested for COVID-19 since vaccination.

Other Meds:

Current Illness:

ID: 1419895
Sex: F
Age:
State: VA

Vax Date: 05/06/2021
Onset Date:
Rec V Date: 06/23/2021
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Symptoms: feeling feverish/I have had a continuous fever; severe allergic reaction; she tasted like a rubbing alcohol taste in the mouth; felt tired; her skin felt hot; feeling so ill; but the thing on her feet blossomed; she gets urine infections; The urine stick test colors came out as pink which indicated nitrites and leukocytes; The urine stick test colors came out as pink which indicated nitrites and leukocytes; she still felt like she had a virus.; chills; Her vaccine blood is showing lower.; she had monocytes in blood work that were low.; very weak; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 06May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included IgA deficiency, IgE deficiency, bacterial infection and urinary infection all from unknown dates and covid-19 from Mar2020 (she was sick with covid). The patient's concomitant medications were not reported. The patient experienced feeling feverish/I have had a continuous fever severe allergic reaction, she tasted like a rubbing alcohol taste in the mouth, felt tired, her skin felt hot, feeling so ill, but the thing on her feet blossomed, she gets urine infections, the urine stick test colors came out as pink which indicated nitrites and leukocytes, she still felt like she had a virus, chills, her vaccine blood is showing lower, she had monocytes in blood work that were low and very weak all on unspecified dates. The event feeling feverish/I have had a continuous fever was marked as medically significant. Reporter mentioned that she is feeling feverish. Her daughter and her got vaccine on 06May2021 Thursday, of this month. This is too much for her right now, she is fighting a fever, she got the vaccine thing and then she tasted like a rubbing alcohol taste in the mouth, it felt like something was in the lower thoracic region in her body. Then on Saturday her daughter and herself both felt tired it was no big deal but then she woke up Sunday enraged with fever, her skin felt hot, almost red on fire, she was feeling so ill, she thought the highly responsible things to do was get the covid test and so she did, she got the covid test on 11May2021 and it was negative. She doesn't know if this is classified with the immune system, but the thing on her feet blossomed before 11May2021. She also tested her urine, her daughter gave strips previously because she would be taking baths, she gets urine infections every 6 months. On 11May2021 she got the covid test and the urine dip stick test. The urine stick test colors came out as pink which indicated nitrites and leukocytes and so she called the doctor. The doctor called in an antibiotic and it was too low, usually they call in 100mg, but she didn't get the antibiotic till Friday, she took it for 3 and half days, she felt like it was reducing the bacteria by 50% but she still felt like she had a virus. She re-tested the urine leukocytes it was pink and that was on Monday, by Tuesday she was back at urgent care, they said she is still fighting something and did a culture, then they switched her to Augmentin, she took it for 5 days, she felt her body was fighting a virus or bacteria, she felt fever and chills before but now this was severe fever chills. She has IgA deficiency and IgE deficiency, she has been in touch with the clinical director when she was sick with covid and she wants to help humanity, there's a whole herd of people out there that believed the vaccine is okay to get. Her vaccine blood is showing lower. She has been reporting this everywhere. She has had no heart attack, no neurologic issue, but she is having severe allergic reactions. Everything in body grew 3-5 times strong, she is schedule for her 2nd dose of vaccine on Thursday and she will not have that. This is too much for her. She got an antibody test and it came up as 2.5. She wants to feel better, she got a call into the immunology office, but he's so new at the immunology off, she needs some sort of immune system soothing, she felt like she her skin was on fire, she had monocytes in blood work that were low. I'm afraid I will never recover. Reporter states she had Covid 19 (not confirmed) in Mar2020 (Mostly had pneumonia symptoms). Since I received my 1st pfizer vaccine "I have been terribly sick. I have had a continuous fever and after 15 days, I can't seem to break it. I am feeling like I am fighting a virus. Any mild symptoms I had before the vaccine seem to have bloomed and grown into bigger health problems. I have had bacterial infections, urinary infections and I am very, very weak." Reporter states an Endocrinologist did IGE and IGA tests and diagnosed her as having IGA deficiency and it was diagnosed using a test to check or tetanus antibodies. "I am positive for the tetanus antibodies and I haven't had a tetanus shot in over 20 yrs." The patient underwent lab tests and procedures which included antibody test: 2.5 on 11May2021, Tetanus Antibodies: positive on 11May2021, Covid-19 test: negative on 11May2021, urine dip stick test: stick test colors came out as pink on 11May2021 (The urine stick test colors came out as pink which indicated nitrites and leukocytes). Therapeutic measures were taken as a result of feeling feverish/I have had a continuous fever, she gets urine infections, the urine stick test colors came out as pink which indicated nitrites and leukocytes. The outcome of all the events was unknown. Information on the lot/batch number has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021601971 Same reporter/drug/event , different patient

Other Meds:

Current Illness:

ID: 1419896
Sex: F
Age:
State: KY

Vax Date: 06/03/2021
Onset Date: 06/03/2021
Rec V Date: 06/23/2021
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Symptoms: Nearly passed out twice; Passing blood clots; GI bleed; Severe body aches; Fatigue; Abdominal pain; Nausea; Vomiting; Fever; Diarrhea; Dehydration; Colitis; This is a spontaneous report from a contactable Nurse (patient) reported for herself. A 42-year-old female patient (not Pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) at 42-year-old, dose 2 via an unspecified route of administration, administered in Arm Left on 03Jun2021 06:30 PM (Lot Number: EW0179) as dose 2, single for covid-19 immunisation in Clinic. Medical history included hypertension, anxiety, seasonal allergy, asthma, Known allergies to Cephalosporin. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications received within 2 weeks included spironolactone; irbesartan; buspirone hydrochloride (BUSPAR); silybum marianum (MILK THISTLE), 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. The patient previously took miralax and experienced Allergy, lisinopril and experienced Allergy, venlafaxine and experienced Allergy, patient previously took first dose of BNT162B2 (Brand: Pfizer, Lot number: EW0177) into left arm on 13May2021 06:30 PM at 42 years old for COVID-19 immunization. Patient experienced Severe body aches, fatigue, abdominal pain, nausea/vomiting, fever, nearly passed out twice, diarrhea followed by passing blood clots, dehydration, treated in ER twice. Once for dehydration, second for colitis with GI bleed. Event Start Date was 03Jun2021 09:00 PM. the adverse event result in Emergency room/department or urgent care. treatment received for the adverse event included IV fluids, antibiotics, and antiemetic. Outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: The limited information provided in this report does not allow a full assessment of the case, however, a possible contributory role of the suspect drug to the reported events "Nearly passed out twice, Passing blood clots and GI bleed" cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: SPIRONOLACTONE; IRBESARTAN; BUSPAR; MILK THISTLE

Current Illness:

ID: 1419897
Sex: F
Age:
State: FL

Vax Date: 06/01/2021
Onset Date: 06/01/2021
Rec V Date: 06/23/2021
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Symptoms: vaccine affected her brain/brain got overloaded /has a lot of things stirring in her brain; had more pronounced insomnia, anxiety, depression and culture anxiousness/couldn't sleep at all/this was different; had more pronounced insomnia, anxiety, depression and culture anxiousness/ Anguish/ over anxious; had more pronounced insomnia, anxiety, depression and culture anxiousness; Feeling weird/whole week she felt mentally/didn't feel like herself/felt this vaccine affected her brain; Diarrhea; Nausea; scared; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 01Jun2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included insomnia, anxiety, depression and culture anxiousness since she suffered from traumatic brain injury after car wreck and its severity, she is recovering, and on medication. She was unemployed and on disability due to her car wreck and she had a degree in marketing. She used to work for financial banking services prior to her traumatic brain injury. Concomitant medication included unspecified medication for traumatic brain injury after car wreck. Patient received her first dose of the Pfizer Covid-19 vaccine on 01Jun2021 and since then has had more pronounced insomnia, anxiety, depression and culture anxiousness (she had these since she had a traumatic brain injury). Her psychologist told her to receive the second dose of the vaccine but patient is wondering if it is okay to just get the one and not the second. Patient stated that she is kind of a weird case. She got her first dose on 01Jun2021 at a local health department and immediately started feeling weird, not during the day but at night. She couldn't sleep at all, but she does have insomnia but this was different. She has insomnia, anxiety and depression and so she was overanxious. She had a lot of weird side of effects, not like throwing up but she did have diarrhea and nausea since 01Jun2021. Here's the bottom line, the whole week she felt mentally. Patient interrupted herself stating remember she had a brain injury, she felt this vaccine affected her brain and she didn't feel like herself. Patient is scared because of the way it made her feel. She stated that she has a lot of things stirring in her brain and causing her a lot of mental anguish, depression and anxiety and this vaccine made it even weirder. She stated everyone in family had had the vaccine with no problems. Patient stated that her side effects have gone away and part of it is because she is missing her mom and lost her dad in 2019, patient stated that she has not recovered from this and they were like peas in pod and the vaccine has amped up these things and how to relate to this. It irritated her when she cannot talk. She has a college degree. She stated she wouldn't know how to relay this to the doctor. Her brain got overloaded and that was another problem. She takes medicine for this as well. Patient stated that she is beginning to feel stupid for calling, because she can understand people that have arm pain and stuff. Patient interrupted herself again and said she would just shut up. Outcome of the events was unknown. Information on batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1419898
Sex: U
Age:
State: NY

Vax Date: 05/14/2021
Onset Date: 05/20/2021
Rec V Date: 06/23/2021
Hospital: Y

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Symptoms: Central venous sinus thrombosis; This is a Spontaneous case report from a contactable nurse reporting for himself/herself, received from Pfizer Sponsored Program. A 20-years-old patient of an unspecified gender received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, at Pharmacy or Drug Store, via intramuscular route on 14May2021, at 20 years of age, (Batch/Lot Number: EW0167) as single dose for COVID-19 immunization. The patient had no relevant medical history, except for diagnosis of COVID-19 on an unknown date prior to vaccination and didn't receive any concomitant medication. It is unknown if the patient has been tested for COVID-19 since the vaccination. The patient didn't receive any other vaccine within 4 weeks prior to the COVID vaccine. On 20May2021 the patient experienced "central" venous sinus thrombosis which resulted in Emergency room/department or urgent care and required the patient's hospitalization. The patient was hospitalized for 4 days. The patient underwent neuro imaging on an unknown date and was treated with enoxaparin (LOVENOX). At the time of the report the event was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Cerebral venous sinus thrombosis due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and angiogram, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1419899
Sex: M
Age:
State: NC

Vax Date: 02/25/2021
Onset Date: 05/01/2021
Rec V Date: 06/23/2021
Hospital: Y

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Symptoms: Cerebral venous thrombosis; bilateral intracerebral hemorrhage in the left, greater than the right; tonic-clonic seizure; brain swelling/cerebral edema; headaches; overall imbalance/having balance problems; he had a decline; kind of getting worse/ had the worst symptoms; His prostate is enlarged; patient's mental status is altered; This is a spontaneous report from a contactable physician. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 25Feb2021 (Batch/Lot Number: EN6203) as 0.3 ml single for COVID-19 immunisation. Patient age at vaccination was 65 years old. Medical history included hyperlipidemia and high cholesterol. Historical vaccine included 1st dose of BNT162B2 (LOT: EL3247) on 03Feb2021 for COVID-19 immunisation. Concomitant medication included pravastatin (strength: 10 mg) taken for an unspecified indication from an unspecified start date and ongoing. Reporter did not know all of the symptoms that the patient had and cannot get the history, because the patient's mental status was altered (from unknown date in 2021). It was reported that he was having symptoms for at least 2 weeks with some increasing over the last 2 weeks. Knew that he had an overall imbalance and was having headaches, both from unknown date in May2021. He had been having symptoms for weeks and went to his doctor as an outpatient. He had initial imaging that was concerning and he went to the hospital because he had a decline (from unknown date in 2021). He had declined and had a hemorrhagic hemorrhage with cerebral venous thrombosis, both from 04Jun2021. He was admitted to the hospital 04Jun2021, and 05Jun2021 he was transferred to the ICU. He had declined since his initial presentation and had been kind of getting worse over the last couple of weeks. Stated the patient was stoic and does not have a lot of medical problems, but everyone knew he was having symptoms over the last 2 weeks. 02Jun2021 he had the worst symptoms and was basically having balance problems. He was getting concerned and had called to get an appointment with his primary care physician. They had done an outpatient CT scan which found the cerebral venous thrombosis and he went to the hospital and was placed on Heparin. While in the hospital, he had a generalized tonic-clonic seizure and had further decline on 04Jun2021. Repeat imaging showed that he had bilateral intracerebral hemorrhaging, the left greater than the right, and they had expanded a bit. He was still on heparin and now (Jun2021) had some cerebral edema due to it but was not on a ventilator. He was still in the time period where he was continuing to have small declines. He was therapeutic on heparin. He had a central line and was getting hypertonic saline for the brain swelling and cerebral edema. Patient previous health condition was reported as he did not have a real significant past medical history. He maybe carried a diagnosis of hyperlipidemia and high cholesterol. He was pretty healthy; regularly went to the doctor and was otherwise pretty stable. Reporter did not even think his LDL was that high. He had never been on any blood thinners or anything like that. They did a full scan to look for cancer and had no history of blood clots. They did a scan that was negative for any types of masses or any concerns for cancer. His prostate was enlarged (from unknown date in 2021) and they had spoken to the family about it and they said he had been worked up with a biopsy which had been negative. Physician Office? Yes, He was directly admitted to the hospital from primary care. He presented to the clinic because he had these symptoms and headaches. The imaging was done and then he was admitted. He never went through the emergency room. Cerebral venous thrombosis, bilateral intracerebral hemorrhage, overall imbalance/having balance problems, he had a decline, headaches resulted in Physician Office Visit. Outcome of cerebral venous thrombosis, bilateral intracerebral hemorrhage was not resolved; outcome of tonic-clonic seizure, brain swelling/cerebral edema, headache, overall imbalance/having balance problems, he had a decline, kind of getting worse/ had the worst symptoms, enlarged prostate and mental status was altered was unknown. Causality: Cerebral venous thrombosis: Can't say for sure because reporter does not know the timeline but can't find any other reason, he would have cerebral venous thrombosis.; Sender's Comments: Based on the temporal relationship, the association between the events cerebral venous thrombosis, intracerebral hemorrhage, tonic-clonic seizure, and brain swelling 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: PRAVASTATIN

Current Illness:

ID: 1419900
Sex: F
Age:
State: PA

Vax Date: 06/04/2021
Onset Date: 06/04/2021
Rec V Date: 06/23/2021
Hospital:

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Symptoms: Passed out 12 hours after receiving the vaccine.; This is a spontaneous report from a contactable consumer(patient). This 16-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0175) at single dose via an unknown route in left arm on 04Jun2021 08:30 at 16-year-old for Covid-19 immunization. Medical history included Paramyotonia-congenita. Prior to vaccination, was the patient diagnosed with COVID-19. Patient had no known allergies. Concomitant drug included fluticasone propionate (FLONASE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Jun2021 08:00 PM, patient passed out "12 hours" (as reported) after receiving the vaccine. No treatment was received. Outcome of the event was resolved. Since the vaccination, the had not patient been tested for COVID-19. The report was assessed as non-serious.

Other Meds: FLONASE [FLUTICASONE PROPIONATE]

Current Illness:

ID: 1419901
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 06/23/2021
Hospital:

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Symptoms: This is a spontaneous report from a contactable physician. This physician reported that a 64-year-old male patient received second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: unknown) on an unknown date at single dose for COVID-19 immunization. The patient had received the first dose of vaccine on an unknown date. Medical history and concomitant drugs were not provided. After the 2nd dose of vaccine shortly within 1 week the patient is developed an awful taste and food was awful did not go much into smell (the reporting physician thought smell was off as well). He also reported fatigue, tiredness and dizziness and continued (hasn't gotten over it yet) reports good days and bad days. He waited a month to let the physician know. He did a home test and nasal test which were negative this was 4-5 weeks out. He stated that the vaccine did that to him. The physician told the patient to think had the covid in between, but he says it was the vaccine. Caller added the patient was pretty adamant that after the second dose the patient lost his taste. The caller suggested maybe the patient picked up the virus. Caller wanted to know if loss of taste was a possible side effect of the vaccine. Caller was not too sure this was a vaccine issue, and that he thinks it seemed like the patient contracted the Covid infection while going through the vaccination process. Patient was tested for Covid but the caller does not have the results. No identified positive test for Covid, but the caller believes the patient was experiencing Covid and not a side effect of the vaccine. The outcome of the events was unknown.; 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

Other Meds:

Current Illness:

ID: 1419903
Sex: M
Age:
State: TX

Vax Date: 03/31/2021
Onset Date:
Rec V Date: 06/23/2021
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Symptoms: This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the first dose of BNT162B2 at 57-year-old, via an unspecified route of administration in arm left on 31Mar2021 at single dose, and the second dose at 57-year-old via an unspecified route of administration on 21Apr2021 at single dose for COVID-19 immunisation, and testosterone, via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose for an unspecified indication. Medical history included COVID-19 from Dec2020, and left arm bothered him. There were no concomitant medications. Patient reported his tongue and taste buds were "screwed up" and it had been painful to eat which had resulted in weight loss of 50 pounds in the last 5 months and this had gotten worse since being vaccinated. He was fatigued and his whole body hurt and sports injuries from past were very painful. He had previous Covid infection in Dec2020. He had seen many doctors and had an appointment with neurologist coming up. He didn't have much hope. He felt like he had 75% Covid all the time and his body felt like he had been hit by a truck. Not really that bad but like his taste buds were screwed up and it kind of progressed since he received the vaccine. Ever since the patient got the vaccine, the arm that he got the vaccine in it killed him, every joint in his body hurt, and he had seen lots of doctors about this and no one could figure it out. The patient was 250 pounds before this started. Patient was having something wrong with his tongue and taste buds, it was hard to explain. It was painful to eat, the patient had been to an ENT and they were sending the patient to neurology to figure it out. The tongue thing went away they thought it was thrush, then talked to another ENT and thought it was something neurological. The patient's whole body hurt. The patient was unsure when all of this started but he stated that it had worsened over the last couple of months. The patient's mouth was in pain. The patient was fatigued. The patient's left arm bothered him before the vaccine but it had progressively gotten worse over time. All of the symptoms that the patient had from COVID got progressively worse after the vaccine. The patient's arms were really lose and it felt like the arms wanted to come out of the socket. The pain could be a 9/10 and nothing touched it. The day after the first shot, the patient got testosterone shots, they found and erratic heartbeat which freaked out the patient. They did and EKG and said it was okay but couldn't determine what it was. Patient was tested and it showed hypothyroid and they did an intake test. The doctors thought it was thyroiditis but that got better but then it snowballed into what it was. Investigations: The patient was tested for cancer, rheumatoid arthritis and all sorts of different things which were all negative. The patient was a healthy guy otherwise, besides these symptoms. Action taken in response to the events for testosterone was unknown. Outcome of events his tongue and taste buds were "screwed up", the arm that he got the vaccine in it kills him/left arm bothered him before the vaccine but it had progressively gotten worse over time, every joint in his body hurt, and erratic heartbeat was not resolved, and of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: Testosterone

Current Illness:

ID: 1419904
Sex: F
Age:
State: OR

Vax Date: 04/10/2021
Onset Date: 04/11/2021
Rec V Date: 06/23/2021
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Symptoms: Extreme muscle fatigue when walking; Weakness in left leg; Frequent muscle spasms; tremors; stabbing muscle pain; "pins and needles" all over body; chest tightness; heart palpitations; myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk."; Myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk."; myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk."; Sharp, stabbing pain in legs; Thousands of fasciculations in all parts of the body, except for the head; inability to sleep; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 46-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 10Apr2021 at 14:30, at patient age of 46-year-old, as single dose (Lot number EW0158) for COVID-19 immunisation. The patient had no COVID prior vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included vestibular migraines, hypothyroidism. The patient's known allergies included multiple environmental allergies, but nor drug. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included levothyroxine sodium (SYNTROID) for hypothyroidism, sertraline hydrochloride (ZOLOFT) for vestibular migraine. The patient experienced the adverse events from 11Apr2021 at 02:15 AM. Symptoms started 12 hours after vaccine, 2:15 at night with sharp, stabbing pain in legs. Thousands of fasciculations in all parts of the body, except for the head. During the day: extreme muscle fatigue when walking, weakness in left leg, frequent muscle spasms, tremors, stabbing muscle pain, "pins and needles" all over body, heart palpitations and chest tightness, tremors upon waking up. 7 weeks later, myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk." Heart palpitations are still very strong, inability to sleep - being awaken by the muscle "jerks" numerous times per night. Blood work and MRI of the spine are normal in Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Clonazepam (CLONOPIN) was prescribed with little effect. The outcome of the events was not resolved. COVID was not tested post vaccination.

Other Meds: SYNTHROID; ZOLOFT

Current Illness:

ID: 1419905
Sex: F
Age:
State: TX

Vax Date: 03/18/2021
Onset Date: 05/01/2021
Rec V Date: 06/23/2021
Hospital: Y

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Symptoms: Blood in stool/Rectal bleeding in my stool; blood in stool wherein they had to remove her bleeding polyp; High white blood cell count/White blood cell count has been like from 24 to 26 all the way up to like 33; Rectal bleeding in my stool; Have lost my 10 pounds; tired; Internal hemorrhage/ internal hemorrhage as well the 'follicles'/Started bleeding pretty bad; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 50 years of age), dose 2 via an unspecified route of administration on 18Mar2021 (Batch/Lot Number: EN6202) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included blood pressure high from an unknown date and unknown if ongoing. Concomitant medication included metoprolol taken for blood pressure measurement, start and stop date were not reported. Historical vaccine included BNT162B2, dose 1 on 25Feb2021 (at 50 years of age) (lot number: EN6202) for COVID-19 immunisation and the patient experienced tiredness. She did not have any other vaccine within four weeks prior to COVID-19 vaccine. The patient reported possible adverse event with the Pfizer COVID-19 vaccine. Throughout the whole pandemic (1.5 years), she hadn't gotten any bloodwork until recently. She said that she had been hospitalized twice. Her first hospitalization was due to the high white blood cell count and the second hospitalization was due to blood in stool wherein they had to remove her bleeding polyp and she would not be discharge because of her high WBC count. When she talked to her blood doctor, her blood doctor told her that she had another patient with the same manifestation, but the other patient had COVID-19. The patient was not sure if she had COVID-19 in the past. She will have more blood work and she will have a biopsy of her bone marrow. In the meantime, she was wondering if it may be an adverse event from the vaccine. She also mentioned that she was part of the clinical trial for the Pfizer COVID-19 vaccine. The patient mentioned that she doesn't know as she had not done blood work since prior to COVID-19 because she hadn't gone to the doctor, so she went to the doctor very recently like at the beginning of May maybe. She guessed that just for something else and she went fasting so they can do routine blood work and incidentally she had a very high white blood cell count (in May2021) and at this point they cannot figure out what was wrong with her. She added that she was very healthy, everything came back pretty normal. She doesn't feel sick, they hospitalized her once for that and then she was hospitalized for (incomplete sentence). She had colonoscopy, she had some issue with (incomplete sentence), they repeated the colonoscopy to put the 'clamp' and then they didn't let her go from the hospital because of the high white blood cell count and so, she guessed she was kind of wondering, if there have been a report on abnormal blood white cell after the Pfizer vaccine and it came earliest thought in her mind today when she was at new doctor who told her about another patient that have high white blood cell count but she had COVID. The patient did not have COVID that she knows, she did not have COVID. The patient added she does not consider it a bad reaction. She mentioned that she was tired. She had undergone multiple blood tests. White blood cell count has been like from 24 to 26 all the way up to like 33. She added that when she originally went to the doctor and when she got this blood work done the first one she was having a little tiny bit of rectal bleeding in her stool and that was because she went to the doctor and she did have a colonoscopy and they basically found some internal hemorrhage as well the follicles and the second time she repeated the blood work, the third time actually she started bleeding pretty bad, so she had to repeat colonoscopy so because of all of this trauma her doctor was repeating the white blood 'sheet' to take blood 'today' to look at her white blood cell a little bit more in depth now that her body was kind of healed for those colonoscopy. She mentioned that now, all this medical test if there was a possibility for her to find out if it could have to do with the vaccine. She added that right now she was 5 feet 6 inches, at that time she was 6 and about 195 pounds. She lost her 10 pounds which the patient commented as "that good news". The patient underwent lab tests and procedures which included biopsy of bone marrow with unknown result on 07Jun2021, blood work and repeated the blood work with unknown result on an unspecified date; Colonoscopy on an unspecified date with unknown result and in May2021 where they found some internal hemorrhage as well the 'follicles'; and white blood cell count: 24 to 26 on May2021 all the way up to like 33 and unknown result on 07Jun2021. The "high white blood cell count" and "Internal hemorrhage/ internal hemorrhage as well the 'follicles' started in May2021 while other events started on an unspecified date. The outcome of the events was unknown.

Other Meds: METOPROLOL

Current Illness:

ID: 1419906
Sex: M
Age:
State: NY

Vax Date: 02/24/2021
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Rec V Date: 06/23/2021
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Symptoms: spiking of his blood pressure; sore arm; legs swollen; pain on one leg; on and off nausea; not feeling right; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 24Feb2021 (Lot number was not reported) at the age of 77 years, as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2, dose 1 on unspecified date for COVID-19 immunization. On an unspecified date the patient experienced spiking of his blood pressure, sore arm, legs swollen, pain on one leg, on and off nausea, not feeling right. The patient had lab tests and procedures which included blood pressure measurement: 190/80. The clinical outcome of the events was unknown. The clinical course was reported as follows: 77-year-old caller reported receiving his second dose of the Pfizer-BioNTech COVID-19 vaccine 24Feb2021 and experienced a "sore arm" after. He explained that a week after vaccination, on the Monday, he " woke up with his legs swollen and pain on one leg". He stated he also experienced spiking of his blood pressure (BP), however on Monday 03Mar2021 he went to the ER since his BP rose over 190/80. He explained at the ER, he guessed they got him more call, and he received a prescription of "water pills" to take for "a couple weeks". He added then, there were moments when he "didn't feel right". He specified he would be "good" in the morning then he "just didn't feel right" in the afternoon. He reported about a month later, 13Apr2021 he had a "second incident with the spiking" of his BP, which led him to the ER. He explained his cardiologist then changed his amlodipine prescription to "5mg in the morning and 5mg at night". He explained he would take 1 pill of Amlodipine 10mg in the morning before vaccination. He added he would take 5mg of amlodipine for a year before being increased to that 10mg a day. He explained before vaccination, he "never experienced such spiking with his BP and considers himself healthy for his age. DSU agent reported his BP is generally around 120/70 and he routinely use the treadmill. He mentioned he now seems ok, has not have a "violent" BP spike, but has "not felt 100%" yet. He added some days he is "fine" and others he has "on and off nausea" or he "feels his legs are swollen in the evening". The main reason for his call is to see if Pfizer have any experience with people who have covid, the long haulers, with the effects for quite a while, that are 3 months in. He was wondering whether or not any long hauler folks that have had on and off side effects attributed it to the vaccine. Information about Lot Batch number has been requested.

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ID: 1419907
Sex: F
Age:
State: PA

Vax Date: 04/16/2021
Onset Date: 04/17/2021
Rec V Date: 06/23/2021
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Symptoms: This is a spontaneous report from a contactable Other HCP (patient). A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 16Apr2021 at the age of 41-years-old (Lot Number: ER8731) as single dose for COVID-19 immunization. Relevant medical history and concurrent conditions was none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took amoxicillin and experienced Known allergies: Amoxicillin. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported: "I broke out in a rash on 17Apr2021. It started on my face in a straight line down my left cheek and neck. Then it appeared in patches on my trunk (both stomach and back). It eventually spread to my legs. I got new patches for 2 weeks following the shot. I went to the doctor and they couldn't prescribe steroids as it was stated that it would lesson the effects of the second shot. When I started my menstrual cycle 3 weeks following the 1st dose of my Pfizer shot I had severe cramping and clotting for 3 days during my period. It was the most pain that I have had from a period. The flow was stronger from the beginning of the cycle than is typical." The adverse event result in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered in 2021.; Sender's Comments: Based on temporal association and known safety profile of the product, there is a reasonable possibility that th event rash is 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.

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ID: 1419908
Sex: M
Age:
State: IN

Vax Date: 04/16/2021
Onset Date: 04/01/2021
Rec V Date: 06/23/2021
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Symptoms: Acute respiratory failure with hypoxia; Acute respiratory failure with hypoxia; Couldn't breathe; Pneumonia due to MRSA/Ground glass pneumonia; weak; lost 20 pounds; fever; Cough; This is a spontaneous report from a contactable consumer (the patient himself). A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6208, Exp 30Jun2021) via an unspecified route of administration in arm left on 16Apr2021 11:00AM (at the age of 64-year-old) at single dose for COVID-19 immunisation. Relevant medical history included heart disease ongoing from 1997 (this happened in 1997 and the patient had been living with it for a little while), heart attack, pacemaker defibrillator because of cardiac arrest (in 2011), atrial fibrillation (diagnosed a little while, he was not sure and had been in and out of the hospital and to heart doctor quite a bit) and hypertension. The patient was administered with first shot of BNT162b2 (Lot number EW0153) in left shoulder on 16Mar2021 11:00AM (at the age of 64-year-old). Concomitant medications were not reported. On 16Apr2021 after the second dose, the patient was fine. There were no reactions after the first dose, but the second dose two days after he started developing a cough and fever. He thought it was a side effect but then ended up in the ER with pneumonia. They gave him antibiotics and sent him home. He went through the antibiotics and went back because he was still sick and not responding. They gave him more antibiotics and sent him home. He went through that batch and ended up really bad so he had to call an ambulance a few weeks later. He was diagnosed with MRSA Pneumonia and stayed in the hospital for 5 days. Then, he was discharged. He went back to the ER again a few days later because he did not seem to be improving. He was coughing and was weak. He was given another batch of antibiotics. He did not know if it was from the shot or what - he was healthy until then. The patient added that she lost 20 pounds and confirmed that it was following the vaccine. Two days after the vaccine, maybe it was 19Apr2021, he had a fever and it was now gone (exact dates were unknown). Cough happened at the same time of the fever but it was not as bad, and then progressively got worse. His lungs started filling up. They thought it was COVID. by the x-rays it looked like COVID lung but they took a sample and it was MRSA (exact dates were unknown). His admission was 18May2021 and was for acute respiratory failure with hypoxia. Discharge paperwork said acute chronic combined systolic diastolic congestive heart failure but he has had that for many years. It also stated primary hypertension but he has had that. The paperwork sayid pneumonia due to MRSA and pneumonia due to unspecified organism. He was hospitalized 18May2021 through 23May2021 with pneumonia and the reason he was hospitalized was because he could not breathe. Lost 20 pounds: after he started getting sick from the beginning of it all, he was coughing and losing weight and all that. It may not be quite 20 pounds, maybe 17, but he just knew that he was down quite a bit. He was 160s now, he was high 170s before (as reported). Treatment included Lasix and all kinds of different antibiotics. They were giving him, he did not know what it was, at first. Then, they narrowed it down and once they found out it was MRSA they gave him Clindamycin he believes. Investigations: they did CT scans, chest X-rays, and labs but he does not know any information. Each time they did a chest x-ray, when he went to get a chest x-ray, each one was worse all the way up to when he was admitted. When he went, they did a bronchial scope or whatever, he was not sure, and they saw lots of swelling and infiltrate. He did not know what this meant, stuff was infiltrating into the tissue and it was not just in the airways. He added it looked like ground glass pneumonia is what they said. The patient added that he was usually pretty active and cannot do anything anymore. He had three or four Covid tests, all negative, no additional details provided. Outcome of the events was unknown. Follow-up attempts are needed. Further information is expected.

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Current Illness: Heart disease, unspecified (Verbatim: heart disease)

ID: 1419909
Sex: M
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Symptoms: This is a spontaneous report from a contactable physician. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: unknown) 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. It was reported that the patient was young and healthy. On an unspecified date, after the vaccination, the patient developed COVID-19. The patient tested positive via SARS-CoV-2 test on an unspecified date. The reporter was concerned that certain retail outlets where vaccines were kept were not adhering to proper storage mechanisms. The reporter did not know of any specific locations and did not know that product incorrect storage was being performed, but wanted Pfizer to be aware of the potential issue. The clinical outcome of "developed COVID" was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

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ID: 1419910
Sex: M
Age:
State: PA

Vax Date: 05/16/2021
Onset Date: 06/01/2021
Rec V Date: 06/23/2021
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Symptoms: Mondor's disease penile; Peripheral penile vein swelling appeared, with little uncomfort and pain; Peripheral penile vein swelling appeared, with little uncomfort and pain; This is a spontaneous report from a contactable pharmacist (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 16May2021 at 15:15 (Batch/Lot Number: EW0177) as single dose 2 for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, hypercholesterolemia, and hypothyroidism. The patient has no known allergies. Concomitant medications included metformin; atorvastatin calcium; levothyroxine sodium (SYNTHROID); all taken for an unspecified indication, start and stop date were not reported. Historical vaccination included BNT162B2 given on 18Apr2021 for COVID-19 immunization at the age of 60 years old (brand: Pfizer, lot number: EW0169, administration time: 3:15 PM, dose number: 1, vaccine location: left arm). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Approximately 20 days after receiving the second dose, peripheral penile vein swelling appeared with little uncomfort and pain. Ibuprofen helped when taken. Event was ongoing. The patient believed it was Mondor's disease penile. The reporter was curious if COVID19 vaccine causes this disease. All events occurred on 01Jun2021 with outcome of not recovered. Treatment received for the events was ibuprofen. The events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the limited in formation provided and due to an unsuitable temporal association, the company, at the present time, deems there is not a reasonable possibility that the reported Mondor's disease, with associated signs and symptoms, are related to BNT162B2 administration. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: METFORMIN; ATORVASTATIN CALCIUM; SYNTHROID

Current Illness:

ID: 1419911
Sex: F
Age:
State: VA

Vax Date: 06/04/2021
Onset Date: 06/01/2021
Rec V Date: 06/23/2021
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Symptoms: Left arm got sore; Shivering and shaking; Shivering and shaking; weak; her body just collapsed to floor; This is a spontaneous report from a contactable nurse (patient herself, retired LPN). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 04Jun2021 at 13:00 at the age of 72 years old (Batch/Lot Number: FE8F37, Expiration date: unknown) as dose 1, single for COVID-19 immunization. The vaccination facility type was a pharmacy/drug store; the vaccine was not administered at military facility. The patient weighed the odds of getting COVID-19 versus getting the vaccine. Relevant medical history included allergies and asthma, both from an unknown date and unknown if ongoing and tightness in her chest and maybe she had caught a bug with congestion treated with antibiotics, both from Feb2021 to an unspecified date. The patient's concomitant medications were not reported. The patient previously used her beclometasone dipropionate (QVAR inhaler). The patient had no family medical history relevant to adverse events (AEs). The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines were administered on same date of the Pfizer suspect. The patient had no prior vaccinations (within 4 weeks). The patient stated she got the Pfizer vaccine last Friday, 04Jun2021 at 13:00, and at 23:00 she started shivering and shaking. She stated she took 1 acetaminophen (TYLENOL) and went to bed and first Tylenol helped. The patient stated she woke up and didn't know what time it was, but she was shivering and shaking again. She stated she had the Tylenol bottle in her hand and a cup of water and her body just collapsed to the floor on an unspecified date in Jun2021. She didn't know if her whole body shook or collapsed her to floor. She said that it seemed like her whole body shook a little bit, but she was not sure. The patient stated she could not get up. She tried to get up and waited for a bit and then was able to get herself up. The patient stated she did some research the day prior reporting and didn't see anything about the collapsing, but she knew the shivering and shaking were to be expected. She stated this was very scary and she couldn't control it. The patient was scared to death to get the second one. The patient stated she worked in a nursing home until it closed, and then they moved her to assisted living. The patient stated that by her research, she knew this was common side effect. She hoped she could be told more information to see if its safe to get the second vaccine. For the events shivering and shaking, the patient stated that sometimes she would stay up to watch a movie. She woke up and it had started again. She wasn't sure if it was after midnight on 04Jun2021 or if it was 05Jun2021 when it resolved. She stated she came in to get the Tylenol and she collapsed on her way back to bed and she was lucky she didn't hit her head. She knew at 2300, she got it to stop and as far as she remembered, the second time she went off to sleep. The patient said that the Tylenol got it under control. She was not shivering and shaking by the next morning. For the event collapse, the patient stated it could have been 05Jun2021. She stated she didn't faint at all and thought her body shook all over. She stated it took her whole body down and the bottle of Tylenol and water flew everywhere. She said that it was very scary. The patient had allergies and asthma and heard if you have COPD or lung issues that it could be much worse. The patient stated she told the pharmacist this before she received her first shot. She stated she had an endoscopy on 15Feb2021 and woke up and everything went fine, everything was negative. Later, on an unspecified date in Feb2021 she had tightness in her chest after she woke up. She called the GI doctor and they said she did so well through the endoscopy, that maybe she had caught a bug. She stated she later did some research and found that 5 percent of people got sick afterwards. She did end up taking 4 bottles of antibiotics and the congestion and everything came back. She stated she told the pharmacist the date of last pill and said everything was ok to get the shot. She stated she took her last pill on 17May2021. The patient mentioned taking her QVAR inhaler. The patient wanted to know if someone could tell her if its safe to get her second dose. The patient said that she was weak all day the day after she collapsed on an unspecified date in Jun2021. On an unspecified date, left arm got sore. The AEs did not require a visit to emergency room or a physician office. Therapeutic measures were taken as a result of shivering and shaking. The patient recovered from shivering and shaking on an unspecified date in Jun2021; she recovered from the event "her body just collapsed to floor" on an unspecified date; while the outcome of the rest of the events was unknown.; Sender's Comments: Based on temporal association and profile of the product, the contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) to reported events is possibly related.

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Current Illness:

ID: 1419912
Sex: F
Age:
State: NC

Vax Date: 01/21/2021
Onset Date: 02/01/2021
Rec V Date: 06/23/2021
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Symptoms: Couldn't feel some of her toes; Toes she couldn't feel were totally white; Raynauds; Shingles; burning; itching and blisters on back; itching and blisters on back; This is a spontaneous report from a contactable other hcp. A 68-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jan2021 07:30 (Batch/Lot Number: EL3248) as single dose for covid-19 immunisation. Medical history included ongoing allergies, ongoing anaphylactic reaction, raynaud's phenomenon from 2021. Patient informed she was MTHFRA1298 positive. it's kind of like a mutation, says when you're homozygous you usually don't have any issues with clotting or bleeding. The trouble was with heterozygous, says some family is heterozygous and have had bleeding and clotting. Her twin sister and brothers are all homozygous. Patient also informed her father has had autoimmune issues like ITP, so his platelets weren't forming, and if there was bleeding he had to be careful. She reported also her platelets have been fine and both hemoglobin and hematocrit were fine. Concomitant medication(s) included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for vitamin d deficiency, start and stop date were not reported. The patient experienced couldn't feel some of her toes (medically significant) on an unspecified date with outcome of unknown , toes she couldn't feel were totally white (medically significant) on an unspecified date with outcome of unknown , raynaud's phenomenon (medically significant) on an unspecified date with outcome of unknown , shingles (non-serious) on Feb2021 with outcome of recovered on 2021, burning (non-serious) on Feb2021 with outcome of recovered on 2021 , itching and blisters on back (non-serious) on Feb2021 with outcome of recovered on 2021, itching and blisters on back (non-serious) on Feb2021 with outcome of recovered on 2021.; Sender's Comments: Based on the current available information, the events Numbness in toes and Skin discolouration, and Raynauds are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: VITAMIN D [COLECALCIFEROL]

Current Illness: Allergy; Anaphylaxis; Raynauds

ID: 1419913
Sex: F
Age:
State: MI

Vax Date: 06/07/2021
Onset Date: 06/07/2021
Rec V Date: 06/23/2021
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Symptoms: looks like fainting but she begin to convulse in her legs in her arms; seizure event; looks like fainting but she begin to convulse in her legs in her arms; seizure event; She couldn't see that her vision was blurry and she was seeing spots in front of her eyes; Dizzy; She couldn't see that her vision was blurry and she was seeing spots in front of her eyes; This is a spontaneous report received from a contactable pharmacist. An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0185 and expiration date 31Aug2021), on 07Jun2021 (at the age of 18-year-old) as 1st dose, single dose (reported as first COVID vaccine) for COVID-19 immunization. The patient's medical history was reported as no appointment history. The patient's concomitant medications were not reported. It was unknown if patient was taking concomitant medications, reporter believed they said like birth control pills. The pharmacist stated that he/she did not believe that patient received other vaccine within 4 weeks, he/she did not know, they did not report that. Pharmacist stated that he/she administered the vaccine to the patient, about he/she would say less than 5 minutes later she said she had been having the reaction to the vaccine she said that she could not see that her vision was blurry and she was seeing spots in front of her eyes. Pharmacist saw, wanted step down and he/she asked her if she was having any signs of the anaphylactic reactions like swelling of the face or top of the lip or tongue if she could swallow correctly, If she felt that she could breath and all of those things were normal however she said that she felt very dizzy so he/she suggested to lay her on the floor because he/she assumed that she was like she was going to faint and then started to, like her eyes sort of curl she looks like fainting. Pharmacist also stated that so, he/she would asking for questions about how she felt and then she said she felt dizzy and he/she suggested that they potentially put her on the floor in case she might faint and then she started to looks like fainting but she began to convulse in her legs in her arms and he/she would say that it happened for roughly he/she did not know 5 seconds only the mom and his/herself the mom really pulled her on the floor urgently and once she was on floor all of all of it stopped and she regained consciousness and the mom was not it was just normal thought she was fainted or she had a seizure event. The mom said that this was not something that ever happened to her daughter before with the vaccination. Pharmacist stated that the event was resolved but she was going to the hospital for a neurological (as reported). Pharmacist did not know if lab data were performed. Pharmacist stated that as he/she know of no treatment due to the event was administered. Reporter's seriousness was not specified. The outcome of the events was resolved.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Seizure and Fainting cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1419914
Sex: F
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Onset Date: 05/01/2021
Rec V Date: 06/23/2021
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Symptoms: My mom has the stroke after the vaccine (Unspecified Vaccine); My mom has a stroke for about 3-4 weeks ago and suffering pretty much on the death bed because of the virus vaccination shot; This is a spontaneous report from a contactable consumer reported for mother. A female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for covid-19 immunization. Medical history and concomitant medications were not reported. The patient had a stroke after the vaccine for about 3-4 weeks ago (May2021) and suffering pretty much on the death bed because of the virus vaccination shot. The outcome of the event was unknown. Information on the lot/batch number has been requested

Other Meds:

Current Illness:

ID: 1419915
Sex: F
Age:
State:

Vax Date: 01/01/2021
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Rec V Date: 06/23/2021
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Symptoms: stroke; This is a spontaneous report from a non-contactable consumer (reported for her mother). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer reported her mother got the first Pfizer vaccine dose in late January but had a stroke unrelated to the vaccine. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on information available, the reported event stroke was most likely an intercurrent disease, and unrelated to dose 1 of the vaccine of bnt162b2.

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Current Illness:

ID: 1419916
Sex: F
Age:
State: PA

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Rec V Date: 06/23/2021
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Symptoms: HCP stated that her TB positive test may be related to her recent COVID-19; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer. (Reference ID: NUS2021US085589_NC). A 59-year-old female patient received BNT162B2 (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that HCP stated that her TB (tuberculosis) positive test may be related to her recent COVID-19 on an unspecified date. The outcome of event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1419917
Sex: F
Age:
State: TX

Vax Date: 05/18/2021
Onset Date: 05/18/2021
Rec V Date: 06/23/2021
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Symptoms: SARS-COV-2; drug ineffective; Hurt to pick it up; Redness and heat; Swelling in the arm with a little knot; lost appetite; sick; itching off the arm/Itchy and wanted to scratch it/Really Itchy; arm pain/Arm got really sore; arms getting stiff and could barely move it/it got stiff; arm swelled up like a baseball and was really itchy and hot to the touch; arm swelled up like a baseball and was really itchy and hot to the touch; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0191), via an unspecified route of administration, administered in Arm Left on 18May2021 as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included immune system disorder. Patient was a kidney transplant recipient, being an immunocompromised patient would be a contraindication in getting the second dose of the vaccine. There were no concomitant medications. On 28May2021, the patient experienced itching off the arm and wanted to scratch it, arm pain got really sore, arms getting stiff and could barely move, pain, arm swelled up like a baseball and was really itchy and hot to the touch, redness and swelling in the arm with a little knot or mass, sickness and loss of appetite.The patient underwent SARS-COV-2 test which was positive on an unspecified date in the past. As the patient was immunocompromised wanted to know whether she could take the second dose. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1419918
Sex: F
Age:
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Vax Date:
Onset Date: 06/10/2021
Rec V Date: 06/23/2021
Hospital: Y

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Symptoms: looking for blood clots on her lungs/Suspected blood clot; she is having trouble breathing; caller's wife turned pale, trachea was closing; caller's wife turned pale, trachea was closing; This is a spontaneous report from a contactable consumer or other non hcp (patient's husband) through medical Information. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on an unknown date, for COVID-19 immunization. The caller's wife (patient) turned pale, and trachea was closing on 10Jun2021 while she is having trouble breathing and looking for blood clots on her lungs/Suspected blood clot on an unspecified date. Caller asked million-dollar question that who was going to pay for all of these bills? his wife has had two ambulance bills, one admission to ER, his wife right now was at the hospital. 45 minutes after receiving the second dose, caller's wife turned pale, trachea was closing. Caller contacted EMS, EMS gave Epi Pen and more medications. After 6-7 hours, his wife needed to be rushed again to hospital, but the fire station was closer. Caller knocked on their door for help and they transported wife to hospital. This happened yesterday 10Jun2021. Callers Wife had two Benadryl within the last two hours today (11Jun2021). She was admitted again today to the hospital. She does not have any medical conditions. She was 36 years. They were looking for blood clots on her lungs because she was having trouble breathing. Caller asked for us to contact her back in one hour (1757 11Jun) to continue the report. She was at the hospital. The seriousness for events was hospitalization. Therapeutic measures were taken as a result events which includes EPI PEN and BENADRYL. The clinical outcome for all events was unknown. Information about batch/Lot number has been requested.

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Current Illness:

ID: 1419921
Sex: M
Age:
State: GA

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Onset Date: 06/10/2021
Rec V Date: 06/23/2021
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Symptoms: began to present strong flu symptoms, so I decided to take the test where I came out positive for COVID-19, I lost my sense of smell, I have a lot of nasal congestion, dry mouth, general malaise.; Covid-19; began to present strong flu symptoms, so I decided to take the test where I came out positive for COVID-19, I lost my sense of smell, I have a lot of nasal congestion, dry mouth, general malaise.; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 22Apr2021 as 2nd dose, single, dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 10Jun2021, patient began to present strong flu symptoms, so he decided to take the test where patient came out positive for COVID-19, he lost his sense of smell, had a lot of nasal congestion, dry mouth, general malaise. The outcome of the event was unknown. Follow-up attempts are needed. Information about lot/batch number has been requested.

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Current Illness:

ID: 1419923
Sex: F
Age:
State: FL

Vax Date: 03/24/2021
Onset Date: 05/21/2021
Rec V Date: 06/23/2021
Hospital: Y

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Symptoms: Numbness and weakness Left Leg; Numbness and weakness Left Leg; diagnosis Guillain Barre; This is a spontaneous report from a contactable consumer (patient). A non-pregnancy 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 24Mar2021 at 13:15 (at age of 55 years old, no pregnancy, Lot Number: EP6955) as a single dose for covid-19 immunization. No medical history and concomitant medications. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. On 21May2021, the patient experienced numbness and weakness left leg. On 29May2021 Emergency room misdiagnosed Sciatica couldn't bear weight used wheelchair. Went to primary 02Jun2021, followed by Neurologist diagnosis Guillain Barre. Confirmed by spinal tap at hospital after ER visit and 5 day stay at hospital with immunoglobulin treatments. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Since the vaccination, the patient was not had been tested for COVID-19. The outcome of the events was not recovered.

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Current Illness:

ID: 1419924
Sex: M
Age:
State: CA

Vax Date: 06/04/2021
Onset Date: 06/06/2021
Rec V Date: 06/23/2021
Hospital: Y

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Symptoms: Sent to ER and placed in ICU for 7 days with Myocarditis; This is a spontaneous report from a contactable consumer (parent). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 04Jun2021 09:00 AM (Batch/Lot Number: EW0186) (at age of 15 years old) as 2ND DOSE, SINGLE for covid-19 immunisation at Hospital. The patient medical history was not reported. No known allergies for the patient. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previous took first dose of Pfizer COVID 19 vaccine on 14May2021 at 09:00 AM administered in left arm (lot number=ER8736) for covid-19 immunisation and no reaction on previous exposure to drug. The patient was sent to ER and placed in ICU for 7 days with myocarditis on 06Jun2021 with outcome of not recovered. The event was resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The treatment for event included IV prednisone. Since the vaccination, the patient performed Nasal Swab covid test on 07Jun2021 with negative result. The reporter classified the event as serious for seriousness criteria-Life threatening and Caused/prolonged hospitalization.

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Date Died:

ID: 1419925
Sex: U
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Rec V Date: 06/23/2021
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Symptoms: patient died recently after getting the vaccine; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient died recently after getting the vaccine. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information about lot/batch number has been requested.; Reported Cause(s) of Death: patient died recently after getting the vaccine

Other Meds:

Current Illness:

ID: 1419926
Sex: F
Age:
State: NC

Vax Date: 06/08/2021
Onset Date: 06/08/2021
Rec V Date: 06/23/2021
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Symptoms: not getting rid of a huge red it's 2 inch red circle around the injection area; abnormal EKG; couldn't breath/shortness of breath; like an anaphylaxis reaction; chest pain; she was coughing a lot; having a flare up of asthma; rash started getting red and bumps started/bumps moved down her left arm; bumps on her left arm; skin colored bumps; developed a Covid rash/rash; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose via an unspecified route of administration, administered in Deltoid Left on 08Jun2021 17:30 (Lot number was not reported) at age of 53 years old as a single dose for covid-19 immunisation. Medical history included asthma from 2014 and ongoing, hypothyroid, allergy to cat, cipro. The patient had no Family Medical History Relevant to events. Concomitant medication included levothyroxine taken for hypothyroidism from an unspecified start date and ongoing. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration on 21May2021 (Lot number was not reported) at age of 53 years old as a single dose for covid-19 immunisation and No reaction on previous exposure to vaccine. The patient experienced couldn't breath/shortness of breath (medically significant, life threatening) on 13Jun2021, like an anaphylaxis reaction (medically significant, life threatening) on 13Jun2021, developed a covid rash/rash (medically significant) on 08Jun2021, chest pain (medically significant) on 13Jun2021, rash started getting red and bumps started/bumps moved down her left arm (medically significant) on 10Jun2021, bumps on her left arm (medically significant) on 10Jun2021, abnormal ekg (medically significant) on 13Jun2021, she was coughing a lot (medically significant) on 12Jun2021, having a flare up of asthma (medically significant) on 12Jun2021, not getting rid of a huge red it's 2 inch red circle around the injection area on 14Jun2021, skin colored bumps on 09Jun2021. The outcome of the event 'abnormal ekg, having a flare up of asthma, skin colored bumps', all was unknown, 'she was coughing a lot and like an anaphylaxis reaction' was resolving, and the other events was not recovered. The patient underwent lab tests and procedures which included chest x-ray: Negative, electrocardiogram: abnormal, Flu Test: negative, metabolic function test and Labs, Cardiac Workup: all unknown results, COVID test: negative, all on 13Jun2021. The patient went to Emergency Room on 13Jun2021. She is on her way out of town, but she just moved to that area, so she will be seeing her doctor tomorrow for follow up from the ER. Prior Vaccinations (within 4 weeks) was None. AE(s) following prior vaccinations was none. Events 'bumps on her left arm, not on the deltoid area, but in front of her deltoid, in the bicep area were 15 raised bumps that were the same color as her skin; developed a Covid rash', 'bumps moved down her left arm', 'bumps went down her other arm, right arm and fully covered it and the bumps became bumps on top of bumps and were turning red', 'couldn't breath and dyspnea; like an anaphylactic reaction', ' Red Circle Around Injection Site Related', 'Abnormal EKG', 'Chest Pain on the right side, a little stabbing pain' were reported as related to suspect vaccine. Clinical course: After 2nd dose of Pfizer covid vaccine on 08Jun, caller experience rash that got worse 1st and 2 day and by the 4th day had shortness of breath, chest pain and like an anaphylaxis reaction, went to ER, was put on IV Decadron, prednisone, and Benadryl. Is still taking prednisone and Benadryl, looking to see if any data on 4 or 5 day effect from this? once she goes off the prednisone and Benadryl her symptoms come back. Still taking medications , when time for next dose, her symptoms start to come back. Once someone has taken medication , what is data on medication and recovery for these side effects? she was concerned, she read up on Adverse reactions and long term effects, she had no problem with first shot., She know second shot you can have problems, when rash started gets stating red and bumprted and 3 days later woke up and couldn't breath, took Benadryl and her in halers and it startled her again in the middle of the night where she needed to get to the ER. She had an abnormal EKG to follow up on and some chest pain. She was concerned because it's the vaccination. She had read the cardiac situation, she read it all. She read about the covid rash, but it turned into something else, now where they gave the injection, the prednisone and Benadryl not getting rid of a huge red it's 2 inch red circle around the injection area, this came up yesterday, not sure if it's because she got the other injection in her arm. When she got her second covid shot, all the symptoms that were described to you and the other agent was reported, this event didn't get written down where this red ring that just came up after the 2nd covid shot. She was currently having, on prednisone tapered dose 60mg on 2nd dose, When She waited to take it at 10, she had a hard time breathing, it was wearing off. Caller states she is a nurse as well. Caller states she is going to write this up of course. Caller states she got her first vaccine and it seemed to go well and then she got the second vaccine and apparently from the literature she was reading, she developed a Covid rash. Caller states on the second day after the vaccine, she had bumps on her left arm, not on the deltoid area, but in front of her deltoid, in the bicep area were 15 raised bumps that were the same color as her skin. Caller states she thought all was fine, she saw this was a common effect. Caller states the day after that, the bumps moved down her arm and she thought no problem, she wasn't concerned, she could breath and was fine. Caller states she called the pharmacy and they said she doesn't need to be worried, patients get bumps some times, so she said okay fine. Caller states the next day, so the 3rd day after, the bumps went down her other arm. Caller states on the 4th day after, she was coughing a lot. Caller states she has asthma and used her inhaler. Caller states she was going to the gym, and said oh, this is getting worse, so she took half of a Benadryl. Caller states she went to meet her daughter for dinner and it was getting worse, so she took the other half, and it seemed to help. Caller states she woke up at 02:00a.m. and she couldn't breath. Caller states the ER is 4 miles away, and when she got there they gave her IV Decadron. Caller states she had an abnormal EKG and dyspnea. Caller states she is now on a tapered dose of prednisone and Benadryl 2-3 times a day. Caller states now she has a big red lump on her arm, even with the medicine, the big red lump is probably 1-2 inches in circumference around the injection site. Caller states she is looking for any data as far as this 4-5 day effect she had or if there are any long term effects from this? Caller states she needs to ease her mind, once she is out of the prednisone and Benadryl, is she going to be alright? Caller states she wants to find out if there are any other reports like this. Caller clarifies the first day after, on her left deltoid muscle, she got risen skin colored bumps. Then the second day after, the bumps went down her left arm. Then on the third day, the bumps went down her other arm and fully covered it and the bumps became bumps on top of bumps and were turning red. Caller states on the fourth day after, when she went to the gym on the 12Jun2021, that evening she thought she was having a flare up of asthma and she was ignoring the bumps because she looked up the Covid rash thing and then started having problems breathing and on 13Jun2021 she went to the ER for like an anaphylactic reaction and cardiac workup. Caller states she still has a red circle around the injection site that has worsened, like where the medication was injected. Caller states the Prednisone and Benadryl aren't helping it. Benadryl: UPC, Lot, Expiration Unknown, states it is ordered every 4-6 h

Other Meds: LEVOTHYROXINE

Current Illness: Asthma

ID: 1419927
Sex: F
Age:
State: NY

Vax Date: 03/10/2021
Onset Date: 03/17/2021
Rec V Date: 06/23/2021
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Symptoms: This is a spontaneous report from a contactable consumer (patient). This is the report with the event related to the first vaccine dose. A 31-year-old female (no pregnancy) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 at 16:00 (Batch/Lot Number: En6204) as 1st dose, single for covid-19 immunisation. Medical history included hypothyroid. Concomitant medications were not reported. The patient developed chronic urticaria after her first shot at 14:00 on 17Mar2021. Patient had never had hives in her life and had never had any allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received prednisone within 2 weeks of vaccination (at the time of the second shot). The adverse event result in emergency room/department or urgent care and life-threatening illness (immediate risk of death from the event). Patient had been on many medications to try and reduce for the event. No known allergies. 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 event was not recovered.

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Current Illness:

ID: 1419928
Sex: F
Age:
State: NY

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Rec V Date: 06/23/2021
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Symptoms: I developed chronic urticaria/the hives got significantly worse.; I developed chronic urticaria/the hives got significantly worse.; I have also developed angioedema; This is a spontaneous report from a contactable consumer. This 31-year old female (no pregnant) consumer (patient) received 2nd dose of BNT162B2 (at the age of 31 years old) on an unspecific date at single dose for COVID-19 immunization. Medical history was Hypothyroid. No known allergies. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. Historical vaccine was 1st dose of BNT162B2 (Lot number=En6204), on 10Mar2021 04:00 AM in Left arm for covid-19 immunization. She developed chronic urticaria after first shot. It started appearing after 1 week (17Mar2021 02:00 PM) and after 10 days was there every single day (AER# 2021702659). By the time of the second shot I was on prednisone to control the hives, but stopped the day before to get the second shot. After the second shot, the hives got significantly worse. It has been 3 months and nothing is helping to stop the hives. She had also developed angioedema and now need to carry an epinephrine (EPIPEN). She had never had hives in her life and have never had any allergies. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). She had been on many medications to try and reduce. Outcome of the event was Not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information about lot/batch number has been requested.

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Current Illness:

ID: 1419929
Sex: F
Age:
State: IL

Vax Date: 05/21/2021
Onset Date: 05/21/2021
Rec V Date: 06/23/2021
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Symptoms: She states that as she was walking, they felt like cement, got very heavy; arm where she got the shot swelled up, was red, and pain was there; arm where she got the shot swelled up, was red, and pain was there; arms started hurting; really bad pains in her legs and feet; really bad pains in her back and side on the right side; side started hurting really, really bad; lower abdomen started hurting/ Lower abdominal pain; head started hurting really, really bad like it was going to explode; whole right side swelled up; started feeling nauseous; throat was also hurting; it was like she was dizzy; started peeing blood; Joint pain; body was aching; skin was itching; arm where she got the shot swelled up, was red, and pain was there; Sinus congestion; basically dropped to her knees. Caller states she was in so much pain; she had recently found out her son and his wife contracted the COVID vaccine/Clarified with caller that she was referring to the COVID virus.; This is a spontaneous report from a contactable consumer(patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0183; Expiration Date: Aug2021) via an unspecified route of administration, administered in Arm Left on 21May2021 12:30(at the age 0f 58-year-old) as single for covid-19 immunisation. Medical history included nephrolithiasis from 2021 and ongoing, Kidney stones, lupus-like syndrome from Nov2019 and ongoing, lupus, rheumatoid arthritis from Nov2019 and ongoing, rheumatoid arthritis, gastroenteritis radiation from Feb2019 and ongoing, chemical colitis, haematuria from 30Jan2021 and ongoing, Recurrent haematuria, arthralgia from Aug2020 and ongoing, Joint pain, ocular hyperaemia from 22Jun2020 and ongoing, Floaters in her eyes, cardiac failure, Heart failure.The patient's concomitant medications were not reported. The patient experienced she had recently found out her son and his wife contracted the covid vaccine and she clarified that she was referring to the covid virus. on 21May2021 arms started hurting, really bad pains in her legs and feet, really bad pains in her back and side on the right side, side started hurting really, really bad, lower abdomen started hurting/ lower abdominal pain, head started hurting really, really bad like it was going to explode, whole right side swelled up, started feeling nauseous, throat was also hurting, it was like she was dizzy, started peeing blood, joint pain, body was aching, skin was itching, arm where she got the shot swelled up, was red, and pain was there, sinus congestion, basically dropped to her knees and patient stated that she was in so much pain. she stated that actually is trying to reach her doctor and she couldn't take the shot on Friday, 11Jun2021, says the doctor told her not to take the shot until she could see her regular physician about everything, including the peeing incident. she wants to see her doctor and ask to see a gynaecologist, says those are things she's going to do before she takes the second shot. The patient underwent lab tests and procedures which included computerised tomogram: kidney stones. They diagnosed her kidney stones and haematuria or whatever it was about a month ago. The outcome of the events headache was not recovered, nausea was recovering and remaining events it was unknown.

Other Meds:

Current Illness: Colitis due to radiation (Verbatim: chemical colitis); Eyes red (Verbatim: Floaters in her eyes); Hematuria (Verbatim: Recurrent hematuria); Joint pain (Verbatim: Joint pain); Kidney stones (Verbatim: Kidney stones); Lupus-like syndrome (Verbatim: lupus); Rheumatoid arthritis (Verbatim: rheumatoid arthritis)

ID: 1419930
Sex: F
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 06/23/2021
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Symptoms: who received their first Pfizer Covid vaccine dose and then tested positive for Covid after; who received their first Pfizer Covid vaccine dose and then tested positive for Covid after; This is a spontaneous report from a Pfizer sponsored program. A contactable reporter (Physician) reporting on behalf of 57-year-old female consumer (patient) reported that. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter states she has a patient (57 y/o female) who received their first Pfizer Covid vaccine dose and then tested positive for Covid after. The patient received monoclonal antibodies for treatment of the Covid infection. Reporter wants to know more information on administering the second vaccine dose. She mentioned that she wanted the patient to wait 90 days after the antibody treatment, but she is looking for any guidance that Pfizer has regarding this scenario. Dose of covid-19 vaccine or restart due to contracting the Covid-19 virus after her first dose of Pfizer covid-19 vaccine. The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the limited information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Covid 19. 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: 1419931
Sex: M
Age:
State: TX

Vax Date: 04/08/2021
Onset Date: 05/12/2021
Rec V Date: 06/23/2021
Hospital:

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Symptom List:

Symptoms: shingles; rash spread down my arm; and was very painful on the surface and extended to deep tissue/ joints; and was very painful on the surface and extended to deep tissue/ joints; arm was sore at the injection site; This is a spontaneous report from a contactable consumer. This contactable Consumer reported events for both doses of Comirnaty for this patient. This is regarding the 2nd dose. A 53-year-old male patient received (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7533) dose 2, administered intramuscular in left deltoid on 08Apr2021 as 2nd dose, single dose for covid-19 immunization. Medical history was not available. Concomitant medications included valacyclovir and gabapentin. Historical vaccine received first dose BNT162B2 (COMIRNATY, Pfizer vaccine, Lot number: EN6204) on 18Mar2021 via intramuscular in right arm/deltoid for Covid-19 immunization and had vaccination site pain. It was reported that, arm was sore at the injection site from the date of the vaccination until the onset of the AE. A rush started forming at the injection site on an unspecified date in 2021. The rash spread down of his Right arm on 12May2021 and was very painful on the surface and extended to deep tissue /joints on an unspecified date in 2021. His physician diagnose shingles on 12May2021 and prescribe antiviral and pain medications. This could be unrelated to the vaccine but he thought they might find it interesting. The outcome of event arm was sore at the injection site was unknown, while with other events was recovering. No follow ups attempt needed. No further information was available.

Other Meds:

Current Illness:

ID: 1419932
Sex: F
Age:
State: NY

Vax Date: 04/10/2021
Onset Date: 05/01/2021
Rec V Date: 06/23/2021
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Symptoms: Mild relapse of shingles; Mild to mid level confusion that is from the cognitive damage; This is a spontaneous report from a contactable consumer (Patient). A 56-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 10Apr2021 08:00 (at the age of 56-years-old) (Batch/Lot Number: ER) as single dose for covid-19 immunisation. Medical history included, multiple sclerosis, herpes zoster (she received the shingles vaccine in 2019 after contracting it at a nursing home she worked at), hypersensitivity and cognitive disorder from an unknown date and unknown if ongoing cognitive damage. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 administered in Arm Right on 20Mar2021 08:00 AM at the age of 55-years-old) (Batch/Lot Number: ER) for covid-19 immunisation. It was reported that 3 weeks after receiving her second dose of the vaccine she began experiencing a mild relapse of shingles. She received the shingles vaccine in 2019 after contracting it at a nursing home. Her primary was aware. She did not take anything for the shingles flare up as she also began to experience mild to mid level confusion that was from the cognitive damage she has from multiple sclerosis. By the third week in May she started feeling fine. The seriousness of the events was reported as non-serious. The patient did not receive treatment for the events. Outcome of the events were reported as recovered on an unspecified date in 2021. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1419933
Sex: F
Age:
State:

Vax Date: 05/25/2021
Onset Date:
Rec V Date: 06/23/2021
Hospital:

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Symptoms: She also had the bleeding under control; She also reported having a period for a week when she has been in menopause for 10 years; She has been having on and off fatigue; Nausea; Headache; Bloating; This is a spontaneous report from a contactable consumer (reported for herself). A 59-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25May2021 (at the age of 59-years-old) as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 04May2021 (at the age of 59-years-old) as 1st dose, single dose for covid-19 immunisation. On an unspecified date, the patient reported that when it started to go downhill. She had been having on and off fatigue, nausea, headache and bloating. She experiences these for 3-4 days out of every week. She has self-medicated with Aspirin and Tylenol. She also reported having a period for a week when she had been in menopause for 10 years. She also had the bleeding under control as she also self-medicated as she cannot get a hold of her gynecologist and it has been frustrating. it has been 6 weeks. The patient is asking whether if this is normal and how long will she experience these. She also added that she doesn't have a primary health care physician and only a gynecologist. Therapeutic measures were taken as a result of events with Aspirin and Tylenol. The event the She also had the bleeding under control was assessed as serious (medically significant). The outcome of the events was not resolved. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

Date Died:

ID: 1419934
Sex: F
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 06/23/2021
Hospital:

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Symptoms: with no health conditions died after the vaccine; This is a spontaneous report from a contactable consumer (patient's friend). A 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. A friend's 25 year old daughter (the patient) with no health conditions died after the vaccine. 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: with no health conditions died after the vaccine

Other Meds:

Current Illness:

ID: 1419935
Sex: F
Age:
State: CA

Vax Date: 06/15/2021
Onset Date: 06/15/2021
Rec V Date: 06/23/2021
Hospital:

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Symptoms: Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; This is a spontaneous report from a contactable consumer (patient). A 35 years old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0180), via an unspecified route, administered in Arm Left on 15Jun2021 at 14:30 (age of 35 years old at vaccination) as 1st dose, single for COVID-19 immunization. The patient's medical history included Covid-19. The patient's concomitant medications included Vitamin (unspecified). Vaccination facility was reported as Pharmacy or drug store. Prior to vaccination the patient was diagnosed with Covid-19. The patient had not received any other vaccine prior 4 weeks to Covid-19 vaccine. On 15Jun2021 at 16:30, the patient experienced Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99 percent of "normal side effects". Since vaccination the patient was not tested for Covid-19 infection. The patient had not received any treatment medications for the resulted events. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1419936
Sex: M
Age:
State: CO

Vax Date: 04/30/2021
Onset Date: 06/01/2021
Rec V Date: 06/23/2021
Hospital:

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Symptoms: We both vaccinated in April, two shots in April. We both had Covid initially in February. He had now tested positive for Covid in June.; SARS-CoV-2 test positive; This is a spontaneous report from a contactable consumer. This consumer (patient wife) reported for a 49-year-old male patient(reporter husband) that received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine Formulation: Solution for injection, Batch/Lot Number: EW0153, Expiration Date: 31Jul2021) via an unspecified route of administration in right arm on 30Apr2021 as 2nd dose, single dose for covid-19 immunisation. Medical history included covid-19 from Feb2021 to an unknown date (Verbatim We both had Covid initially in February). The patient previously received first dose of BNT162B2 (Formulation: Solution for injection, lot number: ER8730) on 10Apr2021 for Covid-19 immunization. On Jun2021, the reporter stated seriousness for we both vaccinated in april, two shots in april. We both had Covid initially in February and he had now tested positive for Covid in June after being fully vaccinated and the instance was as much, all of its severe as first episode of Covid and reporter stated that showing vaccine was not affective for my husband. We both had Covid in February So we had to wait April to get vaccinated and then he unfortunately had it again in the end of may, 1 week of June. The patient underwent lab tests and procedures which included sars-cov-2 test positive on Jun2021. The outcome of the events were unknown. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1419937
Sex: F
Age:
State:

Vax Date: 05/11/2021
Onset Date: 05/16/2021
Rec V Date: 06/23/2021
Hospital:

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Symptom List:

Symptoms: her body is being faint 3 to 4 times a day; Her oxygen drops from the 99 to an 83; her muscles she is suppose to get numb and then she just controls her muscles and she faint; her brain is awake you know close to get an electric shock (further clarification unknown hence not captured in tab) following new things episode; This is a spontaneous report from a contactable consumer reporting for sister. An unspecified age female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 1 via an unspecified route of administration on 11May2021 as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced her body is being faint 3 to 4 times a day on 16May2021, her oxygen drops from the 99 to an 83, her muscles she is supposed to get numb and then she just controls her muscles and she faint, her brain is awake you know close to get an electric shock (further clarification unknown hence not captured in tab) following new things episode on 16May2021. She stated that patient got vaccinated on 11May2021 and completed 5 days after her first vaccine, she started getting, and was not sure if it was side effect which is why reporter called and not sure if it had been reported before. But patient body was being faint 3 to 4 times a day, but it was quite a little episode when patient faint for second and wakes up, faint wakes up faint there was seconds between 2 and 1 and last sometimes less than a minute sometime a few minutes after 5 minutes. Patient oxygen drops from the 99 to an 83 and basically her muscles she was supposed to get numb and then she just controls her muscles and she faint, but she can still here on brain is aware her brain is awake you know close to get an electric shock (further clarification unknown hence not captured in tab) following new things episode. So, reporter was calling to ask if this was the possible side effect if it was reported before. Reporter confirmed that patient only had her first dose. She stated that patient had MRI scan an EEG scan and 'AFib' (further not clarified hence not captured in tab) and they all came out normal which was why reporter was assuming it was a side effect. It was reported that second shot was not scheduled yet and reporter was not sure. On further probing, reporter stated that did reporter need to because reporter was in a kind of a rush right then. Product details and pharmacy details could not be probed as the reporter was unwilling to complete the report. Hence limited information available over the call. The patient underwent lab tests and procedures which included atrial fibrillation, electroencephalogram, magnetic resonance imaging on unspecified date which resulted normal and oxygen saturation decreased to 83 on 16May2021. The clinical outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1419938
Sex: F
Age:
State: NY

Vax Date: 03/11/2021
Onset Date:
Rec V Date: 06/23/2021
Hospital:

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Symptom List:

Symptoms: she tested positive for Covid a week before her scheduled appointment for second dose; tested positive for Covid; This is a spontaneous report from the Pfizer sponsored program. A contactable consumer reported for a patient that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Mar2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of Pfizer Covid-19 vaccine 3 months before on 11Mar2021 and missed her second dose schedule because she tested positive for Covid a week before her scheduled appointment for second dose. Also, there was a wrong name listed on her vaccination card, and wanted it to be corrected, hence the reason why the facility won't give her the second dose. Outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1419939
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 06/23/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

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Symptom List:

Symptoms: she has a reaction to Covid vaccination that caused Bells's Pasly.; face was numb; her face was numb was having a hard time saying words.; This is a spontaneous report form a contactable consumer (patient). A 74-month-old female patient received the dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient she had a reaction to Covid vaccination that caused Bells's Pasly. It was reported that patient was in the hospital and her face was numb was having a hard time saying words. The outcome of the events was reported as unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1419940
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/23/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: blood clot; hand and legs cramps/ay 3 and 4 after the shot her cramps moved to both thighs, in lower right leg, in the sides; earache and pain in the right side of her neck; earache and pain in the right side of her neck; felt clammy; her voice is "rafty" now; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history included allergy to 6 other medications. The patient's concomitant medications were not reported. The patient stated that she experienced hand and leg cramps after the second dose. The patient further stated that her cramps got really bad and her doctor suggested her to drink tonic water each day. The patient stated that on day 3 and 4 after receiving the shot, her cramps moved to both thighs, in lower right leg, in the sides. The patient stated that she also experienced earache and pain in the right side of her neck, felt clammy. The patient stated that she could not check for fever. The patient thought like she has a blood clot traveling in the body, her voice was rafty now. The patient also stated that the pain in the neck right side, cramps in the legs were similar to her allergic reaction after medication. The case was considered as serious (medically significant). The outcome of the events was unknown. Information on lot/batch number has been requested. Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1419941
Sex: M
Age:
State: SC

Vax Date: 05/19/2021
Onset Date: 06/15/2021
Rec V Date: 06/23/2021
Hospital:

Vax Type:
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Symptoms: Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration in the left arm on 19May2021 at 12:00 PM (at the age of 74-year-old) as single dose for COVID-19 immunization. Vaccination facility was a pharmacy or drug store. The patient medical history included heart surgery in Dec2018 and allergy to Sulfa drugs. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included metoprolol, avorstatin, Omeprazole (PROTONIX), Acetylsalicylic acid (ASPIRIN) and TALAFAD (as reported) - all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 via an unspecified route of administration in the left arm on 28Apr2021 02:30 PM as single dose for COVID-19 immunization. On 15Jun2021 at 04:45 PM in the emergency room, the patient was diagnosed with Bell's Palsy. A computed tomogram (CT) scan was performed (result unspecified) and the patient was prescribed prednisone and Valtrex (calaciclovir). Reporter considered event as serious (Disability or permanent damage). Outcome of the event was not recovered. Follow up attempt possible. Information on lot/batch number has been requested.

Other Meds: METOPROLOL; ATORVASTATIN; PROTONIX [OMEPRAZOLE]; ASPIRIN (E.C.)

Current Illness:

ID: 1419942
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/23/2021
Hospital:

Vax Type:
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Symptoms: received first dose and tested positive for SARs-COV-2 a couple of days later; received first dose and tested positive for SARs-COV-2 a couple of days later; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported, the husband received first dose and tested positive for SARs-COV-2 a couple of days later and states "wife never had it". She had not received first dose of product. She was asking for the recommendation of waiting fourteen days between infection and dose, she does not know if previously reported, but "probably not". The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. Outcome of the events was reported as unknown. Follow-up attempts are needed. Information on the lot/batch number has been requested. ; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Drug ineffective and COVID-19 and suspect drug BNT162B2 cannot be excluded.

Other Meds:

Current Illness:

ID: 1419943
Sex: F
Age: 45
State: PA

Vax Date: 06/22/2021
Onset Date: 06/22/2021
Rec V Date: 06/23/2021
Hospital:

Vax Type:
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Lab Data:

Allergies: none

Symptom List:

Symptoms: severe diareah and vomiting

Other Meds: tums mylanta

Current Illness: none

ID: 1419945
Sex: F
Age: 48
State: CA

Vax Date: 05/13/2021
Onset Date: 05/26/2021
Rec V Date: 06/23/2021
Hospital: Y

Vax Type:
Manufacturer:
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Lab Data:

Allergies: CODEINE

Symptom List:

Symptoms: Severe chest pain, shortness of breath, severe headache & fever. Went to an Emergency room on June 1st and was diagnosed with Pericarditis. Was released the same day and given IBprofen & Colchicine as an antiinflammatory for the fluid buildup around the heart. The pain continued despite medication returned to ER on June 3rd, 2021. Was hospitalized through June 8th. Was released. Symptoms and pain continued after release. Revisited ER on June 10th, 2021. At this point, ER doctor reevaluated all symptoms and after further consultation determined the immune system was causing adverse symptoms due to the Covid vaccine and started new treatment to suppress the immune system. This proved to help with pain and symptoms.

Other Meds: NONE

Current Illness: NONE

ID: 1419946
Sex: F
Age: 40
State: TX

Vax Date: 06/18/2021
Onset Date: 06/18/2021
Rec V Date: 06/23/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: Migraine , fatigue, loss of appetite

Other Meds: Effexor,birth control ,flonase

Current Illness:

ID: 1419947
Sex: F
Age:
State: OH

Vax Date: 02/12/2021
Onset Date: 02/22/2021
Rec V Date: 06/23/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: auto- immune disease-eosinophilic faciitis.; Swelling of joints; edema; fatigue; muscle contractures; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 66-years-old female patient received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: EM9809, Expiration date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 12Feb2021 11:45 as SINGLE DOSE for covid-19 immunisation. No covid prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. NO covid tested post vaccination. Medical history included hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 22Feb2021 07:00 the patient experienced adverse event Triggered a response of auto- immune disease-eosinophilic faciitis, swelling of joints, edema, fatigue, muscle contractures. No covid tested post vaccination. The Therapeutic measures were taken as a result of events includes Steroid shot in joint, fluid removed. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome for all the events was reported as recovering. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 599,999

Page last modified: 03 October 2021 5:28pm