chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Facial discomfort, Hypoaesthesia, Movement disorder, Musculoskeletal stiffness
Clinical narrative: feeling movement in my left arm, up my neck, in my left ear; felt tingling across my face; could taste the vaccine; numbness; nerve damage is still around my left eye; causing pain and constant stiffness in my cranial nerve/ jaw; causing pain and constant stiffness in my cranial nerve/ jaw; Laying down on my left side puts pressure on my face; I never sleep well; This is a spontaneous report from a non-contactable consumer (patient herself).  A 38-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number; unknown, expiry date: unknown) via unknown via unspecified route of administration, in left arm on 02Apr2021 14:30 (age at vaccination: 38-years) as dose 1, single for Covid-19 immunization. Patients medical history and concomitant medications were not reported. Facility type vaccine was Pharmacy or Drug Store. Patient took no other vaccine in four weeks and no other medications in two weeks of covid vaccine. On 02Apr2021 15:30 after she sat for 15 minutes she left the (name)pharmacy and drove in her car for another 15 minutes before she started feeling movement in left arm, up her neck, in left ear, and then felt tingling across her face for the next 40 minutes. She thought that was part of the vaccine until she got home and spoke with family members about her experience. Also, she could taste the vaccine. She did go to the er, then to her doctor who prescribed prednisone and Valtrex. Previously she had never had an allergy to anything before taking this vaccine. Her doctor told not to get the second shot. The numbness did not go away, and the nerve damage was still around her left eye, causing pain and constant stiffness in cranial nerve/ jaw. Laying down on her left side puts pressure on her face so she never slept well. Next week she was scheduled to get an MRI from the neurologist. She had already reported side effects to VAERS. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Patient did not have covid prior vaccination and was not covid tested post vaccination also. The outcome of the events was not recovered when reported.  Information about lot/batch has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve injury, Pain, Paraesthesia, Sleep disorder
Clinical narrative: feeling movement in my left arm, up my neck, in my left ear; felt tingling across my face; could taste the vaccine; numbness; nerve damage is still around my left eye; causing pain and constant stiffness in my cranial nerve/ jaw; causing pain and constant stiffness in my cranial nerve/ jaw; Laying down on my left side puts pressure on my face; I never sleep well; This is a spontaneous report from a non-contactable consumer (patient herself).  A 38-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number; unknown, expiry date: unknown) via unknown via unspecified route of administration, in left arm on 02Apr2021 14:30 (age at vaccination: 38-years) as dose 1, single for Covid-19 immunization. Patients medical history and concomitant medications were not reported. Facility type vaccine was Pharmacy or Drug Store. Patient took no other vaccine in four weeks and no other medications in two weeks of covid vaccine. On 02Apr2021 15:30 after she sat for 15 minutes she left the (name)pharmacy and drove in her car for another 15 minutes before she started feeling movement in left arm, up her neck, in left ear, and then felt tingling across her face for the next 40 minutes. She thought that was part of the vaccine until she got home and spoke with family members about her experience. Also, she could taste the vaccine. She did go to the er, then to her doctor who prescribed prednisone and Valtrex. Previously she had never had an allergy to anything before taking this vaccine. Her doctor told not to get the second shot. The numbness did not go away, and the nerve damage was still around her left eye, causing pain and constant stiffness in cranial nerve/ jaw. Laying down on her left side puts pressure on her face so she never slept well. Next week she was scheduled to get an MRI from the neurologist. She had already reported side effects to VAERS. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Patient did not have covid prior vaccination and was not covid tested post vaccination also. The outcome of the events was not recovered when reported.  Information about lot/batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Anaphylactic reaction, Pharyngeal swelling, SARS-CoV-2 test, Tongue discomfort
Clinical narrative: had mild anaphylactic/an allergic reaction to the Covid vaccine; felt like she had a lump in her throat; tongue felt weird; or an adverse reaction; This is a spontaneous report from a contactable consumer or other non-hcp (Patient).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 16Jul2021 as dose 1, single for COVID-19 immunization. Medical history included COVID-19 infection from Mar2020 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date the patient experienced had mild anaphylactic, felt like she had a lump in her throat, tongue felt weird. Caller is reporting an allergic reaction to the Covid vaccine. She had the vaccine Friday, and it was the first dose. After the vaccine, it felt like she had a lump in her throat and her tongue felt weird. She called the doctor the next day and he said that she had mild anaphylactic or an adverse reaction and was recommended to not get the second dose. She is not an anti vaxxer or anything but, she definitely likes to read about everything. Caller states that before her son was born, she read the vaccine book and chose to do the vaccines for him. But with the Covid, she was nervous because it felt like she didn't know enough, like she couldn't get enough information. It felt like the pros outweighed the cons. She is a schoolteacher and is getting ready to go back to full capacity. In the fall, it is going to change. The same with her son, they both had Covid last Mar2020, and had no symptoms but both tested positive. Her son had the fever. States that her students are coming back but, wanted to ask if she did have a reaction, would that warrant not getting the second dose; if she would it be like just going in and taking Benadryl or bring an Epi Pen. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive in Mar2020. The clinical outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Pulsatile tinnitus; This is a spontaneous report from a contactable consumer (patient). A 35-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: ER8732), via an unspecified route of administration on 30Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19.  Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: ER8732), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. It was reported that on 02Apr2021, Pulsatile tinnitus occurred 2 days after the 2nd dose on 30Mar2021. The tinnitus does not go away and the symptom persists. Patient visited physician office. The outcome of event was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Emotional disorder, Hyperpyrexia
Clinical narrative: High fever; body chills; sensitive skin; appetite loss; dizziness; weak muscles; sore body; emotional; drowsy; This is a spontaneous report from a non-contactable consumer (Patient). A 19-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration in left arm on 20Jul2021 09:30 (at the age of 19-year-old) as dose 2, single for COVID-19 immunization. Medical history included asthma and had no allergies. Concomitant medication(s) included acetaminophen. Historical vaccine included BNT162B2 (Lot number and expiration date was not reported), via an unspecified route of administration in left arm on 01Jul2021 09:00 as dose 1, single for COVID-19 immunization. Facility type was pharmacy or drug Store. The patient did not received any other vaccine in four weeks. Patient did not tested for covid prior or post vaccination. The patient experienced high fever, body chills, sensitive skin, appetite loss, dizziness, weak muscles, sore body, emotional and drowsy on 20Jul2021 13:45. The event high fever was serious (medically significant). The patient did not received any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain, Sensitive skin, Somnolence
Clinical narrative: High fever; body chills; sensitive skin; appetite loss; dizziness; weak muscles; sore body; emotional; drowsy; This is a spontaneous report from a non-contactable consumer (Patient). A 19-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration in left arm on 20Jul2021 09:30 (at the age of 19-year-old) as dose 2, single for COVID-19 immunization. Medical history included asthma and had no allergies. Concomitant medication(s) included acetaminophen. Historical vaccine included BNT162B2 (Lot number and expiration date was not reported), via an unspecified route of administration in left arm on 01Jul2021 09:00 as dose 1, single for COVID-19 immunization. Facility type was pharmacy or drug Store. The patient did not received any other vaccine in four weeks. Patient did not tested for covid prior or post vaccination. The patient experienced high fever, body chills, sensitive skin, appetite loss, dizziness, weak muscles, sore body, emotional and drowsy on 20Jul2021 13:45. The event high fever was serious (medically significant). The patient did not received any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Diarrhoea, Feeling abnormal, Haematochezia, Polymerase chain reaction
Clinical narrative: ulcerative colitis/the flare started again very aggressively/t was the longest flare I have ever had in my life; I had blood in my stools/blood in my feces; diarrhea; I had a very bad time; This is a spontaneous report from a contactable Pharmacist (patient). A 38-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in left arm on 21Feb2021 at 12:30 (at the age of 38-year-old), as single dose for COVID-19 immunization at the Hospital. Medical history of the patient included Colitis ulcerosa. Patient did not receive any other medications in two weeks or any other vaccine in four weeks of suspect vaccine. Patient had no known allergies. Patient did not have covid prior vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9266) via an unspecified route of administration on 31Jan2021 at 13:00, as single dose for COVID-19 immunization and experienced a flare up of ulcerative colitis. On an unspecified date in 2021, patient had blood in feces and diarrhea every day, 7-10 times a day and three days after second dose on an unspecified date in Feb2021, patient experienced that flare started again very aggressively (ulcerative colitis). The second flare lasted 4 months until it went away, it was the longest flare that patient have ever had in his life. Patient had to take mesalamine, high two prednisone, dicyclomine and had a very bad time. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. On 01Mar2021, patient underwent lab test for COVID-19 (PCR-nasal swab test) which came negative. Treatment received for the adverse event included Mesalamine, prednisone and dicyclomine. Outcome of the event ulcerative colitis was resolved with sequel on an unspecified date in 2021 and for other events was unknown.  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 of  ulcerative colitis ,haematochezia and suspect drug BNT162B2 cannot be excluded   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Back injury, SARS-CoV-2 test
Clinical narrative: Got hospitalized for my injury for my back; This is a spontaneous report from Pfizer Sponsored Program COVAX Support from a contactable consumer or other non-healthcare professional. A 43-years-old male patient received the first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection) via an unspecified route of administration, administered in Arm Right on 18Jun2021 (at the age of 43-years-old) (Batch/Lot Number: EW0181, Expiry date was not reported) as a single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications reported. On an unspecified date in Jun2021, the patient experienced got hospitalized for injury for his back. It was reported that the patient received his first dose of the vaccine last 18Jun2021. He was scheduled to have the second dose last 10Jul2021. However, he missed his shot because he was in the hospital. He called in to know how to get the second dose of the vaccine. He stated that he got hospitalized for his back injury which was not related to the vaccination. The patient was hospitalized for got hospitalized my injury for my back from Jun2021 to an unknown date. Laboratory tests on an unspecified date in Jul2021 included sars-cov-2 test: negative (COVID test 5-6 days ago. The COVID-19 negative. Everything was negative). The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, it cannot be ascertained with reasonable possibility that suspect therapy BNT162B2 has caused or contributed to the reported event back injury.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Illness, Loss of consciousness, Muscle spasms, Nausea
Clinical narrative: My stomach must full, started cramping up and I started passing out and I counted it, I kept 5 times.; My arm started hurting, right after shot, first about an hour, later it did not hurt.; My stomach must full, started cramping up and I started passing out and I counted it, I kept 5 times.; My back started sweating  from my neck, down to my middle, it was like a cold sweat.; I have a nausea and I threw up.; I got sick.; I have a nausea and I threw up.; This is a spontaneous report from a contactable consumer (patient herself). A 56-year-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was FA7484, Expiry date: Unknown) via an unspecified route of administration on 20Jul2021, 12:45 in right arm at dose 1, single for COVID-19 immunization. No medical history reported. No concomitant medications reported. Patient stated her arm started hurting, right after shot, first about an hour, later it did not hurt, stomach must full, started cramping up and started passing out and counted it, patient kept 5 times, back started sweating from my neck, down to my middle, it was like a cold sweat, nausea, got sick. She was just using a cold bath to keep her mind, from hurting. It makes her feel better, cold bath on her head. Little wash part with cold water. Patient started take things, Saline Salt (intent treatment) for sweating. The outcome of events was unknown.     Follow-up (26Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: My stomach must full, started cramping up and I started passing out and I counted it, I kept 5 times.; My arm started hurting, right after shot, first about an hour, later it did not hurt.; My stomach must full, started cramping up and I started passing out and I counted it, I kept 5 times.; My back started sweating  from my neck, down to my middle, it was like a cold sweat.; I have a nausea and I threw up.; I got sick.; I have a nausea and I threw up.; This is a spontaneous report from a contactable consumer (patient herself). A 56-year-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was FA7484, Expiry date: Unknown) via an unspecified route of administration on 20Jul2021, 12:45 in right arm at dose 1, single for COVID-19 immunization. No medical history reported. No concomitant medications reported. Patient stated her arm started hurting, right after shot, first about an hour, later it did not hurt, stomach must full, started cramping up and started passing out and counted it, patient kept 5 times, back started sweating from my neck, down to my middle, it was like a cold sweat, nausea, got sick. She was just using a cold bath to keep her mind, from hurting. It makes her feel better, cold bath on her head. Little wash part with cold water. Patient started take things, Saline Salt (intent treatment) for sweating. The outcome of events was unknown.     Follow-up (26Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Narcolepsy; Headaches; Brain Fog; Extreme Tiredness; Dizziness; Slight chest discomfort/pain; Slight chest discomfort/pain; Nausea; Is affecting my ability to work as before and perform daily activities at times; This is a spontaneous report from a contactable consumer or other non hcp. A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0186) via an unspecified route of administration, administered in Arm Right on 24May2021 at 17:00 (Age at Vaccination: 50 years) as dose 1, single and dose 2 via an unspecified route of administration, administered in Arm Left on 14Jun2021 at 17:00 (Batch/Lot Number: EW0217) as dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported.The patient previously took codeine and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. On 25May2021, the patient experienced narcolepsy, headaches, brain fog, tiredness, dizziness, slight chest discomfort/pain, nausea and was affecting my ability to work as before and perform daily activities at times. He had taken doctor or other healthcare professional office/clinic visit for events. He had not taken treatment. The outcome of the events were not recovered
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Loss of personal independence in daily activities, Narcolepsy, Nausea
Clinical narrative: Narcolepsy; Headaches; Brain Fog; Extreme Tiredness; Dizziness; Slight chest discomfort/pain; Slight chest discomfort/pain; Nausea; Is affecting my ability to work as before and perform daily activities at times; This is a spontaneous report from a contactable consumer or other non hcp. A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0186) via an unspecified route of administration, administered in Arm Right on 24May2021 at 17:00 (Age at Vaccination: 50 years) as dose 1, single and dose 2 via an unspecified route of administration, administered in Arm Left on 14Jun2021 at 17:00 (Batch/Lot Number: EW0217) as dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported.The patient previously took codeine and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. On 25May2021, the patient experienced narcolepsy, headaches, brain fog, tiredness, dizziness, slight chest discomfort/pain, nausea and was affecting my ability to work as before and perform daily activities at times. He had taken doctor or other healthcare professional office/clinic visit for events. He had not taken treatment. The outcome of the events were not recovered
Sex: F
Vaccine: COVID19
Symptoms: Optic neuritis, Photophobia
Clinical narrative: optic neuritis; Photophobia; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 54-years-old female patient received BNT162B2 (Pfizer/BioNtech COVID-19 vaccine, formulation solution for injection, lot Number unknown, expiration date unknown) via an unspecified route of administration on an unspecified date, dose number unknown as single dose for covid-19 immunization. The patient medical history was not reported. There was no concomitant medication list. It was reported that after receiving the dose of Pfizer-BioNTech vaccine on an unspecified date the patient suffered from photophobia and optic neuritis. Enquiry received in writing, therefore logged with limited information. There was no product complaint associated with this case. The outcome was not recovered for the events at the time of reporting. The sender noted in their email: As the case reports described in this signal have been transmitted to (withheld) we kindly request you not to resubmit them to the correspondent Regulatory Authority as this is where they originate from.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hepatic failure, Renal failure
Clinical narrative: Friend's daughter was feeling fine one day and the next day she was very ill.  They took her to ER and liver and kidneys were failing.; Friend's daughter was feeling fine one day and the next day she was very ill.  They took her to ER and liver and kidneys were failing.; This is a spontaneous report from a contactable consumer. A 16-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date in Jun2021 as a dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  It was reported that, the patient was not pregnant at time of vaccination. Stated that, on an unspecified date in Jul2021, friend's daughter was feeling fine one day and the next day she was very ill. They took her to the emergency room, her liver and kidneys were failing. Stated that, she was stabilized and was back to normal in a few days. Stated that, friend told the reporter that, she had received her COVID-19 shot a week or so before this incident, so the reporter wanted to report it. The patient was hospitalized for the duration of 5 days. The AEs resulted in emergency room/department or urgent care, hospitalization, Life-threatening illness (immediate risk of death from the event). Treatment medication included unknown steroids. The device timestamp was on 21Jul2021. The outcome of the events was recovered on an unspecified date in 2021.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: After the first shot her joints and muscles hurt; After the first shot her joints and muscles hurt; This is a spontaneous report from a non-contactable consumer reported for a female patient (daughter). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date as Dose 1, single for COVID-19 immunization. The patient medical history was not reported. There is no Concomitant list reported. It was reported that patient received Pfizer vaccine. The dates of vaccination and lot numbers are unavailable. On an unspecified date after the first shot her joints and muscles hurt. The same doctor as his put her on steroid pills, and within the next day, all her symptoms went away. The doctor tried to refer her a rheumatologist, but they have to wait a year to get an appointment. The patient states that he received another referral, but it is very hard to get a hold of the doctor. Therapeutic measures were taken as a result of events and treatment included prescribed steroid pills which made her symptoms go away. The outcome of the events was recovered on an unspecified date.  Product Complaint: There is no product complaint associated with this case.  No follow-up attempts are possible, information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100929337 Same patient, drug, reporter and different dose and event.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Joint swelling
Clinical narrative: This is a spontaneous report from a non-contactable consumer (parent). A female patient (daughter) of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history of the patient was not reported. Patient was not taking any concomitant medication [no concomitant list]. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization and experienced joints and muscles hurt. On an unspecified date, after receiving second dose of vaccination, patient condition got worsened and her Joints swelled up-feet, hands, ankles. Reporter stated it was not muscle it was more joints. Doctor put her on steroid pills, and within the next day, all her symptoms went away. When she got off the steroid, everything came back just the way it was. The doctor tried to refer her a rheumatologist but have to wait a year to get an appointment. Reporter assessed the event as non-serious. Treatment received included steroid pills. Outcome of the events were unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100929336
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Diarrhoea, Fatigue, Hepatic cancer, Magnetic resonance imaging
Clinical narrative: Fatigue; red rash; Diarrhea; aches and pains; cancer through the liver; This is a spontaneous report from a contactable consumer (patient's husband). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on 11Jun2021 18:27 (age at vaccination: 62 years) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unknown route on 21May2021 as Dose 1, 0.3ml, SINGLE for COVID-19 immunisation. There were no prior vaccinations within 4 weeks. It was reported that the patient got the second shot on 11Jun2021. The patient experienced fatigue, diarrhea, rashes starting to form on her body that looked like prickly heat a red rash and bumps, aches and pains. On 20Jun2021, the patient experienced fatigue and diarrhea. On an unknown date in June2021, the patient had rashes starting to form on her body that looked like prickly heat a red rash and bumps, cancer through the liver, aches and pains. The patient was hospitalized for fatigue (fatigue) from an unknown date to 09Jul2021. The patient required emergency and physician's office visit. Therapeutic measures were taken as a result of fatigue, red rash and diarrhea. The patient was treated in the nursing home put her in rehab facility under prednisone 60mg for rash, unspecified treatment for fatigue and Mucilex for diarrhea. The patient was hospitalized for red rash from an unknown date to 09Jul2021. On 12Jul2021, the patient underwent biopsy but results were unknown on an unknown date, magnetic resonance imaging showed cancer through the liver. They are saying this is in relation to a malignancy in the body. They do not feel it has to do with what happen. It all came up within a week of getting shot. The outcome of the events hepatic cancer, aches and pain was unknown; fatigue, diarrhoea was not recovered, rash erythematous was recovering.  Information about lot and batch number was requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash erythematous
Clinical narrative: Fatigue; red rash; Diarrhea; aches and pains; cancer through the liver; This is a spontaneous report from a contactable consumer (patient's husband). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on 11Jun2021 18:27 (age at vaccination: 62 years) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unknown route on 21May2021 as Dose 1, 0.3ml, SINGLE for COVID-19 immunisation. There were no prior vaccinations within 4 weeks. It was reported that the patient got the second shot on 11Jun2021. The patient experienced fatigue, diarrhea, rashes starting to form on her body that looked like prickly heat a red rash and bumps, aches and pains. On 20Jun2021, the patient experienced fatigue and diarrhea. On an unknown date in June2021, the patient had rashes starting to form on her body that looked like prickly heat a red rash and bumps, cancer through the liver, aches and pains. The patient was hospitalized for fatigue (fatigue) from an unknown date to 09Jul2021. The patient required emergency and physician's office visit. Therapeutic measures were taken as a result of fatigue, red rash and diarrhea. The patient was treated in the nursing home put her in rehab facility under prednisone 60mg for rash, unspecified treatment for fatigue and Mucilex for diarrhea. The patient was hospitalized for red rash from an unknown date to 09Jul2021. On 12Jul2021, the patient underwent biopsy but results were unknown on an unknown date, magnetic resonance imaging showed cancer through the liver. They are saying this is in relation to a malignancy in the body. They do not feel it has to do with what happen. It all came up within a week of getting shot. The outcome of the events hepatic cancer, aches and pain was unknown; fatigue, diarrhoea was not recovered, rash erythematous was recovering.  Information about lot and batch number was requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: On Monday 19Jul2021 I tested positive for Covid.; On Monday 19Jul2021 I tested positive for Covid.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-year-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, Lot Number: En6199) via an unspecified route of administration, administered in Arm Right on 10Mar2021 as DOSE 1, SINGLE and dose 2 (Lot Number: En6208) via an unspecified route of administration, administered in Arm Left on 31Mar2021 (Age at Vaccination 42-years-old) as DOSE 2, SINGLE both for covid-19 immunisation. Medical history included chronic vitamin b12 deficiency, vitamin d deficiency and Known allergies: Sulpha from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient started sneezing and congested on sunday 18Jul2021 at 08:30. On Monday 19Jul2021, she tested positive for Covid. She experienced severe headaches, incessant sneezing, mild to moderate congestion, moderate to severe body aches. While she understood that there was a chance of this with the vaccine, she wanted to report her experience as she was a healthy individual, but she had a chronic B12 deficiency and vitamin D deficiency. She taken doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included Covid-19 test was positive on 19Jul2021 (On Monday 19Jul2021 I tested positive for Covid), covic 19 home test was positive on 20Jul2021 (Nasal Swab), Sofia 2 rapid COVID-19 antigen test was positive on 18Jul2021 (Nasal Swab). Therapeutic measures were taken as a result of on monday 19Jul2021, i tested positive for covid with prescriptions of zpack, dexamthasone, fluticasone. The outcome of the events were not recovered.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid-19 vaccine in March, then got Covid; Covid-19 vaccine in March, then got Covid; This is a spontaneous report from a contactable pharmacist. A 60-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on Mar2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient got COVID-19 vaccine in March, then got COVID. The outcome of events was unknown.  No follow-up attempts are possible. No further information was expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the event of drug ineffective and COVID-19 cannot be ruled out.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Rash, Swelling
Clinical narrative: Difficulty breathing; Swelling; Rash; This is a spontaneous report received from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on 18Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation; and ziprasidone hcl (GEODON), via an unspecified route of administration, from an unspecified date, at an unknown dose and frequency for an unspecified indication. Medical history included ongoing chronic arthritis. The patient had an arthritis related illness and was receiving biologic treatment. Concomitant medications included unspecified biologic treatment for chronic arthritis. On 18Apr2021, the patient received the first dose of the BNT162B2 vaccine.  On an unspecified date, after vaccination, the patient developed a rash, followed by difficult breathing and swelling. The patient was hospitalized for the adverse events. The action taken in response to the events for ziprasidone hcl was unknown and for the BNT162B2 vaccine was not applicable. The outcome of events rash, difficulty breathing and swelling was unknown.   Information about lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Optic neuritis, Photophobia
Clinical narrative: optic neuritis; photophobia; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route of administration on an unspecified date (at the age of 41-years-old) (Batch/Lot number and Expiry date was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient suffered photophobia and optic neuritis after receiving the Pfizer-BioNTech vaccine. The clinical outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Optic neuritis, Photophobia
Clinical narrative: Photophobia; Optic neuritis; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced photophobia and optic neuritis after receiving the Pfizer-BioNTech vaccine. The event photophobia intervention/medically important reported as yes. The outcome of the events was not recovered at the time of the report.  Follow-up attempts completed. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Optic neuritis, Photophobia
Clinical narrative: Optic neuritis; photophobia; This is a spontaneous report from a contactable consumer.   A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration, on an unspecified date as dose number unknown, single (age at vaccination: 54 years), for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was stated that, on unspecified dates, after receiving the Pfizer-BioNTech vaccine, the patient suffered photophobia and optic neuritis. The seriousness criteria for the events were reported as Intervention/Medically Important (Intervention/Medically Important: Yes) and the rest of the criteria: life threatening, death, hospitalization prolonged disabling/incapacitating, congenital anomaly/birth defect and hospitalization required were denied. No abstracts have been assigned to this case. The outcome of the events were reported as not recovered, at the time of reporting.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Patient had both doses of the Pfizer Covid Vaccine and tested positive for Covid; Patient had both doses of the Pfizer Covid Vaccine and tested positive for Covid; congestion; sore throat; loss of smell; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative.   A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunization. The patient experienced patient had both doses of the pfizer covid vaccine and tested positive for covid (medically significant) on an unspecified date, congestion, sore throat, loss of smell on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Patient had both doses of the Pfizer Covid Vaccine and tested positive for Covid; Patient had both doses of the Pfizer Covid Vaccine and tested positive for Covid; congestion; sore throat; loss of smell; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative.   A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunization. The patient experienced patient had both doses of the pfizer covid vaccine and tested positive for covid (medically significant) on an unspecified date, congestion, sore throat, loss of smell on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Coronavirus test, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: tested postiive for Covid virus; tested postiive for Covid virus; First Dose, 15Jan2021, Second Dose 03Feb2021,; This is a spontaneous report from a contactable consumer (patient herself). A 40-years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, lot number: EL1284, expiry date: unknown) on 15Jan2021 4:45PM (age at vaccination: 40 -years) as single dose and second dose (lot number: EL9263, expiry date: unknown) on 03Feb2021 9:15AM (age at vaccination: 40 -years) via unspecified route of administration in left arm as single dose for covid-19 immunisation. Vaccination facility type was hospital. Patient's medical history and concomitant medications were not reported. Patient was diagnosed with Covid yesterday 20Jul2021, and she was trying to find a way to report the breakthrough COVID diagnosis, had not seen anywhere on the website that they are tracking this information, could only find that they have tracked it through the end of Apr2021. She wanted to know if Pfizer was tracking this information. Patient had physician office visit due to adverse event. She went to respiratory clinic yesterday, doctor had her regen-cov infusion today for treatment, 21Jul2021. Prior Vaccinations (within 4 weeks) no other vaccinations within four weeks prior to the first administration date of the suspect vaccine was given. Patient was on the phone with one of their colleague and was reporting that she had the Pfizer vaccine in January and February but yesterday was diagnosed with COVID-19. So, she was reporting the breakthrough and had just about finished the report, the voluntary report but they were unfortunately disconnected. So, she doesnt know what else she needs to do to answer remaining questions but just wanted to complete that form. The outcome of event was not recovered, when reported.   Follow-Up (26Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: has tested positive for COVID 19 after being fully vaccinated (2 doses) with PFE vaccine several months ago; has tested positive for COVID 19 after being fully vaccinated (2 doses) with PFE vaccine several months ago; This is a spontaneous report from a non-contactable consumer. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Batch number/Lot number: unknown) via an unspecified route of administration on an unspecified date (at the age of 26-year-old) as a dose 2, single and the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Batch number/Lot number: unknown) via an unspecified route of administration on an unspecified date (at the age of 26-year-old) as a dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that by patient family member, patient who was a 26-year-old male has tested positive for COVID-19 after being fully vaccinated (2 doses) with PFE vaccine several months ago. Stated that, he was a healthcare worker. On an unspecified date, the patient underwent lab tests and procedures which included SARS-CoV-2 test resulted as positive. for COVID-19. The outcome of the events was unknown.  No follow up attempts are possible, information about lot/batch no cannot be obtained.