chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Antinuclear antibody, Arthralgia, Back pain, Facial pain, Hypoaesthesia
Clinical narrative: paresthesia of face and arms; numbness and pain of face, arms, legs, and extremities; numbness and pain of face, arms, legs, and extremities; numbness and pain of face, arms, legs, and extremities; Back, Muscle, and Joint pain; Back, Muscle, and Joint pain; Back, Muscle, and Joint pain; This is a spontaneous report from a contactable consumer (patient). An unspecified gender 44-year-old patient received the second dose of BNT162B2 (PFIZER COVID 19) via an unspecified route of administration on the left arm on 25Apr2021 at 15:30 (Batch/Lot Number: ER8735) at the age of 44-year-old as single dose for COVID-19 immunization. Known allergies included ragweed allergy, slight allergy to bananas, cat/dog allergy, alternaria allergy and birch allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient didn't receive other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't received other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 04Apr2021 at 03:30 PM (Batch/Lot Number: ER8737) at the age of 44-year-old as single dose of COVID-19 immunization. On 10Jun2021 at 17:00, the patient experienced initial paresthesia of face and arms, eventual numbness and pain of face, arms, legs, and extremities. Back, Muscle, and Joint pain. ANA positive, 1:1280. Negative for all rheumatoid and autoimmune diseases thus far. Still working with Neurology, no large muscle or nerve issues, small fiber skin biopsy scheduled this week. The patient performed PCR (Nasal Swab) on 07Jun2021 and result was negative. The events resulted in emergency room visit and physician office visit. No treatment was not received. The events were not resulted in hospitalization prolonged. The outcome of events was not recovered.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Laboratory test, Myalgia, Pain in extremity, Paraesthesia, SARS-CoV-2 test
Clinical narrative: paresthesia of face and arms; numbness and pain of face, arms, legs, and extremities; numbness and pain of face, arms, legs, and extremities; numbness and pain of face, arms, legs, and extremities; Back, Muscle, and Joint pain; Back, Muscle, and Joint pain; Back, Muscle, and Joint pain; This is a spontaneous report from a contactable consumer (patient). An unspecified gender 44-year-old patient received the second dose of BNT162B2 (PFIZER COVID 19) via an unspecified route of administration on the left arm on 25Apr2021 at 15:30 (Batch/Lot Number: ER8735) at the age of 44-year-old as single dose for COVID-19 immunization. Known allergies included ragweed allergy, slight allergy to bananas, cat/dog allergy, alternaria allergy and birch allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient didn't receive other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't received other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 04Apr2021 at 03:30 PM (Batch/Lot Number: ER8737) at the age of 44-year-old as single dose of COVID-19 immunization. On 10Jun2021 at 17:00, the patient experienced initial paresthesia of face and arms, eventual numbness and pain of face, arms, legs, and extremities. Back, Muscle, and Joint pain. ANA positive, 1:1280. Negative for all rheumatoid and autoimmune diseases thus far. Still working with Neurology, no large muscle or nerve issues, small fiber skin biopsy scheduled this week. The patient performed PCR (Nasal Swab) on 07Jun2021 and result was negative. The events resulted in emergency room visit and physician office visit. No treatment was not received. The events were not resulted in hospitalization prolonged. The outcome of events was not recovered.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersensitivity, Pyrexia
Clinical narrative: Allergic reaction from the vaccine; Fever; It was very hard for me to breath; This is a spontaneous report received from a contactable consumer(patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 14Jun2021 (Lot Number: ER8736) (at age of 28-year-old) in Left upper arm as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history and concomitant drugs was not reported. There was no prior vaccination (within 4 weeks).  The patient previously took the first dose of BNT162B2 on 07May2021 (at age of 28-year-old) (Lot: EWO164, not sure if this O or 0) for COVID-19 Immunization.  The patient experienced allergic reaction from the vaccine (hypersensitivity) (hospitalization), fever (pyrexia) (hospitalization), it was very hard for me to breath (dyspnoea) (hospitalization), all on 14Jun2021. Consumer stated, "I had my first dose of Pfizer vaccine 07May2021 and my second one is on 14Jun2021 and on 14June night, I started to have like a fever and it was very hard for me to breath. So, I waited to like a few hours I might feel little bit better but my condition got worse. So, I decided to go to an emergency room. On June 15, early morning and  as a resort of that, they gave like a medicine there they managed my breathing problem and my fever and so I went home. And as a resort of that I have a medical bill of # dollars. So, I get energy care and the following morning like 7  they have prescribed me a medicine for allergy, it is like an allergic reaction so like for the allergic reaction that I have from the vaccine, So, after administration of medicine for hour my fever brought down I was able to somehow breathe and everything is manageable at my end." When clarified, consumer stated, "Basically, I was able to breathe a little, what they did in emergency room they just managed me in order for me to breath and all that and then they released me but I still have some fever but I was able to breath. So, it was early morning it was like 3 o'clock in the morning so there was no urgent care or any facility that I can go apart from emergency department at that hour. So, I was able to breathe. So, upon discharge I did take the medical services of an urgent care like 7 o'clock in the morning and they are the ones that prescribed me the medicine for allergy which I bought but that is all started out." Treatment: Consumer stated, "Saline nasal spray, Albuterol Sulfate, its inhalation aerosol inhaler 90 mcg and other one is antihistamine and other one is just Tylenol." The outcome of the events was resolved on 15Jun2021.   Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: I had the shot of Pfizer (Pfizer Covid-19 Vaccine) and I have Covid; I had the shot of Pfizer (Pfizer Covid-19 Vaccine) and I have Covid; This is a spontaneous report from a contactable consumer(patient).  A 50 years old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02Feb2021(vaccination at age of 49 years old) (Batch/Lot number was not reported) as  single dose, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Anatomical site of vaccine administration reported as in the arms, in the upper arms, both arms, on in the right and then one in the left upper arm. Medical history included Hiatal hernia, gastrooesophageal reflux disease, Fibromyalgia, Covid. Concomitant medication(s) included duloxetine hydrochloride (CYMBALTA), omeprazole and duloxetine for Fibromyalgia, taken for an unspecified indication, start and stop date were not reported. The patient underwent lab tests and procedures which included covid-19: positive on unknown date.  Consumer stated "I had the shot of Pfizer (Pfizer Covid-19 Vaccine) and I have Covid. And this is the second time that I have had Covid. This time it has been the worst. I guess, the weird thing was that I got it twice and I don't know if there is something like they should do, like check me or to see if I should have like to check me or to see if I should have like, if I would have scared if I would have to get it again. I just think now that there is something that you guys needed to know because like I work in a hospital in withheld and I am like the first person who has gotten sick, it is like, my whole hospital has like turned away freaky now." (Further clarification unknown), I am a Certified Nursing aide, I would be willing to like your study or something to figure out why, I got sick. I don't want to get sick again, it is weird." Consumer stated, "My first symptoms started. I had a headache on Monday, the 09Aug2021. They put me on withheld what they call it, which is Azithromycin Tablet that is what I am on now."  Outcome for events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: They have 7 or 8 people positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Coivid-19 vaccine; They have 7 or 8 people positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine; This is a spontaneous report from contactable Nurse.  This Nurse reported similar events for 6 patients. This report is for 5th of 6 patient.   A 64-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 28Mar2021 (Lot Number: ER8734; Expiration Date: 31Jul2021) at the age of 64-year-old as dose number unknown, single for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine.  The patient underwent lab tests and procedures which included COVID-19 Virus test: positive on unknown date.  The outcome of events was unknown. As of 19Aug2021, product Quality complaint Group provided conclusion:  The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot ER8734 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8734, fill lot EP8686, and the formulated drug product lot EP8573. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101058200 same product and event, different patients
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Ovarian cyst ruptured, Pain, Rash
Clinical narrative: 2-3 weeks following COVID-19 vaccination the patient suffered a ruptured ovarian cyst. This was followed by a rash and intense pain. The patient is now unable to walk and in a rehab. Not clear if thes; 2-3 weeks following COVID-19 vaccination the patient suffered a ruptured ovarian cyst. This was followed by a rash and intense pain. The patient is now unable to walk and in a rehab. Not clear if thes; 2-3 weeks following COVID-19 vaccination the patient suffered a ruptured ovarian cyst. This was followed by a rash and intense pain. The patient is now unable to walk and in a rehab. Not clear if thes; 2-3 weeks following COVID-19 vaccination the patient suffered a ruptured ovarian cyst. This was followed by a rash and intense pain. The patient is now unable to walk and in a rehab. Not clear if thes; This is a spontaneous report from a contactable consumer. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in May2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included coeliac disease (known allergies: Celiac disease-related issues). The patient's concomitant medications were not reported. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination.Prior to vaccination,  the patient wasn't diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. In May2021, 2-3 weeks following COVID-19 vaccination the patient suffered a ruptured ovarian cyst. This was followed by a rash and intense pain. The patient is now unable to walk and in a rehab. The events resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage. The outcome of the events was recovering. Therapeutic measures were taken as a result of the events.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Tested positive to covid; Tested positive to covid; This is a spontaneous report from a contactable consumer (patient herself). A non-pregnant 55-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in left arm, on 25Feb2021 (Batch/Lot Number: EL3247) as DOSE 1, SINGLE, and dose 2 via an unspecified route of administration, administered in left arm, on 18Mar2021 (Batch/Lot Number: EL3247) as DOSE 2, SINGLE,  for COVID-19 immunization, Age at Vaccination: 55 years (as reported). Relevant medical history includes high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no known allergies. Concomitant medications included losartan and vitamins nos (DAILY VITAMINS), both taken for an unspecified indication, start and stop date were not reported. On 15Aug2021, patient had runny nose, cough, headache, sore throat, chills without fever, watery eyes, heavy eyes. Then on 16Aug2021, patient tested positive to COVID. No treatment was received for the events. Since the vaccination, the patient had been tested for COVID-19 via nasal swab on 16Aug2021 with result positive. Facility where the most recent COVID-19 vaccine was administered was at a workplace clinic. The outcome of the events was not recovered.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to chemicals, Burning sensation, Pruritus, Rash, SARS-CoV-2 test negative
Clinical narrative: continuous rash; itching; burning since second vaccine; allergy to chemical; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient (not pregnant) received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 23Mar2021 at 13:00 (Lot Number: Unknown) at the age of 64-year-old as single dose for COVID-19 immunization. Medical history included hypothyroidism, PTSD, depression, latex allergy and penicillin allergy. The patient was not COVID prior vaccination. The patient performed Covid test (Nasal Swab) post vaccination on 17Jul2021 and result was negative. Concomitant medications included levothyroxine sodium, celecoxib (CELEXA [CELECOXIB]) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on an unspecified date at 13:00 (Lot Number: Unknown) as single dose for COVID-19 immunization. On 24Mar2021 at 01:00 AM, the patient experienced continuous rash, cyclical, itching, and burning since second vaccine. Dermatology biopsies indicate allergy to chemical. The events resulted in emergency room visit and physician office visit. No treatment was received. The outcome of events was not recovered.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Muscular weakness
Clinical narrative: My muscles are becoming very very weak and theres a pulling kind of sensation in my lower abdomen which is not going away and getting worse.Also my legs become very very weak and I am unable to do my; My muscles are becoming very very weak and theres a pulling kind of sensation in my lower abdomen which is not going away and getting worse.Also my legs become very very weak and I am unable to do my; My muscles are becoming very very weak and theres a pulling kind of sensation in my lower abdomen which is not going away and getting worse.Also my legs become very very weak and I am unable to do my; My muscles are becoming very very weak and theres a pulling kind of sensation in my lower abdomen which is not going away and getting worse.Also my legs become very very weak and I am unable to do my; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received the second dose of BNT162B2 via an unspecified route of administration on the right arm on 21Jun2021 at 03:15 (Lot Number: EW0178) at the age of 48-year-old as single dose for COVID-19 immunization. Medical history included sulfa group allergy. It was unknown whether the patient received other vaccine in four weeks. The patient didn't COVID prior vaccination. The patient didn't perform COVID test post vaccination. The patient didn't received other medications in two weeks. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the right arm on 28May2021 at 03:15 (Lot Number: EW0178) at the age of 48-year-old as single dose for COVID-19 immunization. On 01Jul2021, the patient's muscles were becoming very very weak and there a pulling kind of sensation in lower abdomen which was not going away and getting worse. Also the legs become very very weak and the patient was unable to do daily chores. The outcome of events was not recovered. The events resulted in emergency room visit and physician office visit. Treatment included physical therapy and CT scan. The outcome of events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had both doses of the Pfizer vaccine and now has Covid; Had both doses of the Pfizer vaccine and now has Covid; This is a spontaneous report from a contactable consumer (patient's mother) or other non-healthcare professional. A 45-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) as DOSE 2, SINGLE and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had both doses of the Pfizer vaccine and now has covid. The reporter stated that her son is healthy, and he had both of the Covid vaccines, Pfizer, and he got Covid. The patient underwent lab tests and procedures which included Sars-cov-2 test: got positive on an unspecified date. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Cervical radiculopathy, SARS-CoV-2 antibody test, Trigeminal neuralgia
Clinical narrative: On 20Jan2021, Right sided Bell's palsy was developed; After Bell's palsy, right-sided cervical radiculopathy started; Now, right-sided trigeminal neuralgia was started.; This is a spontaneous report from a contactable other healthcare professional. A 54 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 19Jan2021 16:00 (Batch/Lot Number: EL3246) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have COVID prior vaccination. The patient was tested for COVID post vaccination. On 20Jan2021, the patient experienced Right sided Bell's palsy was developed, After Bell's palsy, right-sided cervical radiculopathy started, Now, right-sided trigeminal neuralgia was started. The patient underwent lab tests and procedures which included sars-cov-2 antibody test negative on 21Feb2021 with nasal swab, sars-cov-2 antibody test: negative on 24Feb2021 with nasal swab, sars-cov-2 antibody test negative on 12Jul2021 with nasal swab and sars-cov-2 antibody test negative on 11Aug2021 with nasal swab. Therapeutic measures were taken as a result of this with Tegetol for trigeminal neuralgia. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.; 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 events Bell's palsy 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: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Blood pressure measurement, Fatigue, Headache, Illness
Clinical narrative: In the third week, I woke up in the morning and came down with Bells Palsy; After the second shot two week later I became sick with a fever, super tired, and a massive headache at the back of my head behind the ear.; fever; super tired; massive headache at the back of head behind the ear; sick; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 09Apr2021 at 12:30 (Lot Number: er8731) at the age of 55-year-old as single dose for COVID-19 immunization. Medical history included high blood pressure. known allergy included mangos. The patient was not COVID prior vaccination. The patient didn't perform COVID test post vaccination. The patient didn't receive other vaccine in four weeks. The patient didn't receive other medication in two weeks. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm in Mar2021 at 12:30 PM(Lot Number: er2613) as single dose for COVID-19 immunization. On 01May2021 at 07:00 AM , two weeks after the second shot, the patient became sick with a fever, super tired, and a massive headache at the back of head behind the ear. In the third week, the patient woke up in the morning and came down with Bells Palsy. Treatment included predisone. The events resulted in emergency room visit and physician office visit. The outcome of events was recovered with sequel.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: In the third week, I woke up in the morning and came down with Bells Palsy; After the second shot two week later I became sick with a fever, super tired, and a massive headache at the back of my head behind the ear.; fever; super tired; massive headache at the back of head behind the ear; sick; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 09Apr2021 at 12:30 (Lot Number: er8731) at the age of 55-year-old as single dose for COVID-19 immunization. Medical history included high blood pressure. known allergy included mangos. The patient was not COVID prior vaccination. The patient didn't perform COVID test post vaccination. The patient didn't receive other vaccine in four weeks. The patient didn't receive other medication in two weeks. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm in Mar2021 at 12:30 PM(Lot Number: er2613) as single dose for COVID-19 immunization. On 01May2021 at 07:00 AM , two weeks after the second shot, the patient became sick with a fever, super tired, and a massive headache at the back of head behind the ear. In the third week, the patient woke up in the morning and came down with Bells Palsy. Treatment included predisone. The events resulted in emergency room visit and physician office visit. The outcome of events was recovered with sequel.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, X-ray
Clinical narrative: they ran a COVID test and he tested positive/mild fever; they ran a COVID test and he tested positive/mild fever; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 30Dec2020 (Batch/Lot number was not reported) as dose 1, single dose and on an unspecified date in Jan2021 (three weeks later)(Batch/Lot number was not reported) as dose 2, single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications included blood thinners. The patient received first COVID vaccine on 30Dec2020 and second dose three weeks later. He resided in assisted living facility and had several co-morbidities. He fell was taken to hospital to assess for internal bleeding since he was on blood thinners. He had a mild fever so they ran a COVID test and he tested positive on an unspecified date in 2021. ED physician did X-ray and CT of lungs. Gave patients dose of doxycycline to clear up lungs. Patient home and stable. Event took place after use of product. The outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia
Clinical narrative: Bell's palsy; numbness in their face and in their arms and finger tips; This is a spontaneous report from contactable consumer.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: not reported, Expiration date: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced Bell's palsy and numbness in their face and in their arms and fingertips. Reporter also stated, I was given this number so that I can speak with a medical, somebody that is familiar with the adverse side effects that are not the normal side effects from the Pfizer Covid-19 vaccine. We have a patient that has had their first shot and had an adverse reaction of what appear to be the Bell's palsy where they experienced the numbness in their face and in their arms and fingertips and so for.  Outcome for events was unknown.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Came down with symptoms on 08Aug2021 - headache, fever of 101.2+ and cough. Tested negative on 8/9/21 with Abbott BinaxNow kit and positive on 8/10/21 with Abbott BinaxNow kit; Came down with symptoms on 08Aug2021 - headache, fever of 101.2+ and cough. Tested negative on 8/9/21 with Abbott BinaxNow kit and positive on 8/10/21 with Abbott BinaxNow kit; This is a spontaneous report from a contactable consumer (patient). A 21-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8729), via an unspecified route of administration, administered in Arm Left on 14Apr2021 (at the age of 21-years-old) as dose 2, single and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER2613) via an unspecified route of administration, administered in Arm Left on 22Mar2021 16:00 (at the age of 21-years-old) as dose 1, single for covid-19 immunization at other. The patient medical history was not reported. There were no concomitant medications. No known allergies and no other medical history. No other vaccine in four weeks and other medications in two weeks. No covid prior vaccination. Covid was tested post vaccination. On 08Aug2021 21:00, the patient came down with symptoms of headache, fever of 101.2+ and cough. Tested negative on 09Aug2021 with Abbott BinaxNow kit and positive on 10Aug2021 with Abbott BinaxNow kit and then positive with hospital clinic test on 10Aug2021. Lost sense of smell and taste but symptoms resolved within 8 days. Still cannot taste much. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included body temperature: 101.2 on 08Aug2021, sars-cov-2 test (nasal swab): negative on 09Aug2021, blood test: positive on 10Aug2021, sars-cov-2 test (nasal swab): positive on 10Aug2021. The patient received treatment for events. Received Tylenol for fever and monitoring pulse and oxygen. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Pruritus, Suspected COVID-19, Therapeutic response unexpected
Clinical narrative: Lack of drug effect; Lack of drug effect; Localized itching; Unexpected therapeutic benefit; This is a solicited study report from the marketing program received from a contactable consumer (patient).   A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; risankizumab (SKYRIZI), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose for Moderate to severe chronic plaque psoriasis.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced localized itching, unexpected therapeutic benefit, lack of drug effect on an unspecified date with outcome of not recovered. On unknown dates, the patient experienced itchiness in head, back and buttocks, unexpected benefit/had no joint pain or swelling since starting SKYRIZI and lack of effect. COVID-19 vaccine was also considered suspect. The patient got Covid vaccine and experienced itchiness for about a week or two. He started experiencing itchiness in head, back, and buttocks less than 12 weeks after doing Skyrizi injection. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received 1st dose COVID-19 Vaccine. Primary reporter did not have the lot number information, because the packaging was discarded. The action taken in response to the events for risankizumab was unknown.  Causality for SKYRIZI(RISANKIZUMAB): The reporter's causality for the events of itchiness in head, back and buttocks, unexpected benefit/had no joint pain or swelling since starting SKYRIZI and lack of effect with SKYRIZI(RISANKIZUMAB) was a reasonable possibility.  The reporter's assessment of the causal relationship of the events with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Drug ineffective, Suspected COVID-19, Pruritus and Therapeutic response unexpected cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia, Thrombosis
Clinical narrative: possible blood clotting; burning sensation on her left side particulary her foot and leg same side she got shot in her arm; her toes on left are still a little tingly; This is a spontaneous report from a contactable consumer. This consumer reported for a female other HCP (patient)  that the female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration, administered in arm on an unspecified date in Jul2021 as dose 1, single for covid-19 immunisation. Medical history included history of not responding well to vaccine shots including the flu shot which gave her shingles. No medical conditions beside history of intolerance to vaccines.The patient's concomitant medications were not reported. Patient was a nurse at a dermatology office and she knew who got COVID vaccine in July. She directly reported it to field force (consumer) as both reporter and patient. She experienced a burning sensation on her left side particularly her foot and leg same side she got shot in her arm. She said that her primary care doc was worried about possible blood clotting so advised against her 2nd shot. She said that her toes on left were still a little tingly so she was concerned to take second shot which she was supposed to take on an unspecified date. The outcome of event her toes on left were still a little tingly was not recovered while the outcome of other events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Limb discomfort, Poor peripheral circulation, Thrombosis
Clinical narrative: had a blood clot; developed heart issues, and had to have a pacemaker inserted.; lost circulation to his feet/lose his feet from the vaccine; lost circulation to his feet/lose his feet from the vaccine; This is a follow-up spontaneous report from a Pfizer- sponsored program. This consumer reported for a male consumer(patient). This is a third case out of 4 cases.   A male patient of an unspecified age was received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient had a blood clot, lost circulation to his feet/lose his feet from the vaccine, developed heart issues, and had to have a pacemaker inserted. The reporter reported that, caller states that after three of her family members received the Pfizer Covid-19 vaccine that they all developed blood clots. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075369 same reporter/product, different patient / event.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Illness, Pain in extremity, Thrombosis
Clinical narrative: Thrombosis in Left Leg and Pain; Back pain; he still felt sick; Thrombosis in Left Leg and Pain; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 47-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 21Jul2021 (at the age of 47-years-old) (Batch/Lot Number: EW0198) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (lot number: PA7484, vaccine location: Left arm) on 02Jul2021 for covid-19 immunisation. The patient states that he had pain in his back, so he went to the ER, he still felt sick, so he went to another ER at a different hospital (probably 2 weeks later from  the vaccine) and they told him that he had a thrombosis in his leg (on an unspecified date in 2021) and gave him prescriptions and he left the same day. The patient states his second trip to the ER was on 14Aug2021. As the patient still had the same pain (Pain in leg on an unspecified date In Jul2021) so he went back to an ER for a second time because the first time they didn't check his blood or anything. Caller clarifies that he was not admitted to the hospital, he was treated and released from the ER Caller states he is supposed to go to the hospital today, but he has no one to drive him. Regarding treatment reporter stated they gave him Norco for Pain and Xarelto. patient stated he will probably have to go back to the hospital because he did not see any change in this leg, patient stated he will see if they can see him again for more pain medicine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of back pain was recovered on an unspecified date in 2021. The outcome of still felt sick was unknown. The outcome of the other events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: the patient administered moderna vaccine after the pfizer covid 19 vaccine on 19Aug2021; two doses on one day in 22MAR2021 and a third dose 13APR2021.; patient received three doses of the Pfizer Covid 19 vaccine; This is a spontaneous report from a contactable pharmacist. A 47-years-old male patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 22Mar2021 (age at the vaccination 47-years-old) as dose 2, single, and dose 1 (Batch/Lot number: ER2613) on 22Mar2021 as dose 1 single, and dose 3 as extra dose on 13Apr2021 as dose 3, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. A patient received three doses of the Pfizer COVID 19 vaccine: two doses on one day in 22Mar2021 and a third dose 13Apr2021. The patient came to the pharmacy and the patient stated he had not had a COVID vaccination, so the patient administered moderna vaccine after the pfizer covid 19 vaccine on 19Aug2021 after the pfizer covid 19 vaccine. The events assessed as medically significant. The outcome of events was unknown.  Caller states causality as no, unrelated.   Product: Moderna COVID 19 vaccine; treatment 19AUG2021 at 1615PM in left deltoid; lot 017C21A; NDC 80777-273-10; expiration date 19OCT2021; dose 0.5ml.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events: Extra dose administered and Inappropriate schedule of product administration ;and the administration of the vaccine cannot be excluded.,Linked Report(s) : US-PFIZER INC-202101086686 same AE/drug, different patient.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness bilateral, Diplopia, Dysphagia, Headache, Mastication disorder
Clinical narrative: 70% loss of hearing in both ears within 12 days of vaccine/steady hearing loss; Chewing; swallowing; sore throat; headaches/head pain; Vertigo; double vision in 3 months; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 at 10:30 AM (Batch/Lot Number: ER8734) as DOSE 2, SINGLE (at the age of 78-years-old) for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient had no known allergies. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 16Mar2021 at 10:30 AM (Batch/Lot Number: EP7534) as DOSE 1, SINGLE (at the age of 78-years-old) for COVID-19 immunisation. On 14Apr2021, the patient experienced 70% loss of hearing in both ears within 12 days of vaccine/steady hearing loss, chewing, swallowing, sore throat, headaches/head pain, vertigo, and double vision in 3 months. The adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization, disability, or permanent damage. The patient was hospitalized for 1 day for the events. The patient underwent lab tests and procedures which included covid-19: negative on 01Aug2021. The patient did not receive any treatment for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 and was negative on 01Aug2021. The patient had not recovered from the events.  That information on the Lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Vertigo
Clinical narrative: 70% loss of hearing in both ears within 12 days of vaccine/steady hearing loss; Chewing; swallowing; sore throat; headaches/head pain; Vertigo; double vision in 3 months; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 at 10:30 AM (Batch/Lot Number: ER8734) as DOSE 2, SINGLE (at the age of 78-years-old) for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient had no known allergies. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 16Mar2021 at 10:30 AM (Batch/Lot Number: EP7534) as DOSE 1, SINGLE (at the age of 78-years-old) for COVID-19 immunisation. On 14Apr2021, the patient experienced 70% loss of hearing in both ears within 12 days of vaccine/steady hearing loss, chewing, swallowing, sore throat, headaches/head pain, vertigo, and double vision in 3 months. The adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization, disability, or permanent damage. The patient was hospitalized for 1 day for the events. The patient underwent lab tests and procedures which included covid-19: negative on 01Aug2021. The patient did not receive any treatment for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 and was negative on 01Aug2021. The patient had not recovered from the events.  That information on the Lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Hypoacusis, Tinnitus
Clinical narrative: 70% loss of hearing in both ears within 12 days of vaccine/steady hearing loss; Chewing; swallowing; sore throat; headaches/head pain; Vertigo; double vision in 3 months; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 at 10:30 AM (Batch/Lot Number: ER8734) as DOSE 2, SINGLE (at the age of 78-years-old) for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient had no known allergies. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 16Mar2021 at 10:30 AM (Batch/Lot Number: EP7534) as DOSE 1, SINGLE (at the age of 78-years-old) for COVID-19 immunisation. On 14Apr2021, the patient experienced 70% loss of hearing in both ears within 12 days of vaccine/steady hearing loss, chewing, swallowing, sore throat, headaches/head pain, vertigo, and double vision in 3 months. The adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization, disability, or permanent damage. The patient was hospitalized for 1 day for the events. The patient underwent lab tests and procedures which included covid-19: negative on 01Aug2021. The patient did not receive any treatment for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 and was negative on 01Aug2021. The patient had not recovered from the events.  That information on the Lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Loss of consciousness, Movement disorder
Clinical narrative: I ended up feeling I passed out woke up about 30 seconds after trying to catch my breath and making strange noises with my throat I lost consciousness; I felt a tingling on my left arm and spreading to my back; Shortness of breath; Very dizzy; My throat was swollen, closed, I felt air passage is closed or closing and when I woke up I was making funny noises with my throat trying to clear an air passage; My throat was swollen, closed I felt air passage is closed or closing and when I woke up I was making funny noises with my throat trying to clear an air passage; My arm could not be lifted for 17 hours; Very tired for 2 days 2-4 days; This is a spontaneous report from a contactable consumer or non-HCP reported about herself (patient).  A 48-year-old female patient received first dose of bnt162b2 (BNT162B2; Solution for injection; Lot Number: EW0177), via an unspecified route of administration, administered in left arm as dose 1, single on 08Jun2021 13:00 (at the age of 48-year-old) for covid-19 immunisation. The patient medical history, family medical history and concomitant medications were not reported. As per reporter, patient received the first dose of vaccine on 08Jun2021 and about a minute later had some side effects, she felt a tingling on left arm and spreading to her back, shortness of breath, very dizzy and ended up felt she passed out. Patient lost consciousness for 30 seconds and then woke up and had shortness of breath and throat was swollen, closed, she felt air passage was closed or closing, closing and made funny or strange noises with her throat tried to clear an air passage. She laid down for 30 minutes there at the pharmacy where they monitored her and then they sent her home. Patient's arm could not be lifted for 17 hours and just very tired for 2 days, 2-4 days. Patient's doctor recommended to see an allergist and do not get the second dose. Patient do not have a second vaccination appointment. No treatment was received for side effect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. At the time of this report, outcome of the events was unknown.