chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm really sore; Felt like he had a cold and felt like he was coming down with the flu; Felt like he had a cold and felt like he was coming down with the flu; Tired; Got pretty sick after the second vaccine; He just felt blah; This is a spontaneous report from a contactable consumer (patient wife). A 42-year-old male patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date, at the age of 42-year-old, (Lot number and expiration date was not reported) as dose 2, single for COVID-19 immunization. The vaccine was administered at military base. The patient medical history and concomitant medications were none. No other additional vaccines administered on same date of the suspect. No other vaccine was administered within 4 weeks. Historical vaccine included first dose of BNT162B2 (as reported), via an unspecified route of administration on an unspecified date, at single dose for COVID-19 Immunization and the patient had no reaction. The reporter mentioned that her husband got pretty sick after the second vaccine. The patient was still able to work but his arm was really sore, felt like he had a cold and felt like he was coming down with the flu, and he was tired but not throwing up or anything. He just felt blah. This only lasted 24 hours and then he was fine. The patient did not take any treatment and did not had emergency room/physician office visit and it was gone the next day (as reported). The patient did not have any relevant tests performed. The reporter stated that she guessed it is normal for the second one (second dose of vaccine). The outcome of the events was recovered.  Information on the lot/ batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pain in extremity
Clinical narrative: Approximately 1 week after my second dose of the Pfizer-BioNTech COVID-19 vaccine on May 1st I started experiencing right calf pain. On May 11th, I was diagnosed with a DVT in that same calf.; Approximately 1 week after my second dose of the Pfizer-BioNTech COVID-19 vaccine on May 1st I started experiencing right calf pain. On May 11th, I was diagnosed with a DVT in that same calf. I was ad; This is a spontaneous report from a contactable consumer (patient). A 23-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: EW0172) via an unspecified route of administration on 24Apr2021 (at the age of 23-year-old), as dose 2, single in right arm for COVID-19 immunization. The patient's medical history included migraine, anxiety, and panic attack from an unknown date and unknown if ongoing. Concomitant medication included alprazolam (XANAX), paracetamol (TYLENOL), ethinylestradiol, norethisterone acetate (JUNEL) and Keto Karma Fat Burn Red; all taken for unspecified indications, start and stop dates were not reported. The patient previously took Aimovig and experienced drug allergy. The patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: ER8734) via an unspecified route of administration on 02Apr2021 (at the age of 23-year-old), as single dose in right arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 01May2021 at 17:00, 7 days and 17 hours (approximately 1 week) after the administration of the second dose of vaccine, the patient experienced right calf pain. On May 11th, 17 days after the administration of the second dose of vaccine, the patient was diagnosed with a deep vein thrombosis (DVT) in that same calf. Adverse events resulted in Emergency Room visit and Physician Office Visit. Treatment medication included blood thinners. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome for the events was resolving  Information about lot/batch number was provided. Additional information has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chronic lymphocytic leukaemia
Clinical narrative: Chronic lymphatic leukaemia; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 25Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient experienced chronic lymphatic leukaemia on an unspecified date in Apr2021. The patient (caller) stated that she was diagnosed with chronic lymphatic leukaemia, and she did not have a problem in Jan, so it must had happened between Jan and Apr, that particular situation came up. Caller was wondering if the antibodies from the vaccine are compromised when you have chronic lymphatic leukaemia. Caller stated Chronic Lymphatic Leukemia, was one of those that's not really critical, with that type of leukemia you could have no problem for years and years. Caller added, but if the immune system was compromised to a point, would the antibodies from vaccine be destroyed from the chronic lymphatic leukaemia. Caller stated she could find out by being monitored with blood tests and wanted to see had the antibodies changed or not. Caller stated, she had a blood test back in Apr, and that's how they discovered she had chronic lymphatic leukaemia, at her regular doctor's office. She asked them to check for antibodies, and at that time, she did not know if she had chronic lymphatic leukaemia, she asked them to check antibodies since she was vaccinated. Caller stated they said they were good, and doctor would have the numbers, and if she had another blood test to continue checking them, and if the same, then nothing was happening, she could go that route. The patient visited the physician office for the above event. The patient underwent lab tests and procedures which included blood test: chronic lymphatic leukaemia on an unspecified date in Apr2021. Outcome of the event was reported as Unknown.   Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Polymenorrhoea
Clinical narrative: I have now been bleeding extremely heavily for 9 days; I began my period a bit early. It was more heavy than usual, it went for 10 days very heavy, and abruptly stopped. Then 7 days later, it returned, and I have now been bleeding heavily for 9 days; I began my period a bit early. It was more heavy than usual, it went for 10 days very heavy, and abruptly stopped. Then 7 days later, it returned, and I have now been bleeding heavily for 9 days; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 20Feb2021 12:00 (age at the vaccination: 39-year-old) as dose number unknown, single for covid-19 immunisation in public health clinic/veterans administration facility. Medical history included fibromyalgia. Concomitant medication(s) included tramadol taken for an unspecified indication, start and stop date were not reported; norethindrone acetate taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took ibuprofen for drug hypersensitivity. On an unspecified date, the patient was bleeding extremely heavily for 9 days. On 23May2021, she began her period a bit early. it was more heavy than usual, it went for 10 days very heavy, and abruptly stopped. then 7 days later, it returned, and she have now been bleeding extremely heavily for 9 days. Patient stated that, she was out one evening and she bled through her ultra-tampon, maxi pad and jeans instantaneously. Instead of lasting the usual 5-7 days and tapering offset the end, it went for 10 days very heavy, and abruptly stopped. Then 7 days later, it returned, and she have now been bleeding extremely heavily for 9 days, but 16Jun2021 sought out and received medication to stop it. The events result in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events with norethidrone acetate. The outcome of the events was not recovered.  Follow-up actions are needed. Further information has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Choking, Dizziness, Heart rate increased, Maternal exposure during pregnancy
Clinical narrative: choking a bit.; Right after the vaccination, I felt dizzy; my heart rate went up; is_pregnant-yes; This is a spontaneous report from a contactable consumer or other non HCP (patient, self-reporting). A 36-year-old pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0172 Expiry date: UNKNOWN), via an unspecified route of administration at right arm on 26May2021 at 17:00 (pregnant at the time of vaccination and 36-years-old) as a dose 1, single for COVID-19 immunization. Last menstrual period date was 26Dec2020. Patient had no known allergies. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 and she did not receive any other vaccines within 4 weeks and did not receive any other medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine administered was Hospital. On 26May2021 at 17:00 patient was exposed to vaccination during pregnancy. On 26May2021 at 17:00 after the vaccination patient experienced felt dizzy, heart rate went up and felt choking a bit. No treatment received for the events. The outcome of the events was recovered.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis, Colonoscopy, Diarrhoea haemorrhagic, Frequent bowel movements, SARS-CoV-2 test
Clinical narrative: Pt subsequently had a colonoscopy and was found to have UC (pancolitis).; Pt reports severe reaction to the second dose and immediately reported worsening in stool frequency and bloody diarrhea.; Pt reports severe reaction to the second dose and immediately reported worsening in stool frequency and bloody diarrhea.; This is a spontaneous report received from a contactable physician. A 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. Medical history included eczema. Concomitant medication included ibuprofen prn (as needed). Patient had no known allergies. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient was tested for covid-19 since vaccination. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) received on an unspecified date for covid-19 immunization and two weeks after first dose patient developed diarrhea. On an unspecified date in Apr2021, the patient subsequently had a colonoscopy and was found to have uc (pancolitis), patient reported severe reaction to the second dose and immediately reported worsening in stool frequency and bloody diarrhea. It was reported that, two weeks after first dose patient developed diarrhea. Given symptom improvement, second dose was administered after 1 week delay. Patient reported severe reaction to the second dose and immediately reported worsening in stool frequency and bloody diarrhea. Patient subsequently had a colonoscopy and was found to have UC (pancolitis). The reporter seriousness was reported as serious (hospitalization). The patient visited Emergency room and Physician office due to adverse events. The patient underwent lab tests and procedures which included colonoscopy: uc (pancolitis), sars-cov-2 test (nasal swab): negative on 26May2021, sars-cov-2 test: negative on 01Jun2021. Steroids and Infliximab was received as a therapeutic measure to treat adverse events. The outcome of the events was unknown.   Information about lot/batch number is requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Frequent bowel movements ,Diarrhoea haemorrhagic and Colitis 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.
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Lip swelling, Pharyngeal swelling, Pruritus, Swelling
Clinical narrative: sounded like an anaphylactic reaction; throat which feels like an elevated restriction; had swelling of the upper lip, like a lot like feeling like its going to burst; swelling of the upper lip, a lot, a little bit in the throat; itching and swelling in other areas; Swelling in other areas; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiration date: Not reported), via an unspecified route of administration on 17May2021 as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 as dose 1, single for COVID-19 immunization and had no reaction. On 17May2021, within an hour after second dose, patient's experience sounded like an anaphylactic reaction. Patient had swelling of the upper lip, and had a feeling like its going to burst, a little bit in the throat felt like an elevated restriction, and some itching and swelling in other areas. It has subsided, it took a few days. Even today like right now the patient is feeling some swollen areas and its been a month after the vaccine at the time of report. The outcome of sounded like anaphylactic reaction and swelling in other areas was unknown and rest of the events was recovered on unknown date in 2021.   Additional information on the lot/batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: sounded like an anaphylactic reaction; throat which feels like an elevated restriction; had swelling of the upper lip, like a lot like feeling like its going to burst; swelling of the upper lip, a lot, a little bit in the throat; itching and swelling in other areas; Swelling in other areas; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiration date: Not reported), via an unspecified route of administration on 17May2021 as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 as dose 1, single for COVID-19 immunization and had no reaction. On 17May2021, within an hour after second dose, patient's experience sounded like an anaphylactic reaction. Patient had swelling of the upper lip, and had a feeling like its going to burst, a little bit in the throat felt like an elevated restriction, and some itching and swelling in other areas. It has subsided, it took a few days. Even today like right now the patient is feeling some swollen areas and its been a month after the vaccine at the time of report. The outcome of sounded like anaphylactic reaction and swelling in other areas was unknown and rest of the events was recovered on unknown date in 2021.   Additional information on the lot/batch number has been requested
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Drug ineffective, Pain in extremity, Pneumonia, SARS-CoV-2 test
Clinical narrative: diagnosed with pneumonia; pain in the left arm between the elbow and the shoulder; pain in the left arm between the elbow and the shoulder; positive for COVID-19; Drug ineffective; This is a spontaneous report from a contactable consumer or other non health professional (patient). A 76-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration date was unknown), via an unspecified route of administration, in Left Arm on Jan2021 around 10:30 or 11:00, (at the age of 76-years-old) as a DOSE 2, SINGLE for COVID-19 immunization. The patient previously took first dose of BNT162B2 (Solution for injection) via an unspecified route of administration in left arm on Jan2021 around 10:30 or 11:00 (at the age of 76-years-old) as a DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller is on doxycycline and a couple of other things. The patient has had the flu shot over the years. On an unspecified date, the patient experienced diagnosed with pneumonia; on 18Jun2021 positive for covid-19, drug ineffective; and on an unspecified date pain in the left arm between the elbow and the shoulder. The caller stated there were no Emergency room visits. No Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines. The pain in the caller's left arm between the elbow and the shoulder began about two hours after the caller received both the first and second dose Pfizer Covid 19 shot.  The patient stated that the pain in the left arm between the elbow and shoulder has gone away. On 18Jun2021, the patient underwent lab tests and procedures which included sars-cov-2 test: positive. The caller clarifies he was tested for Covid on 13Jun2021 and received the positive test result today, 18Jun2021. The outcome of event pneumonia was recovering, and outcome for pain in the left arm between the elbow and the shoulder was recovered  and outcome for other events was unknown.  Follow-up attempts are needed. Information on Lot/Batch number can be requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021733999 similar report from same reporter
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: diagnosed with pneumonia; pain in the left arm between the elbow and the shoulder; pain in the left arm between the elbow and the shoulder; positive for COVID-19; Drug ineffective; This is a spontaneous report from a contactable consumer or other non health professional (patient). A 76-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration date was unknown), via an unspecified route of administration, in Left Arm on Jan2021 around 10:30 or 11:00, (at the age of 76-years-old) as a DOSE 2, SINGLE for COVID-19 immunization. The patient previously took first dose of BNT162B2 (Solution for injection) via an unspecified route of administration in left arm on Jan2021 around 10:30 or 11:00 (at the age of 76-years-old) as a DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller is on doxycycline and a couple of other things. The patient has had the flu shot over the years. On an unspecified date, the patient experienced diagnosed with pneumonia; on 18Jun2021 positive for covid-19, drug ineffective; and on an unspecified date pain in the left arm between the elbow and the shoulder. The caller stated there were no Emergency room visits. No Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines. The pain in the caller's left arm between the elbow and the shoulder began about two hours after the caller received both the first and second dose Pfizer Covid 19 shot.  The patient stated that the pain in the left arm between the elbow and shoulder has gone away. On 18Jun2021, the patient underwent lab tests and procedures which included sars-cov-2 test: positive. The caller clarifies he was tested for Covid on 13Jun2021 and received the positive test result today, 18Jun2021. The outcome of event pneumonia was recovering, and outcome for pain in the left arm between the elbow and the shoulder was recovered  and outcome for other events was unknown.  Follow-up attempts are needed. Information on Lot/Batch number can be requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021733999 similar report from same reporter
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: had tested positive for Covid-19; He was due to receive his 2nd Pfizer vaccine on 4/27/21 and he had to cancel due to "He had Covid-19 at the time."; This is a spontaneous report from a non-contactable consumer or other non Healthcare Professional. A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiration date: Not reported), via an unspecified route of administration on 08Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had tested positive for covid-19 on an unspecified date in Apr2021 following his 1st Pfizer vaccine dose and he was due to receive his 2nd pfizer vaccine on 27Apr2021 and he had to cancel due to he had covid-19 at the time on an unspecified date in 2021. Patient was due to receive his 2nd Pfizer vaccine on 27Apr2021 and he had to cancel because He had Covid-19 at the time. On 14May2021 patient had a negative Covid-19 test and went to get a 2nd Pfizer vaccine dose, but he did not receive a vaccination card. When he received his 1st Pfizer vaccine. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on Apr2021 (He had tested positive for Covid-19 following his 1st Pfizer vaccine dose), sars-cov-2 antibody test: negative on 14May2021 (He had a negative Covid-19 test). The outcome for the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Myocarditis, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (reporter's son). A male patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number and expiration date not reported) via an unspecified route of administration on as single dose of for COVID-19 immunization. Patient medical history not reported. Patient concomitant medications include IBUPROFEN (ADVIL 12 HOUR). Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number  expiration date not reported) via an unspecified route of administration on (at age on unspecified date as single for COVID-19 immunization. Reporter reported that her son got the second dose of the COVID vaccine and after the vaccine he had worse side effects on unspecified date. Caller reports he had fever and chills. Caller states she gave him advil and he was able to sleep and 4 hours after the Advil he woke up vomiting. She reports he had a lot of vomit about 20 times, almost 20 times. In the morning he started wheezing, he had a stomach ache and sharp pains in his stomach and was very nauseous. He had a lot of pain in his stomach. Caller states that the pediatrician, was no help to her. She was very worried, today he woke up better, no more vomit, no more stomach ache. She saw on the news, about 1 boy who had the same side effects, inflammation in his heart. Her son is better now but she does not know if he has Myocarditis now because the boy in the news had the same side effects as her son and had vomiting and stomach ache. Caller enquired she just needs to know what she needs to do. Is this a normal side effect. The Outcome of event stomach ache and vomiting recovered in 2021, outcome of other events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting, Wheezing
Clinical narrative: This is a spontaneous report from a contactable consumer (reporter's son). A male patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number and expiration date not reported) via an unspecified route of administration on as single dose of for COVID-19 immunization. Patient medical history not reported. Patient concomitant medications include IBUPROFEN (ADVIL 12 HOUR). Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number  expiration date not reported) via an unspecified route of administration on (at age on unspecified date as single for COVID-19 immunization. Reporter reported that her son got the second dose of the COVID vaccine and after the vaccine he had worse side effects on unspecified date. Caller reports he had fever and chills. Caller states she gave him advil and he was able to sleep and 4 hours after the Advil he woke up vomiting. She reports he had a lot of vomit about 20 times, almost 20 times. In the morning he started wheezing, he had a stomach ache and sharp pains in his stomach and was very nauseous. He had a lot of pain in his stomach. Caller states that the pediatrician, was no help to her. She was very worried, today he woke up better, no more vomit, no more stomach ache. She saw on the news, about 1 boy who had the same side effects, inflammation in his heart. Her son is better now but she does not know if he has Myocarditis now because the boy in the news had the same side effects as her son and had vomiting and stomach ache. Caller enquired she just needs to know what she needs to do. Is this a normal side effect. The Outcome of event stomach ache and vomiting recovered in 2021, outcome of other events was unknown.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Blood test, Cardiospasm, Chest pain, Computerised tomogram thorax
Clinical narrative: This is a spontaneous report from a contactable other hcp.   A 21-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) dose 2 via an unspecified route of administration, administered in Right arm on 12Jan2021 13:30 (at a age of 21-years- old) (Batch/Lot Number: EK3302) as dose 2, single for covid-19 immunisation. Medical history included none. There were no concomitant medications On 22Dec2020 historical Vaccine BNT162B2 dose 1 Lot number: EK5730 right arm. On 16Jan2021 06:30 the patient experienced stabbing chest pains, angina, heart spasms, difficulty breathing (hospitalization). The patient was hospitalized for stabbing chest pains (chest pain) for 1 days. The patient was hospitalized for angina (angina pectoris) for 1 days. The patient was hospitalized for heart spasms (cardiospasm) for 1 days. The patient was hospitalized for difficulty breathing (dyspnoea) for 1 days. The patient underwent lab tests and procedures which included blood test: unknown result computerized tomogram thorax: unknown result, sars-cov-2 test: negative on 19Mar2021, x-ray: unknown result. Therapeutic measures were taken as a result of stabbing chest pains (chest pain), angina (angina pectoris), heart spasms (cardiospasm), difficulty breathing (dyspnoea). On an unspecified date in 2021, the outcome of the events were recovered with sequelae.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information currently available, events with the suspected vaccine BNT162B2 in this patient cannot be completely 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 RAs, Ethics Committees, and Investigators, as appropriate
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, SARS-CoV-2 test, X-ray
Clinical narrative: This is a spontaneous report from a contactable other hcp.   A 21-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) dose 2 via an unspecified route of administration, administered in Right arm on 12Jan2021 13:30 (at a age of 21-years- old) (Batch/Lot Number: EK3302) as dose 2, single for covid-19 immunisation. Medical history included none. There were no concomitant medications On 22Dec2020 historical Vaccine BNT162B2 dose 1 Lot number: EK5730 right arm. On 16Jan2021 06:30 the patient experienced stabbing chest pains, angina, heart spasms, difficulty breathing (hospitalization). The patient was hospitalized for stabbing chest pains (chest pain) for 1 days. The patient was hospitalized for angina (angina pectoris) for 1 days. The patient was hospitalized for heart spasms (cardiospasm) for 1 days. The patient was hospitalized for difficulty breathing (dyspnoea) for 1 days. The patient underwent lab tests and procedures which included blood test: unknown result computerized tomogram thorax: unknown result, sars-cov-2 test: negative on 19Mar2021, x-ray: unknown result. Therapeutic measures were taken as a result of stabbing chest pains (chest pain), angina (angina pectoris), heart spasms (cardiospasm), difficulty breathing (dyspnoea). On an unspecified date in 2021, the outcome of the events were recovered with sequelae.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information currently available, events with the suspected vaccine BNT162B2 in this patient cannot be completely 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 RAs, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Amnesia
Clinical narrative: memory loss for 4 hours; This is a spontaneous report from a contactable consumer (patient's girlfriend). This is report 2 of 3. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: EWO167) intramuscularly on an unspecified date as dose 2 single, for COVID-19 immunization. Patient's medical history and concomitant conditions were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: EWO153) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On an unspecified date, about five days after second dose of vaccination, the patient experienced memory loss for 4 hours and ended up in the ER (emergency room). It was not reported whether patient was admit-ted to the hospital relative to this event (as the reporter was unwilling to complete the report). It took patient about 4 weeks for adverse event to go away; they treated it and they've moved on but maybe they are a little bit more healthy than the next person would be. Reporter stated all was resolved now. Reporter stated the lot numbers for her and her friends were similar and concerned they had gotten bad batches. Reporter wanted to know how many vaccines are in each batch. Re-porter and her girlfriends compared their cards and their vaccines Lot numbers were all within dig-its of each other and felt it was worthwhile to look into it. They were all fine, but it might be an is-sue of bad batches of Lot numbers of the Pfizer Covid Vaccine. Reporter verified she believes 3rd character in Lot was letter O like Oscar, not numeral zero. NDC/Expiry: Not provided, caller unwilling to complete report and for 2nd dose: Lot: EWO167, reporter verified she believes 3rd character in Lot is letter O like Oscar, not numeral zero. NDC/Expiry: Not provided, caller unwilling to complete report. Reportedly, they all recovered; but if there was a bad batch Pfizer needs to know this. This patient and her girlfriends were in different locations for their Pfizer Covid Vaccine doses; they just all happened to sit down together and compare their cards. Reported stated if all of the sudden it was asked why are these people who weren't in the same locations experiencing these ad-verse events, it might be worthwhile to consider if those Lot numbers were bad batches. Patient received treatment for the event (unspecified). Outcome of the event was resolved.  Information on Lot/Batch number was available. Additional information has been requested
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Got Shingles within few days of second shot.; rash; This is a Spontaneous report from a contactable consumer. A 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0172), via an unspecified route of administration on arm right on 26Apr2021(Age at Vaccination: 50 years) at single dose for COVID-19 immunization. The patient medical history was not reported and had no known allergies. The patient has not received other vaccine in four weeks. if covid prior vaccination was reported was unknown. The patient Concomitant medications included Fluconazole. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0151), via an unspecified route of administration on Left arm on 05Apr2021 at single dose for COVID-19 immunization. On 29Apr2021, the patient experienced Shingles within few days of second shot. Went to emergency Care on 11May once rash appeared and was confirmed to be shingles. If covid tested post vaccination was reported as no. The adverse event resulted in Emergency room/department or urgent care. Therapeutic measures were taken and treatment included Valacyclovir HCL 1gm, prednisone 20 mg. The outcome of the events was Resolving.  Other relevant history notes:  1st Dose brand=Pfizer, lot number=EW0151 lot unknown=False administration date=05Apr2021 dose number=1
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Oropharyngeal pain, Rash, Tongue blistering, Tongue discomfort
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp.  A 75-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: ER8733), dose 1 via an unspecified route of administration, administered in Arm Right on 11Jun2021 as dose 1, single for covid-19 immunisation. Medical history included cardiac disorder ongoing Heart problems; multiple allergies Allergic to everything. The patient's concomitant medications were not reported. consumer stated received her first dose of the Pfizer-BioNTech covid19 vaccine last Friday. She has since been experiencing a rash which she has been treating with Benadryl (Lot 1795513, Expiry Jul2022, UPC 125471702) every 4 hours. She went back to her doctor who stated they would normally give a steroid shot in this situation but didn't want to affect the efficacy of the dose she received. Caller is a consumer who took her first dose of the Pfizer COVID shot last Friday, and she had a terrible rash reaction to it all over her body. Caller states that she has been taking Benadryl all week and she is still broken out. Patient saw her doctor this morning and her doctor said that she normally would give the caller a steroid shot, but the doctor decided not to give the steroid to the caller because the doctor was afraid the steroid would deplete the care that the one COVID shot had given to the caller. Patient is wondering about if a steroid injection could affect the effectiveness of the COVID vaccine. Patient reports that the same day as her shot, her tongue had a strange feeling and her throat is sore and she has blisters on her tongue, and these are ongoing. Patient woke up the next morning with the rash, which is also still ongoing, but improved. Patient states that she was holding off on getting the vaccine because she is allergic to everything, so she was afraid, but she ended up taking it and now she wishes she hadn't. Therapeutic measures were taken as a result of rash/ terrible rash reaction to it all over her body (rash). The outcome of the events was recovered and Indicated she would not be receiving her second dose was unknown.  Follow-up (PRD 18Jun2021): This is a follow up spontaneous report from a contactable consumer. This consumer 75-year-old female consumer(patient) reported information included.  Description of complaint: PC for non-suspect product. While completing a safety report for the suspect product, caller mentioned she has been taking Benadryl all week for a rash, and she is still broken out.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: had a stroke; This is a spontaneous report received from a Pfizer sponsored program reported by a non-contactable female consumer (patient). A female patient of an unspecified age received 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 dose 2, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient 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 dose 1, single for COVID-19 immunisation. The patient had a stroke on an unspecified date. The reporter stated that today was her second dose but she just recently had a stroke, and she had been home for one day. The outcome of the event was reported as unknown.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Asthenia, Cardiac disorder, Dyspnoea, Heart rate increased
Clinical narrative: My heart is dropping down; I feel a lot pain in my heart and my heart is rapid; Fell sick; I about to weak; I cant breathe; my heart is dropping down; I feel a lot pain in my heart and my heart is rapid; Dates for I feel bad in my heart; hospital says I cannot receive the Covid vaccination; This is a spontaneous report from a contactable consumer reporting for herself. A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EVV0177, Expiration date: Unknown) via an unspecified route, administered in Right Arm on 20May2021 (35-year-old at vaccination) as a dose 1, single for COVID-19 immunization. The patient's medical history was not reported. The patient was not on any concomitant medications. The patient had not received any other vaccine 4 weeks prior to Covid vaccine. The reported stated that, she had got the first dosage of vaccine of Covid 19 about 1 week (20May2021) after the one week (May2021), she felt sick for about 2 weeks, she cannot breathe and then her heart was dropping down, pain in the heart and her heart was rapid. She did not know what she can do because she was too weak, she was in emergency and she don't know if that takes her the face of Covid. She doesn't know but she thinks it was from the vaccination. She doesn't know what we can do. She doesn't have been in the emergency she had to go to her doctor, she does not have accurate, insurance for her medication. She stated that, she doesn't receive the second shot the first week and she had to do bad because she was sick, she felt bad in her heart and the hospital members said her don't put dose. She only took Tylenol for 3 days because she felt bad. She took Covid-test in hospital on unknown date in 2021 and it was negative, and the hospital said cannot receive the Covid-vaccination (no further clarification was provided). The outcome of the events was unknown.  Information on Batch/lot no. was available. Further information has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test
Clinical narrative: My heart is dropping down; I feel a lot pain in my heart and my heart is rapid; Fell sick; I about to weak; I cant breathe; my heart is dropping down; I feel a lot pain in my heart and my heart is rapid; Dates for I feel bad in my heart; hospital says I cannot receive the Covid vaccination; This is a spontaneous report from a contactable consumer reporting for herself. A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EVV0177, Expiration date: Unknown) via an unspecified route, administered in Right Arm on 20May2021 (35-year-old at vaccination) as a dose 1, single for COVID-19 immunization. The patient's medical history was not reported. The patient was not on any concomitant medications. The patient had not received any other vaccine 4 weeks prior to Covid vaccine. The reported stated that, she had got the first dosage of vaccine of Covid 19 about 1 week (20May2021) after the one week (May2021), she felt sick for about 2 weeks, she cannot breathe and then her heart was dropping down, pain in the heart and her heart was rapid. She did not know what she can do because she was too weak, she was in emergency and she don't know if that takes her the face of Covid. She doesn't know but she thinks it was from the vaccination. She doesn't know what we can do. She doesn't have been in the emergency she had to go to her doctor, she does not have accurate, insurance for her medication. She stated that, she doesn't receive the second shot the first week and she had to do bad because she was sick, she felt bad in her heart and the hospital members said her don't put dose. She only took Tylenol for 3 days because she felt bad. She took Covid-test in hospital on unknown date in 2021 and it was negative, and the hospital said cannot receive the Covid-vaccination (no further clarification was provided). The outcome of the events was unknown.  Information on Batch/lot no. was available. Further information has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Immunodeficiency, Mobility decreased, Upper respiratory tract infection
Clinical narrative: Upper respiratory infection; Immunodeficiency; Mobility decreased; Acute bronchitis; This is a solicited report based on the information received by Pfizer from a Pfizer sponsored program (Mfr. Control No.: 21K-163-3941315-00) received from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), intramuscular on 06Jan2021 (Batch/Lot number was not reported) at the age of 60 years old, as DOSE 2, SINGLE for COVID-19 immunisation; and risankizumab (SKYRIZI), subcutaneous from Dec2019 (Batch/Lot number was not reported) and ongoing, at 150 mg (1 in 12 wk) for psoriasis. The patient's medical history and concomitant medications were not reported. The patient experienced acute bronchitis on 2021, upper respiratory infection on Apr2021, immunodeficiency on 2021, mobility decreased on 2021. The patient was hospitalized due to the events. Clinical course of events was reported as follows: In 2021, the patient experienced acute bronchitis, lowered ability to fight infections and cannot get out of bed. In Apr2021, the patient experienced upper respiratory infection. Additional information: In 2021, after the receipt of second Pfizer injection on 06Jan2021, the patient had first noticed that she was down for four days, felt like flu and could not get out of bed. She was hospitalized for acute bronchitis. In mid Apr2021, she had an upper respiratory infection and was hospitalized. She still had shortness of breath but was improving. She had felt Skyrizi had lowered her ability to fight infections. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer (intramuscular). On 06Jan2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. The action taken in response to the events for risankizumab was dose not changed. Outcome of the events was recovering.   Causality for risankizumab: The reporter's causality for the events of acute bronchitis, upper respiratory infection, immunodeficiency and mobility decreased with risankizumab (SKYRIZI) was a reasonable possibility.   The reporter's assessment of the causal relationship of the events (acute bronchitis, upper respiratory infection, immunodeficiency and mobility decreased) 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.   No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: Pfizer comment: Based on the available information, there was not a reasonable possibility that the events acute bronchitis, upper respiratory infection, immunodeficiency, mobility decreased were related to suspect vaccine bnt162b2 due to the lack of a plausible mechanism implicating the vaccine to the events. The events were most likely related to suspect drug risankizumab based on the known safety profile of the product.