chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Lip swelling
Clinical narrative: lips swelled up; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 25Jan2021 (Lot Number: EL9262, Expiration date unknown) as dose 1, single for COVID-19 immunization (reported as 'Scared of getting COVID 19'). Medical history included knee pain and was prescribed an anti-inflammatory and pre-existing allergy to anti-inflammatories both on unknown dates. The patient also had a family history of heart disease. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) taken for the prevention of heart attack, start and stop date were not reported.  The patient previously took Mobic on an unknown date (reported as about 12 years) and experienced an allergic reaction, Ecotrin (low strength) on 2011 (started 10 years ago) but was stopped due to an allergic reaction, Aleve and Advil for which the patient had allergies to both medications on unknown dates. The patient also previously received a flu vaccine in 2017 for immunization and experienced his arm hurt. The patient reported that after the first shot, maybe a couple of days of the week later, on an unknow date in 2021, his lips swelled up and he was beginning to have an allergic reaction like with his anti-inflammatories. The patient didn't give it a second thought. He thought it could be a shampoo or something. All he did was take a Benadryl and it was gone. Everything's gone. It all went away, it went away the next day. He spoke with an allergist. The events recovered on an unknown date in 2021.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I have the shot yesterday morning at 10:30, I have had since headache; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported) dose number unknown via an unspecified route of administration on 01Aug2021 10:30 as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. On 01Aug2021 the patient had the shot yesterday morning at 10:30, since then had headache. Patient had a question, if patient could take the shot yesterday morning at 10:30 have had since headache. Patient just want to know if patient can take a 200 mg Ibuprofen or can take an Aspirin, or if patient can take a Naproxen just to get the headache better. When probed for the manufacturer, patient stated, it was a Pfizer Covid-19 Vaccine. Patient was informed about the role of Medical Information and provided with the number as # and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday. The clinical outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: COVID positive; COVID positive; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient's Wife) reported for a 48-year-old male patient (reporter's husband). A 48-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735) via an unspecified route of administration, administered in Arm Left on 17May2021 (48-years-old at the time of vaccination), as dose 1, single, dose 2 via an unspecified route of administration, administered in arm left on 07jun2021 (batch/lot number: er8729) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Consumer stated there are six people in her house, and they all got COVID. Her and her husband both got COVID and were both vaccinated, on 29Jul2021 her husband (patient) experienced covid positive. He did not have a prescribing doctor. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 29Jul2021.  Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Oropharyngeal pain, SARS-CoV-2 test, Sinusitis
Clinical narrative: I had Covid 19 until they pcr the entire crew.; After about 35 days upon arrival I contracted Covid 19.; mild soar throat; mild case of sinus infection; This is a spontaneous report from a contactable consumer (patient). A patient of un-specified age and gender received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number: unknown, expiration date: unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. Patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that I have had both does of Covid 19 vaccination. I do have other health issues. Anyway I returned to work. After about 35 days upon arrival I contracted Covid 19. I just want you to know I never knew I had Covid 19 until they PCR the entire crew. We actually had a total of 40 cases. I was still jogging 2 miles a day with Covid 19. The only symptoms I had was a mild soar throat and mild case of sinus infection due to the great vaccination you created in your lab. Lab test included had Covid 19 until they PCR the entire crew: result had Covid 19 (I never knew I had Covid 19 until they PCR the entire crew) on unspecified date. The outcome of the events was as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away 19Jun2021; This is a spontaneous report from a contactable consumer (patient's mother). A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23May2021 (Lot Number: EW0172) (at age of 25-year-old) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included diagnosed with an enlarged vessel sized heart.  The patient's concomitant medications were not reported. The patient experienced passed away on 19Jun2021.An autopsy was performed and results were not provided. Two days after the first vaccine was when the information came out about males 20-30 getting inflammation of the heart. The patient's mother told him not to take the second shot. Then, this happened. She doesn't have the results of the autopsy yet. She believed the Pfizer vaccine escalated his death. He did get diagnosed with an enlarged vessel sized heart. He got it because he thought he was doing the right thing.  There was no history of all previous immunization with the Pfizer vaccine considered as suspect.  No additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks).  Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: passed away 19Jun2021
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: Pins and needles type of sensation in left arm only. However, this tingling was spreading to the left side of face.; Minimal weakness in left arm extremity,; This is a spontaneous report from a contactable healthcare professional, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 09Jun2021 at 09:00 (at the age of 48-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient was not allergic to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Jul2021, the patient experienced pins and needles type of sensation in the left arm only. There was minimal weakness in that extremity, however, the tingling had spread to the left side of the patient's face. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events pins and needles type of sensation in the left arm, minimal weakness in that extremity and the tingling had spread to the left side of the patient's face was not resolved at the time of this report.
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Hypokinesia, Myalgia, Pain, Pyrexia
Clinical narrative: Pain/I feel severe pain; I can not even walk; Fever; Muscle pain; I can not even bend my neck towards my face; This is a spontaneous report from a contactable consumer (patient). This is the second of 2 reports. Only this case is serious. A 41-year-old patient of an unspecified gender received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: FA6780), dose 2 via an unspecified route of administration, in the left arm on 30Jul2021 (at the age of 41 years) as a single dose for COVID-19 immunisation. The patient had no medical history and took no concomitant medications. The patient previously received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EW0180), dose 1 via an unspecified route of administration, in the left arm on 09Jul2021 (at the age of 41 years) as a single dose for COVID-19 immunization and experienced muscle pain. The patient had no prior vaccination before four weeks. The patient got the vaccine, the full dose and since one week almost a week they were feeling fever, pain and muscle pain. The patient was trying to take Tylenol as soon as the time closing about 6 hours, the patient felt severe pain, could not even walk, could not even bend their neck towards their face. The muscle pain started before the patient took the second dose. The outcome of fever, pain, muscle pain, could not even walk, could not even bend their neck towards their face was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Illness, Incoherent, Pyrexia
Clinical narrative: Was also incoherent /remember who she was or what her children's names were or grandchildren's names; Very sick; Super high fever; Had Sweats; This is a spontaneous report from a contactable consumer. A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0176), dose 1 via an unspecified route of administration, administered in Arm on 20May2021 10:00 (at the age of 68-year-old) as DOSE 1, SINGLE for covid-19 immunization. Medical History: The patient had underlying conditions. The patient had two mechanical heart valves from 5 years ago. The patient had 2 knee replacements. The second knee replacement was in Feb2021. The patient recovered from the second knee replacement and was outpatient PT. Two weeks before the first dose Pfizer Covid 19 Vaccine, the patient said for the first time in years she did not have any kind of knee pain of any kind, other than regeneration of nerves, no bone pain from the replacements. The patient was doing so well. There were no concomitant medications. No vaccines administered on same date with the Pfizer vaccine considered as suspect. No any other vaccinations taken within four weeks prior to the first administration date of the suspect vaccine(s). The patient got vaccinated as a child, the age bracket. The patient had flu shots and shingles shots, all of them were given with no adverse reactions other than the patient's arm hurt. The reporter states his wife was fixated on having to have the vaccination card. The patient received the first dose Pfizer Covid 19 Vaccine on 20May2021 and became very sick, very ill. On 20May2021, the patient experienced Very sick, super high fever, sweats which began the same night, and this lasted for about 2 days. The patient was also incoherent. The caller stated his wife was also incoherent after receiving the first dose Pfizer Covid 19 Vaccine. The patient couldn't remember who she was or what her children's names were or grandchildren's names. The patient kind of recovered for 4 days. AE(s) did not require a visit to: Emergency Room/Physician Office. Relevant Tests were none. The outcome of events very sick, Super high fever and Had Sweats was recovered on 24-MAY-2021. The outcome of event was also incoherent /remember who she was or what her children's names were or grandchildren's names was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation, Palpitations
Clinical narrative: A-fib; heart pounding; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced A-fib and heart pounding. The events were considered non-serious by the reporting consumer. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Computerised tomogram, Foot fracture, Inappropriate schedule of product administration, Pain
Clinical narrative: she had a broken foot; My body hurts; My arm hurt terribly; from the elbow it hurts; hard mass that hurts/Underneath the arm there is a hard mass and it is not as big as the hard one and it hurts; hard mass that hurts/Underneath the arm there is a hard mass and it is not as big as the hard one and it hurts; Second dose on 01Aug2021; This is a spontaneous report from a contactable consumer (patient). This 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number FC3180) via an unspecified route of administration in the left arm on 01Aug2021 at 11:00, reported as 11:00 or 12:00, (at 37-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome from an unknown date and ongoing and broke her foot from an unknown date and unknown if ongoing, reported as having a "little fracture and went to a fracture" for which she was given 3 paracetamol (TYLENOL) and ibuprofen but didn't taken them. The patient did not receive any vaccines prior to the COVID vaccine. Concomitant medications included multivitamins from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number FA6780) in the left arm on 19Jul2021 at 11:00, reported as 11:00 or 12:00, for COVID-19 immunisation. The patient stated she was calling because she received her second vaccination yesterday (as of 02Aug2021). She stated that on that day, nothing was wrong, and she woke up this morning (as of 02Aug2021) and her arm hurt terribly, on the beneath there was a hard mass that hurt when she pressed it and it was hurting all the time and her body hurt. She reported it was not like she had the flu or was sick, her body just hurt; further reporting she was driving, and a few rain drops fell on her and it hurt, everything hurt. She stated from the elbow it hurt, underneath the arm there was a hard mass and it is not as big as the hard one and it hurt. She stated just moving her arm trying to do something, that all hurt "super bad" like "anytime anybody rushes up against me somebody rush me, rain drop fell on me, I hurt, it hurts, I hurt, it cannot be normal." The patient reported having no lab tests; she had an x-ray and computerised tomogram (CT) scan on the "17th" which indicated she had a broken foot and a little fracture that went to a facture. She stated she didn't treat the events because she read that she shouldn't take ibuprofen to address her issue and that it might effect the efficacy of the vaccine. She inquired what she should do. The clinical outcomes of her body hurt; her arm hurt terribly/from the elbow it hurt; and hard mass that hurts/underneath the arm there is a hard mass and it is not as big as the hard one and it hurts were not recovered. The outcome of the other event was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tumour pain, X-ray
Clinical narrative: she had a broken foot; My body hurts; My arm hurt terribly; from the elbow it hurts; hard mass that hurts/Underneath the arm there is a hard mass and it is not as big as the hard one and it hurts; hard mass that hurts/Underneath the arm there is a hard mass and it is not as big as the hard one and it hurts; Second dose on 01Aug2021; This is a spontaneous report from a contactable consumer (patient). This 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number FC3180) via an unspecified route of administration in the left arm on 01Aug2021 at 11:00, reported as 11:00 or 12:00, (at 37-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome from an unknown date and ongoing and broke her foot from an unknown date and unknown if ongoing, reported as having a "little fracture and went to a fracture" for which she was given 3 paracetamol (TYLENOL) and ibuprofen but didn't taken them. The patient did not receive any vaccines prior to the COVID vaccine. Concomitant medications included multivitamins from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number FA6780) in the left arm on 19Jul2021 at 11:00, reported as 11:00 or 12:00, for COVID-19 immunisation. The patient stated she was calling because she received her second vaccination yesterday (as of 02Aug2021). She stated that on that day, nothing was wrong, and she woke up this morning (as of 02Aug2021) and her arm hurt terribly, on the beneath there was a hard mass that hurt when she pressed it and it was hurting all the time and her body hurt. She reported it was not like she had the flu or was sick, her body just hurt; further reporting she was driving, and a few rain drops fell on her and it hurt, everything hurt. She stated from the elbow it hurt, underneath the arm there was a hard mass and it is not as big as the hard one and it hurt. She stated just moving her arm trying to do something, that all hurt "super bad" like "anytime anybody rushes up against me somebody rush me, rain drop fell on me, I hurt, it hurts, I hurt, it cannot be normal." The patient reported having no lab tests; she had an x-ray and computerised tomogram (CT) scan on the "17th" which indicated she had a broken foot and a little fracture that went to a facture. She stated she didn't treat the events because she read that she shouldn't take ibuprofen to address her issue and that it might effect the efficacy of the vaccine. She inquired what she should do. The clinical outcomes of her body hurt; her arm hurt terribly/from the elbow it hurt; and hard mass that hurts/underneath the arm there is a hard mass and it is not as big as the hard one and it hurts were not recovered. The outcome of the other event was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Maternal exposure during pregnancy, Muscle spasms, SARS-CoV-2 antibody test, Thrombosis
Clinical narrative: bleeding/I bled without end/more serious bleeding events; passing blood clots as big as tennis balls; had cramps that lasted 72 hours; Maternal Exposure During Pregnancy; This is a spontaneous report from a contactable consumer. This consumer reported information for both mother and fetus/baby. This is a mother report. A 36-years-old pregnant female patient received second dose of bnt162b2 (BNT162B2; Batch/Lot Number: ER8735), via an unspecified route of administration, administered in Arm Right on 03May2021(at the age of 36-years) as single dose for COVID-19 immunisation. Medical history included anxiety, irritable bowel syndrome. Concomitant medications included minerals nos, vitamins nos (PRENATAL VITAMINS) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported. The patient received first dose of BNT162B2(lot Number: EW0153), via unspecified route in right arm, administered on 12Apr2021 at 05:00PM as single dose for COVID-19 immunization. The patient experienced had cramps that lasted 72 hours, bleeding/i bled without end/more serious bleeding, passing blood clots as big as tennis, maternal exposure during pregnancy. Clinical course was reported as I had a subcorionic hemorrhage during my pregnancy. 25 hours after first vaccine I had severe cramping pain that felt like labor and went to the ER for a major bleeding event. The evening of my second vaccine I had cramps that lasted 72 hours and the next two days I had to wear pads because of bleeding. The following weekend I bled without end, checked in to the hospital Sunday night. I continued to have more and more serious bleeding events passing blood clots as big as tennis balls until Monday I has emergency c-section to deliver at 24 weeks. 4 weeks later our preemie baby died in the NICU. The patient was hospitalized for muscle spasms, hemorrhage, thrombosis for 12 days. The mother reported she became pregnant while taking bnt162b2. Last Menstrual date of the patient was 23Nov2020. The mother was due to deliver on 05Sep2021. The patient did not have covid prior vaccination. The patient tested for covid post vaccination. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 17May2021 Nasal Swab. Therapeutic measures were taken as a result of adverse events as bed rest, Magnesium. The outcome of the event maternal exposure during pregnancy was unknown and rest all events were not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100987373 Same reporter/ drug for different patients (baby)
Sex: U
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Premature baby
Clinical narrative: Preemie baby died in the NICU; Maternal Exposure During Pregnancy; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported information for both mother and fetus/baby. This is a baby report. A 36-year-old female pregnant patient received BNT162B2, first dose via an unspecified route of administration, administered in right arm on 12Apr2021 05:00 PM (Batch/Lot Number: EW0153) as dose 1, single; second dose via an unspecified route of administration, administered in left arm on 03May2021 (Batch/Lot Number: ER8735) as dose 2, single for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. Until Monday the 17, She has emergency cesarean to deliver at 24 weeks, 4 weeks later the preemie baby died in the NICU. The preemie baby died in the NICU in 2021. The event was serious per death, life threatening, hospitalization. The patient died in 2021. It was not reported if an autopsy was performed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100986436 mother case;US-PFIZER INC-202100987372 mother case; Reported Cause(s) of Death: Maternal exposure during pregnancy; 4 weeks later our preemie baby died in the NICU
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Full blood count, Pneumonia, Pyrexia, Rash pruritic
Clinical narrative: Hospitalized for pneumonia.; Rash/severe rash that itches; She was running a fever; This is a spontaneous report from a contactable other health care professional. An 80-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Mar2021 11:00 (at the age of 79-years-old) (Batch/Lot Number: EP7534) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included raynaud's phenomenon Takes Procardia for this. Left arm goes ice cold, right is warm. If takes Procardia this not happen, blood pressure high, Heart disorder, Gastric reflux, Congestive heart failure, Extra fluid, Leg jumps, Restless leg syndrome. The patient received first dose of BNT162B2 for COVID-19 immunization on 04Mar2021 at the age of 79-years (Dose :1st, Lot/Expiry Date: EN6199/ UNKNOWN at 10:45 am Administered in her left arm). Concomitant medications included losartan potassium (COZAAR) taken for Blood pressure high; metoprolol tartrate (LOPRESSOR) taken for Blood pressure high; nifedipine (PROCARDIA [NIFEDIPINE]) taken for Heart and raynaud's phenomenon; apixaban (ELIQUIS) taken for blood thinner; omeprazole (PRILOSEC [OMEPRAZOLE]) taken for Gastric reflux; bumetanide (BUMEX) taken for congestive heart failure and To get rid of extra fluid; potassium (POTASSIUM); magnesium (MAGNESIUM) taken for leg jumps, restless leg syndrome. Caller reporting on the covid vaccine. She had a severe rash. It was in the groin, in rectum, inside of her legs, shoulders, upper arms, and stomach. It started Apr2021. She flew to to see her sister and she knew when she went there she had already had the rash for a month before that. She had kept trying different ointments on it. Commented it gets irritable and irritating when the rash gets to itching. It is very disturbing. The doctors have tried everything. She has had 4 doses of Solu-Medrol, Prednisone, Benadryl, and it does not seem to be letting up. She confirmed she has no details to provide lot/exp/NDC. Once the packet is empty she throws it away. She also went to the Emergency Room due to this and was given Benadryl, Pepcid, and Cortisone. She has been given Cortisone pack four times now. The patient was hospitalized on 01Jul2021 to 04Jul2021, but was hospitalized for pneumonia. She was running a fever. She had covid test and they were all negative. She also mentioned she has had other hospitalizations, but no details provided. The patient underwent lab tests and procedures which included body temperature: unknown on an unspecified date, full blood count: unknown results on 01Jul2021 She had a CBC to determine if there was an infection , sars-cov-2 test: negative on an unspecified date, sars-cov-2 test: negative on an unspecified date, sars-cov-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of the events rash pruritic. The outcome of the event Rash/severe rash that itches was not recovered, while unknown for the other events.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Hospitalized for pneumonia.; Rash/severe rash that itches; She was running a fever; This is a spontaneous report from a contactable other health care professional. An 80-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 25Mar2021 11:00 (at the age of 79-years-old) (Batch/Lot Number: EP7534) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included raynaud's phenomenon Takes Procardia for this. Left arm goes ice cold, right is warm. If takes Procardia this not happen, blood pressure high, Heart disorder, Gastric reflux, Congestive heart failure, Extra fluid, Leg jumps, Restless leg syndrome. The patient received first dose of BNT162B2 for COVID-19 immunization on 04Mar2021 at the age of 79-years (Dose :1st, Lot/Expiry Date: EN6199/ UNKNOWN at 10:45 am Administered in her left arm). Concomitant medications included losartan potassium (COZAAR) taken for Blood pressure high; metoprolol tartrate (LOPRESSOR) taken for Blood pressure high; nifedipine (PROCARDIA [NIFEDIPINE]) taken for Heart and raynaud's phenomenon; apixaban (ELIQUIS) taken for blood thinner; omeprazole (PRILOSEC [OMEPRAZOLE]) taken for Gastric reflux; bumetanide (BUMEX) taken for congestive heart failure and To get rid of extra fluid; potassium (POTASSIUM); magnesium (MAGNESIUM) taken for leg jumps, restless leg syndrome. Caller reporting on the covid vaccine. She had a severe rash. It was in the groin, in rectum, inside of her legs, shoulders, upper arms, and stomach. It started Apr2021. She flew to to see her sister and she knew when she went there she had already had the rash for a month before that. She had kept trying different ointments on it. Commented it gets irritable and irritating when the rash gets to itching. It is very disturbing. The doctors have tried everything. She has had 4 doses of Solu-Medrol, Prednisone, Benadryl, and it does not seem to be letting up. She confirmed she has no details to provide lot/exp/NDC. Once the packet is empty she throws it away. She also went to the Emergency Room due to this and was given Benadryl, Pepcid, and Cortisone. She has been given Cortisone pack four times now. The patient was hospitalized on 01Jul2021 to 04Jul2021, but was hospitalized for pneumonia. She was running a fever. She had covid test and they were all negative. She also mentioned she has had other hospitalizations, but no details provided. The patient underwent lab tests and procedures which included body temperature: unknown on an unspecified date, full blood count: unknown results on 01Jul2021 She had a CBC to determine if there was an infection , sars-cov-2 test: negative on an unspecified date, sars-cov-2 test: negative on an unspecified date, sars-cov-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of the events rash pruritic. The outcome of the event Rash/severe rash that itches was not recovered, while unknown for the other events.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Another person who had a heart attack post vaccination; This is a spontaneous report from a contactable consumer or other non hcp.  This consumer reported for a patient (reporter's neighbour). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: 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. The patient's medical history and concomitant medications were not reported. on an unspecified date, the patient experienced "another person who had a heart attack post vaccination" on an unspecified date. The reporter if led was an ingredient used in the Pfizer COVID-19 vaccine. She received some information through an e-mail. It said to stay away from vaccinated people because the virus starts shedding. She reported that the patient had a heart attack post vaccination. This was serious it needed to address by  doctors. The reporter mentioned that as per the e-mail 45000 people died from the vaccines. Some of the doctors are saying breastfeeding mothers are poisoning their child.  This information was available on the website and written by the best doctors. The email they received contains Pfizer's number. The reporter asked if Pfizer-BioNTech COVID-19 vaccine shed the virus. She asked if breastfeeding mothers stay near vaccinated people and if that can harm the child. Reporter told children particles are used in the vaccine. Reporter also asked if any deaths reported with the Pfizer COVID-19 vaccine and if the vaccine was safe.  Outcome of the event was unknown.   The lot number was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: I know four people who had a stroke; This is spontaneous report from a contactable consumer. A contactable consumer reported similar events for 4 patients. This is 1st of 4 reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer reported that "I know four people who had a stroke" on an unspecified date. The outcome of the event was unknown.  The lot number for the vaccine was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: I know four people who had a stroke; This is a spontaneous report from a contactable consumer. Case is for number three of four patient who had a stroke. A patient of an unspecified age and gender received unspecified dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), unspecified dose via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The caller reported that, caller know four people who had a stroke post vaccination. The outcome of the event was unknown.   The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: I know four people who had a stroke; This is a spontaneous report from a contactable consumer or other non hcp. This is for 4 of 4 reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, i know four people who had a stroke on an unspecified date. The outcome for the event was unknown.  The lot number for the vaccine, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Chills; Annoying headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. Historical vaccine of BNT162B2 for COVID-19 immunization and had sore arm after the first dose, felt very tired after it. She provided information on adverse events for second dose of her own. The patient stated after second dose she had chills on first day, annoying headache for 1 week. Now she was fully recovered but she wouldn't go for a third dose if that's required. She did better when she had COVID than with the vaccine. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Limb discomfort, Nausea, Pallor, Paraesthesia
Clinical narrative: Intense vertigo; Spots in vision; Tingling in arms and hands; Pale skin; Burning sensation throughout body and in lungs; Heavy extremities; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 02Aug2021 at 18:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included exercise induced asthma, a known allergy to gluten and several antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 12Jul2021 at 18:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 02Aug2021 at 18:30, within minutes, the patient experienced intense vertigo, spots in vision, tingling in arms and hands, pale skin, burning sensation throughout body and in lungs, heavy extremities and nausea. The patient reported that it took her nearly 40 minutes to feel well enough to walk. She further stated that she was still waiting to see any symptoms over the next day. The events did not result in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event's intense vertigo, spots in vision, tingling in arms and hands, pale skin, burning sensation throughout body and in lungs, heavy extremities and nausea were resolving at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vitreous floaters
Clinical narrative: Intense vertigo; Spots in vision; Tingling in arms and hands; Pale skin; Burning sensation throughout body and in lungs; Heavy extremities; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 02Aug2021 at 18:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included exercise induced asthma, a known allergy to gluten and several antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 12Jul2021 at 18:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 02Aug2021 at 18:30, within minutes, the patient experienced intense vertigo, spots in vision, tingling in arms and hands, pale skin, burning sensation throughout body and in lungs, heavy extremities and nausea. The patient reported that it took her nearly 40 minutes to feel well enough to walk. She further stated that she was still waiting to see any symptoms over the next day. The events did not result in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event's intense vertigo, spots in vision, tingling in arms and hands, pale skin, burning sensation throughout body and in lungs, heavy extremities and nausea were resolving at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: hypertension; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 71-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date (age at the time of vaccination 71-years-old), as a single dose for COVID-19 immunization. The patient's medical history included Smoker. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced hypertension. Reporter stated, my wife and I have each had a Pfizer double jab and would like to know if we can volunteer for a booster clinical trial. The patient on hypertension medication received treatment for adverse event. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Hypertension
Clinical narrative: on hypertension medication; allergy induced asthma; This is a spontaneous report from a contactable consumer or other non hcp. A 71-years-old female patient (reporter's wife) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation (My wife and I have each had a Pfizer double jab and would like to know if we can volunteer for a booster clinical trial). The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced on hypertension medication and allergy induced asthma on an unspecified date. Therapeutic measures were taken as a result of on hypertension medication. The reporter stated, we unfortunately live in a low vaccination area and want to volunteer for a booster clinical trial. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia
Clinical narrative: memory loss but its also time loss; This is a spontaneous report from a contactable consumer (patient). A 20-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6207; NDC and expiration date: unknown) via an unspecified route of administration on 13Mar2021 (at the age of 20-years-old) as dose 1, single and second dose of BNT162b2 (Lot Number: EW0150, NDC and expiration date: unknown) via an unspecified route of administration in left arm on 17Apr2021 as dose 2, single for COVID-19 immunisation. Vaccine was not administered at military facility. The patient medical history includes Crohn's disease from 2013 and unknown whether it's ongoing and chronic fatigue and never officially diagnosed. Family medical history includes mother has colitis and grandmother struggled with strokes. The patient was on immunosuppressant. Concomitant medications include adalimumab (HUMIRA) taken at 40 mg and sertraline taken at 50 mg. The caller was told to skip the Humira the week before the vaccine. On an unspecified date the patient experienced memory loss but it's also time loss. Additional context reported as, the patient was calling about the covid vaccine. The patient believes he had a possible adverse event to the vaccine. The patient has Crohn's and was using Humira. The patient thinks that and it's possible that the Humira and the vaccine caused memory loss. The patient had the shot back in March and he didn't become aware of this event until recently. The patient has memory loss but it's also time loss. The patient can't remember anything from the end of 2020 to May2021. Adverse event require a visit to physician office and not to emergency room. No investigation assessment reported. This event was still relevant. Outcome of the event was not recovered.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Ventricular extrasystoles
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 03Apr2021 at 15:00(at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included premature ventricular contractions (PVCs), 100% controlled by medicine, for about five years and allergy to PCN. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN) from an unknown date for PVC. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 13Mar2021 at 13:30(at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021, one day after the second dose, the PVCs went crazy, hundreds per day, PVCs tapered off over about 3 weeks. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with doubled the medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event PVCs went crazy and condition aggravated was recovered on an unknown date in 2021.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate decreased
Clinical narrative: Decreased heart rate 40-50 five days after getting vaccine; This is a spontaneous report from a contactable nurse. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 17Jul2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included system lupus erythematous , non-celiac gluten sensitivity and GERD (gastroesophageal reflux disease). The patient previously took salbutamol (ALBUTEROL) and hydroxychloroquine sulfate (PLAQUENIL) and experienced drug allergy for both on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included colecalciferol (VITAMIN D3) from unknown date and for unknown indication. On 22Jul2021 the patient experienced decreased heart rate 40-50 five days after getting vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of the event. The clinical outcome of the event decreased heart rate 40-50 five days after getting vaccine was resolving at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.