chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Ultrasound scan
Clinical narrative: high blood pressure/Blood pressure up/blood pressure reading this morning was 152/83; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 13Feb2021 11:00 (Lot Number: EM9809, at the age of 86-year-old) as single dose for covid-19 immunization. Medical history included ongoing difficulty sleeping (onset date: 10 to 20 years), ongoing osteo arthritis (onset date: probably 20 years or more), ongoing osteoporosis (onset date: probably at least 20 years), hip replacement from 1998 (onset date: 64 years old), hip revision (onset date: 83 or 84 years old). Concomitant medication included ongoing trazodone for sleep. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), unspecified route of administration, administered in left arm on 23Jan2021 11:00 (Lot Number: EL9261, at the age of 86-year-old) as single dose for covid-19 immunization and experienced blood clot after first shot and high blood pressure/blood pressure up. Patient developed a blood clot in her leg after receiving the first dose of vaccine on 23Jan2021. She received her second dose on 13Feb2021. Since that time, she's been on Eliquis and blood pressure medications (losartan and metoprolol) because she now had high blood pressure. Her blood pressure reading this morning (on 25Jun2021) was 152/83. She had blood pressure up. Later she clarified that this blood pressure was from this morning. Patient said that last fall it was 126/84. Later she clarified that was taken 08Sep2020. She was wondering and finally realized that the blood pressure had to do with the shot. She knew it was 170s over something when she had the blood clot checked. It was still up there even with the medication. She also commented she had no doubt that the vaccine caused the blood clot. She got like 9,000 to 10,000 steps a day. She wanted to know when the elevated blood pressure issue would resolve. Patient stated that she was off of Eliquis. She took it for 90 days. She said she was doing better. Now her blood pressure was up. She was not sure if she had recovered from the blood clot. They first noticed the high blood pressure when she had her ultrasound for her blood clot. They told her to get to her doctor fast as she had high blood pressure. She stated that her blood pressure improved slightly. It was in the 170s, but now she was on blood pressure medication. Treatment included losartan 100mg, Metoprolol 25mg. She stated that she also gave up wine to see if that would help. Patient stated that she had an appointment to get the ultrasound. She had ultrasound left leg resulted blood clot in vein. She thought she ended up in the emergency room. She had been seeing her doctor as well. The event high blood pressure resulted in emergency room and physician office. There were no prior vaccinations within 4 weeks. The outcome of the event was recovering.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Colitis, Colon injury, Gastrointestinal pain, Illness
Clinical narrative: colon, causing lack of function, some pain; cannot have bowel movements; lower bowel regions became inflamed; Felt some normal symptoms of illness; Inflammation of colon; causing lack of function; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for Injection Batch/Lot number was not reported) via an unspecified route of administration in arm right on 01Apr2021 as dose number unknown, single at the age of 64 year for COVID-19 immunisation. The patient medical history and concomitant medications was 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. Since the vaccination, the patient had not been tested for COVID-19. Anti-inflammatories, stool softeners, laxatives were the other medications the patient received within 2 weeks of vaccination. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On an unknown date in Apr2021, first 30 hours after vaccination it was reported that the patient felt some normal symptoms of illness. Then lower bowel regions became inflamed, had months of symptoms since. Inflammation of colon, causing lack of function, some pain, cannot have bowel movements, said this condition is very rare. My neighbour just one block from here also is reporting same lower bowel symptoms. Cannot have bowel movements without laxatives and softener etc. The clinical outcome of the events on an unspecified date 2021 was resolved with sequel.  Information about lot/batch number has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammatory bowel disease
Clinical narrative: colon, causing lack of function, some pain; cannot have bowel movements; lower bowel regions became inflamed; Felt some normal symptoms of illness; Inflammation of colon; causing lack of function; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for Injection Batch/Lot number was not reported) via an unspecified route of administration in arm right on 01Apr2021 as dose number unknown, single at the age of 64 year for COVID-19 immunisation. The patient medical history and concomitant medications was 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. Since the vaccination, the patient had not been tested for COVID-19. Anti-inflammatories, stool softeners, laxatives were the other medications the patient received within 2 weeks of vaccination. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On an unknown date in Apr2021, first 30 hours after vaccination it was reported that the patient felt some normal symptoms of illness. Then lower bowel regions became inflamed, had months of symptoms since. Inflammation of colon, causing lack of function, some pain, cannot have bowel movements, said this condition is very rare. My neighbour just one block from here also is reporting same lower bowel symptoms. Cannot have bowel movements without laxatives and softener etc. The clinical outcome of the events on an unspecified date 2021 was resolved with sequel.  Information about lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hot flush, Paraesthesia
Clinical narrative: Dizzyness/lightheaded; Tingling; Hot cold flashes; Extreme tiredness; This is a spontaneous report received from a non-contactable consumer. This 45-year-old female consumer (patient) reported for herself.   A 45-year-old female patient received 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 dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID); esomeprazole sodium (NEXIUM); fexofenadine hydrochloride (ALLEGRA); probiotics (PROBIOTICS) and vitamin c [ascorbic acid] (VITAMIN C) all concomitant medications taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not test COVID-19 positive prior to vaccination. On an unspecified date, the patient reported that after receiving the first dose, within 5 mins experienced severe, dizzyness, lightheaded tingling, hot cold flashes all lasting 15-20 minutes, the next 24hrs extreme tiredness and arm soreness for few weeks after the 2nd shot. The patient had not been tested for COVID-19 since the vaccination. Treatment was not received for any of the events. Outcome of the events dizzyness, lightheaded tingling and hot cold flashes was reported as recovered. Outcome of the events extreme tiredness and arm soreness was reported as Unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Parosmia, Thyroid gland scan normal
Clinical narrative: 2nd shot intense headache within 10 mins of shot that persists till now a month later; sense of smell affected sometimes i smell things like kerosene or something acrid burning with no source of either in my home; chills for two days; fatigue that still persists; This is a spontaneous report from a contactable consumer (patient). A 52-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8736), via an unspecified route of administration in left arm on 28May2021 at 03:00 PM as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had allergies to Bactrim. The patient previously received, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8735), via an unspecified route of administration in Arm Left on 07May2021 at 12:15 PM as dose 2, single for covid-19 immunisation and experienced extreme fatigue and fever for 3 days. Patient not received other vaccine in four weeks, it was unknown if patient had COVID prior vaccination and patient had not tested COVID post vaccination. The patient underwent lab test and procedure which included thyroid with result show normal thyroid on 28May2021. On 28May2021 at 03:15 PM, the patient experienced intense headache within 10 mins of shot that persists till now a month later. Patient also experienced chills for two days and fatigue that still persists. At annual physical, dr. noted enlarged thyroid, yet lab results show normal thyroid. Patient sense of smell affected: sometimes she smells things like kerosene or something acrid burning with no source of either in her home. Treatment received for reported adverse events. Tylenol, aspirin received for headache, and it reduced the activity.Since the vaccination, the patient was not tested for COVID-19. The outcome of events chills was resolved and not resolved for other events.  Follow-up attempts are possible. Further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Testicular pain
Clinical narrative: I have lot of testicular pain; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number& Expiry date not reported) via intramuscular route of administration on unspecified date (at age of 41-year-old) as dose 1, single for COVID-19 Immunization. Patient medical history includes blood pressure. Patient concomitant medications include Olmesartan 125 (units unknown) used for blood pressure from unspecified date and ongoing, lisinopril used for blood pressure from unspecified date and unknown ongoing.The patient did not receive any other vaccines within four weeks prior to the vaccination. On unspecified date consumer stated, I received my first vaccination yesterday about 14:00 and last night I am just starting but like this morning, I have lot of testicular pain. Patient enquired about is problem is a normal side effect. The outcome of event was not recovered.   Information about lot/batch number cannot be obtained. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: She states that with her first vaccine, she did have a sore/achy arm for about 24 hours; This is a spontaneous report from a contactable consumer or other non health care professional.  A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0178, Expiration date: Unknown), dose 1 via an unspecified route of administration, in Right Arm on 03Jun2021(at the age of 63-years-old) as DOSE 1, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took morphine and experienced drug hypersensitivity, compazine [prochlorperazine maleate] and experienced drug hypersensitivity.  On Jun2021, the patient had received her first vaccine and then she started experiencing a sore/achy arm for about 24 hours. The outcome of event was recovered.    Information on Lot/Batch number was available. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance, Illness, Movement disorder, Myalgia
Clinical narrative: he is having trouble moving and getting up and walking; he is having trouble moving and getting up; he has never had the back pain before with the pain in the muscle; Sick; My husband experienced lower back pain, well today the back pain is really severe; This is a spontaneous report from a contactable consumer. This consumer (patient's Wife) reported for a 64-year-old Male patient (Reporter's husband) that he received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW017A and expiry date was not reported, at the age of 64-year-old), via an unspecified route of administration, administered in Arm Left on 25Jun2021 08:00 as dose 1, single for covid-19 immunisation. Medical history included ongoing splenectomy. The concomitant medications were not reported. Patients wife reported that her husband experienced lower back pain well today the back pain is really severe, he is having trouble moving and getting up and walking on 25Jun2021. She states she took him to the ER, and they gave him a muscle relaxer and a pain pill, which didn't help at all. She states they were there for about 4 hours and sent home with some more pain pills and still is not helping; when he left the hospital, he was still in pain. He has never had the back pain before with the pain in the muscle. She states he had no soreness in his left arm. She states she told the ER nurse this as well, but he doesn't have a spleen and she doesn't know if the shot affected him worse because of the immune system to fight it. She remarks her husband is having regrets taking the vaccine because he is so sick. She states the second shot is scheduled for 16Jul2021. Additional Vaccines Administered on Same Date of the Pfizer Suspect were none. Other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none. The patient underwent lab tests and procedures which included urine analysis and x-ray both negative on 26Jun2021. The outcome of event low back pain was recovering and for all the events was unknown.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis, X-ray
Clinical narrative: he is having trouble moving and getting up and walking; he is having trouble moving and getting up; he has never had the back pain before with the pain in the muscle; Sick; My husband experienced lower back pain, well today the back pain is really severe; This is a spontaneous report from a contactable consumer. This consumer (patient's Wife) reported for a 64-year-old Male patient (Reporter's husband) that he received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW017A and expiry date was not reported, at the age of 64-year-old), via an unspecified route of administration, administered in Arm Left on 25Jun2021 08:00 as dose 1, single for covid-19 immunisation. Medical history included ongoing splenectomy. The concomitant medications were not reported. Patients wife reported that her husband experienced lower back pain well today the back pain is really severe, he is having trouble moving and getting up and walking on 25Jun2021. She states she took him to the ER, and they gave him a muscle relaxer and a pain pill, which didn't help at all. She states they were there for about 4 hours and sent home with some more pain pills and still is not helping; when he left the hospital, he was still in pain. He has never had the back pain before with the pain in the muscle. She states he had no soreness in his left arm. She states she told the ER nurse this as well, but he doesn't have a spleen and she doesn't know if the shot affected him worse because of the immune system to fight it. She remarks her husband is having regrets taking the vaccine because he is so sick. She states the second shot is scheduled for 16Jul2021. Additional Vaccines Administered on Same Date of the Pfizer Suspect were none. Other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none. The patient underwent lab tests and procedures which included urine analysis and x-ray both negative on 26Jun2021. The outcome of event low back pain was recovering and for all the events was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic mass, Neoplasm progression, Pneumonia, Scan
Clinical narrative: Pneumonia; Disease progression; They found a 9cm mass on her liver.; This is a spontaneous report from a Pfizer Sponsored Program. A contactable pharmacist and Other Health Professional reported that an 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 2021 (Batch/Lot number was not reported) at the age of 83-year-old, at single dose for covid-19 immunisation; palbociclib (IBRANCE, Film-coated tablet, strength 100 mg), via an unspecified route of administration from 24Jul2020 (Batch/Lot number was not reported) to 30May2021, at 100 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. It was reported patient stopped the palbociclib a few days ago. It was notified on 25Jun2021 Friday. Patient was home hospice now. She had pneumonia after her COVID vaccine a month ago and then when she went on for her scans they found a 9cm mass on her liver. So the doctor decided to stop palbociclib as a sign of disease progression and she was declared home hospice. There was no hospitalization. The patient underwent lab tests and procedures which included scan: found a 9cm mass on her liver in 2021. The action taken in response to the events for palbociclib was permanently withdrawn. The outcome of events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association and the limited information available, the causal association between the event pneumonia and the suspect products palbociclib and BNT162B2 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blepharospasm, Headache
Clinical narrative: Headache; Left eye jumping and twitching; bad knee; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 67-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0191), via an unspecified route of administration, administered in Arm Left on 11Jun2021 (at the age of 67-years-old) as single dose for covid-19 immunization. Medical history included ongoing hypertension Diagnosed, ongoing diabetes mellitus, ongoing blood cholesterol, constipation from an unknown date and unknown if ongoing, sinus disorder from an unknown date and unknown if ongoing. The patient's concomitant medication includes that she took 3 different blood pressure medications, diabetic medication, cholesterol medication, medication for bowel problems constipation, and a medication for 21 days for sinus troubles. Caller does not provide any further information on these medications. Caller had stated she did not feel her medications or medical conditions were relevant to these events. The patient did not receive any other vaccines within four weeks prior to the vaccination. AE(s) following prior vaccinations and Relevant tests were reported as none. None of the additional Vaccines were administered on Same Date of the Pfizer Suspect. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0186) via an unspecified route of administration, administered in Arm Left on 21May2021. Reporter stated that she had a headache since 22Jun2021, and it has not gone away and stated she was calling to see what the expected outcome is and how long may this last. Also said that her left eye has been jumping and twitching (on an unspecified date in Jun2021). Stated it has been doing it for a while. Reporter went downstairs to get her vaccination card. Stated it may take her a minute because she lives upstairs and had a bad knee. No further information related to her knee provided by the caller. The patient visited to Emergency Room and Physician Office. The outcome of events was not recovered where as bad knee was unknown.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: On 14 Feb 2021, she received the second dose of the covid vaccine, and has not had to take anything for her blood pressure since; This is a spontaneous report from a contactable physician (patient). An 87-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9266, Expiry date: not reported, age at vaccination: 87-year-old), via an unspecified route of administration, in Arm Left on 14Feb2021 12:00 as single dose for COVID-19 immunization. Medical history included, Afib (atrial fibrillation), thrombosis and cardiac pacemaker insertion (called an electrocardiologist who told her to discontinue taking amlodipine). Concomitant medication included apixaban (ELIQUIS) at a dosage of 2.5mg twice a day, since an unknown date taken to prevent thrombosis as years ago, she had a few episodes of A-fib, but she had none since. Historical vaccine included first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via an unspecified route, in Arm left on 20Jan2021 at 10:50 for (age at the time of vaccination: 86-year-old) for COVID-19 immunization. Patient previously took lisinopril (Taking 40mg of lisinopril a day for 20 years, in addition to amlodipine) and amlodipine (not taken amlodipine in over a year, because she has not needed it). The facility ran out of the Pfizer covid vaccine, so she got her second dose of the covid vaccine four days later than she was suppose to. On 14Feb2021, she received the second dose of covid vaccine, and had not taken anything for her blood pressure since. She can not remember an exact date, she knows that it was around that time. In the beginning, she did not connect not having to take her blood pressure medication was affected by the covid vaccine. It stuck her whenever she realized she has taken nothing for the past few days. She thought that this was not serious at all. However, she was taking the medication and monitoring her blood pressure. If a patient would not have been monitoring their blood pressure, they could have taken it anyways and passed out. If there was a relationship between this and the covid vaccine, she thinks it is medically significant. She thought the time frame was a coincidence. She did not think of it at first, because of the mechanism of action of ace inhibitors. She got to thinking about it and was wondering about the mechanism of action of the covid vaccine, and called Pfizer. No other vaccines were administered on the same date as Pfizer suspect and no other prior vaccinations within 4 weeks. Patient was not administered to ER and not visit physician office. The outcome of events was unknown.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Started breaking out with eczema; This is a spontaneous report from a contactable consumer (patient himself). A 79-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6206; expiration date was not reported), via unspecified route of administration, in the left arm, on 10Mar2021 at 10:00 (at the age of 79-year-old), as single dose for COVID-19 immunization. The patient's medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient's concomitant medications included ongoing allopurinol (strength: 150mg) for gout from unspecified date, taken it for 2 or 3 years and also reported other unspecified concomitant products. The patient's historical vaccine included first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number: EN9809; expiration date was not reported), via unspecified route of administration, in the left arm, on 19Feb2021 (at the age of 79-year-old), as single dose for COVID-19 immunization. Patient got both shots of the COVID Vaccine in mid Mar2021, and he had no side effects and was doing good. About a month later, and he has never had it, he started breaking out with eczema in at the beginning of May2021 at late afternoon. He also went to a dermatologist. Patient had an appointment on 18May2021. When asked if it had improved, was persisting, or had worsened, he states it was not serious and was breaking out in little patches here and there. The dermatologist gave him a steroid cream. No additional vaccines administered on same date of the Pfizer Suspect. Patient did not receive any prior vaccinations within 4 weeks. Patient did not receive any emergency room and physician office visit for eczema. Outcome of the event was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I still have headaches; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0187), dose 1 via an unspecified route of administration, administered in arm left on 21Jun2021 as dose 1, single for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included high blood pressure and vitamins (over the counter vitamin B, C). In Jun2021, the patient experienced "I still have headaches". The patient asked if she should take Tylenol. When probed whether the patient need any medical assistance, she reported that "not really just light headache that I am having since I took, well I should take Tylenol or something will it go away". It was not bad. She was about to go to store to get something maybe to stop the headache. The outcome of the event was not resolved.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Arm is starting to get tired; This is a spontaneous report from a contactable consumer(patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection), first dose via an unspecified route of administration, administered in arm on 28Jun2021 (Batch/Lot number was not reported) at unknown dose single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the first dose like an hour ago. he had no issues right now from the vaccine. his arm was starting to get tired on 28Jun2021. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever 103.0 for 18 hours; This is a spontaneous report from a contactable other Health Care Professional (patient reported for herself).  A 49-year-old female (Non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6199), dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 at 11:00 (at the age of 49 years old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included allergy to penicillin, environmental and hives from an unknown date and unknown if ongoing. Concomitant medication(s) included hydrochlorothiazide, losartan potassium (LOSARTAN/ HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported. Previously patient received bnt162b2 (Batch/Lot Number: EL9261), dose 1 via an unspecified route of administration, administered in Arm Left on 10Feb2021 at 15:30 h (at the age of 49 years old) as DOSE 1, SINGLE for covid-19 immunisation and had experienced generalized pruritus with skin rash. Exactly like a chicken pox rash. Each patch resolved over 7-8 days, 14-15 days until completely of cured. So itchy rash went before crusting over. Bilateral - rash erupted in both sides of body at the same time. Face, lower legs never got a rash (nor hands/feet). Patient did not receive any recent vaccines for any other conditions prior to the event being reported. Patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNtech COVID-19 Vaccine prior to the event reported. Patient had not received any other vaccines around the time of Pfizer-BioNtech COVID-19 Vaccination. After second dose, the patient experienced fever 103.0 for 18 hours on an unspecified date. Saw a doctor. Doctor was puzzled. Vitals normal, no fever. Patient did not require the Emergency department or Intensive Care Unit. The patient was not hospitalized. Multi organ involvement was reported as, dermatological/mucosal, checked. Event did not require the initiation of new medication or other treatment or procedure. laboratory tests or diagnostic studies performed were None. Outcome of the event was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Suspected COVID-19
Clinical narrative: Thinks she might have virus; He does not feel well/has malaise; He had severe fatigue; This is a spontaneous report from a contactable consumer or other non hcp (Patient herself). A female patient of an unspecified age received bnt162b2 (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration on 10Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included patient had heart surgery. The concomitant medications were not reported. The patient experienced he does not feel well/has malaise, thinks she might have virus, he had severe fatigue on an unspecified date. The reporter assessed the events as non-serious. Patient wants to reschedule her appointment to receive the second dose of Pfizer COVID-19 vaccine, she should receive her second dose on Wednesday the 30th, however she wants to reschedule as she is not feeling well and has discomfort, she thinks it may be a virus the patient had heart surgery, when she received the dose she had a lot of fatigue and many side effects. She mentioned that she received the first dose of the vaccine day 10. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Hyperhidrosis, Loss of personal independence in daily activities
Clinical narrative: Couldn't do anything; Sweating like crazy; Light-headedness/ Dizziness; zero energy; Some joint pain; This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number and expiration date were not reported), dose 2 via an unspecified route of administration on 20Apr2021 (age at vaccination: 75-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient stated that two weeks later, he began having reactions which included zero energy and couldn't do anything. The patient also stated that after 45 minutes he was done and had to went to bed, having sweating like crazy, dizziness, and light-headedness. The patient stated these had been going on for over a month. The patient also experiencing some joint pain. The patient denied redness or pain at the injection site and didn't have any redness in his arm. The outcome for the events of sweating like crazy, light-headedness/ dizziness was not yet recovered and other events was unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Accident
Clinical narrative: They had an accident where she ended up in an Emergency room; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable 76-year-old female consumer (patient) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported at the age of 76-year-old) via an unspecified route of administration on an unknown date Dec2020 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported they had an accident where she ended up in an emergency room and was later on in a rehabilitation centre resolving from that. Because of the event, the patient missed the scheduled second dose. The patient would like to know if she can just still get her second dose after 6 months or does she need to be revaccinated again. The patient was asking about information on possible booster dose. The response as follows the need for a booster dose of Pfizer-BioNTech COVID-19 vaccine based on duration of protection or impact of variant strains had not determined. On 25Feb2021, Pfizer and BioNTech announced they initiated an evaluation of the safety and immunogenicity of a potential third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the currently circulating and potential newly emerging variants. It was important for vaccine technology that allows us to both provide boosting doses if needed and to address potential changes in the virus itself if a new variant emerges that the vaccine does not protect against. While we had not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine in our laboratory studies, we were taking multiple steps to be ready in case a strain becomes resistant to the vaccine. The administration of more than a 2-dose series of Pfizer BioNTech COVID-19 Vaccine is not approved. Pfizer is unable to make any recommendations regarding administration of a booster dose of Pfizer-BioNTech COVID-19 Vaccine; Pfizer did not suggest or recommend the use of the vaccine in any manner other than as described in the authorized EUA prescribing information/authorized product monograph. The patient asked any data on patients who received second dose later than the recommended 21 days, specifically just like that of which she was like 6 months from her first dose. The outcome of the event was resolving.  Information about lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: did not feel good for about 4-5 days; sore arm; This is a spontaneous report from a Pfizer sponsored program  received from a contactable consumer(patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EW0168 and expiration date: not reported), via an unspecified route of administration, on 13Jun2021 (at the age of 57-year-old), as DOSE 1, SINGLE for covid-19 immunization. Medical history included covid-19 in Nov2020. The patient's concomitant medications were not reported. After the first dose, for about 4-5 days patient did not feel good, had sore arm and felt like she is coming down with something but never did. The patient's second dose is scheduled on July 6, She would like to know if she can take her second dose earlier than 06Jul.The patient would also like to know about antibodies after covid infection and vaccination. The outcome of the event 'did not feel good for about 4-5 days' was recovered in Jun2021 and that of sore arm was unknown at the time of reporting.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Dysgeusia, Dysphonia, Lethargy, Taste disorder
Clinical narrative: his first cup of coffee about killed him, it tasted so bad; dryness in the mouth; his voice has changed to raspy; his urine has a smell; lethargy; metallic taste in the mouth; This is a spontaneous report from a contactable consumer (patient) reported for herself that.  A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration administered in Arm Left on 08Jun2021 (age at vaccination 61-years) (Batch/Lot Number: EN0180) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient states coffee tastes strange/bad and this is ongoing but had improved some. Caller states starting out his taste was completely gone, his first cup of coffee about killed him, it tasted so bad. Caller states he has dryness in the mouth every day and he was drinking more water. Caller state he normally drinks a lot but this is more. Caller states his voice has changed to raspy most of the time and his urine has a smell. Caller states it was not like when he eats asparagus but another smell he hasn't had before. Caller states it started the morning after on 09Jun2021. Caller states his coffee is not back to normal taste yet, it still just tastes weird. Caller states he was also lethargic but that has improved some. Caller states he figured that out because he usually only has 1 cup of coffee and he was having 2-3 cups so he could stay focused and work, it was kind of weird. He also states he had a metallic taste in the mouth and for a while he had to brush his teeth 5 times a day. Outcome of the events was not recovered.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis abnormal
Clinical narrative: his first cup of coffee about killed him, it tasted so bad; dryness in the mouth; his voice has changed to raspy; his urine has a smell; lethargy; metallic taste in the mouth; This is a spontaneous report from a contactable consumer (patient) reported for herself that.  A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration administered in Arm Left on 08Jun2021 (age at vaccination 61-years) (Batch/Lot Number: EN0180) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient states coffee tastes strange/bad and this is ongoing but had improved some. Caller states starting out his taste was completely gone, his first cup of coffee about killed him, it tasted so bad. Caller states he has dryness in the mouth every day and he was drinking more water. Caller state he normally drinks a lot but this is more. Caller states his voice has changed to raspy most of the time and his urine has a smell. Caller states it was not like when he eats asparagus but another smell he hasn't had before. Caller states it started the morning after on 09Jun2021. Caller states his coffee is not back to normal taste yet, it still just tastes weird. Caller states he was also lethargic but that has improved some. Caller states he figured that out because he usually only has 1 cup of coffee and he was having 2-3 cups so he could stay focused and work, it was kind of weird. He also states he had a metallic taste in the mouth and for a while he had to brush his teeth 5 times a day. Outcome of the events was not recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Movement disorder, Pain in extremity
Clinical narrative: soreness in arm/shoulder; soreness in arm/shoulder; Unable to lift arm properly without pain; This is a spontaneous report from a contactable consumer or other non HCP.   A 51-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 intramuscular on 2021 (at the age of 51-years-old) as dose 1, single, and dose 2 intramuscular, administered in Arm Right on 2021 (at the age of 51-years-old) (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was not reported whether patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was not reported, whether prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unspecified date in 2021, the patient experienced soreness in arm/shoulder. She was unable to lift arm properly without pain. She indicated her doctor put her on steroid to help. Has not been effective. Indicated going on 8 weeks not with little improvement. The adverse event result in doctor or other healthcare professional office/clinic visit.  Information about lot/batch number has been requested.
Age: 14.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lethargy, Pyrexia
Clinical narrative: Headache; fever 101.5; fever of 101.4 for 2 day; lethargy; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two doses. This is the first of two reports regarding dose 2.  A 14 -year-old patient of unspecified gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0186) via intramuscular in left upper arm on 03Jun2021 at 11:15 AM, at patient age of 14-year-old, as a single dose for COVID-19 immunisation. The patient medical history included ongoing oral food allergy (anti histamines 6 months per year), ongoing tree nut anaphylaxis (removed tonsil, Adenoids at age 8. carries an epinephrine injector always). The family medical history included Food allergy to Tree Nut: cashew/pistachio; Pollen allergy- ongoing rhinitis. The patient concomitant medications included ongoing oral antihistamine cetirizine hydrochloride (ZYRTEC) from March (unspecified year) for allergy to pollen.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8735) via intramuscular in left upper arm on 13May2021 at 11:30 AM, at patient age of 14 -year-old as a single dose for COVID-19 immunisation and experienced headache. The patient had none prior vaccinations within 4 weeks. On 04Jun2021, the patient experienced headache with seriousness criteria: persistent/significant disability/incapacity. The patient had 3 days fever 101.5. The event required to visit physicial office call. The patient received Ibuprophen for treatment. The patient experienced fever of 101.4 for 2 day and lethargy after the second vaccine. The outcome of the events was resolved.   Follow-up attempts are completed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021579117 same reporter/patient, different dose/event
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness, Vaccination site pain
Clinical narrative: Arm sore at injection site; my arm was sore; tender to the touch; This is a spontaneous report from a contactable consumer (patient). A 45-year-old patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot/batch number not provided), via an Intramuscular route of administration on 26Mar2021 at 15:00 PM (at the age of 45-years-old) into upper Left arm as a single dose for COVID-19 immunization. The patient had received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot/batch number not provided), via an Intramuscular route of administration on 05Mar2021 at 15:00 PM into upper Left arm as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took Flu vaccine, Quad, Preservative free, TDAP on 15Feb2021.On an unspecified date at 20:00 PM, the patient experienced Arm sore at injection site. In Mar2021, after each shot, about 3 hours later, the patient experienced arm was sore/tender to the touch. Patient took hot tea and rest. No other symptoms.it was reported that My primary inquiry is to try to get my 5-year-old son into a trial for the vaccine. We are supportive and grateful to Pfizer for the life-giving vaccine. We have remained safe and healthy. No treatment was given for Arm sore at injection site. The outcome of the events was recovered. my arm was sore was not recovered.   Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 antibody test
Clinical narrative: COVID-19; Felt terrible; This is a spontaneous report received from Pfizer Sponsored Program. A non-contactable consumer (patient herself) reported that an unspecified aged female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient stated that she received her first dose of Pfizer COVID-19 vaccine and has felt terrible since and explained she was exposed to COVID-19 virus also and she had antibodies tested against the COVID-19 virus, but she tested negative twice for the COVID-19 virus. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High temperatures; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer(patient) reported that, a patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced high temperatures (Misplaced comment, as reported) on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.