chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for covid; positive for covid; This is a spontaneous report from a contactable consumer. A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), (Lot number not reported) via unspecified route of administration on 21Mar2021 as SINGLE DOSE for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. On unspecified date patient tested positive for COVID. Patient was about the Pfizer vaccine. Patient and his daughter (female, age 17) received their first dose on 21Mar2021. Caller was scheduled for his second dose today (18Apr2021). He and his daughter were tested positive for covid. He got negative test results last Friday on 09Apr2021. His daughter tested negative on 06Apr2021. Patient asked can I go for my vaccination today. I travelled outside the country so I may have gotten covid because of that. My daughter lives with me so she may have gotten it from me. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: they tested positive for Covid for the last 3 weeks; they tested positive for Covid for the last 3 weeks; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for 02 patients and Follow-up (18Apr2021) received from same reporter was processed together with initial. This is the 2nd of 2 reports.   A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 21Mar2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient scheduled to take the 2nd dose of the vaccine todays however tested positive for covid for the last 3 weeks on an unspecified date. Patient already tested negative last 09Apr2021. He would like to know if they can proceed with the 2nd dose today and he wants to find out when is the recommended time that he should get the 2nd dose. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on 09Apr2021. The outcome of the events were unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021442097 Same reporter/drug/event and different patient.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Headache
Clinical narrative: She thought she was having a massive stroke; Severe left sided head pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. The patient previously took epinephrine, codeine, acetylsalicylic acid (ASPIRIN) and experienced anaphylactic reactions in the past. The patient stated that 45 minutes after her first vaccine, she experienced severe left sided head pain. She was driving down the road and had to go back because she thought she was having a massive stroke; it was that severe. She asked if she should still get the second dose or if she should reschedule it after she talks to her primary care provider. She is scheduled to get the second dose at the time of report but was nervous because she does not know if she should get it. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Confusional state, Cough, Dyspnoea, Hypoaesthesia
Clinical narrative: Numbness and Paresthesia bilateral feet and shins; Numbness and Paresthesia bilateral feet and shins; right lower extremity weakness; cough; shortness of breath; chest tightness; confusion; This is a spontaneous report from a contactable physician reporting for a patient. A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 13Apr2021 13:00 (Batch/Lot Number: EW0162) as SINGLE DOSE for covid-19 immunisation at 46 years old. Medical history included DJD cervical spine and Raynaud's Phenomenon from an unknown date. Concomitant medications included amlodipine taken for an unspecified indication, start and stop date were not reported. The patient experienced numbness and paresthesia bilateral feet and shins; right lower extremity weakness, cough, shortness of breath, chest tightness, confusion on 13Apr2021 13:15. Treatment included albuterol. The patient was hospitalized for the events on an unspecified date for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (Nasal Swab): negative on 16Apr2021 and 17Apr2021, and blood test (SARS-CoV-2 antibody test) negative on 16Apr2021.Outcome of the events was recovered with sequelae (Recovered with lasting effects) on an unspecified date in 2021.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on the available information and the temporal association of BNT162B2 administration to the events, a possible contribution of the drug to the events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Paraesthesia, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Numbness and Paresthesia bilateral feet and shins; Numbness and Paresthesia bilateral feet and shins; right lower extremity weakness; cough; shortness of breath; chest tightness; confusion; This is a spontaneous report from a contactable physician reporting for a patient. A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 13Apr2021 13:00 (Batch/Lot Number: EW0162) as SINGLE DOSE for covid-19 immunisation at 46 years old. Medical history included DJD cervical spine and Raynaud's Phenomenon from an unknown date. Concomitant medications included amlodipine taken for an unspecified indication, start and stop date were not reported. The patient experienced numbness and paresthesia bilateral feet and shins; right lower extremity weakness, cough, shortness of breath, chest tightness, confusion on 13Apr2021 13:15. Treatment included albuterol. The patient was hospitalized for the events on an unspecified date for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (Nasal Swab): negative on 16Apr2021 and 17Apr2021, and blood test (SARS-CoV-2 antibody test) negative on 16Apr2021.Outcome of the events was recovered with sequelae (Recovered with lasting effects) on an unspecified date in 2021.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on the available information and the temporal association of BNT162B2 administration to the events, a possible contribution of the drug to the events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: developed headache; chills; 102°F fever; vomiting; left arm pain; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: not reported), via an unspecified route of administration, administered in left arm on 17Apr2021 at 11:00 (at the age of 36 years old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Apr2021 the patient experienced headache, chills, 102°F fever, vomiting, and left arm pain. The patient received treatment for the events with ibuprofen. The patient underwent lab tests and procedures which included body temperature 102°F on 17Apr2021. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: developed headache; chills; 102°F fever; vomiting; left arm pain; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: not reported), via an unspecified route of administration, administered in left arm on 17Apr2021 at 11:00 (at the age of 36 years old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Apr2021 the patient experienced headache, chills, 102°F fever, vomiting, and left arm pain. The patient received treatment for the events with ibuprofen. The patient underwent lab tests and procedures which included body temperature 102°F on 17Apr2021. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: Blood in stool; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0150 and expiration date not provided) via an unspecified route of administration, administered in the left arm on 03Apr2021 11:30 as a single dose for COVID-19 immunization. Medical history included high blood pressure and allergies to Penicillin. Concomitant medication included amlodipine besilate (NORVASC). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. The patient had blood in stool 14 days after first COVID shot on 17Apr2021 10:30. No treatment was given in response to the event. The patient has not been tested for COVID post vaccination. The outcome of the event was not recovered.   Information about lot/batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Anal abscess, Intestinal obstruction, Laboratory test, SARS-CoV-2 test
Clinical narrative: intestinal obstruction; I developed a peri-anal abscess/abscess returned; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received the second dose bnt162b2 (BNT162B2, lot number: EP7533), via an unspecified route of administration, administered in Arm Right on 08Apr2021 08:00 (received at 44-years-old) as single dose for covid-19 immunisation. The vaccine was administered at a hospital. The patient did not receive any other vaccines within four weeks prior to receiving BNT162B2. Medical history included crohn's disease (had been in remission for several years) and ileostomy. He had no COVID prior to vaccination. Concomitant medication included vedolizumab (ENTYVIO) taken for an unspecified indication, start and stop date were not reported; esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for an unspecified indication, start and stop date were not reported; loperamide hydrochloride (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; simeticone (GAS-X) taken for an unspecified indication, start and stop date were not reported; calcium carbonate (TUMS [CALCIUM CARBONATE]) taken for an unspecified indication, start and stop date were not reported.  The patient previously took bnt162b2 (BNT162B2, lot number: EN6299) in left arm on 03Mar2021 08:45 AM  (received at 44-years-old) for COVID-19 immunisation and developed a peri-anal abscess; compazine [prochlorperazine maleate] and experienced allergy; dilaudid and experienced allergy. The patient reported he has Crohn's Disease but had been in remission for several years. On 13Mar2021 ten days after his first vaccine, he developed a peri-anal abscess that required treatment via antibiotics. It resolved quickly. On 09Apr2021, one day after his second vaccine, the abscess returned and required more antibiotics. On 15Apr2021, seven days after his second vaccine, he developed an intestinal obstruction that required 2 days of hospitalization. According to him, these are all Crohn's symptoms that seem to have come out of nowhere. He had recent lab work (before vaccine) that showed no issues whatsoever. The patient underwent lab tests and procedures which included COVID-19 Virus test with negative result on 13Mar2021. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Loss of consciousness, Pain
Clinical narrative: passed out at work; extreme fatigue; body aches for a few hours; This is a spontaneous report from a contactable consumer.  An 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 17Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the following day, 18Apr2021, the patient experienced extreme fatigue and body aches for a few hours, then she passed out at work. The outcome of the events was unknown.  Information about lot/batch has been requested.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Haemoptysis, Myalgia, Rash
Clinical narrative: Bleeding in the cough; Rashes; Cough; Tiredness; Muscle Pain; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 30-years-old, via an unspecified route of administration in left arm on 07Apr2021 at 08:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient had no COVID prior to vaccination, did not have any other vaccines in four weeks and no other medications in two weeks. The patient experienced rashes, cough, bleeding in cough, tiredness, and muscle pain on 09Apr2021 at 12:00. There was no treatment given in response to the events. The patient was not tested for COVID post vaccination. The outcome of the event was not recovered. Information about the lot/batch number has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness unilateral, Hypoacusis, Tinnitus
Clinical narrative: Sudden hearing loss in left ear; worsened tinnitus; hearing had decreased by 20 percent; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7533), dose 1 via an unspecified route of administration, administered in Arm Right on 31Mar2021 14:15 (at the age of 67years) as single dose for Covid-19 immunization. Medical history included eosinophilic esophagitis, degenerative disc disease, and food and environmental allergies, and as reported " previously lost hearing in my right ear and partial in my left ear"; all from an unknown date and unknown if ongoing. Concomitant medications included meloxicam, omeprazole, azelastine, and triamcinolone acetonide (NASACORT); all taken for an unspecified indication, start and stop date were not reported. The patient previously took Codeine, Cipro (ciprofloxacin), and Percocet and experienced drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient experienced sudden hearing loss in left ear beginning within a week of taking vaccine. Inability to recognize words and sounds was most apparent, in addition to worsened tinnitus. The patient stated, "I previously lost hearing in my right ear and partial in my left ear in earlier sudden hearing losses, so I was aware of what was happening and scheduled an ENT visit. The patient had a hearing test on an unspecified date, and it showed that hearing had decreased by 20 percent. The ENT started her on the injectable steroid treatment in her left ear. The start date of adverse events was 03Apr2021 (as reported). The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient was treated with interaural steroid injections. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: her body could not stop shaking; This is spontaneous report from non-contactable consumer. A female patient of unspecified age received BNT162B2 first dose on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient received first dose of Pfizer's Covid vaccine and approximately a week later her body could not stop shaking. Consumer was taken to emergency room but no issues were found. Patient had stopped shaking by the time she got to the Emergency Department. Event took place after use of product. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Muscle twitching, Mydriasis
Clinical narrative: fainted; dizzy; warm; arms had seized up and were twitching; leg and body had also briefly been shaking; eyes were dilated; vomiting; arm is sore; sweaty; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Apr2021 11:00 (Batch/Lot Number: Unknown) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination  Medical history was reported as none. There were no concomitant medications. The patient previously had first dose of BNT162B2 (Lot number: ER8727) on 28Mar2021 01:00 PM in the left arm at 28 years old for COVID-19 immunisation and experienced fainted. On 18Apr2021 11:15 AM, the patient fainted about 10 minutes after second dose was vaccinated. The patient became dizzy and very warm and then woke up about 5-7 seconds after had fainted. The patient's arms had seized up and were twitching and leg and body had also briefly been shaking. The patient was very sweaty and warm. The patient's eyes were dilated when woke up according to the overseeing nurse. The patient said it was scary. Half hour after, the patient felt fine but then began vomiting when got home. The patient's arm is sore but nothing else has happened. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No treatment was given to the patient for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Syncope, Tremor, Vomiting
Clinical narrative: fainted; dizzy; warm; arms had seized up and were twitching; leg and body had also briefly been shaking; eyes were dilated; vomiting; arm is sore; sweaty; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Apr2021 11:00 (Batch/Lot Number: Unknown) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination  Medical history was reported as none. There were no concomitant medications. The patient previously had first dose of BNT162B2 (Lot number: ER8727) on 28Mar2021 01:00 PM in the left arm at 28 years old for COVID-19 immunisation and experienced fainted. On 18Apr2021 11:15 AM, the patient fainted about 10 minutes after second dose was vaccinated. The patient became dizzy and very warm and then woke up about 5-7 seconds after had fainted. The patient's arms had seized up and were twitching and leg and body had also briefly been shaking. The patient was very sweaty and warm. The patient's eyes were dilated when woke up according to the overseeing nurse. The patient said it was scary. Half hour after, the patient felt fine but then began vomiting when got home. The patient's arm is sore but nothing else has happened. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No treatment was given to the patient for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Haemoglobin, Heart rate, Heart rate increased
Clinical narrative: Rapid heart rate; 1st dose 10Mar2021, 2nd dose 21Mar2021; 1st dose 10Mar2021, 2nd dose 21Mar2021; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8732), intramuscular, administered in Arm Right on 21Mar2021 12:30 as single dose for COVID-19 immunization in a hospital. Medical history included, colonoscopy and polypectomy both on 08Jan2021. Family history of hypertension from an unknown date on the maternal side. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot number: EN6199) on 10Mar2021 1:15 pm for COVID-19 immunization and experienced insomnia and rapid heart rate that required hospital admission. On 31Mar2021 12:31, the patient experienced rapid heart rate. The patient was observed for 45 mins at site prior to release normal heart rate; cardiologist ordered heart monitoring for 2 day observation. The patient was treated with continuation of atenolol 75 mg. The reporter considered the event as non-serious. The patient received the first dose 10Mar2021, second dose 21Mar2021. The patient underwent lab tests and procedures which included echocardiogram: normal on 13Mar2021, electrocardiogram: 128 bpm fluctuated between normal to high on 12Mar2021, haemoglobin: 11.4 g/dl on 12Mar2021, heart rate: rapid on 31Mar2021, red blood cell count: 4.35 unit: M/Cmm on 12Mar2021, COVID-19 test: negative on 12Mar2021, and white blood cell count: 6.0 k/Cmm on 12Mar2021. The outcome of the event rapid heart rate was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, Red blood cell count, SARS-CoV-2 test, White blood cell count
Clinical narrative: Rapid heart rate; 1st dose 10Mar2021, 2nd dose 21Mar2021; 1st dose 10Mar2021, 2nd dose 21Mar2021; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8732), intramuscular, administered in Arm Right on 21Mar2021 12:30 as single dose for COVID-19 immunization in a hospital. Medical history included, colonoscopy and polypectomy both on 08Jan2021. Family history of hypertension from an unknown date on the maternal side. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot number: EN6199) on 10Mar2021 1:15 pm for COVID-19 immunization and experienced insomnia and rapid heart rate that required hospital admission. On 31Mar2021 12:31, the patient experienced rapid heart rate. The patient was observed for 45 mins at site prior to release normal heart rate; cardiologist ordered heart monitoring for 2 day observation. The patient was treated with continuation of atenolol 75 mg. The reporter considered the event as non-serious. The patient received the first dose 10Mar2021, second dose 21Mar2021. The patient underwent lab tests and procedures which included echocardiogram: normal on 13Mar2021, electrocardiogram: 128 bpm fluctuated between normal to high on 12Mar2021, haemoglobin: 11.4 g/dl on 12Mar2021, heart rate: rapid on 31Mar2021, red blood cell count: 4.35 unit: M/Cmm on 12Mar2021, COVID-19 test: negative on 12Mar2021, and white blood cell count: 6.0 k/Cmm on 12Mar2021. The outcome of the event rapid heart rate was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: High anxiety; This is a spontaneous report from a Pfizer sponsored program . A contactable consumer reported that a female patient (girlfriend) of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 Immunization. Medical history and concomitant medications were not reported. Consumer called in on behalf of his girlfriend, whom was also with him in the car right now. She had her first shot. He stated she has high anxiety as a result of taking the first shot, and wanted to know if she can take something for her anxiety prior to getting the second shot. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Eye pain, Muscle tightness, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: calf feels tight, stiff, it feels like dead weight/started within the last 2- 3 weeks; calf feels tight,; pain running up the right arm up to the shoulder; pain running up the right arm up to the shoulder/his calf pain, started to feel tight, started within the last 2- 3 weeks; He asks if someone can tell him if it is a blood clot in the back of his calf; his eyes also hurt a little bit; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 46-years-old via an unspecified route of administration, administered in arm left on 02Apr2021 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation. There was no medical history reported. There were no concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Mar2021 (lot number: EN6202) at the age of 46-years-old for covid-19 immunisation and experienced If it is a blood clot in the back of his calf, Regular pain feeling, Headache, Muscle pain, Calf feels tight, stiff, it feels like dead weight, Pain running up the right arm up to the shoulder and Calf pain, started to feel tight. The patient reported that he has been feeling the regular pain feeling, a headache, muscle pain before, it comes and goes on 12Mar2021. However, he says that the last few days there had been, by his calf muscle in the back there, they've been tightening, like stiffening up on him when he's sleeping on an unspecified date. It wakes him up at times. He also reports pain running up the right arm up to the shoulder on an unspecified date. He says he is just curious in terms of what that might be. He asks if someone can tell him if it is a blood clot in the back of his calf on an unspecified date. The headache went away after 2-3 days. He says his eyes also hurt a little bit on 12Apr2021 and was the same time frame as the headache. He says those things were just mild, nothing major. He did not take anything for it. He confirmed he no longer has muscle pain. He just has pain behind the calf and right arm up to his shoulder. He says his calf pain, started to feel tight, started within the last 2- 3 weeks. The arm pain in right arm up to shoulder started maybe within the last 2 days. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: calf feels tight, stiff, it feels like dead weight/started within the last 2- 3 weeks; calf feels tight,; pain running up the right arm up to the shoulder; pain running up the right arm up to the shoulder/his calf pain, started to feel tight, started within the last 2- 3 weeks; He asks if someone can tell him if it is a blood clot in the back of his calf; his eyes also hurt a little bit; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 46-years-old via an unspecified route of administration, administered in arm left on 02Apr2021 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation. There was no medical history reported. There were no concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Mar2021 (lot number: EN6202) at the age of 46-years-old for covid-19 immunisation and experienced If it is a blood clot in the back of his calf, Regular pain feeling, Headache, Muscle pain, Calf feels tight, stiff, it feels like dead weight, Pain running up the right arm up to the shoulder and Calf pain, started to feel tight. The patient reported that he has been feeling the regular pain feeling, a headache, muscle pain before, it comes and goes on 12Mar2021. However, he says that the last few days there had been, by his calf muscle in the back there, they've been tightening, like stiffening up on him when he's sleeping on an unspecified date. It wakes him up at times. He also reports pain running up the right arm up to the shoulder on an unspecified date. He says he is just curious in terms of what that might be. He asks if someone can tell him if it is a blood clot in the back of his calf on an unspecified date. The headache went away after 2-3 days. He says his eyes also hurt a little bit on 12Apr2021 and was the same time frame as the headache. He says those things were just mild, nothing major. He did not take anything for it. He confirmed he no longer has muscle pain. He just has pain behind the calf and right arm up to his shoulder. He says his calf pain, started to feel tight, started within the last 2- 3 weeks. The arm pain in right arm up to shoulder started maybe within the last 2 days. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Pain, Pain in extremity
Clinical narrative: pain in arms; she couldn't move her arm; severe pain; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient's mother). The consumer reported similar events for three patients. This is the second of three reports. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on an unspecified date (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient's mother is calling on behalf of her daughter (patient) that had the first dose of the COVID 19 vaccine and her daughter (patient) is experiencing pain in arms. The mother stated her daughter (patient) got the COVID 19 vaccine yesterday and she is in pain. The mother stated she too had the vaccine and had pain but her daughter (patient) is complaining and the mother does not want to do anything wrong and wanted to see if her daughter (patient) could take Ibuprofen or any other pain reliever. The mother says her daughter (patient) is in severe pain. The mother stated she has three daughters and two received the COVID 19 Vaccine and both are the same. The mother stated her daughter (patient) yesterday had no pain, only at night she was complaining about having pain and then woke up this morning and her daughter (patient) said she couldn't move her arm she was in severe pain. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC Same reporter/drug, different patients, similar AEs;US-PFIZER INC Same reporter/drug, different patients, similar AEs.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Pain in extremity
Clinical narrative: both daughters are experiencing the same thing/pain in arms; couldn't move her arm; This is a spontaneous report from a contactable consumer (patient's mother) from a Pfizer sponsored program. The consumer reported similar events for three patients. This is the third of three reports.   A female patient of an unspecified age received bnt162b2 (Pfizer BioNTech Covid 19 vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Not Provided) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter was calling on behalf of her daughter that had the first dose of the COVID 19 vaccine and her daughter was experiencing pain in arms. Reporter stated she had three daughters and two received the COVID 19 vaccine and both were experiencing the same thing. Reporter stated the daughter (patient) yesterday had no pain, only at night she was complaining about having pain and then woke up this morning and the daughter said she couldn't move her arm she was in severe pain. Reporter stated the daughter did not work today but yesterday she worked and last night decided she would not be going because she has to use her arms at work and it was really difficult for her. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021423442 Same reporter/drug, different patients, similar AEs;US-PFIZER INC-2021425734 Same reporter/drug, different patients, similar AEs
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Nasopharyngitis
Clinical narrative: Allergy; Cold; This is a spontaneous report from contactable consumer (patient) via Pfizer sponsored program. A patient of unknown age and gender received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot number not reported and expiry date was unknown), via an unspecified route of administration on as a single dose for covid-19 immunization on 24Mar2021. Patient medical history and concomitant medications were not reported. On an unknown date in 2021 patient had allergy and cold. Reporter seriousness for events was unspecified. Patient had received the first dose and scheduled for second dose tomorrow. Patient had COVID at the Christmas and it was the first year and he did not have really issue with the first one. However, what he thought it was allergies last two week and now believed it was a cold. Normally he did not have a fever. Patient questions that if have cold or flu or whatever should get or pick a vaccine or not.  The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: I have no antibodies/SARS-COV-2-SPIKE AB, Semi-Quant, S showed value negative because it was below 0.40; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 12Jan2021 (Lot Number: EL1283; Expiration Date: Apr2021) as a single dose; and dose 2 via an unspecified route of administration on 02Feb2021 (Lot Number: EL3246; Expiration Date: Apr2021) as a single dose for covid-19 immunisation. Medical history included bilateral lung transplant patient. Concomitant medication included transplant drugs like to suppress her immunity, not totally but just to have a balance so that so her immune systems does not recognize the foreign body and start attacking. The patient reported that she received the two doses of Pfizer Covid-19 vaccine in Jan2021 and early Fe2021 of this year. She recently went to the clinic because she was transplant patient and she have work done in nice doing study on antibodies for transplant patient, so she got the permission to test for the antibodies which is the SARS-covid-19 spike antibody test, the specific and showed that she has no antibodies and it's been over 2 months since she completed, the whole series of covid-19 vaccine. The patient mentioned that since she doesn't know, because she is a transplant patient or maybe, she knows with the covid vaccine is has to be frozen. Any of the hands and the stuff could have compromised the efficacy of the vaccine. She inquired on the information about how the vaccine properly handled because she received the vaccine at the doctor's office, they called me, she went there and they gave her the first dose, the nurse did and the second dose, the doctor herself gave her the second dose. She mentioned that a clinic in a state was doing a study on antibodies for the people who receive the vaccine for the transplant patient. So, what she did was that she gave her blood. She already provided the blood for test to do as her regular routine test, so she gave permission to test for the antibodies. She thought she was the new in after getting the two doses but when they did the test, they called her and told her that her test shows that the antibodies are undetected. It is the below 0.4 u, whatever and the range is 0.80 or something. The specific test that they did, she double checked just to make sure it is correct, and test is the SARS-COVID-19 SPIKE AB test. She called a clinic to find out what else she needs to do because the other clinic suggested that it could be a late response, or she need a booster. So, she right now does not have immunity according to the test. She inquired if she should get a different vaccine. The outcome of the events was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Oropharyngeal discomfort, Throat tightness
Clinical narrative: Voice is completely gone; Throat was feeling like closed and stuff; Throat felt like closing, it completely actually closed because I am able to talk and breath and 'all the other stuff' but I lost my voice; Throat was feeling like closed and stuff; Throat felt like closing, it completely actually closed because I am able to talk and breath and 'all the other stuff' but I lost my voice; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at the age of 36-year-old on 11Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient said she was calling because she had her Pfizer first vaccine on sunday and then she started having like her symptoms which was like her throat was feeling like closed and stuff like that  in Apr2021. She received her Pfizer shot on Sunday morning and now today it's Tuesday (on 13Apr2021) and her voice was completely gone. The symptoms that she was having was that her throat felt like closing, it completely actually closed because she was able to talk and breath and 'all the other stuff' but she lost her voice and it wasn't one of the actual side effects that was listed on the paper that she receive, when she received the first dose of vaccine. When confirmed if it was the first shot or second, consumer stated, this was her first shot she got it, and she received it on Sunday, the Sunday which just passed. It was just Sunday, it was 11th. She received her shot on 11th which was Sunday. The patient stated, Yes, she just need to know if it was one of the actual side effect that they didn't put on the actual paper work, was this actual comment or actual side effect of her receiving her actual shot. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm after first vaccine; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 first dose on 23Mar2021 10:20 Intramuscular on left arm at single dose for COVID-19 immunization. Medical history and Concomitant medications were none. Prior Vaccinations (within 4 weeks) were none. AEs following prior vaccinations were none. Family Medical History Relevant to AEs was None. None Additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient Says with his first dose he had no blood at the injection site he only had a sore arm the next day (24Mar2021) and that was it. Only lasted a couple of hours then it was gone the same day. No AE require a visit to Emergency Room or Physician Office. The outcome of the event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: had a rash that had broken out especially on his scalp, shoulder, back and it itched; had a rash that had broken out especially on his scalp, shoulder, back and it itched; This is a spontaneous report received from a contactable consumer (patient). An 83-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 (lot number: ER2613, NDC number: 59267100002) at 10:30 at single dose for COVID-19 immunization. The relevant medical history included thyroid gland not working. Concomitant medications included ongoing levothyroxine for thyroid gland not working. The patient previously received first dose of BNT162B2 on 18Mar2021 at the age of 83 years old for COVID-19 immunization. The patient had a rash that had broken out especially on his scalp, shoulder, back and it itched on 11Apr2021. The patient received treatment included Eucerin cream, used for relief, just put it on, it's a cream, it had ingredient like "Piroctone Olamine" (not clarified) for protection. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: Runny nose; Sore throat; Body ache; This is a spontaneous report from a contactable consumer. This consumer (patients mother) reported that a 16-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, ER8732) at single dose via an unknown route on 12Apr2021 morning for Covid-19 immunization. She had a runny nose and sore throat before she got the vaccine on 12Apr2021 morning and was figured it was allergy but then the reporter was wondering if she was actually had Covid before she got the vaccine. Concomitant drug was not provided. Patient was very well might just feel badly because of the vaccine. She had a runny nose, sore throat and body ache. The reporter realized she just had a vaccine in the past 24 hours so patient not gotten a test.  Outcome of the events was unknown.   Reporter seriousness was unspecified.    No follow-up attempts are needed: information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pruritus, Rash, Rash macular
Clinical narrative: Rash on the left side of the body that is buttock, stomach, foot and pain and itching; back left side its itching; Rash on the left side of the body that is buttock, stomach, foot and pain and itching; back left side its itching; Rash on the left side of the body that is buttock, stomach, foot and pain and itching; back left side its itching; down on the foot and knee, it is on the left leg near the foot that  inside portion right there around the heel, just above the heel and on the outside leg two spots little pink spots; This is a spontaneous report from a contactable consumer (patient). This Over 65 years old female patient received 2nd dose of BNT162B2 (COVID 19 vaccine) on 01Apr2021 at single dose on left arm for covid-19 immunization. Medial history was not reported. Concomitant Products included Ramipril Tablet, Amlodipine Tablet, ergocalciferol (VITAMIN D, Soft gel), multivitamin, calamine/phenol (CALAMINE LOTION PHENOLATED). Historical vaccine was 1st dose of BNT162B2 on 11Mar2021 at single dose for covid-19 immunization. Consumer stated had the Pfizer and the side effect is a rash on the left side of the body on the buttock, stomach, foot, pain and itching on left side of the back from 08Apr2021. Itching and rash and these effects were experienced after second shot. Consumer stated down on the foot and knee, it is on the left leg near the foot that inside portion right there around the heel, just above the heel and on the outside leg two spots little pink spots and then on the left rectum area, I mean buttock, I am trying to say left buttock quite a bit I mean and itching like I do not know what and then on the stomach and then on the back on the back left side its itching but I cannot really reach that. So, it is there in that area and I got the shot both of them on the left arm. Consumer stated, I mean it is still itching but I put some calamine lotion on it so I am trying to see if that is helping it to subside but it is still there. It might be helping some since I put that on as far as the itching is concerned. Calamine lotion (Treatment) could be helpful for itching so I am trying to see it is going to help it or not, I have to keep on rubbing that area. The rash is large on the buttock than any other parts of the body. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.