chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Fatigue, Influenza like illness
Clinical narrative: Pericarditis from the booster; Tightness in the chest; pain of three out of 10 pain increased to seven and became sharp pain in upper left chest; flu like symptoms; discomfort with deep breathing; aches; pain of three out of 10; discomfort in chest; fatigue; Low fever; This is a spontaneous report from a contactable consumer or other non hcp.  A 48-year-old male patient received bnt162b2 (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was FF2589, Expiration Date: Unknown) as dose 3, (BOOSTER) single via an unspecified route of administration, administered in Arm Right on 14Oct2021 10:00 (age at vaccination 48 years) for covid-19 immunisation. Historical vaccine received was (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was EM9809, Expiration Date: Unknown) as dose 2, single via an unspecified route of administration, administered in Arm Right on 30Mar202110:00 for covid-19 immunisation and also received (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was EM9809, Expiration Date: Unknown) as dose 1, single via an unspecified route of administration, administered in Arm Right on 03Mar2021 10:00 for covid-19 immunisation. Allergy were reported as reaction. Medical history included none-very healthy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 23Oct2021 12:00pm patient experience Tightness in the chest starting nine days after the booster, third shot. After 10 hours of chest tightness and pain of three out of 10, pain increased to seven and became sharp pain in upper left chest. Emergency room visit and subsequent appointments to cardiologist with labs revealed no cardiac abnormalities or blood clots. The primary theory is Pericarditis from the booster. Current symptoms are discomfort in chest and flu like symptoms. Low fever, aches, fatigue and discomfort with deep breathing. The patient underwent lab tests and procedures which included investigation: no cardiac abnormalities on labs revealed no cardiac abnormalities or blood clots , investigation: three out of 10 pain on , investigation: increased on pain of three out of 10 pain increased to seven and became sharp pain in upper left chest. Therapeutic measures were taken and currently patient on anti-inflammatories. The outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Pain, Pericarditis, Pyrexia
Clinical narrative: Pericarditis from the booster; Tightness in the chest; pain of three out of 10 pain increased to seven and became sharp pain in upper left chest; flu like symptoms; discomfort with deep breathing; aches; pain of three out of 10; discomfort in chest; fatigue; Low fever; This is a spontaneous report from a contactable consumer or other non hcp.  A 48-year-old male patient received bnt162b2 (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was FF2589, Expiration Date: Unknown) as dose 3, (BOOSTER) single via an unspecified route of administration, administered in Arm Right on 14Oct2021 10:00 (age at vaccination 48 years) for covid-19 immunisation. Historical vaccine received was (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was EM9809, Expiration Date: Unknown) as dose 2, single via an unspecified route of administration, administered in Arm Right on 30Mar202110:00 for covid-19 immunisation and also received (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was EM9809, Expiration Date: Unknown) as dose 1, single via an unspecified route of administration, administered in Arm Right on 03Mar2021 10:00 for covid-19 immunisation. Allergy were reported as reaction. Medical history included none-very healthy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 23Oct2021 12:00pm patient experience Tightness in the chest starting nine days after the booster, third shot. After 10 hours of chest tightness and pain of three out of 10, pain increased to seven and became sharp pain in upper left chest. Emergency room visit and subsequent appointments to cardiologist with labs revealed no cardiac abnormalities or blood clots. The primary theory is Pericarditis from the booster. Current symptoms are discomfort in chest and flu like symptoms. Low fever, aches, fatigue and discomfort with deep breathing. The patient underwent lab tests and procedures which included investigation: no cardiac abnormalities on labs revealed no cardiac abnormalities or blood clots , investigation: three out of 10 pain on , investigation: increased on pain of three out of 10 pain increased to seven and became sharp pain in upper left chest. Therapeutic measures were taken and currently patient on anti-inflammatories. The outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Musculoskeletal stiffness, Pruritus, Rash, Vaccination site pain
Clinical narrative: itch; rash; Immediately on vaccination I had a heart flutter which lasted about less than second and went away and I felt OK.; stiffness; pain in left arm at the vaccination area/pain at the site of COVID-19 vaccination site; This is a spontaneous report from a contactable healthcare professional (patient). This 64-year-old female patient received dose 1 of BNT162B2 (lot number FH8020) via an unspecified route of administration on 15Oct2021 at 11:00 (at the age of 64-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included sinusitis/rhinitis. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were none. It was unknown if the patient had any allergies. Immediately on vaccination (on 15Oct2021) the patient felt a heart flutter which lasted about less than second and went away and she felt okay. For the next 24 to 36 hours the patient had the usual expected stiffness and pain in left arm at the vaccination area. By 48 hours the stiffness and pain went away and there was no swelling or rash. Exactly two weeks (14 days) later on 29Oct2021, she began to have itch, rash and pain at the site of COVID-19 vaccination site on her left arm. Now (30Oct2021) was the second day and the condition seemed to be getting worse. The events were reported as serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of heart flutter and stiffness were recovered. The outcomes of itch, rash, and pain at the vaccination site were not recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cerebrovascular accident, Drug ineffective
Clinical narrative: had a stroke a couple hours after; The patient was immunocompromised and got sick after taking the vaccine, and got COIVD; The patient was immunocompromised and got sick after taking the vaccine, and got COIVD; This is a spontaneous report from a contactable healthcare professional reporting different events under the same suspect product for 2 patients. This is one of 2 reports. An 83-year-old male patient received BNT162B2 (COMIRNATY; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date, dose number unknown, single for COVID-19 immunisation. Medical history included immunocompromised. The patient's concomitant medications were not reported. The reporter was reporting regarding Pfizer COVID-19 vaccine. The reported noted that in some places like on the news it was saying that it was good for the  immunocompromised, but when she looked at the inserts or even the press release it said that if one was immunocompromised, they should not take this. She had a couple of people that she worked with who had an autoimmune condition and have gotten sick from it. She was trying to see what was the best course of action for a future patient. The reporter stated that the patient was immunocompromised and got sick after taking the vaccine and got COVID. The patient had a stroke a couple hours after. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of the suspect drug cannot be excluded for event cerebrovascular accident and drug ineffective. However, the patient is 83 yo and is at higher risk for stroke. The background medical history for this patient is not available, thus limiting the causality assessment. Event COVID-19 is attributed to an intercurrent medical condition, attributable to the current global COVID-19 pandemic, and is considered unrelated to the suspect product. This case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Investigation, Tricuspid valve incompetence
Clinical narrative: I have been diagnosed as having mild tricuspid regurgitation; I began chest pains within a day of getting the first shot; This is a spontaneous report from a contactable consumer (patient). A 43-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on Aug2021 (Lot Number: FA7484) (at the age of 43-years-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient was healthy and had no known allergies. There were no concomitant medications within 2 weeks of vaccination. 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 and since the vaccination, the patient has not been tested for COVID-19. The patient began chest pains within a day of getting the first shot in 2021. After many heart tests and ER (emergency room) visits, she was diagnosed as having mild tricuspid regurgitation. The patient received treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient reported that the events was serious as disabling/incapacitating. The patient was going to a cardiologist to find out the treatment. The patient received second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on Aug2021 (Lot Number: FA7484) (at the age of 43-years-old) as dose 2, single for covid-19 immunisation. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Hyperhidrosis, SARS-CoV-2 test
Clinical narrative: profuse sweating; Shortness of breath; weakness; This is a spontaneous report from a contactable physician. An 83-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: 0810, Expiration date: Not reported), via intramuscular route in right arm on 14Oct2021 at 13:00 (at the age of 83-years-old) as dose 3 (booster), single for COVID-19 immunization in a pharmacy/drug store. The patient's other medical history included cardiomyopathy and esophagitis. The patient was allergic to shellfish and other fish. Concomitant medications/any other medications received by the patient within 2 weeks of vaccination included carvedilol, furosemide, methylprednisolone and sertraline. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route in right arm on 13Mar2021 at 13:00 (Lot number: 9266, Expiration date: Not reported) as dose 2, single and in Feb2021 at 13:00 (Lot number: Unknown, Expiration date: Not reported) as dose 1, single for COVID-19 immunization (at the age of 83-years-old). The patient was not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. On 14Oct2021 at 23:00, the patient experienced shortness of breath, weakness and profuse sweating. The patient was hospitalized for these events on 14Oct2021 and received treatment with steroids, nutritional support and mycophenolic acid (MYFORTIC) which led to emergency room/department or urgent care, hospitalization/prolongation of existing hospitalization (vaccine received during existing hospitalization) and disability or permanent damage. Since the vaccination (post vaccination), the patient had been tested for COVID-19 by nasal swab with COVID polymerase chain reaction (PCR) and ribonucleic acid (RNA) rapid nucleic acid amplification (NAA) test on 15Oct2021 with negative result. The patient was discharged from the hospital on 30Oct2021 with 16 days of hospitalization. The outcome of these events was not recovered at the time of report.   The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Postmenopausal haemorrhage
Clinical narrative: Brought me out of years of menopause and I had a menstrual cycle for a full week; All my bones ache more; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 59 years old) via an unspecified route of administration, administered in Arm Right on 22Apr2021 (Batch/Lot Number: EN6199) as dose 2, single for covid-19 immunisation. Medical history included known allergies: Penicillin. There were no concomitant medications. The patient had no covid prior vaccination, not other vaccine in four weeks and no other medications in two weeks. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 59 years old) via an unspecified route of administration in the right arm on 25Mar2021 (Batch/Lot No: EN6199) for Covid-19 Immunization. The patient reported that on 25Apr2021, it brought her out of years of menopause, and she had a menstrual cycle for a full week. All her bones ache more. She has been to the doctor and they couldn't find anything wrong. So, the patient would like to know how it changed her system when they said it doesn't affect DNA. The events were treated on check-up. The patient was not tested for covid-19 post vaccination. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Head discomfort, Immunisation, Off label use, Wrong product administered
Clinical narrative: gave me the another Pfizer shot; a fourth booster; gave me the another Pfizer shot; a fourth booster; received a fourth booster dose by mistake (instead of flu shot); head is about to explode; This is a spontaneous report from a contactable consumer (patient). A 65-year-old patient of unspecified gender received fourth dose of bnt162b2 via unspecified route of administration on 29Oct2021 (lot number: FH8020), at the age of 65-years-old, at DOSE 4 (BOOSTER), SINGLE for COVID-19  immunization. Patient medical history and concomitant medications were not reported. The patient previously received third dose of bnt162b2 on unspecified date in Oct2021 (Lot #: FF8839) at the age of 65-years-old at DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. It was reported that the patient went to clinic today (29Oct2021) because last Friday (unspecified date in Oct2021), patient should receive booster Pfizer and a flu shot, however clinic they didn't had the flu and only booster Pfizer (lot number FF8839) was received last Friday, on unspecified date in Oct2021. So, the patient went in today, 29Oct2021, to get the flu shot (Unspecified Shot). However, it was reported that the patient received another Pfizer shot (lot number FH8020) as the man did not check. When patient got outside, the nurse found out that patient received a fourth booster dose on 29Oct2021 by mistake (man confirmed that he made a mistake by giving the patient a "fourth Pfizer"). It was further clarified that patient got the fourth booster dose and did not receive the flu shot. Patient was crying because of the thought of "might be dying". Patient went to doctor and told what happened; doctor put it on patient records that fourth booster shot was received. Patient wanted to know if patient would have side effect because right now, patient head was about to explode on 29Oct2021. Patient further stated that this was the first time they gave four shots so patient was really concerned. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bone deformity, Fatigue, Feeling abnormal, Finger deformity, General physical health deterioration
Clinical narrative: veins are popping out; Her fingers are all getting twisted to the side; Hurting; Fatigue; her body is deteriorating; She cant sleep; her bones, her hands they are becoming deformed.; her bones, her hands they are becoming deformed.; all of a sudden is down; This is a spontaneous report via contactable consumer. A female patient (reporters mother) of an unspecified age received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) as DOSE 1, SINGLE and DOSE 2, SINGLE both on an unspecified date and unspecified route of administration for COVID-19 immunisation. The patients medical history and concomitant medication were not reported. On an unspecified date, patient had veins are popping out, her fingers are all getting twisted to the side, hurting, fatigue, her body is deteriorating, she cant sleep, her bones, her hands they are becoming deformed, all of a sudden is down. It was reported that patient was 100% healthy no health conditions had her body deteriorating, veins popping out, all fingers getting twisted to the side, severe fatigue, with her bones and hands becoming deformed and suddenly felt down after receiving both vaccines. Otherwise, she was previously out going, beautiful, radiant, walked into the room and feel like the sun is shining with her smile. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Hand deformity, Pain, Sleep disorder, Varicose vein
Clinical narrative: veins are popping out; Her fingers are all getting twisted to the side; Hurting; Fatigue; her body is deteriorating; She cant sleep; her bones, her hands they are becoming deformed.; her bones, her hands they are becoming deformed.; all of a sudden is down; This is a spontaneous report via contactable consumer. A female patient (reporters mother) of an unspecified age received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) as DOSE 1, SINGLE and DOSE 2, SINGLE both on an unspecified date and unspecified route of administration for COVID-19 immunisation. The patients medical history and concomitant medication were not reported. On an unspecified date, patient had veins are popping out, her fingers are all getting twisted to the side, hurting, fatigue, her body is deteriorating, she cant sleep, her bones, her hands they are becoming deformed, all of a sudden is down. It was reported that patient was 100% healthy no health conditions had her body deteriorating, veins popping out, all fingers getting twisted to the side, severe fatigue, with her bones and hands becoming deformed and suddenly felt down after receiving both vaccines. Otherwise, she was previously out going, beautiful, radiant, walked into the room and feel like the sun is shining with her smile. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Neuralgia, Pain in extremity
Clinical narrative: pain / the reaction she had was like "charley horse pain" felt like nerve pain in the front of the leg(s)./nerve pain like a charley horse; pain / the reaction she had was like "charley horse pain" felt like nerve pain in the front of the leg(s)./nerve pain to the front of her leg; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 67-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EN6208) via an unspecified route of administration on 21Mar2021 (at the age of 67-year-old) as dose 2, single and bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EN6205) via an unspecified route of administration, administered in arm on 28Feb2021 as dose 1, single for covid-19 immunization. Medical history included diabetes, diagnosed over ten years ago; and the only thing she does have are essential tremors, which she is on medication for, and she is on a medication for diabetes and cancer, she was immunocompromised due to her cancer from an unknown date and unknown if ongoing. There were no concomitant medications. Caller stated she received her booster shot, 6 months later from the first 2 shots but said she does not know if it was a booster for an actual booster or for immunocompromised patients. Caller did not remember if it was after dose one or dose two. She stated that her third dose booster was given on 01Nov2021 of LOT: 30155, and she did't know, but there was a space then BA. On an unspecified date in 2021 the patient experienced pain / the reaction she had was like "charley horse pain" felt like nerve pain in the front of the leg(s)./nerve pain like a charley horse. She didn't took medicine or anything, she just kind of massaged it, and then finally it stopped. She says she couldn't walk on it so she would do a little bit of pulling her leg up and down and straighten it, then after pain stopped. She says she would try to massage it a minute or two, she couldn't walk on it until the pain subsided. She says it lasted maybe a couple minutes then it went away each time after she did those things. She says it may have come back a little again and then it would go away again. She says it probably happened once again after the first, then again for a couple times after the second, and maybe between, where it was tightened. She says she believes it was just the right leg that had the nerve pain to the front of the leg. The patient underwent lab tests and procedures which included computerised tomogram (reported as CT scan): blood clot in her legs, She says she had a scan for blood clots and they said it was fine on an unspecified date in 2021. No treatment received for the events. Outcome of the events were unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Cardiac arrest
Clinical narrative: Cardiac arrest; This is a solicited report via a contactable consumer based on information received by Pfizer from a company (manufacturer control number: 21K-163-4137210-00).   A 47-year-old male patient received bnt162b2 (BNT162B2), intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; risankizumab rzaa (SKYRIZI [RISANKIZUMAB RZAA]), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for psoriasis.  The patient medical history was not reported.     The patient's concomitant medications were not reported. On 29Sep2021, the patient experienced cardiac arrest with outcome of recovered on an unspecified date in 2021.  The action taken in response to the event for risankizumab rzaa was dose not changed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. The reporter's causality for the event of cardiac arrest was not provided. Company's opinion is that the event of cardiac arrest is not assessable.; Sender's Comments: Based on the limited information available, a causal association between the suspect drug and the event 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: extreme pain in lower back; minor pain in the arm; This is a spontaneous report from a contactable consumer (patient).  A 73-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 11Feb2021 13:30 (Batch/Lot Number: EN6201) (at the age of 73-years-old)  as DOSE 1, SINGLE for COVID-19 immunisation. The vaccine was administered in a school/student health clinic.  There were no other vaccines received in four weeks. The patient did not have COVID-19 prior to vaccination. Medical history included cancer, heart attack, and allergies to shellfish, tobacco, and penicillin from unknown dates and unknown if ongoing. Concomitant medications included amiodarone; aspirin [acetylsalicylic acid]; carvedilol (CARVEDIL); furosemide (LASIX [FUROSEMIDE]); and lisinopril, taken for unspecified indications, start and stop dates were not reported.  The patient previously took aspirin and acetaminophen and experienced drug allergies.  On 12Feb2021 (reported as 12:00 AM), the patient experienced extreme pain in lower back and minor pain in the arm. The events were considered serious due to disability, and medically significant by reporter. The patient's clinical course was reported as follows: Minor pain in the arm but by midnight extreme pain in lower back. The patient had lower back pain and thought maybe he overdid some of his physical exercise. After 2 weeks of this pain, he stopped his physical exercise to give back a rest. The back pain had completely disappeared. Over the next 9 days, three trips to the ER (once by ambulance) serious pain pills prescribed. Eventually the pain subsided (corresponding to the pain in the lower back returning) 3 months of physical therapy with (facility name) and he continued treatment at home. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and caused disability or permanent damage.  The patient was tested for COVID-19 post vaccination. The patient underwent lab tests and procedures which included COVID  test nasal swab: negative on 30Apr2021.   Therapeutic measures were taken as a result of the events. The outcome of the events was recovered with sequelae.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: Tinnitus in my left ear; mid fever; This is a spontaneous report from a contactable consumer or other non hcp (patient).    A 27-years-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) as single dose via an unspecified route of administration, administered in Arm Left on 24Apr2021 as dose 2, single (at the age of 27-years-old) for covid-19 immunisation. Medical history reported as none (known allergies: not that I know of other medical history: not that I know of). The patient's concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) via an unspecified route of administration in Arm Left on 03Apr2021 as dose 1, single (at the age of 27-years-old) for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19. On 25Apr2021, 1 days after vaccination the patient experienced tinnitus in her left ear, mild fever after the second shot of the Pfizer shot. events reported as serious Disability. as a resulted events patient visited physician office visit. patient did not received any treatment for events. she went to a hearing specialist and she said everything looks normal. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 20Jul2021. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Neck pain, Pain assessment, Pain in extremity
Clinical narrative: shooting pain that buckled my knees; Extreme pain from top of neck, through shoulders and arms; Extreme pain from top of neck, through shoulders and arms; pain across my upper back and extending down my upper arms; pain across my upper back and extending down my upper arms; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6205), via an unspecified route of administration, in left arm on 04Mar2021 13:30 (at the age of 73-years-old) as dose 2, single for COIVD-19 immunization. Medical history included cancer and heart attack. The patient was allergic to shellfish, tobacco, aspirin, acetaminophen and penicillin. Concomitant medications included amiodarone, acetylsalicylic acid (ASPIRIN), carvedilol (CARVEDIL), furosemide (LASIX) and lisinopril. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6201), via an unspecified route of administration, in left arm on 11Feb2021 01:30 PM as dose 1, single for COIVD-19 immunization after which the patient experienced minor pain in arm and extreme pain in lower back. No other vaccine was given in 4 weeks. Within 4 hours of second shot, the patient experienced building pain across upper back and extending down upper arms on 04Mar2021. By morning, extreme pain from top of neck, through shoulders and arms on 05Mar2021. The pain was on scale 10 with zingers of shooting pain that buckled his knees. Over the next 9 days the patient had three trips to the Emergency Room (once by ambulance) and serious pain pills were prescribed. Eventually the pain subsided (corresponding to the pain in the lower back returning) 3 months of physical therapy with Kaiser and he continued treatment at home. The patient underwent lab tests and procedures which included COVID test result: negative on 30Apr2021. The outcome of the events was recovered with sequalae.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test
Clinical narrative: shooting pain that buckled my knees; Extreme pain from top of neck, through shoulders and arms; Extreme pain from top of neck, through shoulders and arms; pain across my upper back and extending down my upper arms; pain across my upper back and extending down my upper arms; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6205), via an unspecified route of administration, in left arm on 04Mar2021 13:30 (at the age of 73-years-old) as dose 2, single for COIVD-19 immunization. Medical history included cancer and heart attack. The patient was allergic to shellfish, tobacco, aspirin, acetaminophen and penicillin. Concomitant medications included amiodarone, acetylsalicylic acid (ASPIRIN), carvedilol (CARVEDIL), furosemide (LASIX) and lisinopril. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6201), via an unspecified route of administration, in left arm on 11Feb2021 01:30 PM as dose 1, single for COIVD-19 immunization after which the patient experienced minor pain in arm and extreme pain in lower back. No other vaccine was given in 4 weeks. Within 4 hours of second shot, the patient experienced building pain across upper back and extending down upper arms on 04Mar2021. By morning, extreme pain from top of neck, through shoulders and arms on 05Mar2021. The pain was on scale 10 with zingers of shooting pain that buckled his knees. Over the next 9 days the patient had three trips to the Emergency Room (once by ambulance) and serious pain pills were prescribed. Eventually the pain subsided (corresponding to the pain in the lower back returning) 3 months of physical therapy with Kaiser and he continued treatment at home. The patient underwent lab tests and procedures which included COVID test result: negative on 30Apr2021. The outcome of the events was recovered with sequalae.
Age: 54.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal pain, Chest pain, Immunisation, Investigation, Off label use
Clinical narrative: abdominal pain; Chest pain; Dose 3; received bnt162b2 (BNT162B2), intramuscular on Oct2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; This is a solicited report from based on information received by Pfizer, (manufacturer control number: (21K-163-4136859-00).   A contactable consumer (patient) reported that a 54-years-old female patient received bnt162b2 (BNT162B2), intramuscular on Oct2021 at 54-years-old (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, for Moderate to Severe Rheumatoid arthritis. The patient medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient previously took dose 1 and 2 of bnt162b2, intramuscular on an unspecified date for covid-19 immunization. She stated that after she had chest pain and went to the emergency room. She stayed in the hospital and was monitored for 24 hours and then discharged. In 2021, she had abdominal pain and went back to the emergency room. All tests came back normal and she was sent home. The patient experienced chest pain (hospitalization for 1 day) on Oct2021, abdominal pain (hospitalization) on Oct2021. The patient underwent lab tests and procedures which included All Tests: normal on 2021. The action taken in response to the event(s) for adalimumab was unknown. The outcome of the events was unknown. The reporter's causality for Humira and event(s) of chest pain and abdominal pain was not provided. withheld opinion is that the events of chest pain and abdominal pain are not assessable. Causality of Pfizer Biontech Covid-19 Vaccine and events as per reporter was Possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available in narrative the reported  event of  Chest pain, abdominal pain, Booster and off label use are assessed as related to suspected vaccine BNT162B2 The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID about a month ago; got COVID about a month ago; This is a spontaneous report from a non-contactable consumer (patient's parent). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included steroids. It was reported that the patient unfortunately got COVID about a month ago on an unspecified date in 2021. The patient is being followed by Rheumatologists and is on steroids. The patient was treated with monoclonal antibodies. Outcome of events was resolved on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Interchange of vaccine products, Neuropathy peripheral, Off label use, Paraesthesia
Clinical narrative: Itching, like bugs crawling on her, all the time; Felt zapping Electrical shots on her legs, arms, and face; A faint tingling in the legs; Off label use; Interchange of vaccine products; Neuropathy reaction; This is a spontaneous report from a non-contactable consumer (patient). A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported), at dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced neuropathy reaction, itching, like bugs crawling on her, all the time, felt zapping electrical shots on her legs, arms, and face, a faint tingling in the legs on an unspecified date; off label use and interchange of vaccine products on an unspecified date. The course of the events is as follows: Caller stated that she had a reaction to Pfizer's first dose. Three days after vaccination she started having symptoms which she describes as a neuropathy reaction that lasted for five months. She had itching, like bugs crawling on her, all the time. She also felt zapping like electrical shots on her legs, arms, and face. Now, she still has a faint tingling in the legs. Because of this, she did not  get the second dose of the vaccine. She was tested for antibodies and she had none. Her doctor referred her to an immunologist who told her that he could dilute the Moderna vaccine and distribute it that way. He would mix the vaccine with saline and apply it as a six doses series. The patient underwent laboratory tests and procedures which included antibodies: none on an unspecified date. The outcome of event neuropathy reaction was recovered on an unspecified date; outcome of events  itching, like bugs crawling on her, all the time, felt zapping electrical shots on her legs, arms, and face was unknown; outcome of event a faint tingling in the legs was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, SARS-CoV-2 antibody test
Clinical narrative: Itching, like bugs crawling on her, all the time; Felt zapping Electrical shots on her legs, arms, and face; A faint tingling in the legs; Off label use; Interchange of vaccine products; Neuropathy reaction; This is a spontaneous report from a non-contactable consumer (patient). A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported), at dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced neuropathy reaction, itching, like bugs crawling on her, all the time, felt zapping electrical shots on her legs, arms, and face, a faint tingling in the legs on an unspecified date; off label use and interchange of vaccine products on an unspecified date. The course of the events is as follows: Caller stated that she had a reaction to Pfizer's first dose. Three days after vaccination she started having symptoms which she describes as a neuropathy reaction that lasted for five months. She had itching, like bugs crawling on her, all the time. She also felt zapping like electrical shots on her legs, arms, and face. Now, she still has a faint tingling in the legs. Because of this, she did not  get the second dose of the vaccine. She was tested for antibodies and she had none. Her doctor referred her to an immunologist who told her that he could dilute the Moderna vaccine and distribute it that way. He would mix the vaccine with saline and apply it as a six doses series. The patient underwent laboratory tests and procedures which included antibodies: none on an unspecified date. The outcome of event neuropathy reaction was recovered on an unspecified date; outcome of events  itching, like bugs crawling on her, all the time, felt zapping electrical shots on her legs, arms, and face was unknown; outcome of event a faint tingling in the legs was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: she came down with COVID-19; she came down with COVID-19; Off label use; Interchange of vaccine products; This is a spontaneous report based on the information received by Pfizer from a regulatory authority, on behalf of Moderna (Reference: MOD21-158058). A female patient of unknown age received an unknown dose bnt162b2 (COMIRNATY, solution for injection, lot number and expiration date were not reported) via an unspecified route of administration, on an unspecified date in Jan2021, as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter was inoculated with Moderna with second dose at the end of Apr2021. Only side effect was waking up thirsty the night of the shots. In September, the reporter had lunch with someone, vaccinated with Pfizer in Jan2021, that we thought was having allergy issues. They sat across the table from her for over an hour in close contact, and we even kissed when we departed. Two days later she came down with COVID-19. This was diagnosed by two tests and by a physician. The reporter never came down with covid-19. The reporter calls that a success and was very grateful. Outcome of the events were unknown.  The lot number for the vaccine (bnt162b2), was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Malaise, Near death experience, Off label use
Clinical narrative: bnt162b2 as third booster dose; bnt162b2 as third booster dose; I almost died; sick; This is a spontaneous report from a contactable consumer (patient). An elderly female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as third booster dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient is not pregnant. The patient previously received bnt162b2 (lot number: not reported) on unspecified dates as first and second dose, single for covid-19 immunisation. The patient reported that on unspecified date, "I was sick I almost died." Outcome of all the events sick and I almost died was recovered on unspecified date.   The lot number for vaccine [BNT162B2] was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever following vaccination; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP. A patient of an unspecified age and gender received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 3, SINGLE dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously, the patient received two doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single and dose 1, single dose for COVID-19 immunization and no events were reported. On an unspecified date, the patient experienced Fever following vaccination. Event took place after use of product. The clinical outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.