chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion, Pyrexia
Clinical narrative: Congestion; fatigue; fever; This is a spontaneous report from a contactable consumer (patient's wife). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE solution for injection; lot number: 301308A), via an unspecified route of administration on 06Sep2021 at 11:00 (at the age of 62-years-old) at dose 1, single in the left arm for COVID-19 immunization. Medical history included A-fib, hyperlipidemia, bradycardia, obstructive sleep apnea, mitral regurgitation, tricuspid regurgitation, and COVID-19. The patient has no known allergies. The patient was not tested for COVID-19 post vaccination. Concomitant medications included apixaban (ELIQUIS), atorvastatin calcium (LIPITOR), digoxin (DIGOXIN), flecainide (FLECAINIDE), and tadalafil (CIALIS). The patient did not receive any other vaccines in four weeks. On Sep2021, after the first vaccination, the patient experienced congestion, fatigue, and fever. No treatment received for the events. Outcome of the events was unknown.
Age: 0.42
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk, Urticaria
Clinical narrative: mom breastfeeds, got the vaccine and the baby got hives all his around neck and, on his stomach; mom breastfeeds, got the vaccine and the baby got hives all his around neck and, on his stomach; This is a spontaneous report from a contactable consumer (parent). This consumer reported for herself and her child. This is one of three reports (baby case). Only this case is serious.   A 5-month-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), transmammary on 04Oct2021 (Batch/Lot Number: 301458A) (at the age of 5-months-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The mother reported that she breastfeeds, got the vaccine on 04Oct2021 and the baby got hives all his around neck and, on his stomach on 06Oct2021. The mother stated that the ones on his neck are still pretty red and may be from drooling. The mother stated that the ones on his stomach are still there but not as red. The mother has been putting A&D ointment on it. Outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101452994 baby case 2nd dose;US-PFIZER INC-202101452995 mother case
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: a breakout of the hives over parts of my body; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a breakout of the hives over parts of body on 2021. On advice from doctor, patient took one Benadryl for 3 nights. Every time he took the pill it would disappear for a few hours. Finally it vanished after 4 days completely.  Patient was asking if it could be  that he had too many antibodies from the previous 2 Pfizer shots. Outcome of the event was recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeding disorder, Inappropriate schedule of product administration, Insomnia, SARS-CoV-2 test
Clinical narrative: 02Jun2021 first dose; 18Aug2021 with second dose; she was having some wheezing which was keeping her up at night; she was having some wheezing which was keeping her up at night; had persistent cough; The caller states it was really bad, she couldn't eat; This is a spontaneous report from a contactable consumer (patient). A 42-year-old (currently) female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 18Aug2021 (at the age of 41-year-old) (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient had no medical history. The patient had concomitant medications but she was not on any new medications, she reported that everything was the same and had been on the same meds, the only thing that was different was this shot. The patient previously received bnt162b2 on 02Jun2021 for covid-19 immunisation and experienced Bell's Palsy and was still persisting. In 2021, the patient experienced having some wheezing which was keeping her up at night. The patient reported that she was having some wheezing which was keeping her up at night and she was given an inhaler and Z-pak of antibiotics after the second dose. She also had persistent cough and her doctor ran the test to see if she was exposed to COVID or had COVID. The patient stated she knew she could still get COVID even after having the vaccine, but the test was negative in 2021. She has a checkup with her doctor on the 2nd (as reported) and her primary was going to tell her if she possibly has COPD or if it was bronchitis. The patient stated that the Bell's Palsy developed some time in between the two shots and the Bell's Palsy was still persisting, it's gotten somewhat better. Her speech was still off and face was still skewed but it's not where it used to be. She completely had everything done that was needed to determine what she had was Bell's palsy. In 2021, the patient stated that it was really bad and she couldn't eat. The patient initially stated she was 228lbs, but then she may be 220lbs. She was roughly 220-228lbs, she hasn't weighed in a while. There were no additional vaccines administered on same date of the Pfizer suspect, no prior vaccinations (within 4 weeks), and no events following prior vaccinations. Outcome of event persistent cough was not recovered; and outcome of the rest of events was unknown.  The lot number for bnt162b2, was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: 02Jun2021 first dose; 18Aug2021 with second dose; she was having some wheezing which was keeping her up at night; she was having some wheezing which was keeping her up at night; had persistent cough; The caller states it was really bad, she couldn't eat; This is a spontaneous report from a contactable consumer (patient). A 42-year-old (currently) female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 18Aug2021 (at the age of 41-year-old) (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient had no medical history. The patient had concomitant medications but she was not on any new medications, she reported that everything was the same and had been on the same meds, the only thing that was different was this shot. The patient previously received bnt162b2 on 02Jun2021 for covid-19 immunisation and experienced Bell's Palsy and was still persisting. In 2021, the patient experienced having some wheezing which was keeping her up at night. The patient reported that she was having some wheezing which was keeping her up at night and she was given an inhaler and Z-pak of antibiotics after the second dose. She also had persistent cough and her doctor ran the test to see if she was exposed to COVID or had COVID. The patient stated she knew she could still get COVID even after having the vaccine, but the test was negative in 2021. She has a checkup with her doctor on the 2nd (as reported) and her primary was going to tell her if she possibly has COPD or if it was bronchitis. The patient stated that the Bell's Palsy developed some time in between the two shots and the Bell's Palsy was still persisting, it's gotten somewhat better. Her speech was still off and face was still skewed but it's not where it used to be. She completely had everything done that was needed to determine what she had was Bell's palsy. In 2021, the patient stated that it was really bad and she couldn't eat. The patient initially stated she was 228lbs, but then she may be 220lbs. She was roughly 220-228lbs, she hasn't weighed in a while. There were no additional vaccines administered on same date of the Pfizer suspect, no prior vaccinations (within 4 weeks), and no events following prior vaccinations. Outcome of event persistent cough was not recovered; and outcome of the rest of events was unknown.  The lot number for bnt162b2, was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Gestational hypertension, Immunisation, Maternal exposure during pregnancy, Pre-eclampsia, SARS-CoV-2 test
Clinical narrative: Dose 3 (booster), single; Preeclampsia; Gestational Hypertension; The patient was pregnant/ Gestational period 37; This is a spontaneous report received from a contactable consumer (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number 301458A), via unspecified route of administration in left arm on 02Oct2021 13:15 (at the age of 31-year-old) as dose 3 (booster), single for COVID-19 immunization. The patient's medical history included gestational diabetes from unspecified date. The patient had no known allergies. The patient did not have COVID-19 prior vaccination. The patient's concomitant medications within 2 weeks included unspecified pre-natal vitamin. The patient previously received BNT162B2 via unspecified route of administration in left arm on 11Feb2021 12:00 PM (lot number EL9266) (at the age of 31-year-old) and via unspecified route of administration in left arm on 03Mar2021 12:00 PM (lot number EN6202) (at the age of 31-year-old) for COVID-19 immunization. The patient received other unspecified vaccine (reported as Sanofi-Pasteur) within 4 weeks from vaccination on 29Sep2021 (lot number UT7330MA) administered in left arm. The patient was pregnant. Last menstrual date was 15Jan2021 and delivery date was 06Oct2021. Gestational period 37. The patient experienced gestational hypertension and preeclampsia on 05Oct2021 09:30 AM. The events required doctor or other healthcare professional office/clinic visit. The events were reported as serious with hospitalization criterion with number of days of hospitalization reported as 4. Treatment received due to the events included magnesium. The patient was tested for COVID-19 post-vaccination on 12Oct2021 with test type nasal swab and negative result. The outcome of the events was unknown for "the patient was pregnant/ gestational period 37" and resolving for all other events.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, SARS-CoV-2 antibody test
Clinical narrative: Miscarriage; This is a spontaneous report from a contactable other healthcare professional (patient).  A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Sep2021 (Batch/Lot Number: FC3184) (at the age of 35-years-old) as DOSE 2, SINGLE for COVID-19 immunisation.  Medical history included sulfa allergy, polycystic ovarian syndrome (PCOS), pseudotumor cerebri, and depression; from unknown dates and unknown if ongoing. Patient was pregnant at time of vaccination, date of LMP was on 12Jun2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included duloxetine hydrochloride (CYMBALTA); folic acid; ascorbic acid, biotin, calcium pantothenate, camellia sinensis leaf, carotenoids nos, choline bitartrate, chromium picolinate, colecalciferol, copper citrate, ferrous fumarate, folic acid, inositol, magnesium glycinate, magnesium oxide, manganese citrate, mecobalamin, molybdenum aspartate, nicotinamide, phytomenadione, potassium bicarbonate, potassium iodide, punica granatum fruit, pyridoxine hydrochloride, retinol acetate, riboflavin, selenomethionine, thiamine hydrochloride, tocopheryl acid succinate, zinc glycinate (BARIATRIC ADVANTAGE ULTRA MULTI WITH IRON); lorazepam (ATIVAN); and galcanezumab (EMGALITY [GALCANEZUMAB]); all taken for unspecified indications, start and stop dates were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Aug2021 (Batch/Lot Number: FA7485) (at the age of 35-years-old) as DOSE 1, SINGLE for COVID-19 immunization. On 01Oct2021, the patient experienced miscarriage (medically significant).The mother was 16 Weeks pregnant at the onset of the event. The mother was due to deliver on an unknown date.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been has been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab: negative  in Sep2021, negative on 25Oct2021.  The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of miscarriage which included dilation and curettage (D&C). The outcome of the event was recovered with sequelae.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events miscarriage. 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: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhabdomyolysis, SARS-CoV-2 test, Swelling face, Vomiting
Clinical narrative: rhabdomyolysis; Swollen face; high fever; vomit; This is a spontaneous report from a contactable consumer (patient's parent). A 12-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 24Oct2021 16:00 PM (Batch/Lot Number: FF2590) (at the age of 12-years-old) as dose 2, single for COVID-19 immunization. Facility type vaccine was pharmacy or drug store. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. Medical history included allergy (relevant past drug history: Name of Drug as Reported: None, Reaction: Allergy). There were no concomitant medications. The patient had no other medications in two weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in the left arm on 03Oct2021 16:00 PM (Batch/Lot Number: FF8841) (at the age of 12-years-old) for COVID-19 immunization. The reporter stated that on 25Oct2021 at 08:00 AM, the patient experienced severe reaction: Swollen face, high fever, vomit, rhabdomyolysis. The events resulted in emergency room/department or urgent care. The events were reported as non-serious. The patient was tested for COVID post vaccination which was a nasal swab on 25Oct2021, and result is pending. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Cough, Fatigue, Immunisation, Myocarditis
Clinical narrative: Booster; possible myocarditis; extreme fatigue; Cough; sore throat; something is going on with his heart; This is a spontaneous report from a non-contactable consumer (patient). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number was not provided), dose 3 via an unspecified route of administration at the age of 71-year-old on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), all for Covid-19 immunization. The patient experienced possible myocarditis, extreme fatigue, cough, sore throat, something was going on with his heart on an unspecified date. Caller stated that he wanted to know about the symptoms of myocarditis. Stated that he had reported it to the doctor that he had extreme fatigue, cough, sore throat and it never went anywhere. Stated that he was trying to figure out how to request for cardiologist if something was going on with his heart. Is for the Covid 19 vaccination. Stated that he had the third dose. Stated that he was71 years old. Stated that he tried to notify the site on Pfizer but it would not take the report due to required information not filled in. Stated that he should go to his (name-withheld) doctor. The event possible myocarditis was serious for being medical significant. The outcome of events of event was unknown.     No follow up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Booster; possible myocarditis; extreme fatigue; Cough; sore throat; something is going on with his heart; This is a spontaneous report from a non-contactable consumer (patient). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number was not provided), dose 3 via an unspecified route of administration at the age of 71-year-old on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), all for Covid-19 immunization. The patient experienced possible myocarditis, extreme fatigue, cough, sore throat, something was going on with his heart on an unspecified date. Caller stated that he wanted to know about the symptoms of myocarditis. Stated that he had reported it to the doctor that he had extreme fatigue, cough, sore throat and it never went anywhere. Stated that he was trying to figure out how to request for cardiologist if something was going on with his heart. Is for the Covid 19 vaccination. Stated that he had the third dose. Stated that he was71 years old. Stated that he tried to notify the site on Pfizer but it would not take the report due to required information not filled in. Stated that he should go to his (name-withheld) doctor. The event possible myocarditis was serious for being medical significant. The outcome of events of event was unknown.     No follow up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot in leg; This is a spontaneous report from a contactable consumer (patient). An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on 04Oct2021 at age of 36-year-old at single dose, unknown dose number for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had blood clot in leg (also reported as allowed to clock in leg) on 06Oct2021. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient was fully vaccinated, but still got COVID; Patient was fully vaccinated, but still got COVID; This is a spontaneous report from a contactable other health professional (HCP). An adult non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number/s not reported), as dose 1, single, then as dose 2, single, both via an unspecified route of administration on an unspecified date for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was fully vaccinated, but still got COVID on an unspecified date. The patient underwent lab tests and procedures which included Sars-Cov-2 test: got covid on an unspecified date. Treatment was unknown for both events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective / COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Clostridium difficile infection, Clostridium test, Colitis, Diagnostic procedure
Clinical narrative: Clostridium difficile (C-diff) infection; Acute colitis; This is a solicited report from a Non-Interventional Study based on the information received by Pfizer from AbbVie, manufacturer control number: 21K-163-4128768-00. A contactable 71-year-old male consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation; and adalimumab (HUMIRA, Solution for injection in pre-filled pen; citrate free), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose and frequency for psoriatic arthritis. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Patient received 1st dose COVID-19 vaccine manufactured by Pfizer. There was no reported medical history. The patient's concomitant medications were not reported. On unknown dates, the patient experienced acute colitis due to covid vaccine and Clostridium difficile (C-diff) infection. Pfizer Biontech COVID-19 vaccine (tozinameran) was also considered suspect. Relevant laboratory & other diagnostic tests on unknown date included C-diff test and diagnostic test: both waiting for results. The outcome of the events was not recovered/not resolved.  The reporter's assessment of the causal relationship of the events with the PFIZER BIONTECH COVID-19 VACCINE was possible.  The reporter's causality for the events of acute colitis due to covid vaccine and C-diff with Humira (adalimumab) was no reasonable possibility.  No follow-up attempts are needed; information about Lot/Batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the serious events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Loss of control of legs, Muscular weakness, Neuralgia
Clinical narrative: lots of nerve pain in my upper legs; I lost control of my legs; could not stand; could not even turn and put my feet down on the floor; they are very weak for like a week or more; Booster; This is a spontaneous report from a contactable consumer (patient). This 77-year-old female patient received boost dose of BNT162B2 (Batch/lot number: FE3590, expiration date: Nov2021) on 15Oct2021, at the age of 77 years old, administrated in Right Arm at single dose for COVID-19 immunization. Relevant medical history and concurrent conditions was Arthritis. Concomitant drug was atorvastatin.  Prior vaccination within 4 weeks was No. Historical vaccine was 1st and 2nd dose of BNT162B2.  Patient stated, "I got my booster "the third" Pfizer shot on 15Oct2021 and the next evening I lost control of my legs. I could not stand. I could not even turn and put my feet down on the floor right so I like I made it to bed that night. It is got better in the morning but had lots of nerve pain in my upper legs but I could not even stand night before." Patient stated, "No I did not treatment. I got up to next morning and I could walk down and move my legs but they are very weak for like a week or more and I still have some nerve pain from that." Outcome of the event nerve pain and booster was unknown, for other events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain
Clinical narrative: chest pain; This is a spontaneous report from a contactable consumer (patient's mother) from a Pfizer sponsored Program. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FS8841), via an unspecified route of administration, administered in left arm on 21Oct2021 (at an unspecified age) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced chest pain on 22Oct2021. On afternoon of 22Oct2021 the patient started having complaints of chest pain. She went to the Emergency Room on 23Oct2021 where a chest X-ray and blood work was done and everything was "normal" with pateint's heart. She was given a TYLENOL drip in the Emergency Room and had been taking oral TYLENOL but it has not touched the chest pain and has stopped taking the oral Tylenol. Patient did not want to get the second dose of the Pfizer Covid-19 vaccine because she was scared due to her complaints of chest pain. Reporter contacted primary care or physician, took the patient to emergency room all day Saturday and they did all kind of test on her and everything was negative her heart was fine but still she has the chest pain. The outcome of the event was not recovered.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This is a solicited report from a marketing program "FACILITATED COLLECT" based on information received by Pfizer from AbbVie. (MFR Control No. 21K-163-4129645-00). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not reported), intramuscular on an unspecified date as single dose for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen, Lot number not reported), subcutaneous from an unspecified date to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis. The patient's medical history included rheumatoid arthritis. It was unknown if patient was enrolled in a covid-19 vaccine trial. Concomitant medications were not reported. The patient experienced rheumatoid arthritis flare up on an unspecified date. The action taken in response to the event for adalimumab was unknown. Outcome of the event was unknown.   The reporter's causality for the event of rheumatoid arthritis flare up with Humira (adalimumab) was no reasonable possibility. The reporter's causality for the event of rheumatoid arthritis flare up with BNT162b2 was (adalimumab) 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 currently available information the possibility of causal association between the event  rheumatoid arthritis flare up and the suspect drug BNT162B2  cannot be ruled out. 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Sensory disturbance, Sinusitis
Clinical narrative: sinus infection; Tingling; Feeling that something was draining down the side of my face and arm; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at age of 64 years old, dose 1 via an unspecified route of administration on 29Jul2021 (Batch/Lot Number: FA9780) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included breast cancer from 2010 (she had breast cancer (stage) w/ radiation), lumpectomy in 2010, and hysterectomy from 1997 (She had a full hysterectomy in 1997). The patient's concomitant medications were not reported. Patient had for anything was a Tetanus shot for Immunization in 2015 and had no reactions to it. 10 days after patient took her first shot (Aug2021), she thought she had a sinus infection for which she kept Cephalexin around her house. Patient took no drugs of any kind, and that night she took 500MG of Cephalexin, and for the rest of the night and into the next day, she had "tingling" and a feeling that something was draining down the side of her face and arm. It disappeared, for the most part after about 10 hours. The outcome of event sinus infection was unknown and outcome of event tingling was not recovered while other event was recovered on Aug2021.   Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: I had the Pfizer vaccine and the only issues I had was major RA flair-ups.; This is a spontaneous report from a Contactable Consumer (patient). This 68-Year-Old male patient received 1st dose on 22Feb2021, 2nd dose of BNT162B2 on 15Mar2021, at single dose, at the age of 68 years old, location=Left arm for COVID-19 immunization. No Known allergies. Other medical history was liver disease, pre-diabetic, rheumatoid arthritis. No other vaccine in four weeks. Other medications in two weeks were abatacept (ORENCIA) infusion, celecoxib (CELEBREX), simvastatin (ZOCUR). I had the Pfizer vaccine and the only issues I had was major RA flair-ups. 16Feb2021, Orencia- no issues; 22Feb2021, vaccine 1st dose, around 1:30 am next day was awakened with joint pain that kept moving around to various joints thru the night and next two days. 15Mar2021, vaccine 2nd dose, more joint pain than usual until 25Mar2021. 25Mar2021, Orencia - next day instead of feeling better more joint pain. For example could only walk 2,000 steps instead of usual 6,000. 27Mar2021, started prednisone - felt a little better next day and day after that was back to my normal and for instance could walk 6,000 steps. 11Apr2021, stopped prednisone, still feel ok. 18Apr2021, flair up symptoms returned -started another 16 days of prednisone. Felt better after two days. 22Apr2021, Orencia infusion. 03May2021, finished Prednisone. No problems since. Outcome of the event was Recovered. AE Treatment was two courses of prednisone step down 20 mg to 5 mg. No covid prior vaccination. No covid tested post vaccination.  The Lot number for the vaccine, [BNT162B2] was not provided and will be requested during Follow-up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a solicited report from a Non-Interventional Study based on the information received by PFIZER (Mfr. Control No. 21K-163-4127915-00), received from a contactable consumer (patient).   A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscularly on 17Feb2021 (lot number and expiry date were not reported) as dose 2, single and intramuscularly on 25Jan2021 (lot number and expiry date were not reported) as dose 1, single for COVID-19 vaccination; and adalimumab (HUMIRA), subcutaneously from an unspecified date (lot number and expiry date were not reported) to an unspecified date, at an unspecified dose and frequency (reported as citrate free) for moderate to severe rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced COVID-19 on an unspecified date in 2021. It was reported that the patient experienced an event of non-serious Covid-19 with Humira (adalimumab). On an unknown date, the patient experienced Covid-19. Pfizer BioNTech covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a Covid-19 vaccine trial. The patient underwent lab tests and procedures which included Covid-19 virus test: positive on an unspecified date in 2021. The action taken in response to the events for adalimumab was unknown. The outcome of the events was recovering.  The reporter's causality for the event(s) of Covid-19 with Humira (adalimumab) was no reasonable possibility.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and COVID-19 cannot be excluded.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Off label use, Wrong product administered
Clinical narrative: schizophrenia; already received the Janssen Covid vaccine; already received the Janssen Covid vaccine; supposed to receive an antipsychotic injection/got a Pfizer BioNTech Covid vaccination; This is a spontaneous report from a contactable pharmacist. A 71-year-old male patient received the second (booster) dose of BNT162B2 (COMIRNATY, Lot#: FF8839, NDC: 59267-1000-01, Expiration Date: 31Dec2021) at single dose on 27Oct2021 at the age of 71-year-old for COVID-19 immunization; the first dose of COVID-19 VACCINE JANSSEN at single dose in Mar2021 for COVID-19 immunization. Medical history included ongoing schizophrenia; ongoing hypertension. Ongoing concomitant medications included haloperidol; amlodipine for hypertension; lisinopril for hypertension. Patient had schizophrenia came in today and was supposed to receive an antipsychotic injection, but the pharmacist was confused and thought he wanted the Covid vaccine because it was a Covid vaccine clinic and got a Pfizer BioNTech Covid vaccination on 27Oct2021, happened around noon. Patient received the Pfizer Covid vaccine and then they found out he already received the Janssen Covid vaccine in Mar2021. Patient stated his mother was concerned and wondering if it would cause issues. Patient asked if there were any interactions with Haldol Decanoate injection with the Pfizer BioNtech Covid-19 vaccine, it confirmed as not serious. The event reported as schizophrenia on 27Oct2021. The outcome of events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event (Schizophrenia aggravated) cannot be excluded but consider also ongoing condition of Schizophrenia.  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: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid-19; Covid-19; This is a solicited report received from a contactable consumer (patient herself) from the marketing program facilitated collect based on information received by Pfizer (Manufacturer Control Number#: 21K-163-4091835-00). A 48-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, also reported as: Tozinameran), dose 1 intramuscular on Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, and then dose 2 intramuscular on Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, for COVID-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot Number: 1141472) to an unspecified date, at unknown dose, (Citrate Free) for psoriatic arthritis. Relevant medical history includes ongoing psoriatic arthritis. The patient's concomitant medications were not reported. On 21Sep2021, the patient experienced COVID-19. It was also reported that in 2021, the patient experienced developed bizarre rash followed the second COVID vaccine/raised bumps. In 2021, the patient developed bizarre rash followed the second COVID vaccine/raised bumps resolved. The action taken for adalimumab was unknown. The outcome of the event was unknown.   Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran) (Tozinameran), for COVID-19 it was not reported; while for Vaccination site rash and Vaccination site papule, it was possible. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of developed bizarre rash followed the second COVID vaccine/raised bumps onset in 2021, developed bizarre rash followed the second COVID vaccine/raised bumps onset in 2021 and COVID-19 was not provided.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Efficacy of the vaccine varies from patient to patient. However, a contributory role of the usage of the vaccine BNT162B2 to the reported events cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Maternal exposure timing unspecified
Clinical narrative: miscarried; Maternal Drug Exposure; This is a spontaneous report from a non-contactable consumer. A female patient (reporter's friend's daughter-in-law) of unspecified age received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose, and via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced miscarried on an unspecified date. Patient got pregnant, received the Pfizer vaccine, miscarried; got pregnant again, got the Pfizer vaccine and miscarried again. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hemiparaesthesia
Clinical narrative: right sided hemiparesthesia shortly; This is a spontaneous report from a contactable other HCP (physician's assistant). A 40-year-old female patient (reported in her late 30s/early 40s) received the BNT162B2 (COMIRNATY), via unspecified route in left deltoid on 27Oct2021 at 11 AM at patient age of 40-year-old as single dose (Batch/lot number: Unknown) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Oct2021, the patient developed right sided hemiparesthesia shortly after receiving the vaccine and it had persisted for 3 hours. The reporter stated that the paresthesia was sensory in nature with no motor involvement, the patient was normotensive, and was not experiencing a headache. The reporter stated that the patient was experiencing sensory loss in the right arm and right leg and not in the face. The reporter directed the patient to the emergency department when symptoms did not subside. The outcome of the event was not resolved. The reporter stated that she was looking at an adverse event reporting resource on the web for the United Kingdom that makes note of three other people who have experienced hemiparesthesia after receiving Comirnaty. The reporter was asking for further information on this from Pfizer, particularly regarding the mechanism of action that could potentially cause this type of side effect post-vaccination.   The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the Limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out. 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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chronic obstructive pulmonary disease, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Hospitalized overnight for severe shortness of breath along with a COPD attack; Hospitalized overnight for severe shortness of breath along with a COPD attack; feel unwell; headaches; very tired; some dizziness & weakness; some dizziness & weakness; This is a spontaneous report from a Contactable Consumer (patient). This 82-year-old female patient received the third dose of BNT162B2 (Lot number unknown) at arm left at single dose for COVID-19 immunisation on 12Oct2021 at 10:15. Relevant history included AFib (Atrial fibrillation), COPD (Chronic obstructive pulmonary disease) and Arthritis. The patient had allergy with Lovastatin. Concomitant drug included warfarin, lisinopril, sertraline hydrochloride (ZOLOFT) and simvastatin. The patient previously received the first dose of BNT162B2 at arm left for COVID-19 immunisation on 03Feb2021 at 10:30 am, the second dose of BNT162B2 at arm left for COVID-19 immunisation on 24Feb2021 at 8:30 am, both for COVID-19 immunisation. No other vaccine was received in four weeks. The patient felt unwell, headaches, very tired, some dizziness & weakness since 13Oct2021 at 11:00 AM. The patient hospitalized overnight for severe shortness of breath along with a COPD attack. The patient still had some shortness of breath at the reporting time. AEs resulted in Emergency room/department or urgent care and Hospitalization (1 day). Outcome of events was not resolved. Treatment therapy included Oxygen & Breathing treatments.The patient had covid test (Nasal Swab) on 14Oct2021 with negative result.   The Lot number for the vaccine, [BNT162B2] was not provided and will be requested during Follow-up.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, SARS-CoV-2 test
Clinical narrative: Hospitalized overnight for severe shortness of breath along with a COPD attack; Hospitalized overnight for severe shortness of breath along with a COPD attack; feel unwell; headaches; very tired; some dizziness & weakness; some dizziness & weakness; This is a spontaneous report from a Contactable Consumer (patient). This 82-year-old female patient received the third dose of BNT162B2 (Lot number unknown) at arm left at single dose for COVID-19 immunisation on 12Oct2021 at 10:15. Relevant history included AFib (Atrial fibrillation), COPD (Chronic obstructive pulmonary disease) and Arthritis. The patient had allergy with Lovastatin. Concomitant drug included warfarin, lisinopril, sertraline hydrochloride (ZOLOFT) and simvastatin. The patient previously received the first dose of BNT162B2 at arm left for COVID-19 immunisation on 03Feb2021 at 10:30 am, the second dose of BNT162B2 at arm left for COVID-19 immunisation on 24Feb2021 at 8:30 am, both for COVID-19 immunisation. No other vaccine was received in four weeks. The patient felt unwell, headaches, very tired, some dizziness & weakness since 13Oct2021 at 11:00 AM. The patient hospitalized overnight for severe shortness of breath along with a COPD attack. The patient still had some shortness of breath at the reporting time. AEs resulted in Emergency room/department or urgent care and Hospitalization (1 day). Outcome of events was not resolved. Treatment therapy included Oxygen & Breathing treatments.The patient had covid test (Nasal Swab) on 14Oct2021 with negative result.   The Lot number for the vaccine, [BNT162B2] was not provided and will be requested during Follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: chronic pain; This is a spontaneous report from a contactable consumer. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 1, single, then on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included immunosuppressed from an unknown date. The patient's concomitant medications were not reported. It was reported that the patient was immunosuppressed and believed that she has gotten the Pfizer vaccine. The patient experienced chronic pain that might or might not be related to the immunosuppression on an unspecified date, the reporter was not sure if that started before or after vaccination. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Fatigue, Headache, Pain
Clinical narrative: Colitis ulcerative aggravated/ulcerative colitis condition was getting worse; Ache/achiness; Headache; Fatigue; This is a solicited report based on information received by Pfizer (Manufacturer Control Number#: 21K-163-4126630-00). A contactable consumer (patient) reported that a 57-year-old female with events of non-serious ulcerative colitis condition was getting worse, headache, achiness and fatigue with adalimumab (Humira) subcutaneously from unknown dates then in 2020 until unknown date with unknown dose and frequency for moderate to severe ulcerative colitis. There was no reported medical history and concomitant medications. On unknown dates, the patient experienced ulcerative colitis condition was getting worse, headache, achiness and fatigue. On unknown dates, headache, achiness and fatigue resolved while outcome for ulcerative colitis condition was getting worse was unknown. Pfizer Biontech COVID-19 vaccine (tozinameran) was received intramuscularly on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response with the adverse events for adalimumab was permanently withdrawn on unknown date.  The reporter's causality for the event(s) of ulcerative colitis condition was getting worse, headache, achiness and fatigue with Humira (adalimumab) was no reasonable possibility while causality for the event of ulcerative colitis condition was getting worse with PFIZER BIONTECH COVID-19 VACCINE was not reported while not related for headache, achiness and fatigue.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The events of Colitis ulcerative, pain, headache and fatigue are related to the suspect product BNT162B2 based on plausible temporal relationship. 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.