chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use
Clinical narrative: Got the third booster dose on Sept 8 and got diagnosed with COVID on 01Oct; Got the third booster dose on Sept 8 and got diagnosed with COVID on 01Oct; Got the third booster dose on Sept 8; Got the third booster dose on Sept 8; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A patient of unspecified age and gender received third (Booster) dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0187, Expiration date: 30Nov2021) via an unspecified route of administration on 08Sep2021 as dose 3 (booster), single for covid-19 immunization. Medical history included rheumatoid arthritis start and stop date unknown. Concomitant medication(s) included methotrexate (METHOTREXATE, 17.5 mg); abatacept (ORENCIA). Patient previously took first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported, Expiration date: not reported) on an unspecified dates as single doses for COVID-19 immunization. On 01Oct2021, patient was diagnosed with COVID-19. On 01Oct2021, patient underwent lab tests and procedures which included sars-cov-2 test-got COVID. The outcome of all events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose of BNT162B2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced seizure on an unspecified date. Outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Extra dose administered, Off label use
Clinical narrative: SA; Dose received: more than 3; Dose received: more than 3; This is a spontaneous report from a non-contactable other hcp (parent). A patient of unspecified age and gender received fourth dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported) intramuscularly, administered in right arm on 01Oct2021 12:15 as dose 4, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (Lot number not reported) intramuscularly at 12:30, administered in left arm; second dose (Lot number not reported) intramuscularly at 12:15, administered in right arm, and third dose (Lot number not reported) via an unspecified route of administered in right arm at 12:15, all on an unknown date for COVID-19 immunization. On an unspecified date, the patient experienced spondylitis ankylosing (SA) and dose received: more than 3. The outcome of event was unknown. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency.  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 provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the Ankylosing spondylitis, Extra dose administered, Off label use cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Generalised tonic-clonic seizure, Partial seizures, Urticaria
Clinical narrative: focal seizure; chest stabbing pain; grand mal seizure; second hive episode on both legs; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0173), via an unspecified route of administration, administered in the left arm on 09May2021 09:30 (at the age of 16 years old) as dose 2, single for COVID-19 immunisation. Medical history included asthma (prior to 2016, asthma free) and allergies (prior to 2016, underwent allergy shots for 4.5 years). The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient previously took amoxicillin and amoxicillin;clavulanic acid (AUGMENTIN) and experienced drug allergies to both then received the dose 1 of bnt162b2 (lot number: EW0162), via an unspecified route of administration, administered in the left leg on 18Apr2021 13:30 (at the age of 16 years old) for COVID-19 immunisation and experienced lump on left leg. It started the size of eraser. Within 2 hours, it was the size of an eraser, hives all over left leg, and vaccine administered at inappropriate site. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 15Jun2021, the patient experienced second hive episode on both legs. On 16Jun2021, she experienced first grand mal seizure. On 25Jul2021, she had another hives episode on both legs. On 07Aug2021, the patient had severe hive reaction all over both legs, lower torso. On 25Aug2021, she had another hive reaction on lower legs. On 08Sep2021, she experienced second grand mal seizure. On 15Sep2021, levetiracetam (KEPPRA) started. On 16Sep2021, the patient had her first focal seizure. On 27Sep2021, she had two grand mal and one focal seizure. On 29Sep2021, she had another focal seizure. On 01Oct2021, she had grand mal seizure. Chest stabbing pain was reported on 16Sep2021, 27Sep2021 and 02Oct2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: my SBP went up to 130''s; I had a sensation of heat in my whole body; received the Pfizer booster dose 3 after 2 Moderna doses; received the Pfizer booster dose 3 after 2 Moderna doses; This is a spontaneous report from a contactable nurse (patient).  A 53-year-old female patient received bnt162b2 (BNT162B2), dose 3 (booster) intramuscular, administered in arm left on 21Sep2021 16:45 (at the age of 53-year-old) (Batch/Lot Number: FE3592) as single dose for COVID-19 immunisation.  Medical history included hypertension HTN but BP was low that morning, prediabetes, sleep apnoea syndrome, allergies to Sulfa. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included amlodipine (AMLODIPINE) 10 mg 1 tablet po daily taken for an unspecified indication, start and stop date were not reported.  The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Moderna COVID 19 vaccine, dose 1 intramuscular, administered in arm left on 04Jan2021 19:00 (at the age of 53-year-old) (Batch/Lot Number: 025L20) as single dose, dose 2 intramuscular, administered in arm left on 29Jan2021 07:15 AM (at the age of 53-year-old) (Batch/Lot Number: 032L20) as single dose for COVID-19 immunisation.  The patient experienced her SBP went up to 130''s (medically significant) on 21Sep2021 17:00 with outcome of recovered in Sep2021, she had a sensation of heat in her whole body (non-serious) on 21Sep2021 17:00 with outcome of recovered in Sep2021, received the Pfizer booster dose 3 after 2 Moderna doses (non-serious) on 21Sep2021 16:45 with outcome of unknown. The clinical course of events was as follows: Immediately after she received the Pfizer as a booster (dose #3), she had a sensation of heat in her whole body and her SBP went up to 130's. As treatment she took Amlodipine; it was a blessing that she did not take it that morning as her BP was low.  The patient underwent lab tests and procedures which included blood pressure measurement: 130 on 21Sep2021 SBP went up to 130's, Sars-cov-2 test: negative (Nasal Swab qualitative RT-PCR). Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of Systolic pressure increased due to temporal relationship and current known drug safety profile.  Case will be re-assessed upon the additional information provided. 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dry throat, Dyspnoea, Headache, Pharyngeal swelling
Clinical narrative: Chills; Severe Headache and last night she was in bed all day; Throat swelling; Difficulty breathing; Having dry scratchy throat similar reaction as her food allergies; Having dry scratchy throat similar reaction as her food allergies; This is a spontaneous report from a contactable consumer. A 45-year-old female patient (age at vaccination: 45-year-old) received bnt162b2 (BNT162B2, lot unknown), via an unspecified route of administration on 30Sep2021 17:00 as dose 2, single for Covid-19 immunisation. Medical history included has some certain food allergies. There were no concomitant medications. She had her dose 1, single of bnt162b2 (lot unknown) on unspecified date in Sep2021 at age 45-year-old for Covid-19 immunisation (further reported as 21 days before second dose, not clarified). On 30Sep2021, she got chills, severe headache and last night she was in bed all day, started to get some swelling in her throat, difficulty breathing, had dry scratchy throat and similar reaction as she experiences like her food allergies. The swelling in throat, difficulty breathing after taking an antihistamine (treatment) all kind of gone away. Took antihistamine (Loratadine 10 mg) for dry scratchy throat. She took Motrin tablet 200 mg for headache. The outcome of throat irritation, dry throat was not recovered; for difficulty breathing, pharyngeal swelling was recovering; for other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Chills; Severe Headache and last night she was in bed all day; Throat swelling; Difficulty breathing; Having dry scratchy throat similar reaction as her food allergies; Having dry scratchy throat similar reaction as her food allergies; This is a spontaneous report from a contactable consumer. A 45-year-old female patient (age at vaccination: 45-year-old) received bnt162b2 (BNT162B2, lot unknown), via an unspecified route of administration on 30Sep2021 17:00 as dose 2, single for Covid-19 immunisation. Medical history included has some certain food allergies. There were no concomitant medications. She had her dose 1, single of bnt162b2 (lot unknown) on unspecified date in Sep2021 at age 45-year-old for Covid-19 immunisation (further reported as 21 days before second dose, not clarified). On 30Sep2021, she got chills, severe headache and last night she was in bed all day, started to get some swelling in her throat, difficulty breathing, had dry scratchy throat and similar reaction as she experiences like her food allergies. The swelling in throat, difficulty breathing after taking an antihistamine (treatment) all kind of gone away. Took antihistamine (Loratadine 10 mg) for dry scratchy throat. She took Motrin tablet 200 mg for headache. The outcome of throat irritation, dry throat was not recovered; for difficulty breathing, pharyngeal swelling was recovering; for other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Immunisation, Off label use, Oral discomfort, Paraesthesia oral
Clinical narrative: Had an anaphylactic reaction to the third booster shot, I was in the hospital from this morning from 5 to 9; My lip just stated to tingle again; Rest of the mouth feeling weird; Had an anaphylactic reaction to the third booster shot, I was in the hospital from this morning from 5 to 9; Had an anaphylactic reaction to the third booster shot, I was in the hospital from this morning from 5 to 9; This is a spontaneous report from a contactable nurse (patient reported for herself). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 49-years-old, dose 3 via an unspecified route of administration, administered in Deltoid Left on 01Oct2021 06:45 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history included depression, blood pressure abnormal, anxiety and sleep disorder. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as dose 1, single and dose 2, single for COVID-19 immunization. Concomitant medications included duloxetine hydrochloride (CYMBALTA) taken for depression; lisinopril taken for blood pressure (abnormal); buspirone hydrochloride (BUSPAR) taken for anxiety; nortriptyline (NORTRIPTYLINE) taken for sleep disorder; all start and stop date were not reported. The patient experienced had an anaphylactic reaction to the third booster shot. The events occurred on 01Oct2021, within 24 hours after the vaccination. The patient received epi-infusion, Benadryl, Steroids and 'tester'. The patient was in the hospital from the morning from 5 to 9, she had an epi drip gone for little bit and some steroid and some Benadryl (treatment). Her lip just stated to tingle again, and rest of the mouth was feeling weird. The patient wanted to know the half-life of the suspect drug. The outcome of the events was unknown.   The lot number for BNT162B2 was not provided and will be request during follow-up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the unlisted events Oral discomfort and Oral Paraesthesia and 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: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Limb discomfort, Paraesthesia, Peripheral coldness
Clinical narrative: I am having numbness in both of my arm; numbness in both of my arm like 'poor circulation' is numbness; Tingling in my arm/Tingling sensation; her arms get swollen/swelling in both of her arms; They get really cold/my arm stays cold a lot; Shortness of breath; have some issues with her left knee down/problems with left knee; This is a spontaneous report from a contactable consumer (patient herself) via medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: 3013563A and expiry date not reported),via an unspecified route of administration on 18Sep2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date on sep2021, the patient experienced I am having numbness in both of my arm, numbness in both of my arm like 'poor circulation' is numbness, Tingling in my arm/Tingling sensation, her arms get swollen/swelling in both of her arms, They get really cold/my arm stays cold a lot, Shortness of breath and have some issues with her left knee down/problems with left knee. The patient reported that regarding a reaction to the first vaccine shot of Pfizer, I am having numbness in both of my arm like 'poor circulation' is numbness, 'poor circulations' they get really cold and they are swelling, but I have my first shot on the 18th of September. The reporter stated that My side effect is numbness in both my arms and they are swelling, they swell but they go down and it's 'poor circulation' like I just can't feel it." She asked "Well I want to know what to do about it, is there anything I can do about it". There is numbness and there is tingling and shortness of breath, but I think 'it can happen to some other'. You ask me is there anything else you can help me with, my answer is there is numbness and tingling in my arm and the shortness of breath and the swelling is going on and in fact my arm stays cold a lot. The patient was informed about the role of Pfizer Drug Safety and also informed that Pfizer Medical Information is the concerned department to answer the question that consumer have and offered the number. The patient got the first dose of the Pfizer BioNTech COVID-19 vaccine on the 18Sep and she was having numbness in both of her arms, she described it as poor circulation. She had tingling sensation, her arms get swollen, they get very cold. She had tingling, numbness, coldness and swelling in both of her arms and then she says she also had shortness of breath in addition to those symptoms in her arms. She says she also have some issues with her left knee down. She said on Saturday it was hot outside she was out helping her husband cut a tree and her arms would not warmup until she put on a long sleeve shirt and a coat and she said she had to sleep with a heavy blanket on her at night. The outcome of the events her arms get swollen/swelling in both of her arms was not recovered and other events were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Poor peripheral circulation
Clinical narrative: I am having numbness in both of my arm; numbness in both of my arm like 'poor circulation' is numbness; Tingling in my arm/Tingling sensation; her arms get swollen/swelling in both of her arms; They get really cold/my arm stays cold a lot; Shortness of breath; have some issues with her left knee down/problems with left knee; This is a spontaneous report from a contactable consumer (patient herself) via medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: 3013563A and expiry date not reported),via an unspecified route of administration on 18Sep2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date on sep2021, the patient experienced I am having numbness in both of my arm, numbness in both of my arm like 'poor circulation' is numbness, Tingling in my arm/Tingling sensation, her arms get swollen/swelling in both of her arms, They get really cold/my arm stays cold a lot, Shortness of breath and have some issues with her left knee down/problems with left knee. The patient reported that regarding a reaction to the first vaccine shot of Pfizer, I am having numbness in both of my arm like 'poor circulation' is numbness, 'poor circulations' they get really cold and they are swelling, but I have my first shot on the 18th of September. The reporter stated that My side effect is numbness in both my arms and they are swelling, they swell but they go down and it's 'poor circulation' like I just can't feel it." She asked "Well I want to know what to do about it, is there anything I can do about it". There is numbness and there is tingling and shortness of breath, but I think 'it can happen to some other'. You ask me is there anything else you can help me with, my answer is there is numbness and tingling in my arm and the shortness of breath and the swelling is going on and in fact my arm stays cold a lot. The patient was informed about the role of Pfizer Drug Safety and also informed that Pfizer Medical Information is the concerned department to answer the question that consumer have and offered the number. The patient got the first dose of the Pfizer BioNTech COVID-19 vaccine on the 18Sep and she was having numbness in both of her arms, she described it as poor circulation. She had tingling sensation, her arms get swollen, they get very cold. She had tingling, numbness, coldness and swelling in both of her arms and then she says she also had shortness of breath in addition to those symptoms in her arms. She says she also have some issues with her left knee down. She said on Saturday it was hot outside she was out helping her husband cut a tree and her arms would not warmup until she put on a long sleeve shirt and a coat and she said she had to sleep with a heavy blanket on her at night. The outcome of the events her arms get swollen/swelling in both of her arms was not recovered and other events were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Hypoaesthesia, Hypoaesthesia oral, Pain in extremity, Paraesthesia oral
Clinical narrative: I thought I was having a stroke; Little bit of pain in my arm; Tingle on right side of my lip; little bit of numbness; I have some numbness in my left arm, my right throat and my fingers of my right hand; Tingle on right side of my lip; little bit of numbness; This is a spontaneous report from a contactable consumer (Patient). An 80-year-old patient of unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, Solution for injection, Batch/lot number: FF8839) via an unspecified route of administration on 22Sep2021 as dose 1, single for COVID-19 immunization. The patient's medical history had included cellulitis (at that moment but patient used a walker) and debilitating in the legs. The patient concomitant medication was not reported. On 23Sep2021, the patient had experienced little bit of pain in arm but after couple of hours, patient suddenly may got something like tingle on right side of the lip and little bit of numbness that patient had some numbness in the left arm, its right throat and fingers of right hand and that last did to the next day and patient was just wondering than all the of the sudden just went away but if this was the reaction to the first one, I am afraid to take the second one and I called my doctor about that and I tell that I was going to get a response and this had four day now and I have not had a response. Patient had a concern of having a stroke. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: The patient passed out for a minute or two; This is a spontaneous report from a contactable pharmacist. A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, (Batch/Lot Number: FC3180)), dose 1 via an unspecified route of administration on 03Oct2021 (age at the time of vaccination was 22-Year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021, the patient passed out for like a minute or two. This event was assessed as medically significant. At the time of this report, the outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Bone pain, Pyrexia
Clinical narrative: Body was just so weak; I can''t walk and get it, I am too weak; My blood pressure was 181 over 106 over 98; Blood pressure is pretty high, yeah 181 over 106 over 98; My bones are just aching; Fever; No, I can't talk that long; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on Oct2021 as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient got the shot yesterday on Oct2021, and since patient got home, patient body was just so weak. But this morning patient tried to go to work, patient blood pressure was 181 over 106 over 98 and patient bones were just aching. Now patient got a fever and patient just, patient don't know if it was side effects from that. Patient might go to the hospital patient was not sure yet, patient may go or not. patient said patient might go to the doctor, patient was not sure yet, but patient blood pressure was pretty high, yeah 181 over 106 over 98. On an unspecified date in 2021 patient experienced body was just so weak; patient can''t walk and get it, patient was too weak, patient blood pressure was 181 over 106 over 98; blood pressure was pretty high, yeah 181 over 106 over 98, patient bones were just aching, fever, no, patient can't talk that long. The patient underwent lab tests and procedures which included Blood pressure: 181, Blood pressure: 106, Blood pressure: 98, fever: unknown result on an unspecified date in 2021. The outcome of the events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: Body was just so weak; I can''t walk and get it, I am too weak; My blood pressure was 181 over 106 over 98; Blood pressure is pretty high, yeah 181 over 106 over 98; My bones are just aching; Fever; No, I can't talk that long; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on Oct2021 as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient got the shot yesterday on Oct2021, and since patient got home, patient body was just so weak. But this morning patient tried to go to work, patient blood pressure was 181 over 106 over 98 and patient bones were just aching. Now patient got a fever and patient just, patient don't know if it was side effects from that. Patient might go to the hospital patient was not sure yet, patient may go or not. patient said patient might go to the doctor, patient was not sure yet, but patient blood pressure was pretty high, yeah 181 over 106 over 98. On an unspecified date in 2021 patient experienced body was just so weak; patient can''t walk and get it, patient was too weak, patient blood pressure was 181 over 106 over 98; blood pressure was pretty high, yeah 181 over 106 over 98, patient bones were just aching, fever, no, patient can't talk that long. The patient underwent lab tests and procedures which included Blood pressure: 181, Blood pressure: 106, Blood pressure: 98, fever: unknown result on an unspecified date in 2021. The outcome of the 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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 2 doses of the vaccines but tested positive with covid; 2 doses of the vaccines but tested positive with covid; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had 2 doses of the vaccines but tested positive with COVID (drug ineffective) (medically significant) on an unspecified date. The patient underwent lab tests and procedures which included COVID test was positive result on an unspecified date. Outcome of event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; I've had three (3) COVID shots (including booster); I've had three (3) COVID shots (including booster); This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient reported on an unspecified date, event after 3 Covid shots, the patient tested positive for Covid. The patient underwent lab tests and procedures on an unspecified date which included sars-cov-2 test positive. The outcome of the events was unknown at the time of report.   The lot number for (BNT162B2), was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Herpes zoster, Pain
Clinical narrative: Shingles along her waist; got a lot of pain; she is wondering and actually scary; This is a spontaneous report from a contactable consumer reported for her sister (Patient).  A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date was not reported), via an unspecified route of administration, on an unspecified date in 2021, as DOSE 1, SINGLE for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date was not reported), via an unspecified route of administration, on an unspecified date in Feb2021, as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history included Pre-diabetes. Concomitant medication included ATORVASTATIN CALCIUM (lipitor). The reporter stated that they called on behalf of their sister. She actually coming here to get the third dose (Booster) of Pfizer vaccine (Covid-19 Vaccine) but she actually has Shingles along her waist, got a really a lot of pain. The reported stated that they have two questions, she is wondering whether if she can get Booster shot, she is over 65, so she is qualified, but she is wondering because she still has shingles, so is that ok to get the vaccine now. The other question, want to ask because all the Doctors told her shingles probably caused by previous Pfizer Covid-19 Vaccine (first and second dose) that is actually scary and they did not if that is true or not and stated that it was 2 months ago in 2021and asked is that possible, she wants to ask this question. The reporter stated that they don't know what kind of treatment. All her doctors told her shingles was caused by Covod-19 Vaccine, that's why they want to report. The reporter stated that they did not have time and did not have more information for her and would rather like to know answers for all those questions on her behalf. The reporter has was not willing to proceed the call. Limited information available over the call. 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: COVID-19, Drug ineffective, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Breakthrough Covid 19 infection; Breakthrough Covid 19 infection; woke up with a cold; This is a spontaneous report from a contactable other healthcare professional (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date in Jan2021 as a dose 2, single and the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, the patient experienced breakthrough Covid 19 infection on 02Oct2021. Stated that, the patient was a healthcare professional and has her second dose of Pfizer vaccine on an unspecified date in Jan2021. On 30Sep2021, the patient woke up with a cold. On 02Oct2021, the patient was tested positive. Seemed to have a mild case optional information, Healthy otherwise. The events took place after use of product. On 02Oct2021, the patient underwent lab tests and procedures which included on 02Oct tested positive (SARS-CoV-2 test), resulted as positive. 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. Based on the information in the case report, a possible causal association between the events decreased drug ineffective, COVID-19, nasopharyngitis, and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the product is evaluated as part of 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 authoritie, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, Crohn's disease
Clinical narrative: Crohn's disease flare up; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from AbbVie Inc. (Manufacturer Report Number: 21K-163-4096483-00).  A 40-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), intramuscular on 30Apr2021 (Batch/Lot number was not reported) at the age of 40 years old as dose 2, single for COVID-19 immunisation; and adalimumab (HUMIRA), subcutaneous on an unspecified date (Batch/Lot number was not reported), citrate free for Moderate to Severe adult Crohn's disease. Medical history included Moderate to Severe adult Crohn's disease. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) received by the patient on 01Apr2021 (age at first vaccination: 40 years) as dose 1 single, intramuscularly for COVID-19 immunization. Solicited report by a consumer of a 40-year-old female (reported as 39-year-old) with an event of non-serious Crohn's disease flare up with Humira (adalimumab). In 2021, the patient experienced Crohn's disease flare-up. Pfizer BioNTech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01Apr2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer BioNTech. On 30Apr2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer BioNTech. The patient underwent blood work on an unspecified date with unknown result. Outcome of the event was not recovered. The reporter's causality for the event of Crohn's disease flare-up with the suspect products adalimumab (HUMIRA) and BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE) was not provided.  The reporter's assessment of the causal relationship of the event (Crohn's disease flare-up) with the suspect product (BNT162B2) 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The company cannot completely rule out a reasonable possibility that bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) caused the reported Crohn's disease flare-up.  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: U
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Six months after I was diagnosed with DVT or blood clots on my left leg.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 18Mar2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 via an unspecified route of administration on 25Feb2021 for covid-19 immunisation. On an unspecified date in 2021, the patient was diagnosed with DVT or blood clots in left leg. The patient was wondering if the clots were caused by the vaccines. The patient wanted Pfizer to make a study on the case and to find out the real cause of the clots. The outcome of the event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Discouragement, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis symptoms worsened; pain increased in knuckles, fingers, and feet; pain is bad; Feeling discouraged or depressed worsens; Feeling discouraged or depressed worsens; This is a spontaneous report from a contactable healthcare professional and a consumer. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Numbers were not reported), via unspecified routes of administration, in Aug2021 (at the age of 56 years), as dose 1, single, and then in Sep2021, as dose 2, single, for COVID-19 immunization. The patient's medical history included depression, discouraged, and rheumatoid arthritis, all were ongoing. The patient's concomitant medications included tofacitinib citrate (XELJANZ XR) from 2019 and ongoing for rheumatoid arthritis and an unspecified medication for depression. The patient had COVID-19 vaccines in Aug2021 and Sep2021. Tofacitinib citrate was held for 1 week following both vaccines. In 2021, rheumatoid arthritis symptoms worsened following held doses; pain increased in knuckles, fingers, and feet. Symptoms have not returned to baseline following missed doses. The patient generally agrees that generally it's been hard to cope with rheumatoid arthritis and sometimes felt discouraged and/or depressed. Prior to start of therapy, she is treated with medication for depression. Feeling discouraged or depressed worsens when the pain is bad (2021); received treatment for these events. The patient was advised to update physician with new or worse symptoms. The patient had not recovered from the events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Rheumatoid arthritis (aggravated) and 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: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: contracted COVID even though she was inoculated with a vaccine; contracted COVID even though she was inoculated with a vaccine; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient contracted COVID even though she was inoculated with a vaccine. Outcome of the event was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Headache, Investigation, Magnetic resonance imaging, Oral mucosal blistering
Clinical narrative: Severe case of Bells Palsy; blisters in the mouth and throat on one side; blisters in the mouth and throat on one side; severe headache for a month; This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received bnt162b2 (BNT162B2) at the age of 78-years-old, dose 1 via an unspecified route of administration, administered in Arm Left on 12Jan2021 02:15 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Facility type vaccine: Public health clinic/administration facility. No other vaccine in four weeks. No COVID prior vaccination. No known allergies. Medical history included diabetic, heart condition, neuropathy, spondylosis. Concomitant medication(s) included metoprolol (METOPROLOL); glipizide (GLIPIZIDE); pantoprazole (PANTOPRAZOLE); zolpidem (ZOLPIDEM). The patient experienced severe case of bells palsy, blisters in the mouth and throat on one side, severe headache for a month on 20Jan2021 with outcome of not recovered. Severe case of Bells Palsy with severe headache for a month, blisters in the mouth and throat on one side. The patient underwent lab tests and procedures which included VNG test: unknown result on an unknown date (VNG test for dizzy), MRI: unknown results on an unknown date, COVID: negative on 09Jun2021 (Nasal Swab), COVID: negative on 16Sep2021 (Nasal Swab). AE resulted in: [Doctor or other healthcare professional office/clinic visit]. The event received treatment. The patient received dose 2 administered in Arm Right on 04Feb2021 03:15 (Batch/Lot number was not reported) as DOSE 2, SINGLE.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal blistering, SARS-CoV-2 test
Clinical narrative: Severe case of Bells Palsy; blisters in the mouth and throat on one side; blisters in the mouth and throat on one side; severe headache for a month; This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received bnt162b2 (BNT162B2) at the age of 78-years-old, dose 1 via an unspecified route of administration, administered in Arm Left on 12Jan2021 02:15 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Facility type vaccine: Public health clinic/administration facility. No other vaccine in four weeks. No COVID prior vaccination. No known allergies. Medical history included diabetic, heart condition, neuropathy, spondylosis. Concomitant medication(s) included metoprolol (METOPROLOL); glipizide (GLIPIZIDE); pantoprazole (PANTOPRAZOLE); zolpidem (ZOLPIDEM). The patient experienced severe case of bells palsy, blisters in the mouth and throat on one side, severe headache for a month on 20Jan2021 with outcome of not recovered. Severe case of Bells Palsy with severe headache for a month, blisters in the mouth and throat on one side. The patient underwent lab tests and procedures which included VNG test: unknown result on an unknown date (VNG test for dizzy), MRI: unknown results on an unknown date, COVID: negative on 09Jun2021 (Nasal Swab), COVID: negative on 16Sep2021 (Nasal Swab). AE resulted in: [Doctor or other healthcare professional office/clinic visit]. The event received treatment. The patient received dose 2 administered in Arm Right on 04Feb2021 03:15 (Batch/Lot number was not reported) as DOSE 2, SINGLE.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: left arm had been in constant pain / just a deep pain; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient (not pregnant) received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 24Sep2021 at the age of 25-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. COVID prior vaccination was none. COVID tested post vaccination was none. Known allergy was none. The patient didn't received other vaccine in four weeks. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 03Sep2021 (Lot Number: Unknown) at the age of 25-year-old as single dose for COVID-19 immunization. On 03Oct2021, a week after the second dose, the patient's left arm had been in constant pain, not sore muscle pain, just a deep pain. No treatment was received. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Foreign body, Pain in extremity, Pulmonary congestion, Wheezing
Clinical narrative: congested lungs; pain in arm; wheezing; stepped on a nail; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 20Sep2021 (at the age of 61years) as dose 2, single for Covid-19 immunization. The patient medical history was not reported. Concomitant medications included tetanus vaccine (TETANUS VACCINE) taken for an unspecified indication on 20Sep2021. Historical vaccine included first dose of Comirnaty on an unspecified date for Covid-19 immunization. On an unspecified date, the patient experienced he has congested lungs and pain in his arm where it wakes him up due to the pain. The patient added that he was also wheezing on an unspecified date. He further stated that when he got the second dose of the vaccine (20Sep2021) he stepped on a nail and he also got a tetanus shot the following day. The outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.