chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid 19 virus; Covid 19 virus; tired; feels like she has some congestion; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 2021 (at the age of 61 years old) (Batch/Lot number was not reported) as dose 2, single, the first dose via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included influenza vaccine (FLU) taken for an unspecified indication in Sep2021.  Patient received the shots in the spring (unspecified date in 2021) and at the beginning of Sep2021 she was hospitalized with the COVID virus for 15 days. Regarding the COVID virus, even though she was hospitalized, she mentioned it wasn't that severe. The patient clarified that she was actually hospitalized 2 separate times for 7 days each, once at the beginning of Sep2021 and once at the end of Sep2021. She was discharged on 01Oct2021. During this hospitalization she lost her vaccination card and mentioned she can't get her booster without her card. On an unspecified date in 2021, when the patient was asked if she has completely recovered from COVID she said she was real tired and feels like she has some congestion but is feeling much better. She will be going to her doctor next week regarding this. The event COVID virus resulted in an emergency room and physician office visit, the rest of the events resulted in a physician office visit. The outcome of the events was recovering.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Interchange of vaccine products
Clinical narrative: nausea; body aches; headache/ nagging headache; fever; chills; very fatigued; booster dose of Pfizer COVID-19 vaccine. Initial two doses were Moderna; booster dose of Pfizer COVID-19 vaccine. Initial two doses were Moderna; booster dose; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: not reported) via intramuscular route of administration, administered in left deltoid on 26Oct2021 10:45 as DOSE 3 (BOOSTER), SINGLE for COVID- 19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included Moderna vaccine (MODERNA COVID-19 VACCINE, Lot number: not reported) via an unspecified route of administration on an unspecified date as dose 1, single and dose 2 single both for COVID- 19 immunization. Reporter stated on 27Oct2021 about noon started to feel very fatigued, 17:30 noticed fever and chills, 27Oct2021 19:00 headache began (headache/nagging headache), Fever and chills returned by 22:00, night was uncomfortable, on 26Oct2021 10:45 booster dose of Pfizer COVID-19 vaccine. Initial two doses were Moderna, booster dose, 28Oct2021 18:00 body aches started, and headache returned, Minor chills and nausea. Continued nagging headache. Body aches improved throughout day. Slept well that night. Event took place after use of product. Therapeutic measures were taken as a result of the events which included fever, chills, headache/ nagging headache included 400 mg Ibuprofen (Took more Ibuprofen at 12:30. 400 mg), 509 mg of Ibuprofen (By 21:40). Outcome of the events was recovered on 29Oct2021.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Off label use, Pain, Pyrexia
Clinical narrative: nausea; body aches; headache/ nagging headache; fever; chills; very fatigued; booster dose of Pfizer COVID-19 vaccine. Initial two doses were Moderna; booster dose of Pfizer COVID-19 vaccine. Initial two doses were Moderna; booster dose; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: not reported) via intramuscular route of administration, administered in left deltoid on 26Oct2021 10:45 as DOSE 3 (BOOSTER), SINGLE for COVID- 19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included Moderna vaccine (MODERNA COVID-19 VACCINE, Lot number: not reported) via an unspecified route of administration on an unspecified date as dose 1, single and dose 2 single both for COVID- 19 immunization. Reporter stated on 27Oct2021 about noon started to feel very fatigued, 17:30 noticed fever and chills, 27Oct2021 19:00 headache began (headache/nagging headache), Fever and chills returned by 22:00, night was uncomfortable, on 26Oct2021 10:45 booster dose of Pfizer COVID-19 vaccine. Initial two doses were Moderna, booster dose, 28Oct2021 18:00 body aches started, and headache returned, Minor chills and nausea. Continued nagging headache. Body aches improved throughout day. Slept well that night. Event took place after use of product. Therapeutic measures were taken as a result of the events which included fever, chills, headache/ nagging headache included 400 mg Ibuprofen (Took more Ibuprofen at 12:30. 400 mg), 509 mg of Ibuprofen (By 21:40). Outcome of the events was recovered on 29Oct2021.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea after second vaccine, and booster; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 2 and dose 3 (booster), single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the past drug BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced diarrhea after second vaccine, and booster on an unspecified date. It was reported that the patient was reading the post vaccine instructions and it said diarrhea as a side effect. She also had the effect with the second vaccine. Caller stated that with the second vaccine, she had diarrhea for one day, and with the booster, the diarrhea had lasted two days. The outcome of the event was recovered on an unspecified date.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Seizure
Clinical narrative: Patient had 2 seizures on 2/27 after getting 2nd Covid shot; This is a spontaneous report from a contactable consumer, based on information received by Pfizer RA (manufacturer control number: EC-2021-088537), for bnt162b2. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunisation; perampanel (FYCOMPA), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 2 mg, oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 6 mg, oral from an unspecified date (Batch/Lot number was not reported; Expiration Date: 13Sep2022) and ongoing, at 4 mg, 1x/day for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient historical Vaccine included dose 1 COVID-19 VACCINE (MANUFACTURER UNKNOWN) for Covid-19 immunization. Patient's spouse stated patient had a New Seizure (breakthrough seizure) on 10/13. Patient had 2 seizures on 2/27 after getting 2nd Covid shot. Patient's spouse also stated patient has had progressive dose changes FYCOMPA from 2mg to 4mg to 6mg. Patient gets angry and confused on the 6mg dose and also had an outburst of aggressive behavior on the 6mg dose as well. Patient's dose was currently 4mg and seems like a better dose with the patient's all-around behavior. The action taken in response to the event for perampanel was dose not changed. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at dose 2, single and via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was tested positive for covid in Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in Jul2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Gastrointestinal haemorrhage
Clinical narrative: GI Bleeding; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER -BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as DOSE 2, SINGLE, and via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that patient had bleeding, a GI bleed afterwards, (reported as within a couple of months, afterwards got this bleeding, GI bleeding, a hemorrhage, it was terrible, as big as patient's hands and patient's hands coming out of clots). The patient was sent to a Hematologist and had to have blood transfusion. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Lethargy, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional (son). A male patient of an unspecified age received third 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 28Oct2021 (reported as yesterday) as dose 3 (booster), single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included, patient previously 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 and also 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 both for covid-19 immunization. Reporter stated my father had on 28Oct2021 (reported as yesterday) booster Pfizer and right now (captured as 29Oct2021), he has 100.7 temperature and he is little lethargic and his muscles are hurting. The patient underwent lab tests and procedures which included body temperature resulted as 100.7 fahrenheit on an unspecified date in 29Oct2021. Outcome of the events was unknown.Reporter type could not be probed as reporter hung up the call abruptly, hence reporter type captured as consumer or non-healthcare professional by default. The lot number for BNT162B2 was not provided and will be request during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Peripheral swelling
Clinical narrative: I just feel tired; Light headache; My arm is really swollen up much; Patient received booster shot yesterday; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), dose 3 via an unspecified route of administration on 29Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), dose 2 via an unspecified route of administration on unspecified date as dose 2, single for covid-19 immunisation and also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), dose 1 via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation. Patient received booster shot yesterday and experienced mild side effects, patient don't want to be panic. Patient had no fever, and took temperature, didn't had a fever. Patient just felt like tired, headache and arm was really swollen up much and asked are these normal side effects. Patient was stated that It was light headache and I was very much tried. The clinical 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: Dizziness, Fatigue, Feeling cold, Immunisation, Malaise
Clinical narrative: patient had with Pfizer Booster; I was very cold and sick; I was very cold and sick; I have been very tried; Light-headed; I was "sore"; 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 on Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) dose 1 via unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as dose 1, single and dose 2 via unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as dose 2, single, both for covid-19 immunization. On an unspecified date on Oct2021, the patient had with Pfizer Booster, reported that "I had a reaction in general, I was "sore" (further not clarified the word), I was very cold and sick. I had been very tried and Light-headed sometimes I had that since I had the shot, I just wanted to find out whether the reaction I had with Pfizer Booster (Covid-19 Vaccine) shot normal. I had my shot at noon time a week ago on Friday and I am just concerned. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: patient had with Pfizer Booster; I was very cold and sick; I was very cold and sick; I have been very tried; Light-headed; I was "sore"; 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 on Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) dose 1 via unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as dose 1, single and dose 2 via unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as dose 2, single, both for covid-19 immunization. On an unspecified date on Oct2021, the patient had with Pfizer Booster, reported that "I had a reaction in general, I was "sore" (further not clarified the word), I was very cold and sick. I had been very tried and Light-headed sometimes I had that since I had the shot, I just wanted to find out whether the reaction I had with Pfizer Booster (Covid-19 Vaccine) shot normal. I had my shot at noon time a week ago on Friday and I am just concerned. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Musculoskeletal pain, Pain, Vaccination site pain
Clinical narrative: Lot of pain at the injection site on the left arm; has pain on the right side, a lot of like right sided pain; Pain in her arm is now moved to her right shoulder blade area; had a vaccine and this would be her third booster with Pfizer; This is a spontaneous report from a contactable consumer. This consumer reported for a female Patient (sister).   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), dose 3 via an unspecified route of administration, administered in Arm Left on an unspecified date as DOSE 3 (BOOSTER), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient previously had COVID-19 vaccine (manufacturer unknown) first two completed in the series and then decided to do the booster because she works with small children. On an unspecified date, the patient had a lot of pain at the injection site on the left arm which was where the injection was given and about 2 to 3 days after that she has continued to not so well and has pain on the right side, a lot of like right sided pain. So, the pain that was in her arm was exact same pain that she said was now moved to her right shoulder blade area, she went and saw an urgent care doctor who has prescribed a muscle relaxer (treatment). The patient stated that, she was wondering that this was a reactions that you have heard about where like you kind of like have a systemic inflammatory response, do you know about any of this?"  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date in Jan2021 (Batch/Lot number was not reported) as dose 1, single, on an unspecified date in Feb2021 (Batch/Lot number was not reported) as dose 2, single, on an unspecified date in Oct2021 (Batch/Lot number was not reported) as dose 3 (booster), single, all via an unspecified route of administration for Covid-19 Immunization. Age at vaccination was unspecified. The patient medical history and concomitant medications were not reported. The patient travelled internationally in Jun2021 and tested negative 6 times and an antibody SARS-CoV-2 trimeric resulting in 225 AU/mL. He travelled internationally in Aug2021-Sep2021 and tested negative 5 times. In mid-Oct2021 he repeated the SARS-CoV-2 test resulting in 7 AU/mL. In Oct2021 (reported as a week later) he was infected, on the same day he received the booster. In Oct2021 (reported as a week later) he tested positive using Antigen and Rapid. Not good track record. The outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Chest pain, Choking sensation, Electrocardiogram
Clinical narrative: Pain in her chest area and a severe pain under the left chest bone; chest pressure/tightening in the throat and chest; tightening in the throat and chest; choking or tightening sensation; This is a spontaneous report from a contactable consumer (parent) or other non HCP via Medical Information Team.   A 21-year-old female patient received bnt162b2 (Comirnaty, solution for injection, Lot number and Expiry was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medication was not reported. On an unspecified date, the patient experienced pain in her chest area and a severe pain under the left chest bone, chest pressure/tightening in the throat and chest, choking or tightening sensation. Patient was also reporting a tightening in the throat and chest which is worse when she eats. Patient has been uncomfortable. The patient was having a little discomfort in the chest area underneath, it was started a few hours later. The pain was a severe pain under the left chest bone and the caller was told to take the patient to the emergency room. In the emergency room they did an EKG, checked the patient's blood pressure and oxygen. This was all perfect and they couldn't find anything wrong with the patient.  All events resulted in emergency room. The patient underwent lab tests and procedures which included blood pressure measurement resulted unknown results (this was all perfect), electrocardiogram unknown results (everything was perfect), investigation unknown results (this was all perfect) all on unspecified date. Reporter stated patient has been uncomfortable. The clinical outcome of the events was reported as unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Throat tightness
Clinical narrative: Pain in her chest area and a severe pain under the left chest bone; chest pressure/tightening in the throat and chest; tightening in the throat and chest; choking or tightening sensation; This is a spontaneous report from a contactable consumer (parent) or other non HCP via Medical Information Team.   A 21-year-old female patient received bnt162b2 (Comirnaty, solution for injection, Lot number and Expiry was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medication was not reported. On an unspecified date, the patient experienced pain in her chest area and a severe pain under the left chest bone, chest pressure/tightening in the throat and chest, choking or tightening sensation. Patient was also reporting a tightening in the throat and chest which is worse when she eats. Patient has been uncomfortable. The patient was having a little discomfort in the chest area underneath, it was started a few hours later. The pain was a severe pain under the left chest bone and the caller was told to take the patient to the emergency room. In the emergency room they did an EKG, checked the patient's blood pressure and oxygen. This was all perfect and they couldn't find anything wrong with the patient.  All events resulted in emergency room. The patient underwent lab tests and procedures which included blood pressure measurement resulted unknown results (this was all perfect), electrocardiogram unknown results (everything was perfect), investigation unknown results (this was all perfect) all on unspecified date. Reporter stated patient has been uncomfortable. The clinical outcome of the events was reported as unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Headache, Hyperhidrosis, Migraine
Clinical narrative: Fever; Chills; Severe sweating (needed to change clothes); Intense headache that was almost a migraine; Intense headache that was almost a migraine; Frequent urination; 9/10 scale pain on the injection site and in underarm.; 9/10 scale pain on the injection site and in underarm; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 26-year-old female patient received bnt162b2 (BNT162B2 Formulation: Solution for injection), dose 3 via an unspecified route of administration on 21Oct2021 (Batch/Lot number was not reported) as DOSE 3, (BOOSTER), SINGLE (at the age of 26-year-old) for covid-19 immunisation. It was unknown if patient was not pregnant at the time of vaccination or not. The patient did not have any medical history and known allergies. Concomitant medications were not reported. The patient did not have Covid prior vaccination. Historical vaccine included first dose of bnt162b2 on 08Jan2021 and second dose of bnt162b2 on 29Jan2021 (Batch/Lot No: Unknown. Misplaced/discarded) (at the age of 25-year-old) for covid-19 immunisation. The patient experienced severe sweating (needed to change clothes), Intense headache that was almost a migraine, frequent urination, 9/10 scale pain on the injection site and in underarm, Chills and fever on 21Oct2021. The patient not tested for Covid post vaccination. It was unknown if treatment received for events fever and chills and for other events no treatment received. It was reported that all symptoms latest for 3 days. The outcome of events reported as recovered on an unknown date of 2021.   Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Chills; Severe sweating (needed to change clothes); Intense headache that was almost a migraine; Intense headache that was almost a migraine; Frequent urination; 9/10 scale pain on the injection site and in underarm.; 9/10 scale pain on the injection site and in underarm; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 26-year-old female patient received bnt162b2 (BNT162B2 Formulation: Solution for injection), dose 3 via an unspecified route of administration on 21Oct2021 (Batch/Lot number was not reported) as DOSE 3, (BOOSTER), SINGLE (at the age of 26-year-old) for covid-19 immunisation. It was unknown if patient was not pregnant at the time of vaccination or not. The patient did not have any medical history and known allergies. Concomitant medications were not reported. The patient did not have Covid prior vaccination. Historical vaccine included first dose of bnt162b2 on 08Jan2021 and second dose of bnt162b2 on 29Jan2021 (Batch/Lot No: Unknown. Misplaced/discarded) (at the age of 25-year-old) for covid-19 immunisation. The patient experienced severe sweating (needed to change clothes), Intense headache that was almost a migraine, frequent urination, 9/10 scale pain on the injection site and in underarm, Chills and fever on 21Oct2021. The patient not tested for Covid post vaccination. It was unknown if treatment received for events fever and chills and for other events no treatment received. It was reported that all symptoms latest for 3 days. The outcome of events reported as recovered on an unknown date of 2021.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cataract, Dizziness, Immunisation, Off label use, Vaccination site swelling
Clinical narrative: Cataract surgery; Vaccination site swelling; Dizzy; off label use; DOSE 3 (BOOSTER),; This is a Solicited report from a non-interventional (FACILITATED COLLECT) based on the information received by a regulatory authority number 21K-163-4137180-00) from a contactable consumer (reporting for herself). A 72-year-old female patient received bnt162b2 (TOZINAMERAN), dose 3 intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; adalimumab (HUMIRA, citrate free, solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date for moderate to severe rheumatoid arthritis. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient had cataract surgery, arm was swollen (vaccination site swelling) after COVID booster and woke up dizzy with adalimumab (HUMIRA) on an unspecified date. The outcome of cataract surgery, vaccination site swelling and dizzy was unknown. The reporter's causality of cataract surgery, arm was swollen (vaccination site swelling) and woke up dizzy was unknown.   The reporter's assessment 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.  AbbVie's opinion is that there is no reasonable possibility that the events of CATARACT, ARM WAS SWOLLEN AFTER COVID BOOSTER/WOKE UP DIZZY unknown onset and ARM WAS SWOLLEN AFTER COVID BOOSTER/WOKE UP DIZZY unknown onset are related to HUMIRA(ADALIMUMAB).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Sender's Comments: Considering a temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events (except cataract) cannot be completely excluded.  Based on information available, event Cataract is considered unrelated to BNT162B2
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness in hands/ numbness in feet; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: not reported), via an unspecified route of administration on an unspecified date as dose 1, single and second dose via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced numbness in hands/ numbness in feet. Patient called to ask she has numbness in her hands and feet, she thinks, after her first and second dose of the Pfizer vaccine and she wanted to know if getting the booster will make them worse. Clinical outcome of the events was reported as unknown.  The lot number for the vaccine was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Developed covid 19; Developed covid 19; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as unknown dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient developed COVID-19 and drug ineffective on an unspecified date. These events took place after the use of product. The outcome of these events was unknown at the time of report.   The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: 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
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot in my lungs; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration on unspecified date in 2021 (at the age of 56-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced blood clot in lungs on unspecified date in 2021. Consumer stated that he experienced some of the side effects. He took the Pfizer about 6 months ago and ended up getting a blood clot. He was in the emergency room they found the blood clot in his lungs. They said he had a vein (Further clarification unknown). He had a blood clot and it was in lungs. The patient said, he has the blood clot after the vaccination. I need to find out what should I do. What are they going to do? And they tell me what to do after that? The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Constipation, Decreased appetite, Illness
Clinical narrative: Has a sick nauseated feeling all the time; Stomach hurts all the time; Has a sick nauseated feeling all the time; he's constipated; he can't drink or eat much, even drinking water is hard; He feels full very quickly; This is a spontaneous report from a contactable Consumer or other non-HCP. This consumer (patient) reported for a male patient:  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, on an unspecified date, as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On an unspecified date, the patient experienced a sick nauseated feeling all the time, stomach hurts all the time, constipated, can't drink or eat much, even drinking water was hard and feels full very quickly. The reporter stated that the patient had the Pfizer vaccine a few weeks ago and ever since then patient stomach hurts all the time and it feels hard, patient can't drink or eat much, even drinking water was hard. Patient feels 'full' very quickly. Patient had a sick nauseated feeling all the time and he was constipated. Reporter queried if side effects are familiar for someone taking Pfizer. Reporter was informed about the Pfizer Medical Information department and offered the number. Reporter was also informed about the role of Pfizer Drug Safety. Reporter was provided with the number of Pfizer Medical Information. Reporter was informed about the role of Pfizer Drug Safety. The outcome for all the reported events was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Has a sick nauseated feeling all the time; Stomach hurts all the time; Has a sick nauseated feeling all the time; he's constipated; he can't drink or eat much, even drinking water is hard; He feels full very quickly; This is a spontaneous report from a contactable Consumer or other non-HCP. This consumer (patient) reported for a male patient:  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, on an unspecified date, as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On an unspecified date, the patient experienced a sick nauseated feeling all the time, stomach hurts all the time, constipated, can't drink or eat much, even drinking water was hard and feels full very quickly. The reporter stated that the patient had the Pfizer vaccine a few weeks ago and ever since then patient stomach hurts all the time and it feels hard, patient can't drink or eat much, even drinking water was hard. Patient feels 'full' very quickly. Patient had a sick nauseated feeling all the time and he was constipated. Reporter queried if side effects are familiar for someone taking Pfizer. Reporter was informed about the Pfizer Medical Information department and offered the number. Reporter was also informed about the role of Pfizer Drug Safety. Reporter was provided with the number of Pfizer Medical Information. Reporter was informed about the role of Pfizer Drug Safety. The outcome for all the reported events was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer Sales Representative.  A 70-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Lot number unknown), via an unspecified route of administration, on an unspecified date at single booster dose (dose number unknown) for COVID-19 immunization. No relevant medical history and concomitant medications were provided. On unknown date, the patient had shingles. The event was reported serious for hospitalization. The outcome of the event was unknown.  No follow-up attempts are possible. Information about Batch/lot number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary Embolism; This is a spontaneous report from a contactable consumer who reported similar events for two patients. This is the second of two reports. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and the concomitant medications were not reported.  The patient experienced pulmonary embolism on an unspecified date. The outcome was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-2021526199 different patient, similar event and same drug
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Lymphadenopathy, Tremor, Vertigo
Clinical narrative: Tremor; significant vertigo; numbness in her thumb and first finger; Headache; elevated lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received third dose (booster) of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: 301308A and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 01Oct2021 (age at vaccination: 48 years), as dose 3 (booster), single dose for COVID-19 immunization. The patient's medical history included head injury, anxiety, and long QT syndrome. The patient's family medical history relevant to adverse events included heart disease, stroke, and breast cancer. Concomitant medications included metoprolol for heart and her mitral valve, acetylsalicylic acid (aspirin (E.C.) for long QT syndrome and blood clots in her left leg, citalopram for anxiety, and influenza vaccine inact SAG 4V (FLUCELVAX QUADRIVALENT). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3249 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 20Jan2021 (age at vaccination: 48 years), as dose 1, single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9269 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 10Feb2021 (age at vaccination: 48 years), as dose 2, single dose for COVID-19 immunization. She reacted big on the first dose and had really bad headaches and was in bed for the first 48 hours. It was not as bad with the second dose. On 01Oct2021, the patient reported that she immediately had numbness in her thumb and first finger upon injection. She said that later on, about 4 weeks later, she had a tremor on 24Oct2021. She said that she also had the usual headache and things like that on an unspecified date in Oct2021. She had significant vertigo on 17Oct2021. The doctor said that the vertigo was not related to the vaccine. She said that she had elevated lymph nodes about 2 weeks after the injection that were throughout the left arm pit, occipital area, and behind her ear on an unspecified date in Oct2021. She did not know if that contributed to the vertigo. Vertigo occurred the week of 17Oct201 and was most pronounced in the morning and stated that she still has a little bit of it. She has always been sensitive to medicine. She took a very small dose of her medications. Her symptoms after receiving her booster dose mimicked her head injury and she felt like she had a head injury all over again. The events did not required a visit to emergency room and physician office. Outcome of the event tremor was recovered on 27Oct2021, and for all other events, it was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac stress test, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: heart palpitations; it just progressively getting worse; wakes up with chest pain; feels like heart coming out her chest; it just progressively getting worse; wakes up with chest pain; feels like heart coming out her chest; She is not feeling well; she has fatigue; Shortness of breath; having problem sleeping at night; This is a spontaneous report received from a contactable consumer. This 45-year-old female consumer(patient) reported for herself.  A 45-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Batch/Lot number: EN6198), via an unspecified route of administration, administered in Deltoid Left on 04Mar2021 as dose 2, single for covid-19 immunisation. The patient Medical history and concomitant medications were reported as none. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Lot number: EN6201) in Afternoon, via an unspecified route of administration on 12Feb2021 as dose 1, single for covid-19 immunisation and patient was perfectly fine after getting vaccination, she got second one. On an unspecified date on 2021, the patient experienced heart palpitations, it just progressively got worse; wakes up with chest pain; feels like heart coming out her chest, She is not feeling well, she had fatigue, shortness of breath, had problem sleeping at night. The patient stated to through out the course after she received it having heart palpitations, blood pressure her heart was (incomplete sentence), had chest pain and didn't really thought any thing other in beginning and it just progressively got worse. The Secondary Reporter stated, "she has been seeing a cardiologist, she was having a heart monitor and she was placed on several heart medications. (Further clarifications unknown). She was not feeling well and she was very upset. she was little frustrated and little concern it was going. The reporter stated that she had fatigue, she had shortness of breath, she had such things she is having problem sleeping at night she wakes up with chest pain after taking rest it feels like heart coming out her chest. She is on a beta blocker (Treatment), and they put her on the statin (Treatment) as well because of the heart issue. The events heart palpitations, it just progressively getting worse; wakes up with chest pain; feels like heart coming out her chest, Shortness of breath required physician office visit. On an unspecified date on 2021, the patient underwent lab tests and procedures which included blood test: unknown results, cardiac stress test: unknown results, echocardiogram: unknown results, electrocardiogram: unknown results, magnetic resonance imaging heart: unknown result. The outcome of event it just progressively getting worse; wakes up with chest pain; feels like heart coming out her chest was Not recovered and other events were unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Fatigue, Insomnia, Magnetic resonance imaging heart
Clinical narrative: heart palpitations; it just progressively getting worse; wakes up with chest pain; feels like heart coming out her chest; it just progressively getting worse; wakes up with chest pain; feels like heart coming out her chest; She is not feeling well; she has fatigue; Shortness of breath; having problem sleeping at night; This is a spontaneous report received from a contactable consumer. This 45-year-old female consumer(patient) reported for herself.  A 45-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Batch/Lot number: EN6198), via an unspecified route of administration, administered in Deltoid Left on 04Mar2021 as dose 2, single for covid-19 immunisation. The patient Medical history and concomitant medications were reported as none. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Lot number: EN6201) in Afternoon, via an unspecified route of administration on 12Feb2021 as dose 1, single for covid-19 immunisation and patient was perfectly fine after getting vaccination, she got second one. On an unspecified date on 2021, the patient experienced heart palpitations, it just progressively got worse; wakes up with chest pain; feels like heart coming out her chest, She is not feeling well, she had fatigue, shortness of breath, had problem sleeping at night. The patient stated to through out the course after she received it having heart palpitations, blood pressure her heart was (incomplete sentence), had chest pain and didn't really thought any thing other in beginning and it just progressively got worse. The Secondary Reporter stated, "she has been seeing a cardiologist, she was having a heart monitor and she was placed on several heart medications. (Further clarifications unknown). She was not feeling well and she was very upset. she was little frustrated and little concern it was going. The reporter stated that she had fatigue, she had shortness of breath, she had such things she is having problem sleeping at night she wakes up with chest pain after taking rest it feels like heart coming out her chest. She is on a beta blocker (Treatment), and they put her on the statin (Treatment) as well because of the heart issue. The events heart palpitations, it just progressively getting worse; wakes up with chest pain; feels like heart coming out her chest, Shortness of breath required physician office visit. On an unspecified date on 2021, the patient underwent lab tests and procedures which included blood test: unknown results, cardiac stress test: unknown results, echocardiogram: unknown results, electrocardiogram: unknown results, magnetic resonance imaging heart: unknown result. The outcome of event it just progressively getting worse; wakes up with chest pain; feels like heart coming out her chest was Not recovered and other events were unknown.  Follow-up attempts are completed. No further information is expected.