chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Headache, Pyrexia
Clinical narrative: Loss of taste and smell; Loss of taste and smell; sinus congestion; fever; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EWO176, Expiration date: unknown), via unspecified route, administered in left arm on 08Jun2021 at 11:20 am (at the age of 21-year-old) as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No other vaccine taken within in 4 weeks. On 08Jun2021, after the vaccination, the patient experienced fever and chills at night and headache in the afternoon. And later, 10Jun2021 patient experienced Loss of taste and smell and Sinus congestion in the evening. She explained she experienced some of the side effects, on her information sheet, but she is also experiencing sinus congestion along with taste and smell loss. She states that it has already been a week and, clarified her fever, chills and headache, only lasted a few days. She asks, why did she lose her taste and smell, in the first place and when will they return to normal and they were not side effects that were included on her information sheet and asked whether are they normal side effects to have. The outcome of the events pyrexia, chills and headache was recovered on 08Jun2021 and sinus congestion and loss of smell and taste was not recovered or resolved.  No follow-up attempts possible. No further information expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus congestion
Clinical narrative: Loss of taste and smell; Loss of taste and smell; sinus congestion; fever; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EWO176, Expiration date: unknown), via unspecified route, administered in left arm on 08Jun2021 at 11:20 am (at the age of 21-year-old) as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No other vaccine taken within in 4 weeks. On 08Jun2021, after the vaccination, the patient experienced fever and chills at night and headache in the afternoon. And later, 10Jun2021 patient experienced Loss of taste and smell and Sinus congestion in the evening. She explained she experienced some of the side effects, on her information sheet, but she is also experiencing sinus congestion along with taste and smell loss. She states that it has already been a week and, clarified her fever, chills and headache, only lasted a few days. She asks, why did she lose her taste and smell, in the first place and when will they return to normal and they were not side effects that were included on her information sheet and asked whether are they normal side effects to have. The outcome of the events pyrexia, chills and headache was recovered on 08Jun2021 and sinus congestion and loss of smell and taste was not recovered or resolved.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Bradykinesia, Energy increased, Feeling abnormal, Memory impairment, Product dose omission issue
Clinical narrative: feeling very energized; pacing the floor, seems to be turned into a robot, walking in circles,; can not sit down not even to eat; In a total fog; Will not be getting the second dose; She won't eat or go to the bathroom unless she was reminded; psychiatric break.; This is a spontaneous report from a contactable consumer (patient's mother) reported. A female patient of 28 years of age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Jun2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient medical history includes schizoaffective disorder from 4.5 years ago, went into a coma like state from that was four in a half years ago. The patient's concomitant medications were not reported. It was reported that she took the vaccine on last Friday along with two other family members and one of the family members was her daughter who has schizoaffective disorder. On 11Jun2021, the patient reported that within 15 minutes her daughter said to her how she feels very energized which never happens because her daughter takes Abilify and was never energized. Reporter stated the vaccine turned her daughter into a robot where she was walking in circles, cannot sit down not even to eat, and she was in a total fog for 10 to 15 minutes later she was respond because she was in a fog which makes her not able to comprehend what was being said. She won't eat or go to the bathroom unless she was reminded. Her daughter doesn't know what was going on. The nurse that gave it to her could be a witness. Her aunt was a NP. She felt immediately an energy boost. She doesn't think it was being reported. she found a pod cast that Covid itself has caused mental health issues in people, causing long haul bipolar disorder. The vaccine has a dead virus. It makes sense it would make you worse. she knows it had a dead virus in it. She knows people that work at the health program. Caller says she had a friend whose son was at similar age with the same disorder. "He got a Covid 19 vaccine and went on the deep end too". She wasn't sure which one he got. Referring to her daughter: "She's not going to get the second dose. She can't even do her hair. She can't even walk the dog or go outside by herself. The shot takes you back to where you were."Caller states that violent mental health patients shouldn't take it. Reporter stated this was called a psychiatric break. Treatment includes patient did not get any medicine she was just on regular medicine and not be able to get into the doctor until Friday. Therapeutic measures were taken as a result of events in a total fog, she won't eat or go to the bathroom unless she was reminded, psychiatric break. The events outcome was not recovered.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Psychiatric symptom, Sitting disability
Clinical narrative: feeling very energized; pacing the floor, seems to be turned into a robot, walking in circles,; can not sit down not even to eat; In a total fog; Will not be getting the second dose; She won't eat or go to the bathroom unless she was reminded; psychiatric break.; This is a spontaneous report from a contactable consumer (patient's mother) reported. A female patient of 28 years of age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Jun2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient medical history includes schizoaffective disorder from 4.5 years ago, went into a coma like state from that was four in a half years ago. The patient's concomitant medications were not reported. It was reported that she took the vaccine on last Friday along with two other family members and one of the family members was her daughter who has schizoaffective disorder. On 11Jun2021, the patient reported that within 15 minutes her daughter said to her how she feels very energized which never happens because her daughter takes Abilify and was never energized. Reporter stated the vaccine turned her daughter into a robot where she was walking in circles, cannot sit down not even to eat, and she was in a total fog for 10 to 15 minutes later she was respond because she was in a fog which makes her not able to comprehend what was being said. She won't eat or go to the bathroom unless she was reminded. Her daughter doesn't know what was going on. The nurse that gave it to her could be a witness. Her aunt was a NP. She felt immediately an energy boost. She doesn't think it was being reported. she found a pod cast that Covid itself has caused mental health issues in people, causing long haul bipolar disorder. The vaccine has a dead virus. It makes sense it would make you worse. she knows it had a dead virus in it. She knows people that work at the health program. Caller says she had a friend whose son was at similar age with the same disorder. "He got a Covid 19 vaccine and went on the deep end too". She wasn't sure which one he got. Referring to her daughter: "She's not going to get the second dose. She can't even do her hair. She can't even walk the dog or go outside by herself. The shot takes you back to where you were."Caller states that violent mental health patients shouldn't take it. Reporter stated this was called a psychiatric break. Treatment includes patient did not get any medicine she was just on regular medicine and not be able to get into the doctor until Friday. Therapeutic measures were taken as a result of events in a total fog, she won't eat or go to the bathroom unless she was reminded, psychiatric break. The events outcome was not recovered.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Mass, Rash
Clinical narrative: Little lump keep coming up on; Little COVID rash that keeps coming up on my neck and my chin; This is a spontaneous report from a non-contactable consumer (patient). An unspecified age female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number was unknown; formulation: solution for injection; expiration date: unknown), via an unspecified route of administration, on an unknown date in Apr2021 as single dose for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown; formulation: solution for injection; expiration date: unknown), via an unspecified route of administration on an unknown date in 2021 as single dose for COVID-19 Immunization and No reaction on previous exposure to vaccine. Patient stated that after receiving the 2nd COVID Vaccine back in April. That was not a good thing for her and she is still having like those little lump keep coming up on, little COVID rash that keeps coming up on her neck and her chin but it's not near as it was when she first got the shot hours later, so she was blessed to be continued to be living but at the same time she was just continuously monitoring her symptoms and if anything new is occurring because technically this is new." Limited information available as further probing could not be done, since she did not want to report again. Outcome of the events was not recovered  No follow up attempts are possible; Information about batch/ lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test
Clinical narrative: lost her sense of taste and smell; lost her sense of taste and smell; This is a spontaneous report from a contactable nurse (patient's mother). A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 16Jun2021 at 13:30 as a 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not re-ported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a 1st dose, single for COVID-19 immunization and experienced Covid-19 and drug ineffective. Nurse reported that, on 16Jun2021 around 1:30 pm, the patient received the second dose of the Pfizer BioNtech COVID-19 vaccine and about an hour or so after lost her sense of taste and smell on 16Jun2021 at 14:30. She compared the feeling to when something was numb how they can just feel the pressure. Reported no other symptoms or feeling bad. The caller wanted to know whether this symptom has previously been reported. The caller stated that, she will continue to monitor and after 2 days she will go get the patient covid tested per the CDC's recommendation. On an unspecified date, the patient underwent lab tests and procedures which included COVID-19 (SARS-CoV-2 test), resulted as unknown. The outcome of the events was unknown.  Information about lot/batch number has been requested. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: He has been experiencing symptoms of COVID like the lost of taste and smell.; Lost of taste; This is a spontaneous report from a contactable consumer (patient) for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 14Jun2021 as 1st dose, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination the patient  had been experiencing symptoms of COVID like the loss of taste and smell. Reporter seriousness for events was unspecified. Outcome of event was unknown.  Information regarding the lot/batch number has been requested.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Only had arm pain initially.; Bilateral knee pain; This is a spontaneous report from a contactable consumer (Patient's mother). A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via unspecified route of administration, on an unknown date (reported as: 2 weeks ago, as of tomorrow) (at the age of 13 years old)as 1st dose, single dose for COVID-19 Immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced Pain in arm initially, Knee pain started about 2 weeks after getting vaccine, it was like bilateral knee pain mostly with exercise. She did not have it the first few days of the shot like she would expect she normally would. She did not have it until last week. It was only when running last week and now she is still having it. Reporter reported that she was concerned about getting her daughter the second dose of vaccine and would like to know if this has been reported. Reporter does not know whether this was related to the first vaccine. She does not know how to know if it was related to the vaccine. Reporter stated that she does not know, and how does somebody know if it was related or not. Reporter also stated that her daughter was not having problems before and she does not know. Reporter stated that she would like to wait at this time and see, she was not sure she should report this or not. The outcome of the events was not recovered. It was reported as the Reporter stated that she thinks that she was not sure if it was related to the Covid vaccine or not  Information on Lot/Batch has been requested.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Epistaxis, Feeling abnormal, Headache, Nervousness
Clinical narrative: Bloody noses/ Nose bleeds; Runny nose; headache; Little bit of Asthma; Her grandson is nervous about this; Pretty upset; This is a spontaneous report from a contactable consumer or other non hcp (the patient's grandmother). A 15-year-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on 13Jun2021 as single dose for covid-19 immunization. The patient previously received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unknown date in May2021 as single dose for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. On 14Jun202, the patient had a headache and a runny nose and then the following day the patient had 4 bloody noses during the day and one at night. The patient is continuing to have bloody noses. On an unknown date in Jun2021, the reporter also stated that the patient might have a little bit of asthma. The reporter mentioned that the patient was pretty upset, nervous and he had the nose bleeds they are a lot, not just a little drip. The patient was treated with Advil for headache. The outcome of the events nose bleeds was reported as not recovered; runny nose was reported as recovering while other events were reported as unknown at the time of report.  Information on the lot/batch number has been requested.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Bloody noses/ Nose bleeds; Runny nose; headache; Little bit of Asthma; Her grandson is nervous about this; Pretty upset; This is a spontaneous report from a contactable consumer or other non hcp (the patient's grandmother). A 15-year-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on 13Jun2021 as single dose for covid-19 immunization. The patient previously received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unknown date in May2021 as single dose for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. On 14Jun202, the patient had a headache and a runny nose and then the following day the patient had 4 bloody noses during the day and one at night. The patient is continuing to have bloody noses. On an unknown date in Jun2021, the reporter also stated that the patient might have a little bit of asthma. The reporter mentioned that the patient was pretty upset, nervous and he had the nose bleeds they are a lot, not just a little drip. The patient was treated with Advil for headache. The outcome of the events nose bleeds was reported as not recovered; runny nose was reported as recovering while other events were reported as unknown at the time of report.  Information on the lot/batch number has been requested.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a Pfizer sponsored program . A contactable consumer reported for a 12-year-old female patient (reporter's daughter). A 12-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation and no reaction. It was reported that mother calling on behalf of her 12-year-old daughter received the second dose of the vaccine yesterday and has been running a fever and taking Tylenol every 4 hours since this morning. Normally she keep her home from school for 24 hours until she was fever free. Because it generated as a reaction for the shot, does that rule still apply questioned. She has had a fever this evening. she last took her temperature at 4pm and her temperature was 101.8. If she feels fine in the morning should she send her to school Or should she keep her home until her fever breaks, was she contagious questioned by mother. Outcome of the event was unknown.  Information about lot/Batch number has been requested.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dyspnoea, Headache, Paraesthesia
Clinical narrative: Swelling in my chest on the left side with pain; Swelling in my chest on the left side with pain; at times I feel I can't breathe well; tingling in my left arm,; slight fever; headache; chills; This is a Spontaneous report from a contactable consumer (patient). A 42-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE) via an unspecified route of administration on the left arm on 13Jun2021 at 01:45 PM (Lot number: EW0196) at the age of 42-year-old as single dose for COVID-19 immunization. Medication history was yes. Past drug event was none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. known allergies was none. Concomitant medication was not reported.  The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 23May2021 at 12:00 PM (Lot number: EW0187) at the age of 42-year-old as single dose for COVID-19 immunization. On 13Jun2021 at 02:30 PM, the patient experienced swelling in chest on the left side with pain, at times the patient feel can't breath well, tingling in left arm, slight fever, headache and chills. No treatment was received. The outcome of events was not recovered.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: Swelling in my chest on the left side with pain; Swelling in my chest on the left side with pain; at times I feel I can't breathe well; tingling in my left arm,; slight fever; headache; chills; This is a Spontaneous report from a contactable consumer (patient). A 42-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE) via an unspecified route of administration on the left arm on 13Jun2021 at 01:45 PM (Lot number: EW0196) at the age of 42-year-old as single dose for COVID-19 immunization. Medication history was yes. Past drug event was none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. known allergies was none. Concomitant medication was not reported.  The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 23May2021 at 12:00 PM (Lot number: EW0187) at the age of 42-year-old as single dose for COVID-19 immunization. On 13Jun2021 at 02:30 PM, the patient experienced swelling in chest on the left side with pain, at times the patient feel can't breath well, tingling in left arm, slight fever, headache and chills. No treatment was received. The outcome of events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain
Clinical narrative: She was tired; Weakness; Whole body aches; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller stated she was calling regarding the Pfizer Covid 19 shot and stated that she was calling about her daughter and that she was tired, had weakness and whole-body aches on an unspecified date. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity, Vaccination site pain
Clinical narrative: Date of start of drug 23May2021 06Jun2021; Dolor en el brazo donde fue aplicada la vacuna (Pain in the arm where the vaccine was given).; Dolor en el brazo donde fue aplicada la vacuna (Pain in the arm where the vaccine was given).; This is a spontaneous report from a contactable consumer, the patient.   A 40-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, (Batch/Lot Number: EW0187), via unspecified route, in left arm on 23May2021 at 12:00 (at 40-years age) as 1st dose, single for covid-19 immunization at pharmacy or drug store. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The concomitant drugs were not reported. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, (Batch/Lot Number: EW0196), via unspecified route, in left arm on 06Jun2021 at 01:45 PM as 2nd dose, single for covid-19 immunization. On 23May2021 at 19:00 the patient had experienced Dolor en el brazo donde fue aplicada la vacuna (Pain in the arm where the vaccine was given). The device date was reported as 16Jun2021. The patient had not received the treatment. No other medications were taken by the patient within 2 weeks of vaccination. The patient was not hospitalized. The outcome of the events was recovered in 2021.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First Dose: Sore arm; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0175) via an unspecified route of administration in left arm on 04May2021 as 1st dose, single for COVID-19 immunization. Medical history included allergies. Concomitant medication included unspecified allergy pill, but does not really have to take if she was wearing a mask and because she was not going out as much. On 04May2021, patient experienced only sore arm if she touched it. Patient reported that she would not have even known that her arm was sore if she had not touched it. Patient was taking Pfizer Covid-19 Vaccine to preventing coronavirus and to protect herself. It was reported that patient received second dose of Pfizer vaccine on 25May2021 (Lot Number: EW0186) in left arm and experienced left leg felt weird, Joint pain, Back pain, Foot was swollen and painful. Patient reported that with the second dose of the Covid-19 vaccine, she did not have any soreness at the injection site. Patient underwent lab test after second dose for an ultrasound to check for a blood clot but did not find anything. Patient reported that she was diagnosed with tenosynovitis, inflammation of the tendon or sheath around the tendon after the second dose. The outcome of the event was recovered on 05May2021.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. An unspecified age male patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID 19 VACCINE) via an unspecified route of administration on 16Mar2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously took the first dose of BNT162B2 via an unspecified route of administration on 23Feb2021 as single dose for COVID-19 immunization and no reaction on previous exposure to drug. On an unspecified date, the patient had a metallic taste in mouth. And he had this effect ever since he received his shots and until the currently day. The patient wondered whether had a remedy for this effect. The patient had already spoken to his primary care doctor, about his concern. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: arm discomfort; This is a spontaneous report received from a contactable consumer (patients' wife). A 61-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot Number: EW0151; Expiration Date: 01Jan1900), via an intramuscular route of administration, administered in Arm Left (non-dominant, upper arm, closer to shoulder) on 09Apr2021 (at the age of 61-year-old), as single dose, for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 09Apr2021 (onset of symptom occurring after the first dose), the patient experienced arm discomfort and the reporter stated that the symptom seemed to have gone away 24 hours after the first dose and her husband did not take any medication to treat this symptom. There is no product complaint associated with this case. The outcome of the event arm discomfort was resolved on 10Apr2021.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fall, Gait inability, Headache, Illness
Clinical narrative: sick; throwing up; Diarrhea; Headache; feet and legs swollen, left worse than right; he couldn't walk; fell; This is a spontaneous report received from a contactable consumer (patient). A 59-years-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date: Unknown), dose 1 via an unspecified route of administration, administered in right arm on 24Mar2021 in between 10:00 to 11:00 as 1st dose, single(at the age of 59-years-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported patient had no prior vaccinations. The patient has been sick with vaccination, and experienced throwing up, had diarrhea, a headache, and did not realize that when he started walking around that it was doing the damage it was doing until he figured out he couldn't walk, states one of the days, exact date not provided, he got out of bed one day and fell to the floor, states then he realized what happened, states it has been going on for a good while, states his feet and legs swollen, started about 4 weeks ago, exact start dates of all events unknown. States he can hardly walk due to the swelling. States they gave him a medication for the diarrhea, exact name unknown. Patient was not hospitalized and no hospital stay. No Investigation Assessment. Therapeutic measures were taken as a result of diarrhea. Patient was recovering from throwing up, been sick and outcome was unknown for feet and legs swollen, left worse than right, unable to walk, fell, and not recovered from rest of the events.  Follow-up attempts are possible. Further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Vomiting
Clinical narrative: sick; throwing up; Diarrhea; Headache; feet and legs swollen, left worse than right; he couldn't walk; fell; This is a spontaneous report received from a contactable consumer (patient). A 59-years-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date: Unknown), dose 1 via an unspecified route of administration, administered in right arm on 24Mar2021 in between 10:00 to 11:00 as 1st dose, single(at the age of 59-years-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported patient had no prior vaccinations. The patient has been sick with vaccination, and experienced throwing up, had diarrhea, a headache, and did not realize that when he started walking around that it was doing the damage it was doing until he figured out he couldn't walk, states one of the days, exact date not provided, he got out of bed one day and fell to the floor, states then he realized what happened, states it has been going on for a good while, states his feet and legs swollen, started about 4 weeks ago, exact start dates of all events unknown. States he can hardly walk due to the swelling. States they gave him a medication for the diarrhea, exact name unknown. Patient was not hospitalized and no hospital stay. No Investigation Assessment. Therapeutic measures were taken as a result of diarrhea. Patient was recovering from throwing up, been sick and outcome was unknown for feet and legs swollen, left worse than right, unable to walk, fell, and not recovered from rest of the events.  Follow-up attempts are possible. Further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Vomiting
Clinical narrative: itchiness around her whole body especially her back; feeling a lot of nausea; she feels like she wants to throw up; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on the left arm on 02Jun2021 (Lot Number: EW0217) at 48-year-old as single dose for COVID-19 immunization. Medical history was none. Investigation Assessment was none. This report wasn't related to a study or programme. There was none vaccine administered on same date with the Pfizer vaccine. There was none other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient was staying with family then she will move on. Concomitant medication included vitamins nos and it was ongoing. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the right arm on 12May2021 (Batch/Lot number: EW0105) at the age of 48-year-old as single dose for COVID-19 immunization and experienced nausea and couldn't stand up because she threw up everything she had eaten. The patient states she received both doses of the Pfizer Covid-19 vaccine, and 2 weeks after receiving the first and second dose, she was feeling a lot of nausea and feels like she wants to throw up. Itchiness around her whole body especially her back. The nausea for the past 2 or 3 days and the day before the currently day it was very strong. The patient hadn't thrown up but she had taken Pepto Bismol on 15Jun2021. The patient had avoided all tests and medications except for the Pepto Bismol. The patient wants to know if she could take Pepto Bismol for nausea after the vaccine. The patient also asked if after two weeks was it possible to still had side effects, and asked if she could started taken her vitamins and drunk alcohol again. And the patient also asked if this was related to the COVID-19 vaccine. The events were not required emergency room and physician office. The events were not following prior vaccinations. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Muscle disorder, Neck pain, Pain in jaw
Clinical narrative: Head pain; Pain on jaw bone; Pain on both sides of the nose; Pain in neck and shoulders; Froze up her muscles; Physical therapist told her she may have tendinitis in her head/brain; Pain in neck and shoulders; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 26Feb2021 (age at vaccination 77-year-old) as 2nd dose, single for covid-19 immunization. Medical history included fall. Patient stated that in the early 2000s she had a fall as a result of an allergic reaction to a prescription medication and hit her head on the kitchen floor and ended up in the hospital after fall, no further information provided by the caller about what prescription medication this was, allergic reaction to a prescription medication and pacemaker. The patient's concomitant medications were not reported. The patient previously took first dose of BNT62B2 for COVID-19 Immunization. Patient stated she had her second dose of the Pfizer Covid 19 Vaccine on 26Feb2021 and had some side effects and she assumes they were from the vaccine. On 27Feb2021, patient experienced head pain and pain on jawbone. Stated she continued to have pain in her head, neck, and shoulders. She went to her primary care and an ear, nose, and throat doctor. Says she had lots of sinus problems, lots of allergies, and was highly sensitive to medications. On an unspecified date in Feb2021, one night, all night, she had pain on both sides of her nose. States she continued to have serious head pain, pain in neck and shoulders, froze up her muscles, she stated the Covid Vaccine froze up her muscles. She said the physical therapist said she possibly has tendinitis in her head and said physical therapy has been helping, it was not just a minor, dull feeling in her head. Patient stated she was in Physical Therapy because they were working on her muscles and said she goes every Tuesday and Thursday. Said they were working on trying to unfreeze her muscles. Patient stated that she sees an allergist once a year. Patient said she wonders if she got an overdose of the vaccine due to her sensitivity, weight, and size. Patient stated she needs someone with technical expertise. Since she has a pacemaker she went and saw her cardiologist to see if there was any impact on her pacemaker. The cardiologist found no changes. She was concerned going forward how much of a risk was she at of getting Covid 19. Patient stated that the ear, nose, and throat doctor did a scan of her sinuses and an x-ray of her head. Patient stated she cannot have an MRI due to her pacemaker. The patient underwent lab tests and procedures which included scan of her sinuses: unknown, scratch test positive: unknown in an unspecified date in 2005, x-ray of her head: unknown. The outcome of the events was unknown.   Information on Lot/Batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinalgia, Scan, Skin test positive, Tendonitis, X-ray
Clinical narrative: Head pain; Pain on jaw bone; Pain on both sides of the nose; Pain in neck and shoulders; Froze up her muscles; Physical therapist told her she may have tendinitis in her head/brain; Pain in neck and shoulders; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 26Feb2021 (age at vaccination 77-year-old) as 2nd dose, single for covid-19 immunization. Medical history included fall. Patient stated that in the early 2000s she had a fall as a result of an allergic reaction to a prescription medication and hit her head on the kitchen floor and ended up in the hospital after fall, no further information provided by the caller about what prescription medication this was, allergic reaction to a prescription medication and pacemaker. The patient's concomitant medications were not reported. The patient previously took first dose of BNT62B2 for COVID-19 Immunization. Patient stated she had her second dose of the Pfizer Covid 19 Vaccine on 26Feb2021 and had some side effects and she assumes they were from the vaccine. On 27Feb2021, patient experienced head pain and pain on jawbone. Stated she continued to have pain in her head, neck, and shoulders. She went to her primary care and an ear, nose, and throat doctor. Says she had lots of sinus problems, lots of allergies, and was highly sensitive to medications. On an unspecified date in Feb2021, one night, all night, she had pain on both sides of her nose. States she continued to have serious head pain, pain in neck and shoulders, froze up her muscles, she stated the Covid Vaccine froze up her muscles. She said the physical therapist said she possibly has tendinitis in her head and said physical therapy has been helping, it was not just a minor, dull feeling in her head. Patient stated she was in Physical Therapy because they were working on her muscles and said she goes every Tuesday and Thursday. Said they were working on trying to unfreeze her muscles. Patient stated that she sees an allergist once a year. Patient said she wonders if she got an overdose of the vaccine due to her sensitivity, weight, and size. Patient stated she needs someone with technical expertise. Since she has a pacemaker she went and saw her cardiologist to see if there was any impact on her pacemaker. The cardiologist found no changes. She was concerned going forward how much of a risk was she at of getting Covid 19. Patient stated that the ear, nose, and throat doctor did a scan of her sinuses and an x-ray of her head. Patient stated she cannot have an MRI due to her pacemaker. The patient underwent lab tests and procedures which included scan of her sinuses: unknown, scratch test positive: unknown in an unspecified date in 2005, x-ray of her head: unknown. The outcome of the events was unknown.   Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Photopsia
Clinical narrative: developed migraines; Flashes of light in her eyes; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received bnt162b2 (solution for injection), via an unspecified route of administration on an unspecified date as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took previously BNT162B2 (solution for injection), dose1 for covid-19 immunisation and experience no reaction. It was reported that patient had developed migraines, flashes of light in her eyes, and many additional symptoms after receiving the second dose. She was being seen with neurology, neuro ophthalmology, and may other doctors. The clinical outcome of the events was unknown.  Information on Lot/Batch has been requested.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Taste disorder
Clinical narrative: He is having an issue with the taste, when it comes to food; Weird headache; Body Aches; This is a spontaneous report from a non-contactable consumer or other non hcp. A 18-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,formulation: Solution for injection, Batch number/Lot Number: EWO150),via an unspecified route of administration ,administered in arm right on 05Apr2021 14:10 (at the age of 18-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,formulation: Solution for injection, Batch number/Lot Number: EW0169), via an unspecified route of administration,administered in arm right on 26Apr2021 14:05 ((at the age of 18-years-old) for covid-19 immunization .Medical history included allergy,attention deficit hyperactivity disorder from an unknown date and unknown if ongoing. Concomitant medications included methylphenidate taken for attention deficit hyperactivity disorder ,Once a day,start and stop date were not reported; Cetirizine taken for hypersensitivity Once a day ,10mg ,start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 the patient experienced he is having an issue with the taste, when it comes to food on, weird headache, body aches. The reporter did not even know, what even make him to eat. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Hyperhidrosis, Malaise
Clinical narrative: Arm was hurting; Headache; Sweating like my cheeks was sweating, my hair was sweating; Dizzy; Shaky; Feel very weird; I really don't feel good; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received BNT161B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) dose 2 via an unspecified route of administration on 16Jun2021 as single for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 25May2021 as single for COVID-19 immunisation and experienced as, "I got very ill with that first one when I got it, I got flu like symptoms". The patient experienced as, "Yesterday, I got my second vaccine, Pfizer one and my arm was hurting and I had a headache yesterday. Today, I woke up feeling kind of the same. I went to work and I started sweating, sweating like my cheeks was sweating, my hair was sweating and I was getting dizzy, I was very shaky. I don't know what is going on, I left work and came home right now and I just feel like, I feel very weird and I don't know what is going on. I don't know if it is a side effect, I don't know if that is anything to do with my shot but today, I just wasn't, I couldn't get it altogether today, it couldn't be normal". In response to further probing for safety report, consumer stated, "No, not right now, I really don't feel good. At the time of reporting, the outcome of the events were unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Nervousness, Pain in extremity
Clinical narrative: Arm was hurting; Headache; Sweating like my cheeks was sweating, my hair was sweating; Dizzy; Shaky; Feel very weird; I really don't feel good; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received BNT161B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) dose 2 via an unspecified route of administration on 16Jun2021 as single for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 25May2021 as single for COVID-19 immunisation and experienced as, "I got very ill with that first one when I got it, I got flu like symptoms". The patient experienced as, "Yesterday, I got my second vaccine, Pfizer one and my arm was hurting and I had a headache yesterday. Today, I woke up feeling kind of the same. I went to work and I started sweating, sweating like my cheeks was sweating, my hair was sweating and I was getting dizzy, I was very shaky. I don't know what is going on, I left work and came home right now and I just feel like, I feel very weird and I don't know what is going on. I don't know if it is a side effect, I don't know if that is anything to do with my shot but today, I just wasn't, I couldn't get it altogether today, it couldn't be normal". In response to further probing for safety report, consumer stated, "No, not right now, I really don't feel good. At the time of reporting, the outcome of the events were unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Rash
Clinical narrative: He had a pretty bad rash on his back; He was not feeling too well, yeah he fell asleep he is not feeling very well; This is a spontaneous report from a contactable consumer (patient's mother). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0178), via an unspecified route of administration on 15May2021 as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8736). On an unknown date, the patient had a pretty bad rash on his back, he was not feeling too well, he fell asleep he was not feeling very well. The seriousness for both events was not specified by reporter. The outcome of the events was unknown.  Information on the lot/batch was available, Additional information has been requested.