chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Head discomfort, Lymphadenopathy, Swollen tongue
Clinical narrative: my left nostril began to stream a fine line of blood.; Later thatevening, I experienced all of the listedside effects listen on your website,with the addition to a swollen tongueon the left side.; Immediately after the injection (left arm), I had swollen Lymph nodes from under arm/ breast up entire side.; I felt pressure on the top of my head on the same side.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0162) via an unspecified route of administration in the left arm on 02May2021 at 09:30 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included Raynaud's and Vascular injury nos (recovered vascular incident). The patient was allergic to medications, food, or other products but unspecified. Concomitant medication was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0150) via an unspecified route of administration in the left arm on 11Apr2021 at 09:30 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021 at 11:00 the patient experienced immediately after the injection (left arm) swollen lymph nodes from under arm/ breast up entire side. She felt pressure on the top of her head on the same side. An hour and half after the injection, the swelling was more noticeable and her left nostril began to stream a fine line of blood. The nose bleed lasted about 10 minutes. The patient generally does not get nose bleeds. Later that evening, she experienced all of the listed side effects listen on Pfizer vaccine website, with the addition to a swollen tongue on the left side. By Tuesday, most symptoms had subsided. Her tongue was still slightly swollen (Thursday). She could not find any information regarding this on Pfizer vaccine website. The patient had asked about the above events if they were normal. She was nervous about receiving additional boosters in the future without clarity to the nose bleed and tongue reactions. The patient had requested to bed contacted. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the adverse events. The clinical outcome of the events swollen lymph nodes, head pressure were recovered on 04May2021. The clinical outcome of the event nose bleed was recovered 02May2021 at 12:40.  The clinical outcome of the event swollen tongue was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Thyroiditis subacute
Clinical narrative: Subacute Thyroiditis: classic clinical presentation and clinical course.; This is a spontaneous report from a contactable physician. A 64-year-old male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER7832) intramuscular on 26Mar2021 at 13:00 (at the age of 64-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included hyperlipidemia and osteoarthritis. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine the patient was not diagnosed with COVID-19. Concomitant medications included atorvastatin from an unknown date for an unknown indication. The patient previously received tetanus vaccine on an unspecified date and experienced allergy. On 29Mar2021 at 13:00 the patient experienced subacute thyroiditis with classic clinical presentation and clinical course. The event was reported as serious. The patient was not hospitalized for the event. The patient visited a doctor or other healthcare professional/clinic as a result of the event. The patient underwent lab tests and procedures which included  2 RNA QLRRT-PCR (nasal swab) on 22Apr2021 with a result of negative. The patient received treatment with supportive steroids and beta blockers. The outcome of subacute thyroiditis was recovering.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event subacute thyroiditis and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Pain
Clinical narrative: Lack of drug effect; Lack of drug effect; Ache; Fatigue; This is a solicited report received from a contactable consumer (patient), other healthcare professional and based on the information received by Pfizer (MFR Control No. #Mfr. Control No.: 21K-163-3887269-00). This is a Non-interventional clinical study case reporting non-serious events only.  A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via intramuscular route on 29Apr2021, (at the age of 31-year-old) as single dose for COVID-19 immunization; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at CF for ankylosing spondylitis. The patient's medical history and concomitant medications were not reported.  On 30Apr2021 the patient experienced ache and fatigue, moreover it was reported that on an unknown date the patient also experienced "Lack of drug effect" (it was unclear if referred to HUMIRA or to BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine) on an unspecified date. At the time of the report the events ache and fatigue were recovering, whereas other events were not recovered.  The reporter considered that there was not a reasonable possibility that the reported events were related to adalimumab and BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (02Jun2021): 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.  Follow-up (09Jul2021): This follow-up report is being submitted to amend previously reported Information: event covid-19 was added and assessed as serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine on 29Apr2021; adalimumab (HUMIRA) from an unspecified date to an unspecified date for ankylosing spondylitis.  On 30Apr2021, the patient experienced ache and fatigue, and on an unknown date the patient experienced  "Lack of drug effect".  On 06May2021, the reporter reported that there was not a reasonable possibility that the reported events were related to adalimumab and COVID-19 mRNA Vaccine.  Considering temporal relationship, a possible contribution role of COVID-19 mRNA Vaccine to the onset of ache and fatigue cannot be excluded. Considering the very short time lag, the case does not meet the criteria of vaccine Lack of drug effect. This case will be reassessed should additional information become available.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Heart rate increased, Pruritus, Swelling
Clinical narrative: her heartbeat was pounding in her ears and it was faster than normal: Second dose; itching on her arm, it was hot and hard: Second dose; itching on her arm, it was hot and hard: Second dose; itching on her arm, it was hot and hard: Second dose; This is a spontaneous report from a contactable consumer (patient).  A 67-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution of injection, Batch/Lot Number: EW0169), via an unspecified route administered in right arm on 04May2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included, follicular lymphoma from Nov2010, she has to get Rituxan infusions for it. Rituxan infusions. After the first dose that the she received, she got really cold and chilled and her teeth were chattering. From there on she has had to get a steroid and a Benadryl infusion prior. Then the she has to stay there for 6 hours getting the slow drip of the Rituxan, Asthma, blood pressure abnormal, anxiety, anaphylactic reaction, rubber sensitivity and drug hypersensitivity (reaction to all penicillins and aspirin) all from an unknown date and unknown if ongoing. Concomitant medication included amlodipine 10mg once daily by mouth, taken for blood pressure abnormal, alprazolam 0.5 mg 3-4 times a day as needed, taken for anxiety, start and stop dates were not reported. The patient previously took BNT162B2 (BNT162B2, Solution of injection Batch/lot number: EW0151) via an unspecified route on right arm on 08Apr2021 as dose 1, single for covid-19 immunisation and experienced injection site pain. Past drugs include Rituxan infusions for follicular lymphoma, steroids and aspirin. The caller stated that, she had the second vaccine on a Tuesday, 04May2021, and seemed fine and had the reaction on the following Thursday, 06May2021, and Friday, 07May2021, it was a delayed reaction. The patient woke up on 06May2021, after taking Benadryl and she noticed that her heartbeat was pounding in her ears and it was faster than normal. The patient took some more Benadryl and went back to sleep. The patient was itching on her arm, it was hot and hard, when she woke up so she took Benadryl and went back to sleep. This went away after taking some Benadryl. These events started Thursday morning, 06May2021, and happened again on Friday morning, 07May2021, then that was it, she can't tell when it exactly stopped. The patient has been fine since and hasn't had to take Benadryl. The patient didn't feel like she was in danger or anything, she was concerned about her fast heart rate. The patient thinks this was an allergic reaction. The patient underwent lab tests and procedures which included heart rate increased: heartbeat was pounding in her ears and it was fast on an unknown date heartbeat was pounding in her ears and it was faster than normal. Therapeutic measures taken as result of the events includes Benedryl. The outcome of the events was recovered on an unspecified date in 2021.   No follow-up attempts are possible; No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EW0169, Expiration Date: not reported) via unspecified route of administration on 03May2021 (at the age of 59-years-old), as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EW0158, Expiration Date: not reported) via unspecified route of administration on 12Apr2021 (at the age of 59-years-old), as dose 1, single for COVID-19 immunisation. The patient experienced headache on an unspecified date. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Malaise, Tachycardia, Tremor
Clinical narrative: Tachycardia; Tremors; Pressure in the head; Distress; This is spontaneous report from a contactable consumer and a response to the mail trail regarding confirmation of the query. A 52-years-old non-pregnant female consumer (Patient) reported for herself that she received first dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Not provided, Reason why batch/lot is Unknown: Not available/provided to reporter at the time of report completion) via an unspecified route of administration on 04May2021 at 02:00 pm in left arm as dose 1, single for covid-19 immunisation at the age of 52 years old. Vaccine was administered at other facility. Patient's medical history included hypertension (dates unspecified). Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Patient experienced tachycardia, tremor, pressure in the head and distress on 04May2021 at 02:00 pm. AE did not result in emergency room visit or physician's office. No treatment was given for the adverse events. The outcome of events was recovered on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: daughter who received the Pfizer vaccine and does breastfeeding; This is a spontaneous report from a non-contactable consumer (parent). A female patient (reporter's daughter) 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 dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer reported that she has a "daughter who received the pfizer vaccine and does breastfeeding". The consumer asked why was it that only below 12 years old could get vaccinated with Pfizer COVID-19 vaccine because she has a 4 years and 6 months old grandson that was in kinder and she was worried because her grandson could not take a vaccine yet.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Blood glucose decreased, Disturbance in attention, Feeling abnormal, Movement disorder
Clinical narrative: joints froze up- barely get to the bathroom; couldn't move the knees; muscle pain; fever; fuzzy mind was very hard to concentrate; fuzzy mind was very hard to concentrate; she was acting all weird and feels like not herself/nowhere near her normal self; blood sugar dropped fast; This is a spontaneous report from a contactable consumer. A 73-year-old female patient (consumer) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: unknown), via an unspecified route of administration on 14Apr2021 (vaccinated at the age of 73 years) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. She described this side effect as "so pretty bad" but not that bad for her to end up on the emergency room (ER). She said that it was hard to pinpoint if the vaccine had really caused the side effects because she has a lot of underlying health conditions. Caller mentioned that the side effects she experienced 15 minutes after getting the vaccine- no side effects experienced, 1 1/2-2 1/2 hours after first dose, blood sugar dropped fast, 2-3 days later had joints froze up, barely get to the bathroom, couldn't move the knees, muscle pain, fever, fuzzy mind was very hard to concentrate. Her neighbor was with her and neighbor mentioned that she was acting all weird and feels like not herself. Everything was just so worst and have never gone through anything like this. Right now, she was feeling a lot better but nowhere near her normal self. She has had several side effects, but nothing bad enough to go to the hospital. It has been bad. The patient wanted to know if the second vaccine will do like the first vaccine. She was trying to decide if she should take it. She wants to, but if the side effects are the same, she does not worse. There have been various things she has experienced, and she would not know how to pinpoint what was a reaction to the vaccine. She does not want to report her side effects. She just wanted to get over to Medical Information. Outcome the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Personality change, Pyrexia
Clinical narrative: joints froze up- barely get to the bathroom; couldn't move the knees; muscle pain; fever; fuzzy mind was very hard to concentrate; fuzzy mind was very hard to concentrate; she was acting all weird and feels like not herself/nowhere near her normal self; blood sugar dropped fast; This is a spontaneous report from a contactable consumer. A 73-year-old female patient (consumer) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: unknown), via an unspecified route of administration on 14Apr2021 (vaccinated at the age of 73 years) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. She described this side effect as "so pretty bad" but not that bad for her to end up on the emergency room (ER). She said that it was hard to pinpoint if the vaccine had really caused the side effects because she has a lot of underlying health conditions. Caller mentioned that the side effects she experienced 15 minutes after getting the vaccine- no side effects experienced, 1 1/2-2 1/2 hours after first dose, blood sugar dropped fast, 2-3 days later had joints froze up, barely get to the bathroom, couldn't move the knees, muscle pain, fever, fuzzy mind was very hard to concentrate. Her neighbor was with her and neighbor mentioned that she was acting all weird and feels like not herself. Everything was just so worst and have never gone through anything like this. Right now, she was feeling a lot better but nowhere near her normal self. She has had several side effects, but nothing bad enough to go to the hospital. It has been bad. The patient wanted to know if the second vaccine will do like the first vaccine. She was trying to decide if she should take it. She wants to, but if the side effects are the same, she does not worse. There have been various things she has experienced, and she would not know how to pinpoint what was a reaction to the vaccine. She does not want to report her side effects. She just wanted to get over to Medical Information. Outcome the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Feel like someone beat his arm up; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer. A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration on 28Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient wants to reschedule his 2nd dose. Relayed to contact his HCP since that is where he got 1st dose. patient wanted to know how many days he had. Relayed that since his first dose was on 28Apr2021 he would need to get his 2nd dose on 19May2021. patient stated that his 1st dose caused him to feel like someone beat his arm up on an unspecified date in 2021. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Heart rate increased, Hypotension, Malaise
Clinical narrative: She says she has lost some weight; bad headache and it was almost a migraine; bad headache and it was almost a migraine; she didn't feel good to her stomach she felt kind of sick; she didn't feel good to her stomach she felt kind of sick; The 2nd dose created a very fast heartbeat in her; Her blood pressure was low; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0168), via an unspecified route of administration, administered in Arm Left on 07May2021 (age at the vaccination 65-year-old) as single dose for COVID-19 Immunization. Medical history included myocardial infarction and heart surgery from Aug2019 to unknown date. The patient concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (lot number: EW0169) on 16Apr2021 for COVID-19 Immunization and experienced COVID-19 Immunization. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. It was reported that the 2nd dose created a very fast heartbeat in her and she just wanted to let Pfizer know that. Her blood pressure was low, but her heartrate went up and it was higher than what it should have been on 08May2021. She is alright now, but it lasted for a good 12 hours. Patient says she has lost some weight. She got the COVID vaccine at 1500 on Friday 07May2021 and she woke up about 0300 AM on Saturday, 08May2021, with her heart racing and she called the COVID nurse that day and the nurse said to keep an eye on it and to make sure that it did not go higher because if it did go higher than the caller would need to go to the emergency room. It eventually went down but it was high for quite a while. She had every single one and then the heart racing. She did not feel good for about 3 days. Probed for specific side effects, start dates and stop dates and caller says that she does not remember when they all started but she had a headache all day that lasted until the third day, it was a bad headache and it was almost a migraine. Also, she did not feel good to her stomach, she felt kind of sick. There was a lot that she had, it was about 10 on there that she experienced but most of them went away after about a couple days. Patient did not visit emergency room and physician office. The outcome of the event blood pressure low and heartbeats increased was recovered on an unspecified date in 2021 and unknown for other events.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Weight decreased
Clinical narrative: She says she has lost some weight; bad headache and it was almost a migraine; bad headache and it was almost a migraine; she didn't feel good to her stomach she felt kind of sick; she didn't feel good to her stomach she felt kind of sick; The 2nd dose created a very fast heartbeat in her; Her blood pressure was low; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0168), via an unspecified route of administration, administered in Arm Left on 07May2021 (age at the vaccination 65-year-old) as single dose for COVID-19 Immunization. Medical history included myocardial infarction and heart surgery from Aug2019 to unknown date. The patient concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (lot number: EW0169) on 16Apr2021 for COVID-19 Immunization and experienced COVID-19 Immunization. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. It was reported that the 2nd dose created a very fast heartbeat in her and she just wanted to let Pfizer know that. Her blood pressure was low, but her heartrate went up and it was higher than what it should have been on 08May2021. She is alright now, but it lasted for a good 12 hours. Patient says she has lost some weight. She got the COVID vaccine at 1500 on Friday 07May2021 and she woke up about 0300 AM on Saturday, 08May2021, with her heart racing and she called the COVID nurse that day and the nurse said to keep an eye on it and to make sure that it did not go higher because if it did go higher than the caller would need to go to the emergency room. It eventually went down but it was high for quite a while. She had every single one and then the heart racing. She did not feel good for about 3 days. Probed for specific side effects, start dates and stop dates and caller says that she does not remember when they all started but she had a headache all day that lasted until the third day, it was a bad headache and it was almost a migraine. Also, she did not feel good to her stomach, she felt kind of sick. There was a lot that she had, it was about 10 on there that she experienced but most of them went away after about a couple days. Patient did not visit emergency room and physician office. The outcome of the event blood pressure low and heartbeats increased was recovered on an unspecified date in 2021 and unknown for other events.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Fast heart rate; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received BNT162B2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on 11May2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient had vaccine and experienced fast heart rate on 11May2021, and wanted to know if her reaction had anything to do with the vaccine. Outcome of the event was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Wheezing
Clinical narrative: Experienced intermittent wheezing and tachycardia 4 weeks later; Experienced intermittent wheezing and tachycardia 4 weeks later; This is a spontaneous report received from a contactable Nurse. This Nurse reported for a patient (reporter's mother).   A 98-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 18Mar2021 (at the age of 98-years-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Retired nurse stated, On unspecified date of Apr2021, experienced intermittent wheezing and tachycardia 4 weeks later (No history of this before, no history of smoking). She did not receive the second dose and would like to know how to proceed on receiving it now.  Should she start all over or just have second dose. The clinical outcome of the event was unknown at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess, Blood test, Computerised tomogram, Ear haemorrhage, Neuralgia
Clinical narrative: there was a hole inside my left ear; thick yellow, clear puss and blood was oozing out of my left ear; sciatica pain; nerve pain; ear abscess; severed shooting pains up both arms, my hands hurt really bad; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 46-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration, in Left arm on 29Mar2021 (age at the time of vaccination 46-years-old), as a single dose for COVID-19 immunization. The patient's medical history included Depression, Thrombocytopenia, Severe IBS, Carpal tunnel right extremity, and allergies to penicillin, and Sulfa drugs. The patient's concomitant medications included Ondansetron. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 05Apr2021 13:15, the patient experienced there was a hole inside my left ear; thick yellow, clear puss and blood was oozing out of my left ear; sciatica pain; nerve pain; ear abscess; and severed shooting pains up both arms and my hands hurt really bad. On an unspecified date Apr2021, the patient underwent lab tests and procedures which included Bloodwork, Blood test: Unknown; and 25Apr2021, CT scan, Computerized tomogram: Unknown, to figure out what is happening in my ear and showed enlarged parotid glad on the left side and inflamed parotid glands. On 27Apr2021 followed up with ENT and he indicated I needed to see rheumatologist for ANA positive test; on 03May2021 Rheumatologist; on 09May2021 lab work. On 14May2021, Urgent care doctor visit for severe sciatica pain that continues. The adverse event result in Doctor or other healthcare professional office/clinic visits and Emergency room/department or urgent care. Patient received cortisone injections, and deep muscle massage/exercise as a treatment for the adverse events. The outcome for all the events was not recovered.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Preauricular cyst, Sciatica
Clinical narrative: there was a hole inside my left ear; thick yellow, clear puss and blood was oozing out of my left ear; sciatica pain; nerve pain; ear abscess; severed shooting pains up both arms, my hands hurt really bad; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 46-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration, in Left arm on 29Mar2021 (age at the time of vaccination 46-years-old), as a single dose for COVID-19 immunization. The patient's medical history included Depression, Thrombocytopenia, Severe IBS, Carpal tunnel right extremity, and allergies to penicillin, and Sulfa drugs. The patient's concomitant medications included Ondansetron. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 05Apr2021 13:15, the patient experienced there was a hole inside my left ear; thick yellow, clear puss and blood was oozing out of my left ear; sciatica pain; nerve pain; ear abscess; and severed shooting pains up both arms and my hands hurt really bad. On an unspecified date Apr2021, the patient underwent lab tests and procedures which included Bloodwork, Blood test: Unknown; and 25Apr2021, CT scan, Computerized tomogram: Unknown, to figure out what is happening in my ear and showed enlarged parotid glad on the left side and inflamed parotid glands. On 27Apr2021 followed up with ENT and he indicated I needed to see rheumatologist for ANA positive test; on 03May2021 Rheumatologist; on 09May2021 lab work. On 14May2021, Urgent care doctor visit for severe sciatica pain that continues. The adverse event result in Doctor or other healthcare professional office/clinic visits and Emergency room/department or urgent care. Patient received cortisone injections, and deep muscle massage/exercise as a treatment for the adverse events. The outcome for all the events was not recovered.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Irritability, Muscular weakness, Tachycardia
Clinical narrative: tachycardia; fatigue; muscle weakness; irritability/anxious; irritability/anxious; This is a spontaneous report from a contactable nurse reported for herself. A 41-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration in Arm Left on 27Apr2021 16:15 (age at vaccination 41years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. Medical history included raynaud's phenomenon from an unknown date and unknown if ongoing. The patient did not have any allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient did not receive other medications within 2 weeks of vaccination. The patient's concomitant medications were not reported. Since the vaccination, the patient has been tested for COVID-19. On 01May2021 the patient experienced tachycardia, fatigue, muscle weakness, irritability/anxious. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure timing unspecified, Pain in extremity
Clinical narrative: Currently pregnant; Sore arm; This is a spontaneous report from contactable consumer. A 32-Year-old female pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0176, Expiration: 01Jan1900) via an unspecified route of administration, administered in Arm Left (in the upper left arm) on 27Apr2021 as DOSE 1, SINGLE (age at vaccination was 32 years old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient is currently pregnant and last menstrual period was on 06Jan2021 and is due on 17Oct2021. 27Apr2021 ( Post-vaccination), patient only had a sore arm.  Patient is to receive the second dose of the Pfizer COVID-19 vaccine next week. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Pt Reported Having a Rash on Her Face That Lasts Several Days; This is a spontaneous report from a contactable nurse.   A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date (at the age of 65-years-old) as dose number unknown single for covid-19 immunization, patient received celecoxib (CELEBREX, Batch/Lot number was not reported), via an unspecified route of administration from an unspecified date, at 200 mg for an unspecified indication. Medical history included mild tingling in her lips from Nov2020 to an unknown date, moderate left hip pain from Nov2020 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date the patient reported that she had a rash on her face that lasts several days, patient stated the rash was sometimes on her chin, sometimes appears as a mask under eyes, or on her forehead. MD aware. The clinical outcome of event was not recovered.    Follow-up (02Aug2021): 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.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Electrocardiogram abnormal, Heart rate increased, SARS-CoV-2 test
Clinical narrative: hard time breathing. it gets worse at night . heart rates are very fast. ekg shows abnormal; hard time breathing. it gets worse at night . heart rates are very fast. ekg shows abnormal; hard time breathing. it gets worse at night . heart rates are very fast. ekg shows abnormal; This is a spontaneous report received from a contactable consumer (patient himself). A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration in left arm on 23Apr2021 15:30 as single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient medical history included Cardiac failure. Concomitant medications were not reported. Lab data includes EKG was Abnormal on an unspecified date and Nasal Swab was Negative on 30Apr2021. On 23Apr2021 15:45 patient stated that he had hard time breathing. it gets worse at night. heart rates are very fast and EKG shows abnormal. Patient visited with physician office visit and emergency room/department or urgent care. Patient did not receive any treatment for events. Outcome of events was not recovered.  Follow-up attempts have been completed and no further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Muscle tightness
Clinical narrative: numbing & tightness on the right side of jaw hinge area tiring from small events; numbing & tightness on the right side of jaw hinge area tiring from small events; numbing & tightness on the right side of jaw hinge area tiring from small events; This is a spontaneous report from a contactable consumer reported for herself. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EWO186; Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 20May2021 (at the age of 49-years-old) as DOSE 1, SINGLE for covid-19 immunisation at hospital. Medical history included trigeminal neuralgia, rubber sensitivity and hypersensitivity (known allergies: cillians, latax powder) from an unknown date and unknown if ongoing. Concomitant or other medications within 2 weeks of vaccination included baclofen (BACLOFEN); misoprostol (MISOPROSTOL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced numbing & tightness on the right side of jaw hinge area tiring from small events on 21May2021 07:00 hr. No treatment was received for the events. Clinical outcome of the events was not recovered.  Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nervousness, Vaccination site bruising, Vaccination site erythema, Vaccination site warmth
Clinical narrative: small bruise at the vaccination site; developed into a red spot; hot to the touch; small bruise at the vaccination site; developed into a red spot; hot to the touch; small bruise at the vaccination site; developed into a red spot; hot to the touch; I got nervous; something wrong with me; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program.  A female patient of an unspecified age received a BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on 13May2021 as dose number unknown, single for COVID-19 immunisation. The medical history and concomitant medication was not reported. On an unknown date the patient experienced small bruise at the vaccination site; developed into a red spot; hot to the touch and she got nervous. She told that she got the vaccine 2 weeks ago the COVID vaccine she felt a small bruise at the vaccination site, small bruise then after a while she noticed she it developed into a red spot, she said it was hot to the touch. . she just noticed that she wanted to go for shower and got nervous and thought something wrong with her. The outcome of the event was unknown.   Information on the lot/batch number has been requested.  Follow-up (26Jul2021): 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 had been completed and no further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Heart rate irregular, Posture abnormal
Clinical narrative: Second day after vaccine around noon she felt dizzy; she was laying down and her heart felt like it was beating really hard; was like leaning to the left; First day I had fatigue; This is a spontaneous report from a contactable consumer. A 36-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0185, Expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 18May2021 09:15 as dose 1, single for covid-19 immunisation administered at Pharmacy or Drug Store. Medical history included Penicillin allergy. Concomitant medications within 2 weeks of vaccination includes womens multivitamin. The patient did not receive any treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18May2021 18:00, the patient reported, first day she had fatigue, she was laying down and her heart felt like it was beating really hard. Second day after vaccine around noon she felt dizzy and was like leaning to the left. It went away that night. She need to know whether to get the second dose. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. Outcome of events was recovered on an unspecified date in May2021.   Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Affect lability, Anger, Depressed mood, Feeling abnormal, Headache
Clinical narrative: Patient initially had severe pain and brining at injection site that began a few hours following the vaccination.; extreme anger; intense sadness that were extremely out of character; intense sadness that were extremely out of character; Intense erratic emotions were followed by headache that has lasted greater than 25hrs.; Patient initially had severe pain and brining at injection site that began a few hours following the vaccination.; Intense erratic emotions were followed by headache that has lasted greater than 25hrs.; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 20-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration, administered in Arm Left on 30May2021 11:00 (age at vaccination: 20-years-old) as single dose for covid-19 immunization. (Vaccination facility: Pharmacy or Drug Store). Medical history included allergies to Soy, cefpodoxine, penicillin, Allergy to dairy  from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (IBUPROFEN), diphenhydramine (DIPHENHYDRAMINE) both taken for an unspecified indication, start and stop date were not reported. The patient previously took cefpodoxime and experienced Drug allergy. Patient did not receive any other vaccine in four weeks. It was reported that on 30May2021 17:00 Patient initially had severe pain and brining at injection site that began a few hours following the vaccination. The following day patient experienced episodes of extreme anger followed by intense sadness that were extremely out of character. Intense erratic emotions were followed by headache that has lasted greater than 25hrs. Patient has no history of severe headache or migraine. Patient did not for covid tested post vaccination. Patient did not receive any treatment for the event. Device Date: 01Jun2021. The outcome for the events was reported as resolving at the time of this report.   Follow-Up (30Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site pain
Clinical narrative: Patient initially had severe pain and brining at injection site that began a few hours following the vaccination.; extreme anger; intense sadness that were extremely out of character; intense sadness that were extremely out of character; Intense erratic emotions were followed by headache that has lasted greater than 25hrs.; Patient initially had severe pain and brining at injection site that began a few hours following the vaccination.; Intense erratic emotions were followed by headache that has lasted greater than 25hrs.; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 20-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration, administered in Arm Left on 30May2021 11:00 (age at vaccination: 20-years-old) as single dose for covid-19 immunization. (Vaccination facility: Pharmacy or Drug Store). Medical history included allergies to Soy, cefpodoxine, penicillin, Allergy to dairy  from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (IBUPROFEN), diphenhydramine (DIPHENHYDRAMINE) both taken for an unspecified indication, start and stop date were not reported. The patient previously took cefpodoxime and experienced Drug allergy. Patient did not receive any other vaccine in four weeks. It was reported that on 30May2021 17:00 Patient initially had severe pain and brining at injection site that began a few hours following the vaccination. The following day patient experienced episodes of extreme anger followed by intense sadness that were extremely out of character. Intense erratic emotions were followed by headache that has lasted greater than 25hrs. Patient has no history of severe headache or migraine. Patient did not for covid tested post vaccination. Patient did not receive any treatment for the event. Device Date: 01Jun2021. The outcome for the events was reported as resolving at the time of this report.   Follow-Up (30Jun2021): Follow-up attempts are completed. No further information is expected.