chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata, Basal cell carcinoma, Diffuse alopecia
Clinical narrative: Basal cell carcinoma in nose; Alopecia Areata; Telugen effluvium; Lost lots of hair, eventually noticed it started to fall in patches.; This is a spontaneous report received from a contactable consumer.  A 39-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, in Arm Left on 31Mar2021 14:30 (Batch/Lot Number: Ep 1533) (at the age of 39 years-old) as single dose for covid-19 immunisation . The patient had received the first dose of vaccine on 31Mar2021 at 02:30 PM (Lot Ep 1533) in Left arm. The patient medical history was not reported.  The patient's concomitant medications 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. Patient was not pregnant. Drug history included drug allergy to bactrim. On 05Apr2021 the patient experienced lost lots of hair, eventually noticed it started to fall in patches. She saw 2 doctors and both diagnosed alopecia areata and Telogen effluvium in May2021. At the same time while going through the process she was also diagnosed with a basal cell carcinoma in her nose. The adverse events resulted in the Doctor or other healthcare professional office/clinic visit . Treatment received for the adverse events inclued steroid shots, steroid topical creams, uv light tr. The outcome of the events was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Nausea, Near death experience, Vomiting
Clinical narrative: going to die from your vaccine; nausea; vomiting; high blood pressure; This is a spontaneous report from contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as a dose number unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported that, going to die from your vaccine, nausea, vomiting and high blood pressure. Patient asked, me how long after the vaccine can be nausea, vomiting last. I am already 2 weeks here with nausea, vomiting with the high blood pressure. I am going to die from your vaccine, I am going to die. The patient underwent lab tests and procedures which included blood pressure measurement which was high on an unspecified date. The outcome of the events were unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Weight decreased
Clinical narrative: hard lump where I got the vaccination; just lost 35 pounds; This is a spontaneous report from a contactable consumer reported for herself. A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 28Jul2021 (at the age of 29-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history, concomitant medications, investigation assessment and prior vaccinations within 4 weeks included none. he patient experienced hard lump where she got the vaccination, just lost 35 pounds on Jul2021. Patient had my vaccination (confirmed as Pfizer Covid vaccine) on Wednesday and had a very hard lump where she got the vaccination. And asked if that was normal. In response to weight, patient stated as 380, just lost 35 pounds (further clarification unknown). No treatment taken for event and stated she just didn't find it normal. Her friend just told to call and double check as how hard it was. Clinical outcome of events was unknown.  Information about lot/batch number will be obtained during follow-up.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Muscle twitching
Clinical narrative: Metallic taste in my mouth; Right eye started to twitch/ Eye twitching; This is a spontaneous report from a contactable consumer (patient).  A 61-year-old patient of an unspecified gender received first dose of BNT162b2 (COVID-19 Vaccine-Manufacturer Unknown, solution for injection), at an unknown route of administration at right arm on 28Jul2021 (lot Number: EW0161, expiry date: unknown), (at the age of 61-year-old), first dose, single for COVID-19 immunisation. The patient had no medical history and concomitant medications. The patient experienced metallic taste in the mouth and right eye started to twitch/eye twitching on 28Jul2021. The patient did not received treatment to the events. The event right eye started to twitch/eye twitching was not recovered. The event metallic taste in the mouth was recovered on 28Jul2021.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: left hand fingers went to sleep for about 7-8 hours; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0181 and expiration date was not reported), first dose via an unspecified route of administration, administered in the left arm on 29Jun2021 (at the age of 62-year-old) as single for covid-19 immunization. The patient's medical history included drug hypersensitivity for septra and bactrim. The patient's concomitant medications were not reported. Patient did not had any other vaccinations within four weeks prior to the first administration date of the suspect vaccines. On unspecified date in 2021, the patient experienced left hand fingers went to sleep for about 7-8 hours. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: like my arm pit is kind of swollen and it hurts little bit; like my arm pit is kind of swollen and it hurts little bit; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the Shot (Pfizer Covid Vaccine) in left arm and slept on the arm on day the patient gets shot, the patient slept on arm and only need arm, when the knees, like arm pit was kind of swollen and it hurts little bit, so tried to figure out was it normal in arm or the patient do not know. The reporter reported "What number do you want? It's on the Vaccination card on the back of the Vaccination card. Okay on the Vaccination card I don't see a number on here, I just see my name". Consumer stated, "I am calling just to find out, I have swelling on my arm, I want to know if it's come from the shot. That's all I want to know. I don't need the address that's all I want to know where all this came to my arm, that's all I want to know. I don't want to need all this address all I want to know where this come did from the shot. Where did this come from the shot all I want to know because if this came from the shot, I won't be taking the second one. I didn't even know, could you send to the people I want to talk". The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Poor quality sleep
Clinical narrative: I feel a little tired; Did not sleep well; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer sponsored program.   A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 31Jul2021 at 09:30 am (Batch/Lot Number: EW0182) as dose 1, single for covid-19 immunization (at the age of 62-years-old). The patient medical and concomitant medications were not reported. It was reported that after receiving the first dose of vaccine on an unspecified date in 2021, the patient felt a little tired and did not sleep well. The patient further stated she was calling also because she wants to know if ever she will feel headache or something and fever, what does she need to take as a medication. She was scheduled for the second dose on 21Aug2021 at 9:30am. She further stated that she was feeling okay and she felt a little tired because she did not sleep well last night and it might be from that and she was not sure. The outcome of the event was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased, Hypoaesthesia, Swelling
Clinical narrative: Increased heart rate; Facial swelling; some swelling in my neck right underneath my chin; Shortness of breath and difficulty in breathing when my heart rate spikes; Numbness down my right arm; This is a spontaneous report from a contactable consumer. This 36-years old female consumer (patient) reported for herself.  A 36-year-old female patient received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EW0180, Expiration date: unknown), via unspecified route, administered in right arm on 29Jul2021 (at the age of 36-year-old) as dose 2, single for COVID-19 immunization. The patient medical history includes Coeliac disease from an unspecified date to unknown ongoing and concomitant medications includes loratadine, pseudoephedrine sulphate (CLARITIN-D) for an unknown indication, cyanocobalamin (B-12) for unknown indication, cholecalciferol, menaquinone-7, Phyto menadione, retinol palmitate, tocopherol, tocotrienols nos (VITAMIN D COMPLEX) for unknown indication. No vaccine was taken within four weeks prior to vaccinations. On 29Jul2021, immediately after the vaccination, the patient experienced increased heart rate that went down on its own within 15-to-20-minute, patient noticed that her heart rate was experiencing spikes even when she was sitting completely still. Her heart rate was increased to 110, 120 and 125. she wears a heart monitor, a watch that monitors her heart rate. Patient also experienced facial swelling and some swelling in the neck right underneath her chin, which was noticeable externally. Patient also started to experience some shortness of breath and difficulty in breathing when her heart rate spikes. patient also experienced numbness down the right arm, the same arm that she got the shot, not at the injection site its down the higher length of her arm. The patient lab data includes heart rate readings on unspecified dates which showed 110, 120, and 125. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Increased heart rate; Facial swelling; some swelling in my neck right underneath my chin; Shortness of breath and difficulty in breathing when my heart rate spikes; Numbness down my right arm; This is a spontaneous report from a contactable consumer. This 36-years old female consumer (patient) reported for herself.  A 36-year-old female patient received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EW0180, Expiration date: unknown), via unspecified route, administered in right arm on 29Jul2021 (at the age of 36-year-old) as dose 2, single for COVID-19 immunization. The patient medical history includes Coeliac disease from an unspecified date to unknown ongoing and concomitant medications includes loratadine, pseudoephedrine sulphate (CLARITIN-D) for an unknown indication, cyanocobalamin (B-12) for unknown indication, cholecalciferol, menaquinone-7, Phyto menadione, retinol palmitate, tocopherol, tocotrienols nos (VITAMIN D COMPLEX) for unknown indication. No vaccine was taken within four weeks prior to vaccinations. On 29Jul2021, immediately after the vaccination, the patient experienced increased heart rate that went down on its own within 15-to-20-minute, patient noticed that her heart rate was experiencing spikes even when she was sitting completely still. Her heart rate was increased to 110, 120 and 125. she wears a heart monitor, a watch that monitors her heart rate. Patient also experienced facial swelling and some swelling in the neck right underneath her chin, which was noticeable externally. Patient also started to experience some shortness of breath and difficulty in breathing when her heart rate spikes. patient also experienced numbness down the right arm, the same arm that she got the shot, not at the injection site its down the higher length of her arm. The patient lab data includes heart rate readings on unspecified dates which showed 110, 120, and 125. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Head injury, Hyperhidrosis, Palpitations, Seizure
Clinical narrative: fainted; seizure; heart racing; head still hurts to touch; sweating; shaking; extremely confused; This is a spontaneous report received from a contactable consumer (patient). A 23-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198), via an unspecified route of administration, administered in left arm on 16Jul2021 at 16:00 (at the age of 23-years-old) as dose 2, single for COVID-19 immunisation. The patient previously received the first dose of bnt162b2 (Lot no: EW1198) on 24Jun2021. The patient medical history was not reported. The patient was not COVID tested post vaccination. The patient had no known allergies. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) taken for attention deficit hyperactivity disorder (ADHD), start and stop date were not reported, and unspecified birth control. The patient reported that after receiving her 2nd vaccination dose, she fainted and had a seizure in the pharmacy. Initially after receiving the shot, she felt normal for 30 seconds. She was browsing because they instructed her to wait 10 mins. She started to feel her heart racing as if she just sprinted, and she felt confused. She was worried she was going to be sick, so she went to sit back down in the patient area. That was all she remembered. She woke up to pharmacists and bystanders helping her. She was told that she landed on her head and had a seizure in the fetal position. Her head still hurts to touch that area the day of reporting. She was shaking and sweating after waking up and was extremely confused. Her head hurt so badly. There was a very nice pharmacist and bystander who helped keep her calm until the EMS arrived. Nothing like this has ever happened to her before and she did not have allergies. She was completely fine after her first dose. The events were treated with EMS care. The outcome of events was recovering.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tremor
Clinical narrative: fainted; seizure; heart racing; head still hurts to touch; sweating; shaking; extremely confused; This is a spontaneous report received from a contactable consumer (patient). A 23-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198), via an unspecified route of administration, administered in left arm on 16Jul2021 at 16:00 (at the age of 23-years-old) as dose 2, single for COVID-19 immunisation. The patient previously received the first dose of bnt162b2 (Lot no: EW1198) on 24Jun2021. The patient medical history was not reported. The patient was not COVID tested post vaccination. The patient had no known allergies. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) taken for attention deficit hyperactivity disorder (ADHD), start and stop date were not reported, and unspecified birth control. The patient reported that after receiving her 2nd vaccination dose, she fainted and had a seizure in the pharmacy. Initially after receiving the shot, she felt normal for 30 seconds. She was browsing because they instructed her to wait 10 mins. She started to feel her heart racing as if she just sprinted, and she felt confused. She was worried she was going to be sick, so she went to sit back down in the patient area. That was all she remembered. She woke up to pharmacists and bystanders helping her. She was told that she landed on her head and had a seizure in the fetal position. Her head still hurts to touch that area the day of reporting. She was shaking and sweating after waking up and was extremely confused. Her head hurt so badly. There was a very nice pharmacist and bystander who helped keep her calm until the EMS arrived. Nothing like this has ever happened to her before and she did not have allergies. She was completely fine after her first dose. The events were treated with EMS care. The outcome of events was recovering.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Hypoaesthesia, Muscle twitching, Pain in extremity, Paraesthesia
Clinical narrative: soreness in the leftcalf; slight fever; occasional pressure inthe head; muscle twitches in theleft calf; strange tinglingsensations in the face; numbness spread across the left side of the body. Through the arm, shoulder, neck, face and down the leg; minor swelling in the throat; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Jul2021 at 17:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any medication within two weeks of COVID-19 vaccine. On 27Jul2021 at 17:45, the patient experienced minor swelling in her throat but nothing alarming. On the same day at 18:00, the patient experienced strange tingling sensations in face, and after that a numbness spread across her left side of the body, Through her arm, shoulder, neck, face and down her leg. On the same day at 18:15, the patient experienced soreness in her left calf. Even her tongue was divided in two sides, numbness was slight but feeling sense was different on one each side. This had now persisted for 72 hours, and she had a slight fever, she experienced occasional pressure in her head and muscle twitches in her left calf. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events minor swelling in her throat, strange tingling sensations in face, and after that a numbness spread across her left side of the body, through her arm, shoulder, neck, face and down her leg, soreness in her left calf. Even her tongue was divided in two sides, numbness was slight but feeling sense was different on one each side, a slight fever, occasional pressure in her head and muscle twitches in her left calf was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pyrexia
Clinical narrative: soreness in the leftcalf; slight fever; occasional pressure inthe head; muscle twitches in theleft calf; strange tinglingsensations in the face; numbness spread across the left side of the body. Through the arm, shoulder, neck, face and down the leg; minor swelling in the throat; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Jul2021 at 17:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any medication within two weeks of COVID-19 vaccine. On 27Jul2021 at 17:45, the patient experienced minor swelling in her throat but nothing alarming. On the same day at 18:00, the patient experienced strange tingling sensations in face, and after that a numbness spread across her left side of the body, Through her arm, shoulder, neck, face and down her leg. On the same day at 18:15, the patient experienced soreness in her left calf. Even her tongue was divided in two sides, numbness was slight but feeling sense was different on one each side. This had now persisted for 72 hours, and she had a slight fever, she experienced occasional pressure in her head and muscle twitches in her left calf. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events minor swelling in her throat, strange tingling sensations in face, and after that a numbness spread across her left side of the body, through her arm, shoulder, neck, face and down her leg, soreness in her left calf. Even her tongue was divided in two sides, numbness was slight but feeling sense was different on one each side, a slight fever, occasional pressure in her head and muscle twitches in her left calf was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative
Clinical narrative: Ulcerative Colitis within 2 weeks of the second shot of Pfizer ER8731; This is a spontaneous report from a contactable other health professional (patient).  A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 19Apr2021 (Lot Number: ER8731) (at the age of 55-year-old) as single dose for COVID-19 immunisation. The patient did not experienced COVID-19 before or after vaccination. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medications included losartan; potassium; hydrochlorothiazide and amlodipine besylate, all concomitants were taken for an unspecified indication, start and stop date were not reported.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on an unspecified date (Lot Number: EW0168) as single dose for COVID-19 immunisation, the patient previously took propranolol and experienced allergy.  The patient experienced ulcerative colitis within 2 weeks of the second shot of Pfizer ER8731 (as reported) on 24May2021. The event was serious, disabling. The event required doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of ulcerative colitis and included treatment with mesalamine. The patient outcome of the event was not recovered.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of ulcerative colitis due to temporal relationship.  Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen node on top of collar bone; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 07Jul2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patients' medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09Jul2021, the patient experienced swollen node on top of collar bone. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen node on top of collar bone was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, General physical health deterioration, Somnolence
Clinical narrative: Light headed immediately afterwards; Loss of body function; Disoriented; Sleepy; This is a spontaneous report from a contactable healthcare professional, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 30Jul2021 at 16:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin, sulfur and latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient did not receive any concomitant medications. On 30Jul2021 at 16:30, the patient felt light headed immediately afterwards. She also experienced loss of body function, felt disoriented and sleepy. The events resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events light headed immediately afterwards, loss of body function, disoriented and sleepy were resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: Injection site pain immediately after receiving vaccine; This is a spontaneous report from a non-contactable nurse, the patient. A 49-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration on 30Jul2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jul2021, immediately after receiving the vaccine, the patient experienced injection site pain. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent antibody test and the result was unknown. The clinical outcome of the event injection site pain was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia oral, Tongue disorder
Clinical narrative: lip feels little bit tingling; Lip or tongue reaction; This is a spontaneous report from a contactable consumer. This consumer (patient) of unknown age and gender reported that he/she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date the patient experienced lip feels little bit tingling and Lip or tongue reaction (Unspecified condition of the tongue). The event outcome was unknown. Consumer stated that he/she got ready to get my get my second shot after 3 weeks and had side effect which was lip feels little bit tingling and lip or tongue reaction. Consumer hung up the call abruptly. Hence further probing could not be done. Limited information available over the call. Report Comment: Reporter type could not probed, hence captured as Consumer or other non-health professional in tab by default. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: I am not functioning well at all; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced i am not functioning well at all. I went to the Doctor like 5 times they cannot find anything wrong it is all because I have to get the second vaccine. Consumer was informed about Pfizer Medical Information Department. As consumer abruptly hung up the call. Product details, Pharmacy details and further probing could not be done. Limited information available over the call and appropriate response could not be provided. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Pain, Paraesthesia, Pyrexia
Clinical narrative: Fever; Body aches; Ankles pain; Knees pain; Hip pain; Unable to lift injected site arm; Face swelling; Tingling of feet and hands; Throwing up; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 27Jul2021 at 09:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had known allergies to hay fever, opioids and some fruit. Concomitant medications included vitamins. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 28Jun2021 at 12:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Jul2021 at 06:00, the patient experienced fever, body aches, ankles, knees pain, hip pain, unable to lift injected site arm, face swelling, tingling of feet, hands and throwing up. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, body aches, ankles, knees pain, hip pain, unable to lift injected site arm, face swelling, tingling of feet, hands and throwing up was recovering at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Vomiting
Clinical narrative: Fever; Body aches; Ankles pain; Knees pain; Hip pain; Unable to lift injected site arm; Face swelling; Tingling of feet and hands; Throwing up; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 27Jul2021 at 09:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had known allergies to hay fever, opioids and some fruit. Concomitant medications included vitamins. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 28Jun2021 at 12:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Jul2021 at 06:00, the patient experienced fever, body aches, ankles, knees pain, hip pain, unable to lift injected site arm, face swelling, tingling of feet, hands and throwing up. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, body aches, ankles, knees pain, hip pain, unable to lift injected site arm, face swelling, tingling of feet, hands and throwing up was recovering at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Jul2021 at 10:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 28Jul2021, the patient experienced painful and large swelling of lymph nodes (especially around neck, underarms and chest), swelling of lips and numbness. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the events painful and large swelling of lymph nodes (especially around neck, underarms and chest), swelling of lips and numbness were not recovered at the time of this report. The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood lactic acid, Body temperature, C-reactive protein, Cytokine storm, Dyspnoea
Clinical narrative: Cytokine storm; fever; short of breath; ground-glass opacities with the lung; This is a spontaneous report from a contactable consumer (husband) reported for a female patient  A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on Apr2021 as single dose for covid-19 immunisation. First dose was administered in an unknown date in 2021. The patient medical history was not reported. The patient's concomitant medications were not reported. A month later, in the end of May, she started to have fever, and it lasted over 5 weeks. On the week five, she was admitted to withheld and after ruling out all infectious reasons, she was diagnosed as cytokine storm (onset in an unspecified date in 2021) related with the Covid vaccine. Her Covid19 antibody is >2500. She has been taking steroids (prednisone 50mg) since then, all metrics and cytokine storm are getting better. But in week nine, all of a sudden, the fever came back at 40.8 degree, and had short of breath symptom. She had to go ER at 2am on Sat and was transferred to ICU then, the doctor said many metrics and symptoms were very similar to Covid19 patients, but her covid19 test result was still negative. The symptoms she had including short of breath, fever, ground-glass opacities with the lung, and some metrics including WBC:35.56, Ferritin: 35114, CRP: 173.0, Lactic dehydrogenase: 2871, Ddimer>1000. Reporter said his wife is suffering from Cytokine storm which is very likely causing by the Covid19 vaccine, and she is having symptoms very similar to Covid19 patients. Her current doctors do not have much knowledge about the vaccine, so they cannot provide good solution for this issue.  The outcome of Cytokine storm was recovering. The outcome of fever was not recovered. The outcome of short of breath and ground-glass opacities with the lung was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Lung opacity, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Cytokine storm; fever; short of breath; ground-glass opacities with the lung; This is a spontaneous report from a contactable consumer (husband) reported for a female patient  A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on Apr2021 as single dose for covid-19 immunisation. First dose was administered in an unknown date in 2021. The patient medical history was not reported. The patient's concomitant medications were not reported. A month later, in the end of May, she started to have fever, and it lasted over 5 weeks. On the week five, she was admitted to withheld and after ruling out all infectious reasons, she was diagnosed as cytokine storm (onset in an unspecified date in 2021) related with the Covid vaccine. Her Covid19 antibody is >2500. She has been taking steroids (prednisone 50mg) since then, all metrics and cytokine storm are getting better. But in week nine, all of a sudden, the fever came back at 40.8 degree, and had short of breath symptom. She had to go ER at 2am on Sat and was transferred to ICU then, the doctor said many metrics and symptoms were very similar to Covid19 patients, but her covid19 test result was still negative. The symptoms she had including short of breath, fever, ground-glass opacities with the lung, and some metrics including WBC:35.56, Ferritin: 35114, CRP: 173.0, Lactic dehydrogenase: 2871, Ddimer>1000. Reporter said his wife is suffering from Cytokine storm which is very likely causing by the Covid19 vaccine, and she is having symptoms very similar to Covid19 patients. Her current doctors do not have much knowledge about the vaccine, so they cannot provide good solution for this issue.  The outcome of Cytokine storm was recovering. The outcome of fever was not recovered. The outcome of short of breath and ground-glass opacities with the lung was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Serum ferritin, White blood cell count
Clinical narrative: Cytokine storm; fever; short of breath; ground-glass opacities with the lung; This is a spontaneous report from a contactable consumer (husband) reported for a female patient  A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on Apr2021 as single dose for covid-19 immunisation. First dose was administered in an unknown date in 2021. The patient medical history was not reported. The patient's concomitant medications were not reported. A month later, in the end of May, she started to have fever, and it lasted over 5 weeks. On the week five, she was admitted to withheld and after ruling out all infectious reasons, she was diagnosed as cytokine storm (onset in an unspecified date in 2021) related with the Covid vaccine. Her Covid19 antibody is >2500. She has been taking steroids (prednisone 50mg) since then, all metrics and cytokine storm are getting better. But in week nine, all of a sudden, the fever came back at 40.8 degree, and had short of breath symptom. She had to go ER at 2am on Sat and was transferred to ICU then, the doctor said many metrics and symptoms were very similar to Covid19 patients, but her covid19 test result was still negative. The symptoms she had including short of breath, fever, ground-glass opacities with the lung, and some metrics including WBC:35.56, Ferritin: 35114, CRP: 173.0, Lactic dehydrogenase: 2871, Ddimer>1000. Reporter said his wife is suffering from Cytokine storm which is very likely causing by the Covid19 vaccine, and she is having symptoms very similar to Covid19 patients. Her current doctors do not have much knowledge about the vaccine, so they cannot provide good solution for this issue.  The outcome of Cytokine storm was recovering. The outcome of fever was not recovered. The outcome of short of breath and ground-glass opacities with the lung was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: facial swelling on the left side of the face; facial swelling on the left side of the face; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on an unknown date in Jul2021 at 10:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for unknown indication and birth control (MANUFACTURER UNKNOWN) both from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jul2021 at 05:00 the patient experienced facial and lip swelling on the left side of the face. It was reported that the patient had filler on both the left and right side of the face but only the left side was swollen. Therapeutic measures were not taken as a result of the events. The event resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event facial and lip swelling on the left side of the face was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; Chills; Body ache; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 30Jul2021 at 17:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient has not reported any other health issues. The patient had no allergies to medications, food and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of the COVID vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jul2021 at 21:00, the patient experienced fever, chills and body ache. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit or emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported adverse events. The clinical outcome of the events, fever, chills and body ache was recovering at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Blood oestrogen, Pruritus, Urticaria, Vitamin D
Clinical narrative: Blisters; Hives extreme itchiness on left arm and toes , ankles and bottom of feet/ hives; Hives extreme itchiness on left arm and toes, ankles and bottom of feet./ Itchiness; This is a spontaneous report from a contactable consumer (patient). An adult female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 28Jul2021 at 18:00 (Lot Number: FA7484) as single dose for COVID-19 immunisation. Medical history included low vitamin D and estrogen levels. The patient reported known allergies to FLAGYL and as a child to raw shrimp shells. There were no concomitant medications. The patient reported hives, extreme itchiness on left arm and toes, ankles and bottom of feet. The shot was Wednesday evening. Hives, blisters, itchiness Saturday (on 31Jul2021 at 8:00). Saturday night took BENADRYL because itchiness was so bad. Since the vaccination the patient has not been tested for COVID-19. The patient outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging, Multiple sclerosis, Muscular weakness, Nervous system disorder
Clinical narrative: it is like multiple sclerosis presentation; lower extremities weakness; he is undergoing plasmapheresis to try to restore his neurological functions; This is a spontaneous report from a contactable physician. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 at the age of 41-years-old via an unspecified route of administration on 25May2021 (Batch/Lot Number: EW0182) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included anxiety from an unknown date. Concomitant medications included escitalopram oxalate (LEXAPRO) and escitalopram (ESCITALOPRAM) taken for anxiety, start and stop date were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 41-years-old on 04May2021 (Lot No: EW0173) for covid-19 immunisation. The physician reported that on an unspecified date in 2021 (reported as half a month ago; for further clarification), the patient came in with lower extremities weakness, he had MRI, which shows abnormalities, may be suggestive of multiple sclerosis and enhancing bilateral wide regions of brain, cervical and thoracic cords, suggesting multiple sclerosis or the other ideologies are possible. He had a final tap that was also abnormal. And he is undergoing plasmapheresis to try to restore his neurological functions. The patient was hospitalized due to the events on 22Jul2021. The outcome of the events was unknown.; Sender's Comments: The events most likely an intercurrent conditions and unrelated to suspect product  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). Case will be reassessed when additional information is received.