chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Presyncope, Sluggishness, Syncope, Taste disorder
Clinical narrative: I did have diarrhea the next morning; Panic attack; It was a near fainting episode; It was a near fainting episode; Feel a flush go through my chest and then up through my face; I had an antiseptic taste in my mouth; feel hot all over; Sweating beads of sweat on my forehead running down; Suddenly my hearing went muffled almost completely out; Heart was also racing; Felt very lightheaded and dizzy; My hands and fingertips were tingling and felt numb; My hands and fingertips were tingling and felt numb; I had extreme arm soreness on the arm with the injection; I felt extremely tired and sluggish for the rest of the evening; I felt extremely tired and sluggish for the rest of the evening; This is a spontaneous report from a contactable consumer (patient). A 41-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EW0191 and Expiration date: unknown), via an unspecified route of administration, in left arm on 15Jun2021 at 15:00 (at the age of 41-years-old) as dose 1, single for covid-19 immunisation. Medical history included PCOS and thyroid nodules from an unknown date. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC) taken for oral contraception, start and stop date were not reported. The patient previously took erythromycin. Patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and not tested for covid-19 since the vaccination. On 15Jun2021 at 15:00, within about 30 seconds of receiving the vaccine she could feel a flush go through her chest and then up through her face. She had an antiseptic taste in her mouth. She began to feel hot all over, started sweating beads of sweat on her forehead running down, suddenly her hearing went muffled almost completely out, heart was also racing and felt very lightheaded and dizzy. She had to lean back in the chair and close her eyes for about 15 minutes until it stopped. Afterwards when she got up to leave, still felt dizzy and her hands and fingertips were tingling and felt numb. Either this was a panic attack or it was a near fainting episode. Afterwards she had extreme arm soreness on the arm with the injection. She felt extremely tired and sluggish for the rest of the evening. The next day (as reported) she felt better, just a little sluggish with arm soreness. On 16Jun2021 the patient experienced that, she did have diarrhea the next morning which was not normal for her. Hospitalization was not required for events. No treatment was received for events. Outcome of events was recovered on an unknown date in Jun2021.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I did have diarrhea the next morning; Panic attack; It was a near fainting episode; It was a near fainting episode; Feel a flush go through my chest and then up through my face; I had an antiseptic taste in my mouth; feel hot all over; Sweating beads of sweat on my forehead running down; Suddenly my hearing went muffled almost completely out; Heart was also racing; Felt very lightheaded and dizzy; My hands and fingertips were tingling and felt numb; My hands and fingertips were tingling and felt numb; I had extreme arm soreness on the arm with the injection; I felt extremely tired and sluggish for the rest of the evening; I felt extremely tired and sluggish for the rest of the evening; This is a spontaneous report from a contactable consumer (patient). A 41-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EW0191 and Expiration date: unknown), via an unspecified route of administration, in left arm on 15Jun2021 at 15:00 (at the age of 41-years-old) as dose 1, single for covid-19 immunisation. Medical history included PCOS and thyroid nodules from an unknown date. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC) taken for oral contraception, start and stop date were not reported. The patient previously took erythromycin. Patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and not tested for covid-19 since the vaccination. On 15Jun2021 at 15:00, within about 30 seconds of receiving the vaccine she could feel a flush go through her chest and then up through her face. She had an antiseptic taste in her mouth. She began to feel hot all over, started sweating beads of sweat on her forehead running down, suddenly her hearing went muffled almost completely out, heart was also racing and felt very lightheaded and dizzy. She had to lean back in the chair and close her eyes for about 15 minutes until it stopped. Afterwards when she got up to leave, still felt dizzy and her hands and fingertips were tingling and felt numb. Either this was a panic attack or it was a near fainting episode. Afterwards she had extreme arm soreness on the arm with the injection. She felt extremely tired and sluggish for the rest of the evening. The next day (as reported) she felt better, just a little sluggish with arm soreness. On 16Jun2021 the patient experienced that, she did have diarrhea the next morning which was not normal for her. Hospitalization was not required for events. No treatment was received for events. Outcome of events was recovered on an unknown date in Jun2021.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Hypersensitivity
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration as dose number unknown, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date patient had an allergic, anaphylaxis, reaction to the pfizer vaccine. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on his palm and it was that spreading over 2 weeks to the hand and to the feet, also rash on the tongue; This is a spontaneous report from a contactable physician. A 15-years-old male patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: was not reported) via an unspecified route of administration on 27May2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had not any other history and products. It was reported that, patient had the reaction to the COVID-19 vaccine. Patient had vaccine on 27May2021 and next day on 28May2021 he developed rash on his palm and it was that spreading over 2 weeks to the hand and to the feet, also rash on the tongue. So, the rashes were for 2 weeks. The department of health told the physician that not to give the second dose of vaccine to the patient. Reporter seriousness for Rash on his palm and it was that spreading over 2 weeks to the hand and to the feet and rash on the tongue was unspecified. Therapeutic measures were taken as a result of adverse events as patient had received treatment with Benadryl, Prednisone, Cefalexin. Cefalexin was 500 mg 2 times a day for 7 days, Benadryl 25 mg 2 times a day prm (further not clarified) and Prednisone 60mg once a day for 3 days. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of rash cannot be excluded. 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: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lip swelling, Peripheral swelling, Pruritus, Rash
Clinical narrative: Full body rash; full body itchiness; swelling of the skin, toes, fingers and lips.; swelling of the skin; swelling of the skin, toes, fingers and lips.; Joint pain from minimal movement.; swelling of the skin, toes, fingers and lips.; This is a spontaneous report from a contactable consumer (patient). A 15-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number: unspecified) via unspecified route of administration in the left arm, as dose 2, single on 10Jun2021 for COVID-19 immunization (at the age of 15-years-old). The patient medical history was not reported. The patient received birth control medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. There were no known allergies. On 12Jun2021 16:00, the patient experienced Full body rash, full body itchiness, swelling of the skin, toes, fingers, and lips. Swelling goes up at night and down after waking up, Joint pain from minimal movement. The events led to emergency room visit and hospitalization for 2 days. The patient underwent lab tests and procedures which included nasal swab and results were negative on 13Jun2021. Treatment received included benadryl, motrin and atakin, no imaging or steroid medication given. The outcome for the events was not recovered.  Information on Lot/Batch number has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Skin swelling, Swelling
Clinical narrative: Full body rash; full body itchiness; swelling of the skin, toes, fingers and lips.; swelling of the skin; swelling of the skin, toes, fingers and lips.; Joint pain from minimal movement.; swelling of the skin, toes, fingers and lips.; This is a spontaneous report from a contactable consumer (patient). A 15-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number: unspecified) via unspecified route of administration in the left arm, as dose 2, single on 10Jun2021 for COVID-19 immunization (at the age of 15-years-old). The patient medical history was not reported. The patient received birth control medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. There were no known allergies. On 12Jun2021 16:00, the patient experienced Full body rash, full body itchiness, swelling of the skin, toes, fingers, and lips. Swelling goes up at night and down after waking up, Joint pain from minimal movement. The events led to emergency room visit and hospitalization for 2 days. The patient underwent lab tests and procedures which included nasal swab and results were negative on 13Jun2021. Treatment received included benadryl, motrin and atakin, no imaging or steroid medication given. The outcome for the events was not recovered.  Information on Lot/Batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis, Palpitations
Clinical narrative: myocarditis; Heart palpitations; This is a spontaneous report from a non-contactable consumer (patient). A 23-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in Arm Left on 14Jun2021 at 05:00 PM (at the age of 23-years-old) as a single dose for covid-19 immunisation at Pharmacy/drug store. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administration on 22May2021 at 09:00 AM (at the age of 23-years-old) as a single dose for covid-19 immunisation. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 14Jun2021, the patient experienced myocarditis, and heart palpitations. Events resulted in emergency room visit. Treatment received was unknown for events. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste; This is a spontaneous report from a non-contactable consumer or report from a Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 (Pfizer Covid-19 Vaccine,Solution for injection,Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as Dose Number Unknown.Single for COVID-19 immunization.The patient's medical history and concomitant medications were not reported.The patient experienced metallic taste.The patient asked What if the second dose cannot be provided at 3 weeks (21 days)? When do I receive my second dose of the Pfizer-BioNTech COVID-19 Vaccine? The outcome for the events was Unknown.                          . No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate irregular, Muscle spasms, Pain in extremity, Peripheral swelling
Clinical narrative: Severe swelling of lower legsPain in entire legs constant worse when using stairsCramping severe tonightIrregular heart beatTired  other pains off and onThis has been on going since my vaccine an; Severe swelling of lower legsPain in entire legs constant worse when using stairsCramping severe tonightIrregular heart beatTired  other pains off and onThis has been on going since my vaccine an; Severe swelling of lower legsPain in entire legs constant worse when using stairsCramping severe tonightIrregular heart beatTired  other pains off and onThis has been on going since my vaccine an; Severe swelling of lower legsPain in entire legs constant worse when using stairsCramping severe tonightIrregular heart beatTired  other pains off and onThis has been on going since my vaccine an; Severe swelling of lower legsPain in entire legs constant worse when using stairsCramping severe tonightIrregular heart beatTired  other pains off and onThis has been on going since my vaccine an; This is a spontaneous report from a contactable consumer (Patient). A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot Number: Unknown) via an unspecified route of administration in right arm on 01Jun2021 at 07:30 as dose 1, single (at the age of 38-years-old) for COVID-19 immunization at Doctor's office/urgent care. Medical history included Penicillin allergy from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.), Baby Aspirin) and LORAZEPAM taken within 2 weeks for an unspecified indication, start and stop date were not reported. Prior to vaccination the patient was not diagnosed with COVID-19 and not received any other vaccines within 4 weeks. On 01Jun2021 at 08:00, the patient experienced severe swelling of lower legs, pain in entire legs constant worse when using stairs, cramping severe tonight, irregular heartbeat, tired other pains off and this has been ongoing since she took the vaccine and is not getting better. The adverse event leads to visit Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No prolonged hospitalization and no treatment received for events. Since the vaccination, the patient has not been tested for COVID-19. Patient was not recovered from events.  Information on the lot/batch number has been requested.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Electrocardiogram, Electrocardiogram ST segment elevation, Myocarditis
Clinical narrative: Elevation of the ST in the EKG; pericarditis; Myocarditis; Chest tightening and chest pain; Chest tightening and chest pain; Ever harder for him to laid down so he is no comfortable in sitting up he woke up with a chest pain lying down; This is a spontaneous report from a contactable consumer or other non hcp. A 17-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number: EW0173 and Expiration date was not reported), via intramuscular, administered in Deltoid Right on 04Jun2021 15:00 (Age at vaccination was 17-year-old) as dose 2 single for covid-19 immunization. The patient medical history was not reported. Concomitant medication included no, Vitamins (It is the gummy bear vitamins multivitamins for kids). The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included first dose of BNT162B2 for covid-19 immunization. On 06Jun2021the second day they have to go, he woke up with chest tightening and chest pain, and know it was ever harder for him to laid down, so he was not comfortable in sitting up and he woke up with a chest pain lying down. so they had gone to the emergency room and there were some test that they run and one of which the ultrasound of the heart and the EKG in which they saw that that there was elevation of the ST in the EKG and then he was given some medicine she thought it was Ibuprofen or something and then they said that it was fine or it was like pericarditis or myocarditis something like that so when they were advised in the discharged notes that for like more than was whole night they were discharge at the ER on Monday 07Jun2021 around 4 am. The discharge note it says that if you still feel the chest pain or anything or he feel like get sore and feel not much better than they had to go back then and advised to be seen by the primary care doctor or pediatrician which they did on 3 days after on the 09Jun2021, that was the Wednesday seen by his primary doctor so all the paper work was sent and they were advised to be seen still waiting to be seen our current pediatric current in neurology. They do not really know if from the plan of the ER if they know what was going on with his heart hopefully it get resolved or something but then they still do not know firstly was on the ER do not know and there was no medication only in the discharge note if he feel pain or something give him like the Ibuprofen (treatment), Morphine other stuff but a since the time that we were out of the ER, did not give him that because he did not feel the way he did when we went to the ER. The patient underwent lab tests and procedures which included electrocardiogram: elevation of the st on 06Jun2021, ultrasound chest: unknown results on 06Jun2021. Therapeutic measures were taken because of chest tightening and chest pain. The outcome of the events was unknown.  Information on lot/batch number was available. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pericarditis, Ultrasound chest
Clinical narrative: Elevation of the ST in the EKG; pericarditis; Myocarditis; Chest tightening and chest pain; Chest tightening and chest pain; Ever harder for him to laid down so he is no comfortable in sitting up he woke up with a chest pain lying down; This is a spontaneous report from a contactable consumer or other non hcp. A 17-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number: EW0173 and Expiration date was not reported), via intramuscular, administered in Deltoid Right on 04Jun2021 15:00 (Age at vaccination was 17-year-old) as dose 2 single for covid-19 immunization. The patient medical history was not reported. Concomitant medication included no, Vitamins (It is the gummy bear vitamins multivitamins for kids). The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included first dose of BNT162B2 for covid-19 immunization. On 06Jun2021the second day they have to go, he woke up with chest tightening and chest pain, and know it was ever harder for him to laid down, so he was not comfortable in sitting up and he woke up with a chest pain lying down. so they had gone to the emergency room and there were some test that they run and one of which the ultrasound of the heart and the EKG in which they saw that that there was elevation of the ST in the EKG and then he was given some medicine she thought it was Ibuprofen or something and then they said that it was fine or it was like pericarditis or myocarditis something like that so when they were advised in the discharged notes that for like more than was whole night they were discharge at the ER on Monday 07Jun2021 around 4 am. The discharge note it says that if you still feel the chest pain or anything or he feel like get sore and feel not much better than they had to go back then and advised to be seen by the primary care doctor or pediatrician which they did on 3 days after on the 09Jun2021, that was the Wednesday seen by his primary doctor so all the paper work was sent and they were advised to be seen still waiting to be seen our current pediatric current in neurology. They do not really know if from the plan of the ER if they know what was going on with his heart hopefully it get resolved or something but then they still do not know firstly was on the ER do not know and there was no medication only in the discharge note if he feel pain or something give him like the Ibuprofen (treatment), Morphine other stuff but a since the time that we were out of the ER, did not give him that because he did not feel the way he did when we went to the ER. The patient underwent lab tests and procedures which included electrocardiogram: elevation of the st on 06Jun2021, ultrasound chest: unknown results on 06Jun2021. Therapeutic measures were taken because of chest tightening and chest pain. The outcome of the events was unknown.  Information on lot/batch number was available. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Fatigue
Clinical narrative: Kind of tired; Fluttering around her heart, can't seem to stop it; This is a spontaneous report received from a contactable consumer. A 65-year-old female consumer (patient) reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0170) via an unspecified route of administration on 27-May-2021 at 15:00 hours (at 65-years old) on left arm, as dose 1, single for COVID-19 immunization.  Medical history included systemic lupus erythematosus, hypertension, asthma, rheumatoid arthritis (start date 2004 and ongoing). It was mentioned that investigation Assessment was performed. The emergency room and physician office visit were reported as no. History of all previous immunization with the Pfizer vaccine considered as suspect was none, prior vaccinations (within 4 weeks) and events following prior vaccinations, family medical history and relevant tests were reported as none. Caller stated that she was in the hospital the week before she got that shot for bowel rupture so they had gave her something for pain, but no vaccines. Concomitant medications included acetylsalicylic acid (Aspirin) taken for rheumatoid arthritis, amlodipine besilate taken for hypertension. On 16Jun2021 the patient experienced fluttering around her heart, it could not seem to stop it (cardiac flutter) (medically significant). The patient had it every now and then with a flare. Caller stated that she does not know why it was reacting like that. She was supposed to get her second shot on 17Jun2021, but she does not think she wanted to get the second shot because she had these issues. It started yesterday and today and it had not stopped. Caller mentioned that this morning it was acting real strong and she took the Bayer aspirin, so it slowed now and it would jump every now and then. On an unknown date the patient mentioned that she was kind of tired, she could maybe later in the future get her second dose when she would feel better. The outcome of kind of tired was unknown and Heart fluttering was recovering.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Overdose
Clinical narrative: 2 days after taking the second dose on my left arm I got a lump  under my arm pit; administration_date=21/May/2021; dose_number=1/other_vaccine_same_date_vaccine_d; This is a spontaneous report from a contactable consumer. A 38-year-old male patient reported for himself.  This patient reported for himself that a 38-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine, Formulation: Solution for injection, Batch/Lot number: 59267-1000-1/EW0217), via an unspecified route of administration, administered in Left arm on 21May2021 (38-year-old at the time of vaccination) as dose 2, single and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine, Formulation: Solution for injection, Batch/Lot number: 59267-1000-1/EW0183), via unspecified route in right arm on 21May2021 13:30 (38-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The COVID-19 vaccine was administered at hospital facility. Patient had no medical history. Patient had no known allergies. Concomitant medication(s) included zolpidem (ZOLPIDEM) 10mg. The patient was not diagnosed with COVID-19 prior to vaccination. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. On 21May2021, the patient received 2 doses of vaccine on 21May2021 (same date). On 16Jun2021 19:00, after taking the second dose on left arm he got a lump under my arm pit. Patient was not received treatment for events. Since the vaccination, patient has been not tested for COVID-19. The clinical outcome of event 2 days after taking the second dose on her left arm she got a lump under her arm pit was not recovered and other event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysgeusia, Paraesthesia oral, Pharyngeal disorder, Pharyngeal swelling
Clinical narrative: Swelling of throat; Tongue tingling; metal taste on tongue; Congestion; coughing; This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old non-pregnant female patient received bnt162b2 (COMIRNATY,Solution for injection,Batch/Lot number was not reported),administered in Arm Left on Mar2021 03:00 PM as Dose 1 SINGLE for covid-19 immunisation. Patient was not diagnosed with covid prior vaccination. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.  Medical history included osteoporosis ,bursitis ,mastectomy,hysterectomy,appendicectomy, sciatica, radiculopathy ,anxiety, depression from an unknown date and unknown if ongoing and had allergies to shellfish, dander, pollen, milk, flowers, chilli powder. Concomitant medications within 2 weeks included cetirizine hydrochloride(ZYRTEC ALLERGY) and levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient experienced swelling of throat, tongue tingling, metal taste on tongue ,congestion and cough on Mar2021.The patient underwent lab tests and procedures which included polymerase chain reaction: negative on Apr2021. The patient did not receive any treatment for the events. The outcome of events was resolved on an unspecified date.  Information about lot/batch number is requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Polymerase chain reaction
Clinical narrative: Swelling of throat; Tongue tingling; metal taste on tongue; Congestion; coughing; This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old non-pregnant female patient received bnt162b2 (COMIRNATY,Solution for injection,Batch/Lot number was not reported),administered in Arm Left on Mar2021 03:00 PM as Dose 1 SINGLE for covid-19 immunisation. Patient was not diagnosed with covid prior vaccination. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.  Medical history included osteoporosis ,bursitis ,mastectomy,hysterectomy,appendicectomy, sciatica, radiculopathy ,anxiety, depression from an unknown date and unknown if ongoing and had allergies to shellfish, dander, pollen, milk, flowers, chilli powder. Concomitant medications within 2 weeks included cetirizine hydrochloride(ZYRTEC ALLERGY) and levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient experienced swelling of throat, tongue tingling, metal taste on tongue ,congestion and cough on Mar2021.The patient underwent lab tests and procedures which included polymerase chain reaction: negative on Apr2021. The patient did not receive any treatment for the events. The outcome of events was resolved on an unspecified date.  Information about lot/batch number is requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Raynaud's phenomenon
Clinical narrative: Developed Raynaud's Phenomenon in the hand of the arm that received the vaccination.; This is a spontaneous report from a contactable consumer (patient).   A 33-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER2613), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 at 11:45 (at the age of 33-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included known allergies to latex, red dye, and tree nuts and past drug included PCOS, and LHON. The patient received other medications within 2 weeks of vaccination. 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. Facility where the most recent COVID-19 vaccine was administered was a clinic. On 20Mar2021, patient experienced Raynauds phenomenon in the hand of the arm that received the vaccination. Device Date: 17Jun2021. There was no treatment for the event. The adverse event resulted in a visit to doctor or other healthcare professional office/clinic. The event was assessed as non-serious. The outcome of event was not recovered.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Hypoaesthesia, Hypokinesia, Impaired work ability, Lymphoedema
Clinical narrative: developed pain in my left arm; Within two weeks it was so painful I could not move out of bed; Within two weeks it was so painful I could not move out of bed; developed myofascial and now it is into lymphodemia  also; developed myofascial and now it is into lymphodemia  also; have nerves that are entrapped and numbness in arm and fingers.; have nerves that are entrapped and numbness in arm and fingers.; unable to work; have nerves that are entrapped and numbness in arm and fingers.; This is a spontaneous report from a contactable consumer (patient) or other non hcp.   A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Er8737 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 at 10:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Crohns disease. Concomitant medications included anastrozole, propranolol, and azathioprine. The patient previously took sulfa 12 and experienced drug hypersensitivity, humarap and experienced drug hypersensitivity. 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 08Apr2021 at 12:00, the patient developed pain in left arm. Within two weeks it was so painful she could not move out of bed. She developed myofascial and now it is into lymphodemia also. Also have nerves that are entrapped and numbness in arm and fingers. She was unable to work. The outcome of all the events was not recovered.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myofascial spasm, Nerve injury, Pain in extremity
Clinical narrative: developed pain in my left arm; Within two weeks it was so painful I could not move out of bed; Within two weeks it was so painful I could not move out of bed; developed myofascial and now it is into lymphodemia  also; developed myofascial and now it is into lymphodemia  also; have nerves that are entrapped and numbness in arm and fingers.; have nerves that are entrapped and numbness in arm and fingers.; unable to work; have nerves that are entrapped and numbness in arm and fingers.; This is a spontaneous report from a contactable consumer (patient) or other non hcp.   A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Er8737 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 at 10:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Crohns disease. Concomitant medications included anastrozole, propranolol, and azathioprine. The patient previously took sulfa 12 and experienced drug hypersensitivity, humarap and experienced drug hypersensitivity. 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 08Apr2021 at 12:00, the patient developed pain in left arm. Within two weeks it was so painful she could not move out of bed. She developed myofascial and now it is into lymphodemia also. Also have nerves that are entrapped and numbness in arm and fingers. She was unable to work. The outcome of all the events was not recovered.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Influenza virus test, Mononucleosis heterophile test, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: a few weeks- months my tonsils got swollen; arm swollen/ inflammation; arm swollen/ inflammation; This is a spontaneous report from a contactable Other Health Professional (patient). A 24-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EH9899), dose 1 via an unspecified route of administration on 18Dec2020 (at the age of 24-year-old) as dose 1, single for COVID-19 immunization. Medical history included ITP and blood disorder from an unknown date and unknown if ongoing. There were no concomitant medications. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not have any relevant past drug history. On 05Jan2021, patient experienced for few weeks- months tonsils got swollen, arm swollen/ inflammation. Patient stated, went to urgent care got a shot decreased my tonsils slightly, went to doctors, tried allergy meds did not work. Referred to ENT, tried strong meds did not work. Stated it was odd, I have never had issues with my tonsils. Pending if I need surgery to removed them. Due to events patient visited doctor or other healthcare professional office/clinic and emergency room/department or urgent care. Patient received medications as a treatment for the adverse events. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient underwent lab tests and procedures which included flu/mono test, Covid-19 and strep: negative on 05Jan2021. Therapeutic measures were taken as a result of a few weeks- months my tonsils got swollen, arm swollen/ inflammation. The outcome of events was not recovered.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, there is a reasonable possibility that event tonsillar hypertrophy were related to suspect drug based on the temporal relation between the vaccination and onset of events. 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: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Streptococcus test, Tonsillar hypertrophy
Clinical narrative: a few weeks- months my tonsils got swollen; arm swollen/ inflammation; arm swollen/ inflammation; This is a spontaneous report from a contactable Other Health Professional (patient). A 24-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EH9899), dose 1 via an unspecified route of administration on 18Dec2020 (at the age of 24-year-old) as dose 1, single for COVID-19 immunization. Medical history included ITP and blood disorder from an unknown date and unknown if ongoing. There were no concomitant medications. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not have any relevant past drug history. On 05Jan2021, patient experienced for few weeks- months tonsils got swollen, arm swollen/ inflammation. Patient stated, went to urgent care got a shot decreased my tonsils slightly, went to doctors, tried allergy meds did not work. Referred to ENT, tried strong meds did not work. Stated it was odd, I have never had issues with my tonsils. Pending if I need surgery to removed them. Due to events patient visited doctor or other healthcare professional office/clinic and emergency room/department or urgent care. Patient received medications as a treatment for the adverse events. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient underwent lab tests and procedures which included flu/mono test, Covid-19 and strep: negative on 05Jan2021. Therapeutic measures were taken as a result of a few weeks- months my tonsils got swollen, arm swollen/ inflammation. The outcome of events was not recovered.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, there is a reasonable possibility that event tonsillar hypertrophy were related to suspect drug based on the temporal relation between the vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet count increased, White blood cell count, White blood cell count increased
Clinical narrative: CBC test that shows high platelets and high white blood cells; CBC test that shows high platelets and high white blood cells; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient) reported for herself. A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 2nd dose, single for COVID-19 immunization. The patient's medical history included Hashimoto's disease. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 1st dose, single for COVID-19 immunization. The patient had received both doses of the COVID 19 vaccine. The patient recently had a CBC test that showed high platelets and high white blood cells. It was drawn two weeks after she got her second shot, and she wondered if the shot would have caused those things to increase temporarily. She said this test was done two weeks after her second shot. She had Hashimoto's disease, and did not have a bad reaction to the shots. The outcome of the events was unknown.  Follow-up (17Jun2021): New information received from a contactable consumer (patient) included: Updated the patient's demographics and details regarding Follow-up attempts.  Follow-up attempts are needed; information about lot/batch number can be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pruritus, Rash, Vaccination site rash, Vision blurred
Clinical narrative: terrible rash / It is spreading and not getting better, it is all over her body, stomach, face.; My eyes started to getting itchy now, this is blinding my eyesight. I can't go to work; itchy and miserable; itchy and miserable; it started on the arm that consumer got the vaccination; This is a spontaneous report from a contactable Consumer (Patient). A 61-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EWO180) via an unspecified route of administration on an unspecified date (61 years age at the time of vaccination) as dose 2, single for COVID-19 immunization. The patient medical history had chemotherapy and radiation (further not clarified) in the past and high blood pressure. The concomitant medications were not reported. The patient previously received the first dose of the covid vaccine, consumer thought that it was a low dose and felt tired. But nothing really traumatic. It was not so bad. Consumer stated that consumer took the second vaccination, probably now, after eight to nine days, consumer have a terrible series of rash throughout my body. Consumer can't think of anything else it would be coming from and it started on the arm that consumer got the vaccination, and it seems to be travelling around my body and it went from my arm to my stomach to the other side. It's terribly itchy. It is on my face. When probed for the date of first shot: The last one was on June 5th I believe. The first one was on 15May. The second one was on 05Jun and the both was on right date. Consumer had chemotherapy and radiation (further not clarified) in the past and high blood pressure. Maybe it was not approved for people with chemotherapy in the past and radiation. I mean this is pretty miserable and consumer don't want to miss work for it. If this is going, my eyes started to getting itchy now, this is blinding my eyesight. Consumer can't go to work. The outcome of the events was unknown.  Follow attempts are needed; Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Off label use, Product use issue
Clinical narrative: 24 hours later - sudden onset of nausea; Day 2 fatigue; I am nursing; I am nursing; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 40-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 16Jun2021 10:00 ( at age of 40-years-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history included breastfeeding, drug allergy to Penicillin allergy , erythromycin allergy  Bactrim allergy , codeine allergy . The patient concomitant medications included probiotics (PROBIOTICS), paracetamol (TYLENOL), ibuprofen (IBUPROFEN), prenatal vitamins (PRENATAL VITAMINS (ASCORBIC ACID; BETACAROTENE; CALCIUM SULFATE; COLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RETINOL ACETATE; RIBOFLAVIN; THIAMINE MONONITRATE; TOCOPHERYL ACETATE; ZINC OXIDE)) 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 vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.None other vaccine on same date.On 16Jun2021 she was on nursing day 2 fatigue, on 17Jun2021 24 hours later vaccination the patient experienced sudden onset of nausea. The reporter assessed the event as non serious.No treatment was received for event .The outcome the event she was on nursing day was recovered on an unspecified date in Jun2021, and other events recovered on 17Jun2021.  Information on the lot/batch number has been requested.