chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Vaccination site rash
Clinical narrative: Rash beginning at injection site; slightly swollen; red; itchy; slightly sore; Left side of tongue and under the left side of tongue feel like they've been injected with novocaine; left side of neck feels slightly numb; going down about 6 inches on the arm; This is a spontaneous report from a contactable consumer or other non hcp. A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: F87484), via an unspecified route of administration, administered in Arm Left on 29Jul2021 17:00 (at the age of 59 years old) as DOSE 2, SINGLE for covid-19 immunization.  Medical history included High Blood Pressure from an unknown date and unknown if ongoing, Acid Reflux (gastrooesophageal reflux) disease from an unknown date and unknown if ongoing, glaucoma from an unknown date and unknown if ongoing, psoriasis from an unknown date and unknown if ongoing, sleep apnoea syndrome from an unknown date and unknown if ongoing, Thyroid Nodules (thyroid mass) from an unknown date and unknown if ongoing. Concomitant medication(s) included VIT C (Ascorbic Acid); VIT. E (Tocopherol); Vitamin D3, all taken for an unspecified indication, start and stop date were not reported.  The patient previously took percocet [oxycodone hydrochloride;paracetamol], cefdinir, Enbrel and had allergy. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FA6780), via an unspecified route of administration on 08Jul2021 12:00 administered in left arm as single dose for. The patient was not pregnant at the time of vaccination. It was reported that covid prior to vaccination was No. It was reported that covid tested post vaccination was No. The patient did not received 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 did not tested for COVID-19. The patient experienced rash beginning at injection site, slightly swollen, red, itchy, slightly sore, left side of tongue and under the left side of tongue feel like they've been injected with novocaine, left side of neck feels slightly numb, going down about 6 inches on the arm on 02Aug2021 08:00. No trouble swallowing but feels funny. Therapeutic measures were taken as no as a result of all events. The outcome of events was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Decreased appetite, Diarrhoea, Fatigue, Nausea
Clinical narrative: Severe diarehera 5; fever; abdominal pain; severe fatigue; nausea; weakness; very thirsty; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 44-year) in left arm on 02Aug2021 as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications were unspecified, received in two weeks of COVID vaccine. No known allergies were reported. No Covid prior vaccination was reported, the patient tested Covid post vaccination. The patient received no other vaccine in four weeks. Reported facility type vaccine was Pharmacy or Drug Store. On 02Aug2021 the patient experienced severe diarehera 5, fever, abdominal pain, severe fatigue, nausea, weakness, very thirsty. It was reported that she still had diarrhea and abdominal pain. AE resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures on an unspecified date which included SARS-COV-2 test: unknown result. The clinical outcome of the events was not resolved.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Severe diarehera 5; fever; abdominal pain; severe fatigue; nausea; weakness; very thirsty; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 44-year) in left arm on 02Aug2021 as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications were unspecified, received in two weeks of COVID vaccine. No known allergies were reported. No Covid prior vaccination was reported, the patient tested Covid post vaccination. The patient received no other vaccine in four weeks. Reported facility type vaccine was Pharmacy or Drug Store. On 02Aug2021 the patient experienced severe diarehera 5, fever, abdominal pain, severe fatigue, nausea, weakness, very thirsty. It was reported that she still had diarrhea and abdominal pain. AE resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures on an unspecified date which included SARS-COV-2 test: unknown result. The clinical outcome of the events was not resolved.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Asthenia, Diarrhoea, Fatigue, Nausea
Clinical narrative: Severe diarehera 5; fever; abdominal pain; severe fatigue; nausea; weakness; very thirsty; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 44-year) in left arm on 02Aug2021 as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications were unspecified, received in two weeks of COVID vaccine. No known allergies were reported. No Covid prior vaccination was reported, the patient tested Covid post vaccination. The patient received no other vaccine in four weeks. Reported facility type vaccine was Pharmacy or Drug Store. On 02Aug2021 the patient experienced severe diarehera 5, fever, abdominal pain, severe fatigue, nausea, weakness, very thirsty. It was reported that she still had diarrhea and abdominal pain. AE resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures on an unspecified date which included SARS-COV-2 test: unknown result. The clinical outcome of the events was not resolved.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Thirst
Clinical narrative: Severe diarehera 5; fever; abdominal pain; severe fatigue; nausea; weakness; very thirsty; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 44-year) in left arm on 02Aug2021 as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications were unspecified, received in two weeks of COVID vaccine. No known allergies were reported. No Covid prior vaccination was reported, the patient tested Covid post vaccination. The patient received no other vaccine in four weeks. Reported facility type vaccine was Pharmacy or Drug Store. On 02Aug2021 the patient experienced severe diarehera 5, fever, abdominal pain, severe fatigue, nausea, weakness, very thirsty. It was reported that she still had diarrhea and abdominal pain. AE resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures on an unspecified date which included SARS-COV-2 test: unknown result. The clinical outcome of the events was not resolved.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Dyspnoea exertional, Electrocardiogram
Clinical narrative: Chest pain; There is pressure when taking a deep breath.; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 10Aug2021 as dose 1, single for COVID-19 immunisation. The caller was wondering and experienced today's chest pain and there is the pressure when taking a deep breath on 11Aug2021. The outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Chest pain; There is pressure when taking a deep breath.; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 10Aug2021 as dose 1, single for COVID-19 immunisation. The caller was wondering and experienced today's chest pain and there is the pressure when taking a deep breath on 11Aug2021. The outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac monitoring, Dizziness, Echocardiogram, Electrocardiogram abnormal
Clinical narrative: fast irregular HR 120's while laying in the bed; I felt flushed; I felt hot; My face also felt full and tingly; felt dizzy and off; 8 days past vaccine now have ringing in my ears; numbness to my right forearm and hand; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 33-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EW0175), via intramuscular route of administration in right arm on 09Aug2021 (Monday morning) at 09:15 (at the age of 33-year-old) as dose 1, single for COVID-19 immunisation at hospital. The patient's medical history included penicillin allergy. Concomitant medication was not reported. No other vaccine in four weeks. Other medications in two weeks was multivitamin. On 09Aug2021 at 23:00, the patient had a fast irregular HR 120's while laying in the bed. She felt flushed and hot. Her face also felt full and tingly. She felt dizzy and off. The next day she still felt her heart rate elevated and went to her primary care physician where her EKG was abnormal and then sent to cardiologist on Thursday of the same week. Echocardiogram performed and heart monitor for 14 days. 8 days past vaccine now have ringing in her ears and numbness to her right forearm and hand. Event resulted to visit doctor or other healthcare professional office/clinic. No COVID prior vaccination. COVID tested post vaccination. COVID test name post vaccination was rapid by nasal swab on 12Aug2021 which resulted as negative. The outcome of the events was recovered with lasting effects.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Flushing, Heart rate irregular, Hypoaesthesia, Insomnia
Clinical narrative: fast irregular HR 120's while laying in the bed; I felt flushed; I felt hot; My face also felt full and tingly; felt dizzy and off; 8 days past vaccine now have ringing in my ears; numbness to my right forearm and hand; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 33-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EW0175), via intramuscular route of administration in right arm on 09Aug2021 (Monday morning) at 09:15 (at the age of 33-year-old) as dose 1, single for COVID-19 immunisation at hospital. The patient's medical history included penicillin allergy. Concomitant medication was not reported. No other vaccine in four weeks. Other medications in two weeks was multivitamin. On 09Aug2021 at 23:00, the patient had a fast irregular HR 120's while laying in the bed. She felt flushed and hot. Her face also felt full and tingly. She felt dizzy and off. The next day she still felt her heart rate elevated and went to her primary care physician where her EKG was abnormal and then sent to cardiologist on Thursday of the same week. Echocardiogram performed and heart monitor for 14 days. 8 days past vaccine now have ringing in her ears and numbness to her right forearm and hand. Event resulted to visit doctor or other healthcare professional office/clinic. No COVID prior vaccination. COVID tested post vaccination. COVID test name post vaccination was rapid by nasal swab on 12Aug2021 which resulted as negative. The outcome of the events was recovered with lasting effects.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Sleep disorder
Clinical narrative: fast irregular HR 120's while laying in the bed; I felt flushed; I felt hot; My face also felt full and tingly; felt dizzy and off; 8 days past vaccine now have ringing in my ears; numbness to my right forearm and hand; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 33-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EW0175), via intramuscular route of administration in right arm on 09Aug2021 (Monday morning) at 09:15 (at the age of 33-year-old) as dose 1, single for COVID-19 immunisation at hospital. The patient's medical history included penicillin allergy. Concomitant medication was not reported. No other vaccine in four weeks. Other medications in two weeks was multivitamin. On 09Aug2021 at 23:00, the patient had a fast irregular HR 120's while laying in the bed. She felt flushed and hot. Her face also felt full and tingly. She felt dizzy and off. The next day she still felt her heart rate elevated and went to her primary care physician where her EKG was abnormal and then sent to cardiologist on Thursday of the same week. Echocardiogram performed and heart monitor for 14 days. 8 days past vaccine now have ringing in her ears and numbness to her right forearm and hand. Event resulted to visit doctor or other healthcare professional office/clinic. No COVID prior vaccination. COVID tested post vaccination. COVID test name post vaccination was rapid by nasal swab on 12Aug2021 which resulted as negative. The outcome of the events was recovered with lasting effects.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling hot, Flushing, Heart rate increased, Hypoaesthesia
Clinical narrative: fast irregular HR 120's while laying in the bed; I felt flushed; I felt hot; My face also felt full and tingly; felt dizzy and off; 8 days past vaccine now have ringing in my ears; numbness to my right forearm and hand; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 33-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EW0175), via intramuscular route of administration in right arm on 09Aug2021 (Monday morning) at 09:15 (at the age of 33-year-old) as dose 1, single for COVID-19 immunisation at hospital. The patient's medical history included penicillin allergy. Concomitant medication was not reported. No other vaccine in four weeks. Other medications in two weeks was multivitamin. On 09Aug2021 at 23:00, the patient had a fast irregular HR 120's while laying in the bed. She felt flushed and hot. Her face also felt full and tingly. She felt dizzy and off. The next day she still felt her heart rate elevated and went to her primary care physician where her EKG was abnormal and then sent to cardiologist on Thursday of the same week. Echocardiogram performed and heart monitor for 14 days. 8 days past vaccine now have ringing in her ears and numbness to her right forearm and hand. Event resulted to visit doctor or other healthcare professional office/clinic. No COVID prior vaccination. COVID tested post vaccination. COVID test name post vaccination was rapid by nasal swab on 12Aug2021 which resulted as negative. The outcome of the events was recovered with lasting effects.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test, Tinnitus
Clinical narrative: fast irregular HR 120's while laying in the bed; I felt flushed; I felt hot; My face also felt full and tingly; felt dizzy and off; 8 days past vaccine now have ringing in my ears; numbness to my right forearm and hand; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 33-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EW0175), via intramuscular route of administration in right arm on 09Aug2021 (Monday morning) at 09:15 (at the age of 33-year-old) as dose 1, single for COVID-19 immunisation at hospital. The patient's medical history included penicillin allergy. Concomitant medication was not reported. No other vaccine in four weeks. Other medications in two weeks was multivitamin. On 09Aug2021 at 23:00, the patient had a fast irregular HR 120's while laying in the bed. She felt flushed and hot. Her face also felt full and tingly. She felt dizzy and off. The next day she still felt her heart rate elevated and went to her primary care physician where her EKG was abnormal and then sent to cardiologist on Thursday of the same week. Echocardiogram performed and heart monitor for 14 days. 8 days past vaccine now have ringing in her ears and numbness to her right forearm and hand. Event resulted to visit doctor or other healthcare professional office/clinic. No COVID prior vaccination. COVID tested post vaccination. COVID test name post vaccination was rapid by nasal swab on 12Aug2021 which resulted as negative. The outcome of the events was recovered with lasting effects.  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Anaphylactic reaction, Asthenia, Chills, Dizziness
Clinical narrative: Leg cramps; abdominal pain; shortness of breath; weak; vomiting; teeth pain; facial swelling; sweating uncontrollably; blurred vision; dizzy/lightheaded; Headache; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: C3184, Expiration date: Not reported) via an unspecified route of administration in left arm on 26Aug2021 at 13:00 (at the age of 27-year-old) as single dose for COVID-19 immunization. Medical history of the patient included asthma, migraine, Hypermobile Ehlers Danlos Syndrome, allergy to latex, bananas, CT contrast, eye drops. Concomitant/other medications in two weeks: Montelukast, Fluticasone, Tylenol, Vitamins all taken for unspecified indication. Patient did not receive any other vaccine on the same date of suspect product or in four weeks of COVID vaccine. Patient did not have Covid prior vaccination. Patient previously took diphenhydramine hydrochloride (BENADRYL), NSAIDS, dextromethorphan hydrobromide doxylamine succinate ephedrine sulfate ethanol paracetamol (NYQUIL) on an unspecified dates and experienced allergy. On 26Aug2021, at 13:30, patient began feeling dizzy and had a sudden headache. By 17:00, patient was sweating uncontrollably and experiencing blurred vision. At 19:00 she felt lightheaded, leg cramps, severe abdominal pain, shortness of breath, weak, vomiting, teeth pain, and facial swelling. She tried taking Claritin, Tylenol, warm bath, ice packs, drinking lots of water, and resting with no relief. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Patient was tested for COVID post vaccination via nasal swab, covid test name post vaccination: PCR, covid test date: 26Aug2021, covid test result: Negative. Treatment included IV, Pepcid, Antihistamine, and Steroids. Outcome of the events were recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on available information and the close drug event temporal association, a possible contributory role of suspect product BNT162B2 to the development of events dizziness, headache, hyperhidrosis, vision blurred, muscle spasms, abdominal pain, dyspnoea, asthenia, vomiting, toothache and swelling face cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry mouth, Dyspnoea, Headache, Hyperhidrosis, Muscle spasms
Clinical narrative: Leg cramps; abdominal pain; shortness of breath; weak; vomiting; teeth pain; facial swelling; sweating uncontrollably; blurred vision; dizzy/lightheaded; Headache; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: C3184, Expiration date: Not reported) via an unspecified route of administration in left arm on 26Aug2021 at 13:00 (at the age of 27-year-old) as single dose for COVID-19 immunization. Medical history of the patient included asthma, migraine, Hypermobile Ehlers Danlos Syndrome, allergy to latex, bananas, CT contrast, eye drops. Concomitant/other medications in two weeks: Montelukast, Fluticasone, Tylenol, Vitamins all taken for unspecified indication. Patient did not receive any other vaccine on the same date of suspect product or in four weeks of COVID vaccine. Patient did not have Covid prior vaccination. Patient previously took diphenhydramine hydrochloride (BENADRYL), NSAIDS, dextromethorphan hydrobromide doxylamine succinate ephedrine sulfate ethanol paracetamol (NYQUIL) on an unspecified dates and experienced allergy. On 26Aug2021, at 13:30, patient began feeling dizzy and had a sudden headache. By 17:00, patient was sweating uncontrollably and experiencing blurred vision. At 19:00 she felt lightheaded, leg cramps, severe abdominal pain, shortness of breath, weak, vomiting, teeth pain, and facial swelling. She tried taking Claritin, Tylenol, warm bath, ice packs, drinking lots of water, and resting with no relief. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Patient was tested for COVID post vaccination via nasal swab, covid test name post vaccination: PCR, covid test date: 26Aug2021, covid test result: Negative. Treatment included IV, Pepcid, Antihistamine, and Steroids. Outcome of the events were recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on available information and the close drug event temporal association, a possible contributory role of suspect product BNT162B2 to the development of events dizziness, headache, hyperhidrosis, vision blurred, muscle spasms, abdominal pain, dyspnoea, asthenia, vomiting, toothache and swelling face cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, SARS-CoV-2 test, Swelling face, Toothache, Vomiting
Clinical narrative: Leg cramps; abdominal pain; shortness of breath; weak; vomiting; teeth pain; facial swelling; sweating uncontrollably; blurred vision; dizzy/lightheaded; Headache; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: C3184, Expiration date: Not reported) via an unspecified route of administration in left arm on 26Aug2021 at 13:00 (at the age of 27-year-old) as single dose for COVID-19 immunization. Medical history of the patient included asthma, migraine, Hypermobile Ehlers Danlos Syndrome, allergy to latex, bananas, CT contrast, eye drops. Concomitant/other medications in two weeks: Montelukast, Fluticasone, Tylenol, Vitamins all taken for unspecified indication. Patient did not receive any other vaccine on the same date of suspect product or in four weeks of COVID vaccine. Patient did not have Covid prior vaccination. Patient previously took diphenhydramine hydrochloride (BENADRYL), NSAIDS, dextromethorphan hydrobromide doxylamine succinate ephedrine sulfate ethanol paracetamol (NYQUIL) on an unspecified dates and experienced allergy. On 26Aug2021, at 13:30, patient began feeling dizzy and had a sudden headache. By 17:00, patient was sweating uncontrollably and experiencing blurred vision. At 19:00 she felt lightheaded, leg cramps, severe abdominal pain, shortness of breath, weak, vomiting, teeth pain, and facial swelling. She tried taking Claritin, Tylenol, warm bath, ice packs, drinking lots of water, and resting with no relief. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Patient was tested for COVID post vaccination via nasal swab, covid test name post vaccination: PCR, covid test date: 26Aug2021, covid test result: Negative. Treatment included IV, Pepcid, Antihistamine, and Steroids. Outcome of the events were recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on available information and the close drug event temporal association, a possible contributory role of suspect product BNT162B2 to the development of events dizziness, headache, hyperhidrosis, vision blurred, muscle spasms, abdominal pain, dyspnoea, asthenia, vomiting, toothache and swelling face cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: Leg cramps; abdominal pain; shortness of breath; weak; vomiting; teeth pain; facial swelling; sweating uncontrollably; blurred vision; dizzy/lightheaded; Headache; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: C3184, Expiration date: Not reported) via an unspecified route of administration in left arm on 26Aug2021 at 13:00 (at the age of 27-year-old) as single dose for COVID-19 immunization. Medical history of the patient included asthma, migraine, Hypermobile Ehlers Danlos Syndrome, allergy to latex, bananas, CT contrast, eye drops. Concomitant/other medications in two weeks: Montelukast, Fluticasone, Tylenol, Vitamins all taken for unspecified indication. Patient did not receive any other vaccine on the same date of suspect product or in four weeks of COVID vaccine. Patient did not have Covid prior vaccination. Patient previously took diphenhydramine hydrochloride (BENADRYL), NSAIDS, dextromethorphan hydrobromide doxylamine succinate ephedrine sulfate ethanol paracetamol (NYQUIL) on an unspecified dates and experienced allergy. On 26Aug2021, at 13:30, patient began feeling dizzy and had a sudden headache. By 17:00, patient was sweating uncontrollably and experiencing blurred vision. At 19:00 she felt lightheaded, leg cramps, severe abdominal pain, shortness of breath, weak, vomiting, teeth pain, and facial swelling. She tried taking Claritin, Tylenol, warm bath, ice packs, drinking lots of water, and resting with no relief. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Patient was tested for COVID post vaccination via nasal swab, covid test name post vaccination: PCR, covid test date: 26Aug2021, covid test result: Negative. Treatment included IV, Pepcid, Antihistamine, and Steroids. Outcome of the events were recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on available information and the close drug event temporal association, a possible contributory role of suspect product BNT162B2 to the development of events dizziness, headache, hyperhidrosis, vision blurred, muscle spasms, abdominal pain, dyspnoea, asthenia, vomiting, toothache and swelling face cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Asthenia, Dizziness, Dyspnoea, Headache
Clinical narrative: Leg cramps; abdominal pain; shortness of breath; weak; vomiting; teeth pain; facial swelling; sweating uncontrollably; blurred vision; dizzy/lightheaded; Headache; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: C3184, Expiration date: Not reported) via an unspecified route of administration in left arm on 26Aug2021 at 13:00 (at the age of 27-year-old) as single dose for COVID-19 immunization. Medical history of the patient included asthma, migraine, Hypermobile Ehlers Danlos Syndrome, allergy to latex, bananas, CT contrast, eye drops. Concomitant/other medications in two weeks: Montelukast, Fluticasone, Tylenol, Vitamins all taken for unspecified indication. Patient did not receive any other vaccine on the same date of suspect product or in four weeks of COVID vaccine. Patient did not have Covid prior vaccination. Patient previously took diphenhydramine hydrochloride (BENADRYL), NSAIDS, dextromethorphan hydrobromide doxylamine succinate ephedrine sulfate ethanol paracetamol (NYQUIL) on an unspecified dates and experienced allergy. On 26Aug2021, at 13:30, patient began feeling dizzy and had a sudden headache. By 17:00, patient was sweating uncontrollably and experiencing blurred vision. At 19:00 she felt lightheaded, leg cramps, severe abdominal pain, shortness of breath, weak, vomiting, teeth pain, and facial swelling. She tried taking Claritin, Tylenol, warm bath, ice packs, drinking lots of water, and resting with no relief. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Patient was tested for COVID post vaccination via nasal swab, covid test name post vaccination: PCR, covid test date: 26Aug2021, covid test result: Negative. Treatment included IV, Pepcid, Antihistamine, and Steroids. Outcome of the events were recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on available information and the close drug event temporal association, a possible contributory role of suspect product BNT162B2 to the development of events dizziness, headache, hyperhidrosis, vision blurred, muscle spasms, abdominal pain, dyspnoea, asthenia, vomiting, toothache and swelling face cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Muscle spasms, SARS-CoV-2 test, Swelling face, Toothache
Clinical narrative: Leg cramps; abdominal pain; shortness of breath; weak; vomiting; teeth pain; facial swelling; sweating uncontrollably; blurred vision; dizzy/lightheaded; Headache; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: C3184, Expiration date: Not reported) via an unspecified route of administration in left arm on 26Aug2021 at 13:00 (at the age of 27-year-old) as single dose for COVID-19 immunization. Medical history of the patient included asthma, migraine, Hypermobile Ehlers Danlos Syndrome, allergy to latex, bananas, CT contrast, eye drops. Concomitant/other medications in two weeks: Montelukast, Fluticasone, Tylenol, Vitamins all taken for unspecified indication. Patient did not receive any other vaccine on the same date of suspect product or in four weeks of COVID vaccine. Patient did not have Covid prior vaccination. Patient previously took diphenhydramine hydrochloride (BENADRYL), NSAIDS, dextromethorphan hydrobromide doxylamine succinate ephedrine sulfate ethanol paracetamol (NYQUIL) on an unspecified dates and experienced allergy. On 26Aug2021, at 13:30, patient began feeling dizzy and had a sudden headache. By 17:00, patient was sweating uncontrollably and experiencing blurred vision. At 19:00 she felt lightheaded, leg cramps, severe abdominal pain, shortness of breath, weak, vomiting, teeth pain, and facial swelling. She tried taking Claritin, Tylenol, warm bath, ice packs, drinking lots of water, and resting with no relief. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Patient was tested for COVID post vaccination via nasal swab, covid test name post vaccination: PCR, covid test date: 26Aug2021, covid test result: Negative. Treatment included IV, Pepcid, Antihistamine, and Steroids. Outcome of the events were recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on available information and the close drug event temporal association, a possible contributory role of suspect product BNT162B2 to the development of events dizziness, headache, hyperhidrosis, vision blurred, muscle spasms, abdominal pain, dyspnoea, asthenia, vomiting, toothache and swelling face cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred, Vomiting
Clinical narrative: Leg cramps; abdominal pain; shortness of breath; weak; vomiting; teeth pain; facial swelling; sweating uncontrollably; blurred vision; dizzy/lightheaded; Headache; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: C3184, Expiration date: Not reported) via an unspecified route of administration in left arm on 26Aug2021 at 13:00 (at the age of 27-year-old) as single dose for COVID-19 immunization. Medical history of the patient included asthma, migraine, Hypermobile Ehlers Danlos Syndrome, allergy to latex, bananas, CT contrast, eye drops. Concomitant/other medications in two weeks: Montelukast, Fluticasone, Tylenol, Vitamins all taken for unspecified indication. Patient did not receive any other vaccine on the same date of suspect product or in four weeks of COVID vaccine. Patient did not have Covid prior vaccination. Patient previously took diphenhydramine hydrochloride (BENADRYL), NSAIDS, dextromethorphan hydrobromide doxylamine succinate ephedrine sulfate ethanol paracetamol (NYQUIL) on an unspecified dates and experienced allergy. On 26Aug2021, at 13:30, patient began feeling dizzy and had a sudden headache. By 17:00, patient was sweating uncontrollably and experiencing blurred vision. At 19:00 she felt lightheaded, leg cramps, severe abdominal pain, shortness of breath, weak, vomiting, teeth pain, and facial swelling. She tried taking Claritin, Tylenol, warm bath, ice packs, drinking lots of water, and resting with no relief. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Patient was tested for COVID post vaccination via nasal swab, covid test name post vaccination: PCR, covid test date: 26Aug2021, covid test result: Negative. Treatment included IV, Pepcid, Antihistamine, and Steroids. Outcome of the events were recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on available information and the close drug event temporal association, a possible contributory role of suspect product BNT162B2 to the development of events dizziness, headache, hyperhidrosis, vision blurred, muscle spasms, abdominal pain, dyspnoea, asthenia, vomiting, toothache and swelling face cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Blood test, Chills, Cough, Endoscopy abnormal
Clinical narrative: Brain aneurysm; Can't speak, speech problems; Diagnosed with bilateral paresis of the vocal cord; Diagnosed with dysarthria/Very slurred; First Dose: 17Feb2021/Second dose: 12Aug2021; Felt a rush to the brain, wanted to cough; Tingly in the mouth; Tingly in the mouth, throat area; Problems with the head, dizziness; She is very sick; This is a spontaneous report from a contactable consumer (Patients mother)   A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0186) on 12Aug2021 at single dose via an unspecified route of administration on arm for COVID-19 immunization. Relevant medical history included kidney problems that occurred after infection in 2020. Concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ENG200, age of vaccination 45 years) on 17Feb2021 and experienced throat irritation, oral pruritus, chest pain, oropharyngeal discomfort, aphonia, speech disorder, secretion discharge, cough, upper-airway cough syndrome, hypersensitivity, skin discoloration, white blood cell count increased, red blood cell count decreased, haemoglobin decreased, blood potassium decreased, blood chloride decreased, blood creatinine increased, blood glucose increased, alanine aminotransferase increased, dysphonia, gerd. On 12Aug2021 about 2 or 3 minutes, right after the second dose the patient a rush to the brain, then she wanted to cough. She started getting very tingly. She clarified that her mouth was tingly in the throat area. It lasted until now.  She had it at the allergist office. They had told her because of the first incident that happened, she should take the vaccine in the presence of the allergist.  She can't speak, and is sorry to say but, it is like someone who is mentally challenged and verbally challenged. It has stayed the same and she is not able to speak. Her diagnosis was bilateral paresis of the vocal cord, dysarthria, brain aneurysm.  This diagnosis was because  the patient cannot verbalize clearly. The patient's verbal language right now is very slurred and very, like a person who is mentally disabled with speech problems. The allergist gave her some prednisone and allergy medication to take. It was not very much medication. Then, they sent her home. It wasn't getting much better. Then, she started getting sicker and had problems with the head. Reporter informed that the problems with the head started on the same day, 12Aug2021 and never went away. It just stayed the same and did not bring the speech back. At the time of the reporting outcome for the event Felt a rush to the brain, wanted to cough' and Brain aneurysm,  Problems with the head, dizziness and inappropriate schedule of vaccine administered was unknown, while outcome of other reported evens was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vocal cord paresis
Clinical narrative: Brain aneurysm; Can't speak, speech problems; Diagnosed with bilateral paresis of the vocal cord; Diagnosed with dysarthria/Very slurred; First Dose: 17Feb2021/Second dose: 12Aug2021; Felt a rush to the brain, wanted to cough; Tingly in the mouth; Tingly in the mouth, throat area; Problems with the head, dizziness; She is very sick; This is a spontaneous report from a contactable consumer (Patients mother)   A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0186) on 12Aug2021 at single dose via an unspecified route of administration on arm for COVID-19 immunization. Relevant medical history included kidney problems that occurred after infection in 2020. Concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ENG200, age of vaccination 45 years) on 17Feb2021 and experienced throat irritation, oral pruritus, chest pain, oropharyngeal discomfort, aphonia, speech disorder, secretion discharge, cough, upper-airway cough syndrome, hypersensitivity, skin discoloration, white blood cell count increased, red blood cell count decreased, haemoglobin decreased, blood potassium decreased, blood chloride decreased, blood creatinine increased, blood glucose increased, alanine aminotransferase increased, dysphonia, gerd. On 12Aug2021 about 2 or 3 minutes, right after the second dose the patient a rush to the brain, then she wanted to cough. She started getting very tingly. She clarified that her mouth was tingly in the throat area. It lasted until now.  She had it at the allergist office. They had told her because of the first incident that happened, she should take the vaccine in the presence of the allergist.  She can't speak, and is sorry to say but, it is like someone who is mentally challenged and verbally challenged. It has stayed the same and she is not able to speak. Her diagnosis was bilateral paresis of the vocal cord, dysarthria, brain aneurysm.  This diagnosis was because  the patient cannot verbalize clearly. The patient's verbal language right now is very slurred and very, like a person who is mentally disabled with speech problems. The allergist gave her some prednisone and allergy medication to take. It was not very much medication. Then, they sent her home. It wasn't getting much better. Then, she started getting sicker and had problems with the head. Reporter informed that the problems with the head started on the same day, 12Aug2021 and never went away. It just stayed the same and did not bring the speech back. At the time of the reporting outcome for the event Felt a rush to the brain, wanted to cough' and Brain aneurysm,  Problems with the head, dizziness and inappropriate schedule of vaccine administered was unknown, while outcome of other reported evens was not recovered.