chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test, Chills, Dizziness, Electric shock sensation
Clinical narrative: extreme electric shocks down both arms and legs; racing heartbeat/High heart rate; stomach pain and contractions; involuntary muscle contractions of hands so extreme I couldn't move them; involuntary muscle contractions of hands so extreme I couldn't move them; Chills; itching; numbness in hands and feet; High blood pressure; felt dizzy; nauseous; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: ER2613) via an unspecified route of administration in left arm on 22Mar2021 at 12:00 (age at vaccination 47-year-old) as 1st dose, single for covid-19 immunization at Health Clinic/ facility. Patient medical history included allergies, asthma, reflux, osteopenia. Patient was allergic to Chickpeas, adhesives. Patient received other medications within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, at 12:15 patient Immediately felt dizzy and nauseous. Sat for 15 mins and felt a bit better, but off. Within 5 mins of driving experienced extreme electric shocks down both arms and legs, racing heartbeat, stomach pain and contractions, and involuntary muscle contractions of hands so extreme that she could not move them. Rushed to emergency room by ambulance. Chills and itching occurred, numbness in hands and feet. High blood pressure and heart rate. Adverse events resulted into Emergency room/department or urgent care. Treatment given for adverse event was 50 mg of Benadryl which did nothing, added IV of. Fluids and Pepcid, lidocaine with Maalox. Stayed over four hours before anything helped. Still having symptoms on day of reporting. The patient underwent lab tests and procedures which included blood test: unknown on 22Mar2021, electrocardiogram: unknown on 22Mar2021. The outcome of the events was not recovered at the time of reporting.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate increased, Hypertension, Hypoaesthesia, Movement disorder
Clinical narrative: extreme electric shocks down both arms and legs; racing heartbeat/High heart rate; stomach pain and contractions; involuntary muscle contractions of hands so extreme I couldn't move them; involuntary muscle contractions of hands so extreme I couldn't move them; Chills; itching; numbness in hands and feet; High blood pressure; felt dizzy; nauseous; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: ER2613) via an unspecified route of administration in left arm on 22Mar2021 at 12:00 (age at vaccination 47-year-old) as 1st dose, single for covid-19 immunization at Health Clinic/ facility. Patient medical history included allergies, asthma, reflux, osteopenia. Patient was allergic to Chickpeas, adhesives. Patient received other medications within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, at 12:15 patient Immediately felt dizzy and nauseous. Sat for 15 mins and felt a bit better, but off. Within 5 mins of driving experienced extreme electric shocks down both arms and legs, racing heartbeat, stomach pain and contractions, and involuntary muscle contractions of hands so extreme that she could not move them. Rushed to emergency room by ambulance. Chills and itching occurred, numbness in hands and feet. High blood pressure and heart rate. Adverse events resulted into Emergency room/department or urgent care. Treatment given for adverse event was 50 mg of Benadryl which did nothing, added IV of. Fluids and Pepcid, lidocaine with Maalox. Stayed over four hours before anything helped. Still having symptoms on day of reporting. The patient underwent lab tests and procedures which included blood test: unknown on 22Mar2021, electrocardiogram: unknown on 22Mar2021. The outcome of the events was not recovered at the time of reporting.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle contractions involuntary, Nausea, Pruritus
Clinical narrative: extreme electric shocks down both arms and legs; racing heartbeat/High heart rate; stomach pain and contractions; involuntary muscle contractions of hands so extreme I couldn't move them; involuntary muscle contractions of hands so extreme I couldn't move them; Chills; itching; numbness in hands and feet; High blood pressure; felt dizzy; nauseous; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: ER2613) via an unspecified route of administration in left arm on 22Mar2021 at 12:00 (age at vaccination 47-year-old) as 1st dose, single for covid-19 immunization at Health Clinic/ facility. Patient medical history included allergies, asthma, reflux, osteopenia. Patient was allergic to Chickpeas, adhesives. Patient received other medications within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, at 12:15 patient Immediately felt dizzy and nauseous. Sat for 15 mins and felt a bit better, but off. Within 5 mins of driving experienced extreme electric shocks down both arms and legs, racing heartbeat, stomach pain and contractions, and involuntary muscle contractions of hands so extreme that she could not move them. Rushed to emergency room by ambulance. Chills and itching occurred, numbness in hands and feet. High blood pressure and heart rate. Adverse events resulted into Emergency room/department or urgent care. Treatment given for adverse event was 50 mg of Benadryl which did nothing, added IV of. Fluids and Pepcid, lidocaine with Maalox. Stayed over four hours before anything helped. Still having symptoms on day of reporting. The patient underwent lab tests and procedures which included blood test: unknown on 22Mar2021, electrocardiogram: unknown on 22Mar2021. The outcome of the events was not recovered at the time of reporting.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage, Menstruation irregular
Clinical narrative: Blood vessel in eye burst; Missed period; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 15:30 (35-year old at the time of vaccination)  (Batch/Lot Number: EN6204) as DOSE 1, SINGLE for covid-19 immunisation. Medical history reported as none. Concomitant medications was not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any other medications received within 2 weeks of vaccination. On 17Mar2021 15:30 the patient experienced blood vessel in eye burst and missed period. Patient did not receive any treatment for the adverse events. The reported seriousness of the event was medically significant. The clinical outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dysphonia, Dyspnoea, Hypertension, Peripheral swelling
Clinical narrative: Rash; Itching; Burning; selling of hands face and feet; High blood pressure; Shortness of breath; Change in voice; selling of hands face and feet; This is a spontaneous report from a contactable other hcp (patient). A 36-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date: Not reported), via an unspecified route of administration as dose 1, single on 19Mar2021 (at the age of 36-years-old) for covid-19 immunization at Public Health Clinic facility. Medical history included Hashimoto, asthma, linden factor 5 and patient was allergic to Latex, sulfa drugs, chicken, tree nuts, peanuts, insect bites, pumpkin, sunflower from an unknown date. Concomitant medications within 2 weeks included levothyroxine; colecalciferol (VITAMIN D 3); bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC); ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN C) taken for an unspecified indication, start and stop date were not reported. 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 19Mar2021, the patient experienced rash, burning, itching, swelling of hands face and feet (Selling of hands face and feet as reported), high blood pressure, shortness of breath and change in voice. The case was assessed as non-serious. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for events included inhailer, left art shot of Benadryl mdl. Outcome of events was not recovered.   Information about lot/batch number is requested.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events burning sensation ,hypertension, dyspnoea, dysphonia, pruritus, rash cannot be completely excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling face
Clinical narrative: Rash; Itching; Burning; selling of hands face and feet; High blood pressure; Shortness of breath; Change in voice; selling of hands face and feet; This is a spontaneous report from a contactable other hcp (patient). A 36-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date: Not reported), via an unspecified route of administration as dose 1, single on 19Mar2021 (at the age of 36-years-old) for covid-19 immunization at Public Health Clinic facility. Medical history included Hashimoto, asthma, linden factor 5 and patient was allergic to Latex, sulfa drugs, chicken, tree nuts, peanuts, insect bites, pumpkin, sunflower from an unknown date. Concomitant medications within 2 weeks included levothyroxine; colecalciferol (VITAMIN D 3); bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC); ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN C) taken for an unspecified indication, start and stop date were not reported. 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 19Mar2021, the patient experienced rash, burning, itching, swelling of hands face and feet (Selling of hands face and feet as reported), high blood pressure, shortness of breath and change in voice. The case was assessed as non-serious. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for events included inhailer, left art shot of Benadryl mdl. Outcome of events was not recovered.   Information about lot/batch number is requested.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events burning sensation ,hypertension, dyspnoea, dysphonia, pruritus, rash cannot be completely excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: Menstrual disorder
Clinical narrative: Menstrual flow (spotting) started on 07Mar (day 5 of new combo pill pack), light flow started on 12Mar; as of report date 18Mar, still experiencing light menstrual flow; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 22Feb2021 as a Dose 1, single for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included dienogest, ethinylestradiol (LARISSA) taken for contraception, started on unknown date, which was ongoing. Patient had no significant medical history. The patient experienced menstrual flow started on 07mar (day 5 of new combo pill pack), light flow started on 12Mar2021 as of report date 18Mar2021, still experiencing light menstrual flow on 07Mar2021. It was reported that, patient was currently on Larissa (combo pill, birth control). Normal cycle was 28 days, lasting for 5 days, with moderate flow. She been on Larissa for 3 years, never had irregular period, always 28 days cycle. Event took place after use of product. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: started feeling small symptoms of AFib sometimes/that on the next day he was definitely having the A fib symptoms; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EN6203), dose 1 via an unspecified route of administration, administered in arm left on 28Feb2021 at 12:30 (at the age of 61-year-old) as dose 1 single dose for COVID-19 immunization. Medical history included ankylosing spondylitis, psoriasis and atrial fibrillation, corrected by ablation surgery in Jan2017 with no problem. The patient did not have allergies to medications, food, or other products. Concomitant medications (within 2 weeks of vaccination) included metoprolol 25 mg taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Prior to vaccination, patient was not diagnosed with Covid-19 and since the vaccination, the patient had not been tested positive for Covid-19. It was reported that on 28Feb2021 the patient received first dose of vaccine and stated that on an unspecified date he started feeling small symptoms of atrial fibrillation sometimes. He stated that he received second dose on 21Mar2021 and after that on the next day he was definitely having the A fib symptoms again short breath just walking doing simplest little things and had rapid heartbeat again and mentioned that he had no problems before when took first dose of Pfizer vaccination. The patient did not receive treatment received for the event. The reporter provided seriousness of the event as non-serious. The patient was not recovered from the event.  Follow-up attempts are possible. Further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Eustachian tube disorder, Eye inflammation, Eye irritation, Hypoacusis
Clinical narrative: Ears: L and R Eustachian tube swelling; distorted sounds, amplified sounds, felt muffled but loud at the same time; both eyes felt irritated; eye drops for inflammation; This is a spontaneous report from a non-contactable consumer or other non hcp. A 52-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, in Arm Left, on 18Mar2021 at 13:30 (at the age of 52 years), as a single dose for covid-19 immunisation. The patient medical history included allergies of Cipro, Erythromycin and Sulfa. The patient concomitant medications were not reported. Known allergies included Cipro and Erythromycin or Sulfa. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Patient was not received any other medications the patient received within 2 weeks of vaccination. On 20Mar2021, at 08:00 AM, the patient had experienced ears: l and r eustachian tube swelling, distorted sounds, amplified sounds, felt muffled but loud at the same time; both eyes felt irritated then left eye became swollen, red and painful to use the eye muscle. Patient received eye drops as treatment for inflammation. Patient visited to emergency room. The clinical outcome of all events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dyspnoea
Clinical narrative: shortness of breathe; Raised BP; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was En6201 and expiration date was not reported), dose 1 via an unspecified route of administration, administered in arm right on 19Mar2021 at 17:00 (at the age of 42-year-old, non-pregnant) as dose 1, single for COVID-19 immunisation. Medical history reported as none and did not have allergies to medications, food, or other products. Concomitant medications included amlodipine besilate taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 17:15, the patient experienced shortness of breath and raised bp (blood pressure). The adverse events resulted in emergency room visit/department or urgent care. The patient received treatment Epi though IV (intravenous) for the reported adverse events. The outcome of the events was resolved on an unspecified date in Mar2021.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Outbreak of cold sores in, on and around my nose with one on my cheek under left eye.; This is a spontaneous report received from a contactable consumer, a patient (reported for self). A 59-years-old (non-pregnant) female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot no: UNKNOWN), via an unspecified route of administration in the right arm on 19Mar2021 at 19:45 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. Medical history included transient ischemic attack (TIA) and hypertension. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASP) all for unspecified indications from unknown dates. The patient previously received first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine, lot number: unknown) via unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 22Mar2021, approximately 3 days after second injection, the patient had an outbreak of cold sores in, on and around her nose with one on her cheek under her left eye. No cold related symptoms, so the patient was not sure if this was brought on by the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of cold sores was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza, Pain
Clinical narrative: Pounding headache; Feel like I have the flu.; Extremely tired; Body started aching; This is a spontaneous report from a contactable consumer, the patient.   A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration in the right arm on 23Mar2021 at 15:15 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685), via an unspecified route of administration in the right arm on 02Mar2021 at 16:30 (at the age of 54-years-old), as a single dose for COVID-19 immunization and patient experienced just a little tired. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 20:00 (also reported as early evening), the patient was extremely tired. Then, overnight, the patient's body started aching. On 24Mar2021, in the morning, the patient experienced pounding headache and felt like she had flu. The patient did not receive any treatment for the reported events. The clinical outcome of the events tiredness, body ache, headache and felt like flu were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Sneezing
Clinical narrative: sneezing; Pressure headaches; This is a spontaneous report from a non-contactable healthcare professional. A 25-year-old non pregnant female patient received the first dose of BNT162b2(PFIZER- BIONTECH COVID-19 mRNA Vaccine, Lot number: UNKNOWN) via an unspecified route of administration on the left arm on 20Mar2021 at 18:45 (at the age of 25-years-old), as a single dose for COVID-19 immunization. Medical history included known allergies to keflax, lavender and nitrile non latex material. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not tested positive for COVID-19. On 20Mar2021 at 21:00, the patient experienced sneezing and pressure headaches. No therapeutic measures were taken as a result of the adverse events. The clinical outcome of the events sneezing and pressure headaches was recovering, at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Patient's initial captured in First name field of the patient tab. Removed name from last name field 2. Relevant Med History#1, verbatim updated to Allergy to nitrile non-latex material; Relevant Med History#2, verbatim updated to Allergy to Lavender 3. Past Drug Event#3, drug Keflax coded to Keflex 4. Event Pressure headaches was recoded to head pressure 5. Final sentence in analysis tab updated to No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain
Clinical narrative: Very sore eyes; This is a spontaneous report received from a non-contactable consumer, the patient. A 55-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 18Mar2021 (at the age of 55-year-old) as a single dose, for COVID-19 immunisation. Medical history included asthma. The patient was allergic to penicillin. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On an unknown date in Mar2021, the patient had very sore eyes. It was unknown if the patient receive treatment for the adverse event. The clinical outcome of very sore eyes was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient country added in patient tab; Verbatim of Relevant Med History updated from "Penicillin allergy" to "known allergies: penicillin", note added and Final sentence was updated as "No follow-up attempts are needed; information about lot/batch number cannot be obtained".
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypersensitivity, Hypertension
Clinical narrative: she was diagnosed in the ER with an allergic reaction with a rapid heart rate and high blood pressure of 220/120.; she was diagnosed in the ER with an allergic reaction with a rapid heart rate and high blood pressure of 220/120.; she was diagnosed in the ER with an allergic reaction with a rapid heart rate and high blood pressure of 220/120.; This is a spontaneous report from a contactable consumer.   A 70-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 24Mar2021, (Batch/Lot number was not reported) as a single dose for covid-19 immunization Medical history and concomitant medications were not reported. The patient reported that she received the Pfizer COVID vaccine received yesterday, 24Mar2021. Around 2pm (date not specified), she had an allergic reaction with a fast heart rate and had to go to the ER. She was diagnosed in the ER with an allergic reaction with a rapid heart rate and high blood pressure of 220/120. She was released after 5 hours. The outcome of the events was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint aches; This is a spontaneous report from a non-contactable consumer or other non hcp.   A 64-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 19Mar2021 12:45 (at the age of 64-year-old) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not diagnosed with COVID-19. The patient has not tested for COVID-19 since the vaccination. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 20Mar2021 18:00, the patient experienced joint aches. Patient has not received any treatment for the event. The clinical outcome of the event was recovered on unknown date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Protect Confidentiality unticked since reporter is not patient, reported for the patient added in narrative and final sentence was updated as "No follow-up attempts are needed; information about lot/batch number cannot be obtained".
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Crepitations
Clinical narrative: All my joints making cracking noises. Pinky, fingers, knees, ankles, elbows. Odd. Not all the time but I crack a joint almost every hour. Been 2 weeks.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on 09Mar2021 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Mar2021, the patient experienced all the joints making cracking noises. Pinky finger, knees, ankles, elbows and this was odd, not all the time but the patient cracked a joint almost every hour. This had been for 2 weeks. The patient did not receive any treatment for the adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event all the joints making cracking noises, pinkie finger, knees, ankles, elbows and this was odd, not all the time but the patient cracked a joint almost every hour was not recovered.   No follow-up attempts are possible; information about lot number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: added into Country field under Patient information section. Narrative statement "Since the vaccination, the patient had not been tested positive for COVID-19." updated as "Since the vaccination, the patient had not tested for COVID-19.".
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Infected dermal cyst
Clinical narrative: asymptomatic sebaceous cyst over mid-sternum present for over 20 years became infected; This is a spontaneous report from a contactable nurse (patient herself).   A 72-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6200, Expiration date: unknown), via an unspecified route of administration, administered in left arm on 06Mar2021 (age at vaccination: 72 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included arthritis (osteo/psoriatic), silent reflux, psoriasis and asymptomatic sebaceous cyst over mid-sternum present for over 20 years became infected. Concomitant medication(s) included apremilast (OTEZLA); dexlansoprazole (DEXILANT); ubidecarenone (COQ10) and multiple vitamins, all taken for unspecified indication start and stop date were not reported. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201) via unknown route in the left arm on 13Feb2021 18:00 (age at vaccination: 72 years) as DOSE 1, SINGLE for covid-19 immunisation. On 21Mar2021 03:00 (after 2 weeks), the patient's asymptomatic sebaceous cyst over mid-sternum present for over 20 years became infected. Allergies to medications, food, or other productswas  unknown. The patient had incision for drainage and antibiotics as treatment for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events caused the patient for doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with covid-19 prior to vaccination nor was tested for coivd-19 since the vaccination. The outcome of the event was recovering.  Follow-up attempts are needed. Further information is requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, SARS-CoV-2 test, Stomatitis
Clinical narrative: Blood pressure increased to around 212/101; Extreme dizziness with the room spinning; Extreme dizziness with the room spinning; Sores in her mouth and on her tongue; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199), via unspecified route of administration in left arm, on 19Mar2021 at 00:45 (at the age of 65 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included hypertension (controlled with medication) and COVID-19 in Dec2020 (prior to vaccination; tested positive for COVID-19 in early December). The patient's concomitant medications included many (unspecified) medications. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 24Mar2021 at 07:00, the patient experienced extreme dizziness with the room spinning and her blood pressure increased to around 212/101 for most of the day and it eventually subsided later in the day and the dizziness settled down. The patient also developed sores in her mouth and on her tongue on 24Mar2021 at 07:00. They still remained the next day (25Mar2021). The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The patient was recovering from the events.  No follow-up attempts are possible; information about lot or batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: The event Blood pressure increased has been upgraded to serious as medically significant; updated reporter information; the event term "Sores in her mouth and on her tongue" has been recoded from Sore mouth to Sores mouth; Sore tongue was deleted as an event; updated patient information (age at event and vaccination was updated from 66 to 65 years); and narrative.  No follow-up attempts are possible; information about lot or batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Blood pressure increased to around 212/101; Extreme dizziness with the room spinning; Extreme dizziness with the room spinning; Sores in her mouth and on her tongue; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199), via unspecified route of administration in left arm, on 19Mar2021 at 00:45 (at the age of 65 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included hypertension (controlled with medication) and COVID-19 in Dec2020 (prior to vaccination; tested positive for COVID-19 in early December). The patient's concomitant medications included many (unspecified) medications. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 24Mar2021 at 07:00, the patient experienced extreme dizziness with the room spinning and her blood pressure increased to around 212/101 for most of the day and it eventually subsided later in the day and the dizziness settled down. The patient also developed sores in her mouth and on her tongue on 24Mar2021 at 07:00. They still remained the next day (25Mar2021). The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The patient was recovering from the events.  No follow-up attempts are possible; information about lot or batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: The event Blood pressure increased has been upgraded to serious as medically significant; updated reporter information; the event term "Sores in her mouth and on her tongue" has been recoded from Sore mouth to Sores mouth; Sore tongue was deleted as an event; updated patient information (age at event and vaccination was updated from 66 to 65 years); and narrative.  No follow-up attempts are possible; information about lot or batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: Infection; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 80-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 20Feb2021 as dose 1, single for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease. No concomitant medication was reported. The patient has an infection currently, patient received first Pfizer COVID-19 vaccine dose 20Feb2021 and due for second dose on 27Mar2021. Patient was taking an antibiotic currently and wants to know go ahead and get the second dose or should wait. Patient hears that, some people saying the vaccine can affect your DNA - was this true and would it be beneficial to delay getting the second dose. Patient wants to know the percentages of people reporting side effects from the vaccine. The outcome of the event was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Eyelid oedema, Face oedema
Clinical narrative: Swollen eyes; Edema on top and bottom of eyes & cheeks; edema on top and bottom of eyes & cheeks; This is a spontaneous report from a non-contactable consumer. A 63-year old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in Left Arm on 25Feb2021 at 08:00PM as Dose number Unknown, Single for COVID-19 immunization. The patient's medical history included food allergy to msg, nuts and melons. The patient previously took cefalexin monohydrate (KEFLEX) and experienced allergy. The patient's Concomitant medications included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication. On 16Mar2021 at 03:00PM, the patient experienced swollen eyes, edema on top and bottom of eyes & cheeks. Therapeutic measures were taken as a result of this with cortisone shot and prednisone tapered dosage. The outcome for the events was recovering.     Information on Lot/Batch number was available. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea
Clinical narrative: Asthma attack; trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 51-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER-8730), via an unspecified route of administration, administered in arm left on 22Mar2021 at 12:00 (at the age of 51-years-old), as DOSE 1, SINGLE for covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included ongoing asthma, obesity, and seasonal allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 22Mar2021 at 12:00, the patient experienced trouble breathing the same day. And next day and 48 hours after the vaccine , on 24Mar2021 at 12:00, she had asthma attack. Adverse events resulted in emergency room/department or urgent care visit. As corrective treatment she received nebulizer, magnesium, and steroids. Outcome of the events was not resolved.   No follow up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Heart rate increased
Clinical narrative: Bp spike; Heart rate increase; Head rushes (lightheaded feeling); This is a spontaneous report from a non-contactable consumer (patient) reported for himself. A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP8727), via an unspecified route of administration, administered in Arm Left on 19Mar2021 (at the age of 63-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included Thyroid- cloestoral. Allergies to medications, food, or other products was reported as none. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) (125mcg), atorvastatin (ATORVASTATIN) (20mg) taken for an unspecified indication, within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 19Mar2021The patient experienced bp spike, heart rate increase, head rushes.  Therapeutic measures were taken as a result of bp spike, heart rate increase, head rushes (lightheaded feeling). Events resulted in Emergency room/department or urgent care. Events were considered as serious (medically significant). Patient received treatment with IV solution. The outcome of events were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Drug ineffective; She experienced COVID vaccine also states she had a virus with diarrhea, stomach ache, swollen glands, headache, stuffy/runny nose; This is a spontaneous report from a contactable nurse (patient herself). A 71-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose number unknown single (at the age of 71-years-old) for COVID-19 immunization. Patient medical history were not reported. The concomitant medications included filgrastim sndz (ZARXIO). Patient reported that she experienced COVID vaccine also states she had a virus with diarrhea, stomach ache, swollen glands, headache, stuffy/runny nose, was off IBRN for one week. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Mast cell activation syndrome, Migraine with aura
Clinical narrative: Brain fog; Dizziness; migraine headache with visual aura (stars); tingling that started at the base of my neck and spread over my entire head that lasted about 7 hours (sensory aura); felt fatigue; tension; suspicion of a possible MCAS reaction; This is a spontaneous report from a contactable other health care professional (patient). A 23-years-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 the right arm on 20Feb2021 at 18:30 (at the age of 23-years-old) as dose 1, single for covid-19 immunisation. Medical history included celiac disease, MCAS (mast cell activation syndrome), CKD (chronic kidney disease), MTHFR (methylenetetrahydrofolate reductase deficiency), HLA-B27+, Morton's Neuroma, migraines, pancreatic insufficiency. Known allergies reported zofran, tanalbit, gluten, wheat, dairy, pineapple, lobster, crab, potatoes, egg plant allergies. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. Concomitant medications were not reported. Patient received other medications in two weeks. The patient did not receive any vaccines within four weeks prior to the vaccination. On 20Feb2021 at 18:45 (about 5-10 minutes after receiving the vaccine), the patient experienced migraine headache with visual aura (stars) and tingling that started at the base of her neck and spread over her entire head that lasted about 7 hours (sensory aura). She felt fatigue and tension. She took 25mg diphenhydramine an hour before, stayed at the administration site for about an hour, and took another 25mg about 1.5 hours after on suspicion of a possible MCAS reaction. Day 2 side effects involved brain fog, dizziness, and migraines. Events seriousness criteria reported as non-serious. The patient did not receive any treatment for the event. The patient underwent lab tests and procedures which included negative sars-cov-2 test (PCR, nasal swab), on 23Mar2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of event suspicion of a possible MCAS reaction unknown and for all other events was recovered in 2021.   Information about lot/batch number has been requested.; Sender's Comments: based on the reported information ,a causal relationship between the events and suspected drug 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