chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Laboratory test, Respiration abnormal, SARS-CoV-2 test
Clinical narrative: My heart rate and blood pressure jumped; My heart rate and blood pressure jumped; I had trouble calming down my breathing; the waves started to come again and would not stop; had this weird sensation run through my body but it passed much quicker; This is a spontaneous report from a contactable consumer (patient).    A 42-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP7533), via an unspecified route of administration, administered in right arm on 15Apr2021 at 14:15 (at the age of 42 years) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications included vitamin D (colecalciferol) and multivitamin nos in two weeks. The patient previously took vicodin and experienced allergies. The patient also received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8732), via an unspecified route of administration, administered in right arm on 25Mar2021 14:15 (at the age of 42 years) as dose 1, single for COVID-19 immunization and experienced a weird sensation ran through her body, from her head to feet, she got lightheaded and weak, she had trouble texting like her fingers did not have the strength, warm and agitated. The patient did not have COVID prior vaccination. The patient did get COVID tested post vaccination. On 15Apr2021, the patient experienced had this weird sensation run through her body but it passed much quicker, her heart rate and blood pressure jumped, she had trouble calming down her breathing. On 15Apr2021, at 15.20 the patient experienced the waves started to come again and would not stop, her heart rate and blood pressure jumped. The patient reported that she had her second shot on 15Apr2021, again she had this weird sensation run through her body but it passed much quicker and she left the facility within 20 minutes. An hour after her shot (15.20) the waves started to come again and would not stop. Her heart rate and blood pressure jumped, she had trouble calming down her breathing. She called a nurse who told her to go to the emergency room as her heart rate had been 133 while sitting down. They did a lot of tests, told to the patient she was not having a reaction but she continued to experience these symptoms (22Apr2021). The patient did not receive other vaccine in four weeks. The patient underwent lab tests and procedure which includes on 01Apr2021 the patient had COVID test (Saliva based test) with result negative; On 13Apr2021 the patient had COVID test (Saliva based test) with result negative; heart rate: 133 on 15Apr2021, Laboratory test: unknown results, blood pressure: increased on 15Apr2021. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diastolic dysfunction, Dyspnoea exertional, Echocardiogram, Joint swelling, Nocturia
Clinical narrative: shortness of breath upon activity; palpitations; Swelling of ankles; Getting up many times at night to pee; echocardiogram which revealed diastolic dysfunction; This is a spontaneous report from a contactable consumer (patient). This 72-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6206) on 04Mar2021 at 08:30 via an unspecified route of administration in left arm as DOSE 2, SINGLE for COVID-19 immunization (age at vaccination: 72-years-old). Patient medical history included: high blood pressure, high cholesterol, treated with meds. Obesity untreated. Major depression treated with meds. The patient reported allergies to Cats, mold, dust mites, and formaldehyde. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient took other unspecified medication within two weeks of the vaccination. The patient did not have Covid prior vaccination neither covid tested post vaccination. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6201) on 11Feb2021 at 08:30 via an unspecified route of administration in left arm as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date, after the second shot the patient experienced shortness of breath upon activity, no matter how minimal. She began having palpitations, had swelling of ankles and was getting up many times at night to pee. She went to her PCP who ordered an echocardiogram which revealed diastolic dysfunction. She never had heart trouble, nor these symptoms. The patient did not receive any treatment for the events. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: shortness of breath upon activity; palpitations; Swelling of ankles; Getting up many times at night to pee; echocardiogram which revealed diastolic dysfunction; This is a spontaneous report from a contactable consumer (patient). This 72-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6206) on 04Mar2021 at 08:30 via an unspecified route of administration in left arm as DOSE 2, SINGLE for COVID-19 immunization (age at vaccination: 72-years-old). Patient medical history included: high blood pressure, high cholesterol, treated with meds. Obesity untreated. Major depression treated with meds. The patient reported allergies to Cats, mold, dust mites, and formaldehyde. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient took other unspecified medication within two weeks of the vaccination. The patient did not have Covid prior vaccination neither covid tested post vaccination. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6201) on 11Feb2021 at 08:30 via an unspecified route of administration in left arm as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date, after the second shot the patient experienced shortness of breath upon activity, no matter how minimal. She began having palpitations, had swelling of ankles and was getting up many times at night to pee. She went to her PCP who ordered an echocardiogram which revealed diastolic dysfunction. She never had heart trouble, nor these symptoms. The patient did not receive any treatment for the events. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Pain in extremity, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: Hands and feet were swollen; Hands now are swollen and painful/ the fingers on my right hand started to throb; The inside of my wrist hurt when I moved it.; This has continued until the present and the fingers and wrists on both hands now are swollen and painful.; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6205 and expiration dates were not reported), via unspecified route of administration in the left arm on 07Mar2021 at 16:00 (at the age of 74-years-old) as dose 2, single for COVID-19 immunization. Medical history included Asthma, from an unknown start date and unknown if ongoing. The patient had no known allergies. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL9267 and expiration dates were not reported), via unspecified route of administration in the left arm on 14Feb2021 at 16:00 (at the age of 74-years-old) as dose 1, single for COVID-19 immunization. On 23Mar2021, the patient experienced hands and feet were swollen, Hands now are swollen and painful/ the fingers on her right hand started to throb, the inside of her wrist hurt when she moved it, This has continued until the present and the fingers and wrists on both hands now are swollen and painful. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 22Apr2021 (nasal swab). The event resulted in doctor or other health care professional visit. Treatment drugs included prednisone 40 mg for 5 days and gabapentin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Crying, Epistaxis, Feeling abnormal
Clinical narrative: 10pm laughing; Crying fit for over 60 mins; 15 min sneezing fit; stopped up nose bleed; Head and neck became worse/pain was worse; foggy in judgement; felt different and headache started, neck, her left shoulder and arm; felt different and headache started, neck, her left shoulder and arm; felt different and headache started, neck, her left shoulder and arm; felt different and headache started, neck, her left shoulder and arm; felt different and headache started, neck, her left shoulder and arm; This is a spontaneous report from a contactable consumer (patient). This 69-year-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN5318 and Expiration date was not reported) on 28Jan2021 at 09:30 hours via an unspecified route of administration, administered in left arm as dose 1, single (age at vaccination: 69-years-old) for COVID-19 immunization. Patient had unspecified medical history and had known allergies. Patient had no other vaccine in four weeks. The patient took other unspecified medication/concomitant medications within two weeks of the vaccination. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 28Jan2021 at 09:50 hours, 20 mins after the shot, patient felt different and headache started, neck, her left shoulder and arm. Patient came home and took 650mg of Tylenol, at 14:15 hours, patient had a 15 min sneezing fit, stopped up nosebleed, head and neck became worse and foggy in judgement, at 22:00 hours, patient had laughing and crying fit for over 60 mins until she fell asleep. Patient stated that nosebleed and headache continued for 25 days, 24/7 pain levels 6 & 7. Patient had doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit for the events. Therapeutic measures were taken as a result of the events and treatment included Tylenol, nurse on site and urgent care. The outcome of stopped up nosebleed and headache were recovered on 22Feb2021 (25 days duration) and not recovered for rest of the events.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate affect, Judgement impaired, Neck pain, Pain assessment
Clinical narrative: 10pm laughing; Crying fit for over 60 mins; 15 min sneezing fit; stopped up nose bleed; Head and neck became worse/pain was worse; foggy in judgement; felt different and headache started, neck, her left shoulder and arm; felt different and headache started, neck, her left shoulder and arm; felt different and headache started, neck, her left shoulder and arm; felt different and headache started, neck, her left shoulder and arm; felt different and headache started, neck, her left shoulder and arm; This is a spontaneous report from a contactable consumer (patient). This 69-year-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN5318 and Expiration date was not reported) on 28Jan2021 at 09:30 hours via an unspecified route of administration, administered in left arm as dose 1, single (age at vaccination: 69-years-old) for COVID-19 immunization. Patient had unspecified medical history and had known allergies. Patient had no other vaccine in four weeks. The patient took other unspecified medication/concomitant medications within two weeks of the vaccination. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 28Jan2021 at 09:50 hours, 20 mins after the shot, patient felt different and headache started, neck, her left shoulder and arm. Patient came home and took 650mg of Tylenol, at 14:15 hours, patient had a 15 min sneezing fit, stopped up nosebleed, head and neck became worse and foggy in judgement, at 22:00 hours, patient had laughing and crying fit for over 60 mins until she fell asleep. Patient stated that nosebleed and headache continued for 25 days, 24/7 pain levels 6 & 7. Patient had doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit for the events. Therapeutic measures were taken as a result of the events and treatment included Tylenol, nurse on site and urgent care. The outcome of stopped up nosebleed and headache were recovered on 22Feb2021 (25 days duration) and not recovered for rest of the events.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sneezing
Clinical narrative: 10pm laughing; Crying fit for over 60 mins; 15 min sneezing fit; stopped up nose bleed; Head and neck became worse/pain was worse; foggy in judgement; felt different and headache started, neck, her left shoulder and arm; felt different and headache started, neck, her left shoulder and arm; felt different and headache started, neck, her left shoulder and arm; felt different and headache started, neck, her left shoulder and arm; felt different and headache started, neck, her left shoulder and arm; This is a spontaneous report from a contactable consumer (patient). This 69-year-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN5318 and Expiration date was not reported) on 28Jan2021 at 09:30 hours via an unspecified route of administration, administered in left arm as dose 1, single (age at vaccination: 69-years-old) for COVID-19 immunization. Patient had unspecified medical history and had known allergies. Patient had no other vaccine in four weeks. The patient took other unspecified medication/concomitant medications within two weeks of the vaccination. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. On 28Jan2021 at 09:50 hours, 20 mins after the shot, patient felt different and headache started, neck, her left shoulder and arm. Patient came home and took 650mg of Tylenol, at 14:15 hours, patient had a 15 min sneezing fit, stopped up nosebleed, head and neck became worse and foggy in judgement, at 22:00 hours, patient had laughing and crying fit for over 60 mins until she fell asleep. Patient stated that nosebleed and headache continued for 25 days, 24/7 pain levels 6 & 7. Patient had doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit for the events. Therapeutic measures were taken as a result of the events and treatment included Tylenol, nurse on site and urgent care. The outcome of stopped up nosebleed and headache were recovered on 22Feb2021 (25 days duration) and not recovered for rest of the events.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Movement disorder, Neck pain, Neuralgic amyotrophy
Clinical narrative: Pain in neck, down arm; Pain in neck, down arm; numbness in arm; loss of range of motion; weakness; Parsonage Turner Syndrom; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 56-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration in left arm on an unspecified date in Mar2021 (Batch/Lot Number: EN6206) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypothyroidism and high blood pressure. Known allergies: Penicillin. Concomitant medication(s) included losartan potassium (LOSARTIN) and levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. No covid prior vaccination and covid was not tested post vaccination. No other vaccine in four weeks. On an unspecified date on Mar2021, the patient experienced pain in neck, down arm, numbness in arm, loss of range of motion and weakness. Dr believed Parsonage Turner Syndrom. AE resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of all the events (Prednisone). The outcome of the events was recovering.  No follow-up attempts are required. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in neck, down arm; Pain in neck, down arm; numbness in arm; loss of range of motion; weakness; Parsonage Turner Syndrom; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 56-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration in left arm on an unspecified date in Mar2021 (Batch/Lot Number: EN6206) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypothyroidism and high blood pressure. Known allergies: Penicillin. Concomitant medication(s) included losartan potassium (LOSARTIN) and levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. No covid prior vaccination and covid was not tested post vaccination. No other vaccine in four weeks. On an unspecified date on Mar2021, the patient experienced pain in neck, down arm, numbness in arm, loss of range of motion and weakness. Dr believed Parsonage Turner Syndrom. AE resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of all the events (Prednisone). The outcome of the events was recovering.  No follow-up attempts are required. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Ocular hyperaemia
Clinical narrative: Right eye turned blood red; the eye ball itself was swollen; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (a family friend) that: A 59-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8730,) via an unspecified route of administration, in left arm on an unspecified date in Apr2021 12:30 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization at Public Health Clinic. The patient medical history included prediabetic from an unknown date. The patient was not pregnant at the time of vaccination. The patient concomitants were included berberine (BERBERINE), cinnamon (CINNAMOMUM VERUM), ascorbic acid, zinc (ZINC C) and ascorbic acid (VITAMIN C ACID) all were taken for unknown indication, start and stop were unspecified date. The patient had previously received TETRACYCLIN and TERRAMYCIN after both drugs experienced allergy. The patient did not receive any vaccine within four weeks. The patient did not suffer from covid prior vaccination and did not underwent any covid test post vaccination. On Apr2021 12:00 AM the patient had experienced Right eye turned blood red and the eye-ball itself was swollen. It was reported that, Right eye turned blood red, no pain though. Next day the eye-ball itself was swollen, especially at the interior corner of eye. Still no pain. No discharge. Eye doctor could find no indication of anything in eye. Not allergies. Left eye was fine. This occurred 2 weeks past 1st vaccine. Doctor finally put me on Prednisone which helped. Both my father, a family friend and another patient at same doctor office all experienced same thing. We would not have attributed it to the vaccine if we had not been talking and realized we all had same symptoms, same time frame past vaccine for symptoms to show up and Pfizer vaccine. The patient received Fluorometholone and then Prednisone as treatment for the adverse events. The clinical outcome of the events was reported as unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: about three weeks later i got the same rash on the left leg; This is a spontaneous report from a contactable consumer or other non hcp.     A 74-year-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6198), via an unspecified route of administration, administered in Arm Right in Mar2021 as DOSE 2, SINGLE for covid-19 immunization. The patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration, administered in Arm Left on Feb2021 12:00 as DOSE 1, SINGLE for covid-19 immunization. The patient did not had Covid prior to vaccination nor tested Covid post vaccination. Medical history included known allergies from Deodorants, Insect Bites from an unknown date and unknown if ongoing. Past drug event experienced was known allergies with Penicillin, Concomitant medications included tadalafil (CIALIS), atorvastatin calcium, ageless male and oxymetazoline hydrochloride (CLARITIN ALLERGIC) taken for an unspecified indication, start and stop date were not reported. About three weeks later, the patient experienced the same rash on the left leg on Mar2021. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was taken. At the time of reporting the outcome of the event was not recovered.    No follow up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Pain, Swelling
Clinical narrative: skin sensitivity; soreness; swelling; This is a spontaneous report from a contactable consumer and other health care professional (Patient). A 28-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 Vaccine, Formulation: Solution for injection, Lot Number: ER8733) via an unspecified route of administration in left arm on 06Apr2021 at 02:15 PM (Age at vaccination 28-year) as dose 1, single for COVID-19 immunization. Medical history included obesity and known allergies of penicillin, both from an unknown date and unknown if ongoing. Concomitant medications included naproxen sodium (ALEVE); acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN EXTRA STRENGTH); both taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced allergies. Reported facility type vaccine was hospital. Patient received other vaccine in four weeks. No COVID prior vaccination was reported; patient was not tested COVID post vaccination. On 06Apr2021 at 06:15 PM, the patient experienced skin sensitivity, soreness and swelling. Patient received no treatment for the adverse events. The clinical outcome of the events was resolved on an unspecified date in 2021.   No follow up attempts are possible. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Ocular hyperaemia
Clinical narrative: Headache; Fatigue; Joint Pain; Red eyes; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 19-year-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, administered in Arm Left on 19Apr2021 at 19:45 (at the age of 19-years-old) as a dose 1, single for COVID-19 immunization. The patient medical history included asthma and ehlers danlos syndrome from an unspecified date and unknown if was ongoing. There were no concomitant medications. Historical vaccine included Meningitis Vaccine (Lot Number: unknown), via an unspecified route of administration on unspecified date followed with the reaction of Known allergies to the Meningitis Vaccine. The patient did not receive any other vaccine within 4 weeks. The patient did not have any other medications in two weeks. Reportedly, patient did not have any COVID prior vaccination. Patient was not tested for covid post vaccination. On 20Apr2021 at 12:00, patient experienced headache, fatigue, joint pain and red eyes. The patient did not receive any treatment for the events. Outcome of all the events were not resolved.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysmenorrhoea, Fatigue, Headache, Nausea
Clinical narrative: Menstrual cramps but no period; Exhaustion; Nausea; Headache; Low fever; Cough; This is a spontaneous report from a contactable consumer (Patient). A 43-year-old non pregnant female patient received second dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: ER8731 and expiration dates were not reported), via unspecified route of administration in the left arm on 18Apr2021 as dose 2, single for COVID-19 immunization. The patient's medical history included Rheumatoid arthritis, bipolar type 2, asthma from an unknown date and unknown if ongoing. On an unknown date the patient experienced allergy to Penicillin, erythromycin, Zithromax, vancomycin, duracef, darveset, amoxicillin from an unknown date. Concomitant medications included ZYPREXA (olanzapine), LAMICTAL (lamotrigine), OTREXUP (methotrexate), CELEBREX (celecoxib), B12-VITAMIIN (cyanocobalamin), VitaminD3 (cholecalciferol) all products from an unknown date for an unknown indication. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: ER877 and expiration dates were not reported), via unspecified route of administration in the left arm on 28Mar2021 as dose 1, single for COVID-19 immunization. On 22Apr2021 after 04 days the patient experienced Menstrual cramps but no period, exhaustion, nausea, headache, low fever and cough. The patient did not received treatment for the adverse event. No other vaccine in four weeks and no vaccine was administered prior to the COVID vaccination. The outcome of the all events was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Menstrual cramps but no period; Exhaustion; Nausea; Headache; Low fever; Cough; This is a spontaneous report from a contactable consumer (Patient). A 43-year-old non pregnant female patient received second dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: ER8731 and expiration dates were not reported), via unspecified route of administration in the left arm on 18Apr2021 as dose 2, single for COVID-19 immunization. The patient's medical history included Rheumatoid arthritis, bipolar type 2, asthma from an unknown date and unknown if ongoing. On an unknown date the patient experienced allergy to Penicillin, erythromycin, Zithromax, vancomycin, duracef, darveset, amoxicillin from an unknown date. Concomitant medications included ZYPREXA (olanzapine), LAMICTAL (lamotrigine), OTREXUP (methotrexate), CELEBREX (celecoxib), B12-VITAMIIN (cyanocobalamin), VitaminD3 (cholecalciferol) all products from an unknown date for an unknown indication. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: ER877 and expiration dates were not reported), via unspecified route of administration in the left arm on 28Mar2021 as dose 1, single for COVID-19 immunization. On 22Apr2021 after 04 days the patient experienced Menstrual cramps but no period, exhaustion, nausea, headache, low fever and cough. The patient did not received treatment for the adverse event. No other vaccine in four weeks and no vaccine was administered prior to the COVID vaccination. The outcome of the all events was recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gingival swelling, Swollen tongue
Clinical narrative: 2nd shot lips gums and tongue are has swollen upon day one; 2nd shot lips gums and tongue are has swollen upon day one; This is a spontaneous report from a contactable consumer or other non hcp. A 48-year-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 24Apr2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported and concomitant medication(s) included insulin (INSULIN). The historical vaccines include bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 04Apr2021 08:15 as DOSE 1, SINGLE for COVID-19 immunisation and experienced chills. The patient experienced drug hypersensitivity to Ibuprofen and Zpack. The patient's lips gums and tongue has swollen upon day one on 25Apr2021 08:30. Therapeutic measures were taken as a result of 2nd shot lips gums and tongue with Benadryl and steroids. The events outcome was reported as not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenitis, Lymphadenopathy, Malaise, Myalgia
Clinical narrative: have become very tender/sensitive to touch.; I noticed my submandibular, superficial cervical and tonsillar lymph nodes began to swell; Severe body, joint and muscle aches/pain; Severe body, joint and muscle aches/pain; Severe body, joint and muscle aches/pain; malaise.; This is a spontaneous report from a contactable other hcp (patient).   A 31-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: ER8734) via intramuscularly, administered in left arm on 19Apr2021 18:30 (age at vaccination 31 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypothyroidism, polycystic ovarian syndrome (PCOS) and known allergies: Sulfa antibiotics. Concomitant medications in two weeks included levothyroxine, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and metformin taken for unspecified indication from an unknown date. The patient previously received first dose of bnt162b2 (Solution for injection, Batch/Lot Number: EN6203) via intramuscularly, administered in left arm on 05Mar2021 15:15 (at the age of 31 years) as DOSE 1, SINGLE for covid-19 immunisation and experienced severe headache 30 minutes after initial injection. Patient had not received any other vaccine within 4 weeks. Patient was not pregnant at time of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. It was reported that 24 hours after 2nd injection on 20Apr2021 at 18:30 the patient experienced severe body, joint and muscle aches/pain and overall malaise. The patient reported that she was on day 7 after injection and still experiencing those symptoms. On 24Apr2021 on day 5 after injection the patient noticed her submandibular, superficial cervical and tonsillar lymph nodes began to swell and at 18:30 it become very tender/sensitive to touch. It was further reported that on day 7 after injection and still experiencing all of these side effects without relief in sight. The patient was received NSAIDs as a treatment to help with total body discomfort. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: have become very tender/sensitive to touch.; I noticed my submandibular, superficial cervical and tonsillar lymph nodes began to swell; Severe body, joint and muscle aches/pain; Severe body, joint and muscle aches/pain; Severe body, joint and muscle aches/pain; malaise.; This is a spontaneous report from a contactable other hcp (patient).   A 31-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: ER8734) via intramuscularly, administered in left arm on 19Apr2021 18:30 (age at vaccination 31 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypothyroidism, polycystic ovarian syndrome (PCOS) and known allergies: Sulfa antibiotics. Concomitant medications in two weeks included levothyroxine, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and metformin taken for unspecified indication from an unknown date. The patient previously received first dose of bnt162b2 (Solution for injection, Batch/Lot Number: EN6203) via intramuscularly, administered in left arm on 05Mar2021 15:15 (at the age of 31 years) as DOSE 1, SINGLE for covid-19 immunisation and experienced severe headache 30 minutes after initial injection. Patient had not received any other vaccine within 4 weeks. Patient was not pregnant at time of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. It was reported that 24 hours after 2nd injection on 20Apr2021 at 18:30 the patient experienced severe body, joint and muscle aches/pain and overall malaise. The patient reported that she was on day 7 after injection and still experiencing those symptoms. On 24Apr2021 on day 5 after injection the patient noticed her submandibular, superficial cervical and tonsillar lymph nodes began to swell and at 18:30 it become very tender/sensitive to touch. It was further reported that on day 7 after injection and still experiencing all of these side effects without relief in sight. The patient was received NSAIDs as a treatment to help with total body discomfort. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dysphagia, Pharyngeal swelling, Swollen tongue
Clinical narrative: 20 min after vaccine shot I had very dry mouth; difficult to swallow saliva; Back of tongue seemed swollen; feeling of swelling in the back of my throat 6 hours after vaccine; This is a spontaneous report from a contactable other health care professional (patient). A 48-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8736), via an unspecified route of administration, administered in right arm on 26Apr2021 14:45 (at the age of 48 years) as dose 2, single for COVID-19 immunization. The patient medical history was none. There were no concomitant medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP7533), via an unspecified route of administration, administered in left arm on 05Apr2021 14:30 (at the age of 47 years) as dose 1, single for COVID-19 immunization and experienced normal soreness around injection site, tenderness, soreness in the entire arm developed, 5-6 days post injection a small rash. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient did not have COVID prior vaccination. The patient did not get COVID tested post vaccination. On 26Apr2021 15:05 (20 min after vaccine shot) the patient had very dry mouth and she had trouble swallowing. Back of tongue seemed swollen and it was difficult to swallow saliva. A few hours after shot swallowing got better. She still had a slight problem with a feeling of swelling in the back of her throat 6 hours after vaccine. This is very concerning and scary to feel like she cannot swallow easily and constantly having to swallow saliva. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The outcome of the events was unknown.  No Follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mobility decreased, Tenderness
Clinical narrative: very tender; limited range of motion in neck due to pain.; 30Apr2021 lymph node extremely painful to touch; lymph node the size of a golf ball within 6hrs after injection; This is a spontaneous report from a contactable other health care professional (patient). A 34-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Ew0161), via an unspecified route of administration, administered in left arm on 29Apr2021 (at the age of 34 years) as dose 2, single for COVID-19 immunization. The patient's medical history included allergy to pears. The patient's concomitant medications were not reported. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient did not have COVID prior vaccination. The patient did not get COVID tested post vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8730), via an unspecified route of administration, administered in left arm on 06Apr2021 10:00 (at the age of 34 years) as dose 1, single for COVID-19 immunization and noticed swollen lymph node after 1 week, was smaller but still noticeable. On 29Apr2021 lymph node the size of a golf ball within 6hrs after injection on 30Apr2021 lymph node extremely painful to touch and limited range of motion in neck due to pain on an  unspecified date patient experienced very tender. It was reported that Swollen lymph node above collarbone on same side as injection after both doses. Very swollen and very tender after 2nd dose. Received 2nd dose 29Apr2021, lymph node the size of a golf ball within 6hrs after injection. 30Apr2021 lymph node extremely painful to touch, limited range of motion in neck due to pain. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient had a large rash begin to appear on her right thigh on April 25 2021.; This is a spontaneous report from a contactable consumer (reported for himself). A 28-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8737), via an unspecified route of administration, administered in arm left on 06Apr2021 at 14:00 (at the age of 28 years old) as dose 1, single for covid-19 immunisation at Hospital. Medical history included attention deficit hyperactivity disorder, Other medical history: Adult ADHD. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included lisdexamfetamine mesilate (VYVANSE) at a dose of 60 mg, daily taken for an unspecified indication, start and stop date were not reported. The patient previously took bactrum, minocycline, formaldehyde and experienced hypersensitivity. On 25Apr2021, the patient experienced had a large rash begin to appear on her right thigh. The adverse event resulted in doctor or other healthcare professional office and clinic visit. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient scheduled second dose on 27Apr2021. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Culture urine, Haematuria, Menstruation irregular, Urinary tract infection, Urine analysis
Clinical narrative: This is the first of two spontaneous reports from a contactable consumer (patient) or other non-healthcare professional (HCP). A 38-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EW0151), at the age of 38, via an unspecified route of administration, in left arm, on Apr 5, 2021, at 12:00, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. No known allergies. On an unspecified date in Apr 2021, patient experienced urinary tract infections, blood in urine and irregular period. Reportedly, patient had urinary tract infections after first and second shots (negative culture tests), blood in urine and also skipped period (after first shot). Therapeutic measures taken for urinary tract infection included treatment with cipro antibiotics for 10 days. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures, which included urine culture test on an unknown date, with negative result and urine analysis revealed blood in urine on an unspecified date. The outcome of urinary tract infections, irregular period: recovering; and of blood in urine: unknown at the time of this report. No follow-up attempts needed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nosebleeds/have had 11 episodes since then. Mostly from the left side, last 20 min to 65 min; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 68-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration in left arm on 12Mar2021 at 12:45 (Batch/Lot Number: EN6208) as (At the age of 68-years) dose 1, single for covid-19 immunisation. Medical history included hypothyroidism and glaucoma, known allergies: Sulfa. Concomitant medication(s) included levothyroxine 0.088mcg; latanoprost 125 mcg and vitamin taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021, at 07:30 the patient experienced nosebleeds. Began 25Mar2021 and has had 11 episodes since then. Mostly from the left side, last 20 min to 65 min. AE resulted in doctor or other healthcare professional office/clinic visit. Patient received no treatment for the event. The outcome of the event was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid, Vaccination site pain
Clinical narrative: Mild swelling of lower left eyelid; 1. Pain at injection site (sore upper arm) - immediate onset; This is a spontaneous report from a contactable consumer, the patient.  A 49-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: EW0176), via an unspecified route of administration, in arm left on 03May2021 18:15 (age at vaccination 49 years) as dose 1, single for covid-19 immunisation. Medical history included allergy to latex, benadryl, wellbutrin. The patient did not have Covid prior vaccination. No other vaccine was taken in four weeks. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC); ibuprofen; colecalciferol (VIT D); melatonin since an unknown date. The patient experienced Pain at injection site (sore upper arm) - immediate onset on 03May2021 at 18:15 and mild swelling of lower left eyelid beginning approximately 3.5 hours after injection on 03May2021 at 21:45 and lasting about an hour. No treatment was taken for the events. The patient was not tested for Covid post vaccination. The outcome of the event pain at injection site was recovering and for mild swelling of lower left eyelid was recovered on 03May2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Vaccination site swelling
Clinical narrative: injection site became swollen; hard and red for 3 days; had a flush of chills; was extremely tired every day; This is a spontaneous report from a contactable consumer (patient). This 54-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Batch/lot number: unknown) on an unspecified date in Apr2021 at 15:30 via an unspecified route of administration in right arm as DOSE 2, SINGLE for covid-19 immunization. The patient other medical history included: High triglycerides. No known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination neither COVID tested post vaccination. The patient took other medications: Fenofibrate, Multi-Vitamin, and Fish Oil within two weeks of the vaccination. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Batch/lot number: unknown) on an unspecified date in Apr2021 at 14:00 via an unspecified route of administration in right arm as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date in Apr2021 after second dose the patient experienced injection site became swollen, hard and red for 3 days, had a flush of chills, and was extremely tired every day for about 3 days after that. The patient did not receive any treatment for the events. The outcome of the events was resolved on an unspecified date in 2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.