chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Muscular weakness, Paraesthesia
Clinical narrative: Full body pins and needles; numb arm; malaise; chest pain; insomnia; cramped legs; brain fog/cannot feel the weight of my own body; cognitive dysfunction; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15May2021 (Lot Number: EW0186, expiration date not provide) at age of 33 years old as a single dose for covid-19 immunisation. The patient was not pregnancy at time of vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced full body pins and needles, numb arm, malaise, chest pain, insomnia, cramped legs, brain fog/cannot feel the weight of my own body, cognitive dysfunction, all on 15May2021. The outcome of the events was not recovered. Clinical course: Full body pins and needles for a month, numb arm, malaise, cramped legs, chest pain, brain fog, cognitive dysfunction, insomnia. Currently the patient couldn't feel the weight of her own body for the last four weeks. These last two months had been hell. She couldn't convey how bad it was been. She felt lucky to be alive. All events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No other vaccine received in four weeks. The patient was not COVID prior vaccination. The patient was not tested post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Cognitive disorder, Feeling abnormal, Hypoaesthesia, Insomnia
Clinical narrative: Full body pins and needles; numb arm; malaise; chest pain; insomnia; cramped legs; brain fog/cannot feel the weight of my own body; cognitive dysfunction; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15May2021 (Lot Number: EW0186, expiration date not provide) at age of 33 years old as a single dose for covid-19 immunisation. The patient was not pregnancy at time of vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced full body pins and needles, numb arm, malaise, chest pain, insomnia, cramped legs, brain fog/cannot feel the weight of my own body, cognitive dysfunction, all on 15May2021. The outcome of the events was not recovered. Clinical course: Full body pins and needles for a month, numb arm, malaise, cramped legs, chest pain, brain fog, cognitive dysfunction, insomnia. Currently the patient couldn't feel the weight of her own body for the last four weeks. These last two months had been hell. She couldn't convey how bad it was been. She felt lucky to be alive. All events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No other vaccine received in four weeks. The patient was not COVID prior vaccination. The patient was not tested post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Muscle spasms, Paraesthesia
Clinical narrative: Full body pins and needles; numb arm; malaise; chest pain; insomnia; cramped legs; brain fog/cannot feel the weight of my own body; cognitive dysfunction; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15May2021 (Lot Number: EW0186, expiration date not provide) at age of 33 years old as a single dose for covid-19 immunisation. The patient was not pregnancy at time of vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced full body pins and needles, numb arm, malaise, chest pain, insomnia, cramped legs, brain fog/cannot feel the weight of my own body, cognitive dysfunction, all on 15May2021. The outcome of the events was not recovered. Clinical course: Full body pins and needles for a month, numb arm, malaise, cramped legs, chest pain, brain fog, cognitive dysfunction, insomnia. Currently the patient couldn't feel the weight of her own body for the last four weeks. These last two months had been hell. She couldn't convey how bad it was been. She felt lucky to be alive. All events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No other vaccine received in four weeks. The patient was not COVID prior vaccination. The patient was not tested post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: headache; tinnitus; This is a spontaneous report from a contactable consumer. A 67-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection,Batch/Lot Number: EW0167), via an unspecified route of administration, administered in Arm Left on 11May2021 13:45 (age at vaccination 67-year-old) as DOSE 2, 0.3ML SINGLE for COVID-19 immunisation. Facility type for vaccination was hospital. Medical history included Penicillin Allergy and Pennnicillin, Tinnitus has gotten loud as it was in 1991 from 1991 to an unknown date. Patient was not tested for COVID-19 post vaccination. The patient did not receive any other vaccines in four weeks prior vaccination. Concomitant medication(s) included levothyroxine sodium (SYNTHROID), estradiol (ESTRADIOL), Multivitamins taken for an unspecified indication, start and stop date were not reported.The patient previously took oregano and experienced drug hypersensitivity, oxycodone and experienced drug hypersensitivity. Historical vaccine included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8737) administered in Arm Left on 21Apr2021  16:00 as DOSE 1, SINGLE for COVID-19 immunisation. On 12May2021 07:00, the patient experienced headache, tinnitus.The patient underwent lab tests and procedures which included pain assessment: between a 5 - 7 on a 1-10 scale on. Therapeutic measures were taken as a result of headache, tinnitus tried Toradol shot, Chiropractic, Craniosacral Therapy. Clinical course reported as: As of today She have had a nonstop headache for the past 36 days and her tinnitus had gotten as loud as it was when she had an accident in 1991. She have not had headaches in over 35 years. She had tried a chiropractor, massage, craniosacral practitioner as well as her doctor who gave her a Toradol shot. Her headaches range between a 5 - 7 on a 1-10 scale. Tylenol will take the pain down a notch but it was never gone. The Toradol did nothing. The craniosacral therapy helped temporarily and brought the pain down to a level 4.Nothing was helping the tinnitus. She was suggested by her doctor to see a neurologist. The outcome of events were not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain assessment, Tinnitus
Clinical narrative: headache; tinnitus; This is a spontaneous report from a contactable consumer. A 67-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection,Batch/Lot Number: EW0167), via an unspecified route of administration, administered in Arm Left on 11May2021 13:45 (age at vaccination 67-year-old) as DOSE 2, 0.3ML SINGLE for COVID-19 immunisation. Facility type for vaccination was hospital. Medical history included Penicillin Allergy and Pennnicillin, Tinnitus has gotten loud as it was in 1991 from 1991 to an unknown date. Patient was not tested for COVID-19 post vaccination. The patient did not receive any other vaccines in four weeks prior vaccination. Concomitant medication(s) included levothyroxine sodium (SYNTHROID), estradiol (ESTRADIOL), Multivitamins taken for an unspecified indication, start and stop date were not reported.The patient previously took oregano and experienced drug hypersensitivity, oxycodone and experienced drug hypersensitivity. Historical vaccine included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8737) administered in Arm Left on 21Apr2021  16:00 as DOSE 1, SINGLE for COVID-19 immunisation. On 12May2021 07:00, the patient experienced headache, tinnitus.The patient underwent lab tests and procedures which included pain assessment: between a 5 - 7 on a 1-10 scale on. Therapeutic measures were taken as a result of headache, tinnitus tried Toradol shot, Chiropractic, Craniosacral Therapy. Clinical course reported as: As of today She have had a nonstop headache for the past 36 days and her tinnitus had gotten as loud as it was when she had an accident in 1991. She have not had headaches in over 35 years. She had tried a chiropractor, massage, craniosacral practitioner as well as her doctor who gave her a Toradol shot. Her headaches range between a 5 - 7 on a 1-10 scale. Tylenol will take the pain down a notch but it was never gone. The Toradol did nothing. The craniosacral therapy helped temporarily and brought the pain down to a level 4.Nothing was helping the tinnitus. She was suggested by her doctor to see a neurologist. The outcome of events were not recovered.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray abnormal, Chest pain, Echocardiogram abnormal, Electrocardiogram abnormal
Clinical narrative: Myocarditis; Pericarditis; This is a spontaneous report from a contactable consumer (patient's parent). A 19-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration administered in the left arm on 28May2021 (Batch/Lot Number: EW0167) as single dose (at age of 19 years old) for COVID-19 immunisation. The patient had no medical history and did not receive concomitant medications. The patient previously received the first dose of BNT162b2 on 07May2021 (Lot Number EW0167) for COVID-19 immunization. The patient's parent reported that the patient had an adverse reaction resulting in myocarditis and pericarditis to the second vaccine dose, two days after having it (however the first onset of symptoms was reported as 28May2021). The patient received no other medication, just what he had just been prescribed after the myocarditis diagnosis, nothing prior to that. He was administered in to the local hospital emergency room and then admitted in the cardiac unit and they administered some type of Corticosteroid (as reported). At the time of reporting, the patient was still experiencing the events, any significant exertion caused cardiac pain. The reporter stated that definitely symptoms improved from initial onset. The outcome of the events was considered as recovering.  Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Myocarditis, Pericarditis, Ultrasound scan abnormal
Clinical narrative: Myocarditis; Pericarditis; This is a spontaneous report from a contactable consumer (patient's parent). A 19-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration administered in the left arm on 28May2021 (Batch/Lot Number: EW0167) as single dose (at age of 19 years old) for COVID-19 immunisation. The patient had no medical history and did not receive concomitant medications. The patient previously received the first dose of BNT162b2 on 07May2021 (Lot Number EW0167) for COVID-19 immunization. The patient's parent reported that the patient had an adverse reaction resulting in myocarditis and pericarditis to the second vaccine dose, two days after having it (however the first onset of symptoms was reported as 28May2021). The patient received no other medication, just what he had just been prescribed after the myocarditis diagnosis, nothing prior to that. He was administered in to the local hospital emergency room and then admitted in the cardiac unit and they administered some type of Corticosteroid (as reported). At the time of reporting, the patient was still experiencing the events, any significant exertion caused cardiac pain. The reporter stated that definitely symptoms improved from initial onset. The outcome of the events was considered as recovering.  Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Pericarditis
Clinical narrative: Myocarditis; Pericarditis; This is a spontaneous report from a contactable consumer (patient's parent). A 19-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration administered in the left arm on 28May2021 (Batch/Lot Number: EW0167) as single dose (at age of 19 years old) for COVID-19 immunisation. The patient had no medical history and did not receive concomitant medications. The patient previously received the first dose of BNT162b2 on 07May2021 (Lot Number EW0167) for COVID-19 immunization. The patient's parent reported that the patient had an adverse reaction resulting in myocarditis and pericarditis to the second vaccine dose, two days after having it (however the first onset of symptoms was reported as 28May2021). The patient received no other medication, just what he had just been prescribed after the myocarditis diagnosis, nothing prior to that. He was administered in to the local hospital emergency room and then admitted in the cardiac unit and they administered some type of Corticosteroid (as reported). At the time of reporting, the patient was still experiencing the events, any significant exertion caused cardiac pain. The reporter stated that definitely symptoms improved from initial onset. The outcome of the events was considered as recovering.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer, Joint swelling, Peripheral swelling, Synovial cyst, Ultrasound Doppler abnormal
Clinical narrative: left leg DVT ultrasound found a baker's cyst; Left calf (more serious closed to knee) stiff, pain and swollen; Left calf (more serious closed to knee) stiff, pain and swollen; Left calf (more serious closed to knee) stiff, pain and swollen; red, swollen and pain on left ankle; red, swollen and pain on left ankle; red, swollen and pain on left ankle; headache for 3 days; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection; Lot Number: EW0167), via an unspecified route of administration, administered in left arm on 02May2021 at 15:00 (at the age of 64-years-old) as single dose for covid-19 immunisation at Pharmacy or Drug Store. Medical history included hepatitis B career, minor left knee pain for last 2 years and platelet clumper needs extra blue tube for platelet test. The patient's concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection; Lot Number: ER8730), via an unspecified route of administration, administered in left arm on 04Apr2021 at 15:15 (at the age of 64-years-old) as single dose for covid-19 immunisation at Pharmacy or Drug Store. 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 03May2021 at 07:00, patient experienced left calf (more serious closed to knee) stiff, pain and swollen on 5/3 morning woke up. 3 days later, red, swollen and pain on left ankle and headache for 3 days. In 2nd and 3rd week, ankle was not red, but light swollen on ankle and calf. After 4.5 weeks ankle swollen was gone, and calf was still swollen with less pain. The patient underwent lab tests and procedures which included d-dimer blood test 0.54 on 19May2021, left leg DVT ultrasound found a baker's cyst on 21May2021. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. No hospitalization prolonged. No treatment received. The outcome of the events red, swollen on left ankle was recovered in 2021; for other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Erythema, Fibrin D dimer, Headache, Joint swelling
Clinical narrative: left leg DVT ultrasound found a baker's cyst; Left calf (more serious closed to knee) stiff, pain and swollen; Left calf (more serious closed to knee) stiff, pain and swollen; Left calf (more serious closed to knee) stiff, pain and swollen; red, swollen and pain on left ankle; red, swollen and pain on left ankle; red, swollen and pain on left ankle; headache for 3 days; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection; Lot Number: EW0167), via an unspecified route of administration, administered in left arm on 02May2021 at 15:00 (at the age of 64-years-old) as single dose for covid-19 immunisation at Pharmacy or Drug Store. Medical history included hepatitis B career, minor left knee pain for last 2 years and platelet clumper needs extra blue tube for platelet test. The patient's concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection; Lot Number: ER8730), via an unspecified route of administration, administered in left arm on 04Apr2021 at 15:15 (at the age of 64-years-old) as single dose for covid-19 immunisation at Pharmacy or Drug Store. 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 03May2021 at 07:00, patient experienced left calf (more serious closed to knee) stiff, pain and swollen on 5/3 morning woke up. 3 days later, red, swollen and pain on left ankle and headache for 3 days. In 2nd and 3rd week, ankle was not red, but light swollen on ankle and calf. After 4.5 weeks ankle swollen was gone, and calf was still swollen with less pain. The patient underwent lab tests and procedures which included d-dimer blood test 0.54 on 19May2021, left leg DVT ultrasound found a baker's cyst on 21May2021. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. No hospitalization prolonged. No treatment received. The outcome of the events red, swollen on left ankle was recovered in 2021; for other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Peripheral swelling, Synovial cyst, Ultrasound testes
Clinical narrative: left leg DVT ultrasound found a baker's cyst; Left calf (more serious closed to knee) stiff, pain and swollen; Left calf (more serious closed to knee) stiff, pain and swollen; Left calf (more serious closed to knee) stiff, pain and swollen; red, swollen and pain on left ankle; red, swollen and pain on left ankle; red, swollen and pain on left ankle; headache for 3 days; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection; Lot Number: EW0167), via an unspecified route of administration, administered in left arm on 02May2021 at 15:00 (at the age of 64-years-old) as single dose for covid-19 immunisation at Pharmacy or Drug Store. Medical history included hepatitis B career, minor left knee pain for last 2 years and platelet clumper needs extra blue tube for platelet test. The patient's concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection; Lot Number: ER8730), via an unspecified route of administration, administered in left arm on 04Apr2021 at 15:15 (at the age of 64-years-old) as single dose for covid-19 immunisation at Pharmacy or Drug Store. 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 03May2021 at 07:00, patient experienced left calf (more serious closed to knee) stiff, pain and swollen on 5/3 morning woke up. 3 days later, red, swollen and pain on left ankle and headache for 3 days. In 2nd and 3rd week, ankle was not red, but light swollen on ankle and calf. After 4.5 weeks ankle swollen was gone, and calf was still swollen with less pain. The patient underwent lab tests and procedures which included d-dimer blood test 0.54 on 19May2021, left leg DVT ultrasound found a baker's cyst on 21May2021. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. No hospitalization prolonged. No treatment received. The outcome of the events red, swollen on left ankle was recovered in 2021; for other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Menstrual disorder
Clinical narrative: I have a Nexplanon implant and do not experience menstruation typically since receiving the implant. I had light spotting in April 2021 and a full heavy period in May 2021.; I have a Nexplanon implant and do not experience menstruation typically since receiving the implant. I had light spotting in April 2021 and a full heavy period in May 2021.; This is a spontaneous report from a contactable consumer (patient herself). A 34-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6207), dose 2 via an unspecified route of administration, administered in Arm Left on 18Mar2021 at 07:15 as dose 2, single for COVID-19 immunisation. The patient received first dose of BNT162B2 (lot number: EN6198) administered in Arm Left on 25Feb2021 at 07:15 AM (at the age of 34-year-old) for COVID-19 immunisation. Medical history included Hidradenitis Suppurativa, depression and generalised anxiety disorder. The patient previously took nexplanon and experienced amenorrhoea (do not experience menstruation typically since receiving the implant). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did receive any other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID 19 prior to vaccination. On 18Apr2021, the patient experienced i have a nexplanon implant and do not experience menstruation typically since receiving the implant. i had light spotting in april 2021 and a full heavy period in may 2021. Patient not received treatment for the adverse event. Since the vaccination, patient has not been tested for COVID-19. At the time of this report events outcome was unknown.  Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Intermenstrual bleeding, Menstrual disorder
Clinical narrative: I have a Nexplanon implant and do not experience menstruation typically since receiving the implant. I had light spotting in April 2021 and a full heavy period in May 2021.; I have a Nexplanon implant and do not experience menstruation typically since receiving the implant. I had light spotting in April 2021 and a full heavy period in May 2021.; This is a spontaneous report from a contactable consumer (patient herself). A 34-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6207), dose 2 via an unspecified route of administration, administered in Arm Left on 18Mar2021 at 07:15 as dose 2, single for COVID-19 immunisation. The patient received first dose of BNT162B2 (lot number: EN6198) administered in Arm Left on 25Feb2021 at 07:15 AM (at the age of 34-year-old) for COVID-19 immunisation. Medical history included Hidradenitis Suppurativa, depression and generalised anxiety disorder. The patient previously took nexplanon and experienced amenorrhoea (do not experience menstruation typically since receiving the implant). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did receive any other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID 19 prior to vaccination. On 18Apr2021, the patient experienced i have a nexplanon implant and do not experience menstruation typically since receiving the implant. i had light spotting in april 2021 and a full heavy period in may 2021. Patient not received treatment for the adverse event. Since the vaccination, patient has not been tested for COVID-19. At the time of this report events outcome was unknown.  Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Pruritus, Urticaria
Clinical narrative: Immediately following the shot became lightheaded.; developed a headache.; small diameter flesh colored hives on face, neck and torso.; Scratching itchy areas left bright red marks onbody.; Scratching itchy areas left bright red marks onbody.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 14May2021 at 13:30 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history included allergic reaction/ once elevated autoimmune urticaria markers ("normal now" as reported at the time of reporting), fruit allergy and meat allergy. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), clonazepam (KLONOPIN), zinc (MANUFACTURER UNKNOWN) and calcium gluconate, magnesium gluconate, potassium chloride (BIO CMP); all for unspecified indication from unknown date. The patient previously took moxifloxacin hydrochloride (AVELOX), levofloxacin (LEVAQUIN), hydrocortisone (CORTISOL) and glycyrrhiza glabra (LICORICE); all for unspecified indication from unknown date and experienced drug allergy to moxifloxacin hydrochloride (AVELOX), levofloxacin (LEVAQUIN), hydrocortisone (CORTISOL) and glycyrrhiza glabra (LICORICE). 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 14May2021, immediately following the shot,  the patient became lightheaded and developed a headache . On 14May2021 at 15:00, within a few hours, the patient experienced small diameter flesh colored hives on face, neck and torso and scratching itchy areas left bright red marks on body. Over 24 hours later, and hives/bumps were still present and body was itchy. No throat swelling or large red raised bumps/welts. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event immediately following the shot became lightheaded, developed a headache, small diameter flesh colored hives on face, neck and torso, scratching itchy areas left bright red marks on body was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Erythema, Headache, Pruritus, Urticaria
Clinical narrative: Immediately following the shot became lightheaded.; developed a headache.; small diameter flesh colored hives on face, neck and torso.; Scratching itchy areas left bright red marks onbody.; Scratching itchy areas left bright red marks onbody.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 14May2021 at 13:30 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history included allergic reaction/ once elevated autoimmune urticaria markers ("normal now" as reported at the time of reporting), fruit allergy and meat allergy. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), clonazepam (KLONOPIN), zinc (MANUFACTURER UNKNOWN) and calcium gluconate, magnesium gluconate, potassium chloride (BIO CMP); all for unspecified indication from unknown date. The patient previously took moxifloxacin hydrochloride (AVELOX), levofloxacin (LEVAQUIN), hydrocortisone (CORTISOL) and glycyrrhiza glabra (LICORICE); all for unspecified indication from unknown date and experienced drug allergy to moxifloxacin hydrochloride (AVELOX), levofloxacin (LEVAQUIN), hydrocortisone (CORTISOL) and glycyrrhiza glabra (LICORICE). 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 14May2021, immediately following the shot,  the patient became lightheaded and developed a headache . On 14May2021 at 15:00, within a few hours, the patient experienced small diameter flesh colored hives on face, neck and torso and scratching itchy areas left bright red marks on body. Over 24 hours later, and hives/bumps were still present and body was itchy. No throat swelling or large red raised bumps/welts. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event immediately following the shot became lightheaded, developed a headache, small diameter flesh colored hives on face, neck and torso, scratching itchy areas left bright red marks on body was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Menstrual disorder
Clinical narrative: I have been in menapause for 18 months. 3 days after my 2nd dose (5-3) I have started my cycle again, & am still having it.; This is a spontaneous report received from a contactable consumer (reported herself).   A 48-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: Ew0161), via an unspecified route of administration, administered in arm left on an unspecified date (age at vaccination was 48-year-old) as dose 2, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was other. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medications included ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) and lisinopril for an unspecified indication, start and stop date were not reported received within two weeks of vaccination. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: Ep7533), via an unspecified route of administration, administered in arm left on an unspecified date as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient stated that she had been in menapause for 18 months and 3 days after her 2nd dose (5-3) she had started her cycle again and she still having it, on 03May2021 01:00. The patient was not hospitalised. Since the vaccination, the patient had not tested for COVID-19. The patient not received treatment for the event. The outcome of the event was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: I have been in menapause for 18 months. 3 days after my 2nd dose (5-3) I have started my cycle again, & am still having it.; This is a spontaneous report received from a contactable consumer (reported herself).   A 48-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: Ew0161), via an unspecified route of administration, administered in arm left on an unspecified date (age at vaccination was 48-year-old) as dose 2, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was other. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medications included ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) and lisinopril for an unspecified indication, start and stop date were not reported received within two weeks of vaccination. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: Ep7533), via an unspecified route of administration, administered in arm left on an unspecified date as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient stated that she had been in menapause for 18 months and 3 days after her 2nd dose (5-3) she had started her cycle again and she still having it, on 03May2021 01:00. The patient was not hospitalised. Since the vaccination, the patient had not tested for COVID-19. The patient not received treatment for the event. The outcome of the event was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Cardiac monitoring normal, Chest X-ray normal, Dyspnoea, Dyspnoea exertional
Clinical narrative: Could not sleep well; Felt dry in mouth even after drinking water; cannot take food; Acid reflux was worsening, could not take food; Rapid heartbeat immediately after the injection; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 22Mar2021 at 14:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux, gastroesophageal reflux disease (GERD). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 22Mar2021 at 14:00, the patient experienced rapid heartbeat immediately after the injection. Two days later, on 24Mar2021, the patient's acid reflux was worsening, could not take food. Three weeks later, on 12Apr2021, the patient experienced another rapid heartbeat and could not sleep well. The patient always felt dry in mouth even after drinking water. The events resulted in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. Therapeutic measures were taken as a result of events, rapid heartbeat, acid reflux was worsening, could not take food, could not sleep well and felt dry in mouth even after drinking water and included treatment with medicines for acid reflux and EKG (electrocardiogram) was performed on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rapid heartbeat, acid reflux was worsening, could not take food, could not sleep well and felt dry in mouth even after drinking water was not resolved at the time of this report.   No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram normal, Electrocardiogram normal, Fatigue, Gastrooesophageal reflux disease, Heart rate increased
Clinical narrative: Could not sleep well; Felt dry in mouth even after drinking water; cannot take food; Acid reflux was worsening, could not take food; Rapid heartbeat immediately after the injection; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 22Mar2021 at 14:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux, gastroesophageal reflux disease (GERD). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 22Mar2021 at 14:00, the patient experienced rapid heartbeat immediately after the injection. Two days later, on 24Mar2021, the patient's acid reflux was worsening, could not take food. Three weeks later, on 12Apr2021, the patient experienced another rapid heartbeat and could not sleep well. The patient always felt dry in mouth even after drinking water. The events resulted in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. Therapeutic measures were taken as a result of events, rapid heartbeat, acid reflux was worsening, could not take food, could not sleep well and felt dry in mouth even after drinking water and included treatment with medicines for acid reflux and EKG (electrocardiogram) was performed on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rapid heartbeat, acid reflux was worsening, could not take food, could not sleep well and felt dry in mouth even after drinking water was not resolved at the time of this report.   No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperacusis, Hyperhidrosis, Hypoaesthesia, Hypopnoea, Immediate post-injection reaction
Clinical narrative: Could not sleep well; Felt dry in mouth even after drinking water; cannot take food; Acid reflux was worsening, could not take food; Rapid heartbeat immediately after the injection; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 22Mar2021 at 14:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux, gastroesophageal reflux disease (GERD). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 22Mar2021 at 14:00, the patient experienced rapid heartbeat immediately after the injection. Two days later, on 24Mar2021, the patient's acid reflux was worsening, could not take food. Three weeks later, on 12Apr2021, the patient experienced another rapid heartbeat and could not sleep well. The patient always felt dry in mouth even after drinking water. The events resulted in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. Therapeutic measures were taken as a result of events, rapid heartbeat, acid reflux was worsening, could not take food, could not sleep well and felt dry in mouth even after drinking water and included treatment with medicines for acid reflux and EKG (electrocardiogram) was performed on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rapid heartbeat, acid reflux was worsening, could not take food, could not sleep well and felt dry in mouth even after drinking water was not resolved at the time of this report.   No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Muscle spasms, Palpitations, Photophobia, Tachycardia
Clinical narrative: Could not sleep well; Felt dry in mouth even after drinking water; cannot take food; Acid reflux was worsening, could not take food; Rapid heartbeat immediately after the injection; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 22Mar2021 at 14:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux, gastroesophageal reflux disease (GERD). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 22Mar2021 at 14:00, the patient experienced rapid heartbeat immediately after the injection. Two days later, on 24Mar2021, the patient's acid reflux was worsening, could not take food. Three weeks later, on 12Apr2021, the patient experienced another rapid heartbeat and could not sleep well. The patient always felt dry in mouth even after drinking water. The events resulted in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. Therapeutic measures were taken as a result of events, rapid heartbeat, acid reflux was worsening, could not take food, could not sleep well and felt dry in mouth even after drinking water and included treatment with medicines for acid reflux and EKG (electrocardiogram) was performed on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rapid heartbeat, acid reflux was worsening, could not take food, could not sleep well and felt dry in mouth even after drinking water was not resolved at the time of this report.   No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tidal volume abnormal, Urine analysis normal
Clinical narrative: Could not sleep well; Felt dry in mouth even after drinking water; cannot take food; Acid reflux was worsening, could not take food; Rapid heartbeat immediately after the injection; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 22Mar2021 at 14:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux, gastroesophageal reflux disease (GERD). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 22Mar2021 at 14:00, the patient experienced rapid heartbeat immediately after the injection. Two days later, on 24Mar2021, the patient's acid reflux was worsening, could not take food. Three weeks later, on 12Apr2021, the patient experienced another rapid heartbeat and could not sleep well. The patient always felt dry in mouth even after drinking water. The events resulted in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. Therapeutic measures were taken as a result of events, rapid heartbeat, acid reflux was worsening, could not take food, could not sleep well and felt dry in mouth even after drinking water and included treatment with medicines for acid reflux and EKG (electrocardiogram) was performed on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rapid heartbeat, acid reflux was worsening, could not take food, could not sleep well and felt dry in mouth even after drinking water was not resolved at the time of this report.   No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dry mouth, Electrocardiogram, Food aversion, Gastrooesophageal reflux disease, Heart rate increased
Clinical narrative: Could not sleep well; Felt dry in mouth even after drinking water; cannot take food; Acid reflux was worsening, could not take food; Rapid heartbeat immediately after the injection; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 22Mar2021 at 14:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux, gastroesophageal reflux disease (GERD). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 22Mar2021 at 14:00, the patient experienced rapid heartbeat immediately after the injection. Two days later, on 24Mar2021, the patient's acid reflux was worsening, could not take food. Three weeks later, on 12Apr2021, the patient experienced another rapid heartbeat and could not sleep well. The patient always felt dry in mouth even after drinking water. The events resulted in doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. Therapeutic measures were taken as a result of events, rapid heartbeat, acid reflux was worsening, could not take food, could not sleep well and felt dry in mouth even after drinking water and included treatment with medicines for acid reflux and EKG (electrocardiogram) was performed on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rapid heartbeat, acid reflux was worsening, could not take food, could not sleep well and felt dry in mouth even after drinking water was not resolved at the time of this report.   No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.