chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza virus test, Lichen planus, Mononucleosis heterophile test, Oral mucosal erythema, Oropharyngeal pain
Clinical narrative: Extreme fatigue; Headache; Sore throat; Mouth sores; Diagnosed with lichen planus; gums and palate swollen and red; gums and palate swollen and red; gums and palate swollen and red; gums and palate swollen and red; Aches; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 19Apr2021 at 17:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included mono as a teenager. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7S34) via an unspecified route of administration in the left arm on 29Mar2021 at 17:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation and received hyoscine (SCOPOLAMINE) for an unknown indication on an unknown date and experienced drug allergy. On 20Apr2021, day after 2nd shot, the patient experienced aches, chills and fever and over in 24 hours. On 29Apr2021, 10 days after 2nd shot, the patient experienced gums and palate swollen and red. On 30Apr2021, next day, the patient started with fever, extreme fatigue, headache, sore throat, aches, chills, mouth sores developed next to the negative tests for the following: strep, mono, elevated WBC, COVID, flu A or B and was diagnosed with lichen planus. Now, 7 days later, the patient still had unexplained fever, headache and mouth sores. By the way the patient did not agree with our privacy policy as it relates to anything besides the effects of the vaccine, but she felt this needs to be reported in the public interest. On 03May2021, the patient underwent PCR test (nasal swab) and the result was Negative. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the mouth sores and included treatment with oral steroid. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events aches, chills, fever, gums and palate swollen and red, extreme fatigue, headache, sore throat, mouth sores and lichen planus was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palatal swelling, Pyrexia, SARS-CoV-2 test, Stomatitis
Clinical narrative: Extreme fatigue; Headache; Sore throat; Mouth sores; Diagnosed with lichen planus; gums and palate swollen and red; gums and palate swollen and red; gums and palate swollen and red; gums and palate swollen and red; Aches; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 19Apr2021 at 17:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included mono as a teenager. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7S34) via an unspecified route of administration in the left arm on 29Mar2021 at 17:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation and received hyoscine (SCOPOLAMINE) for an unknown indication on an unknown date and experienced drug allergy. On 20Apr2021, day after 2nd shot, the patient experienced aches, chills and fever and over in 24 hours. On 29Apr2021, 10 days after 2nd shot, the patient experienced gums and palate swollen and red. On 30Apr2021, next day, the patient started with fever, extreme fatigue, headache, sore throat, aches, chills, mouth sores developed next to the negative tests for the following: strep, mono, elevated WBC, COVID, flu A or B and was diagnosed with lichen planus. Now, 7 days later, the patient still had unexplained fever, headache and mouth sores. By the way the patient did not agree with our privacy policy as it relates to anything besides the effects of the vaccine, but she felt this needs to be reported in the public interest. On 03May2021, the patient underwent PCR test (nasal swab) and the result was Negative. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the mouth sores and included treatment with oral steroid. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events aches, chills, fever, gums and palate swollen and red, extreme fatigue, headache, sore throat, mouth sores and lichen planus was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Streptococcus test, White blood cell count
Clinical narrative: Extreme fatigue; Headache; Sore throat; Mouth sores; Diagnosed with lichen planus; gums and palate swollen and red; gums and palate swollen and red; gums and palate swollen and red; gums and palate swollen and red; Aches; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 19Apr2021 at 17:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included mono as a teenager. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7S34) via an unspecified route of administration in the left arm on 29Mar2021 at 17:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation and received hyoscine (SCOPOLAMINE) for an unknown indication on an unknown date and experienced drug allergy. On 20Apr2021, day after 2nd shot, the patient experienced aches, chills and fever and over in 24 hours. On 29Apr2021, 10 days after 2nd shot, the patient experienced gums and palate swollen and red. On 30Apr2021, next day, the patient started with fever, extreme fatigue, headache, sore throat, aches, chills, mouth sores developed next to the negative tests for the following: strep, mono, elevated WBC, COVID, flu A or B and was diagnosed with lichen planus. Now, 7 days later, the patient still had unexplained fever, headache and mouth sores. By the way the patient did not agree with our privacy policy as it relates to anything besides the effects of the vaccine, but she felt this needs to be reported in the public interest. On 03May2021, the patient underwent PCR test (nasal swab) and the result was Negative. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the mouth sores and included treatment with oral steroid. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events aches, chills, fever, gums and palate swollen and red, extreme fatigue, headache, sore throat, mouth sores and lichen planus was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Rash, Somnolence
Clinical narrative: Extreme Muscle & Joint Pain; Extreme Muscle & Joint Pain; Swelling; Rash; Pain at injection site; Drowsy as if drugged; Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 29Apr2021 at 13:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, osteoarthritis, sciatica and shellfish allergy. 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 included metformin (MANUFACTURER UNKNOWN) and loratadine (CLARITIN) both for an unknown indication from an unknown date and were unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 08Apr2021 at 13:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 12:00, the patient experienced exhaustion, extreme muscle and joint pain, swelling, rash, pain at injection site and drowsy as if drugged. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events exhaustion, extreme muscle and joint pain, swelling, rash, pain at injection site and drowsy as if drugged were resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site pain
Clinical narrative: Extreme Muscle & Joint Pain; Extreme Muscle & Joint Pain; Swelling; Rash; Pain at injection site; Drowsy as if drugged; Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 29Apr2021 at 13:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, osteoarthritis, sciatica and shellfish allergy. 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 included metformin (MANUFACTURER UNKNOWN) and loratadine (CLARITIN) both for an unknown indication from an unknown date and were unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 08Apr2021 at 13:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 12:00, the patient experienced exhaustion, extreme muscle and joint pain, swelling, rash, pain at injection site and drowsy as if drugged. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events exhaustion, extreme muscle and joint pain, swelling, rash, pain at injection site and drowsy as if drugged were resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Headache, Pain
Clinical narrative: Headache; Body aches; Extreme tiredness; Body heaviness; This is a spontaneous report from a non-contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Apr2021 at 23:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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. The patient previously took modafinil (PROVIGIL) and cisapride (PROPULSID) and experienced drug allergy. The patient previously 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 12Apr2021 at 12:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. On 29Apr2021 the patient experienced headache, body aches, extreme tiredness and body heaviness lasting through the next day. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with alternate paracetamol (TYLENOL) and ibuprofen (ADVIL) as per doctor instruction. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, body aches, extreme tiredness and body heaviness were resolved on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Discomfort, Headache, Paraesthesia
Clinical narrative: Fever; Chills; Sharp pain on top of head and right shoulder; Sharp pain on top of head and right shoulder; Felt like a pin was pricking right shoulder and right side of neck; My molars were on edge - both sides; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05May2021 at 15:55 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and no known allergies. 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 included vitamins (MANUFACTURER UNKNOWN)) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Apr2021 at 16:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. On 05May2021 at 16:30, 35 minutes after shot the patient experienced sharp pain on top of head and right shoulder when the patient was driving home. This did not last more than a minute. Then, the patient felt like a pin was pricking on right shoulder and right side of neck. The patient molars were on edge both sides. The patient experienced all of these strange reactions while driving home in the car and were gone within 30 minutes. On 06May2021 at 09:30, beginning the next day the patient experienced fever and chills. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sharp pain on top of head and right shoulder, pin was pricking right shoulder and right side of neck and molars were on edge both sides were recovered on 05May2021 at 17:00. The clinical outcome of the events fever and chills were recovered on an unknown date in May2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Chills; Sharp pain on top of head and right shoulder; Sharp pain on top of head and right shoulder; Felt like a pin was pricking right shoulder and right side of neck; My molars were on edge - both sides; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05May2021 at 15:55 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and no known allergies. 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 included vitamins (MANUFACTURER UNKNOWN)) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Apr2021 at 16:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. On 05May2021 at 16:30, 35 minutes after shot the patient experienced sharp pain on top of head and right shoulder when the patient was driving home. This did not last more than a minute. Then, the patient felt like a pin was pricking on right shoulder and right side of neck. The patient molars were on edge both sides. The patient experienced all of these strange reactions while driving home in the car and were gone within 30 minutes. On 06May2021 at 09:30, beginning the next day the patient experienced fever and chills. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sharp pain on top of head and right shoulder, pin was pricking right shoulder and right side of neck and molars were on edge both sides were recovered on 05May2021 at 17:00. The clinical outcome of the events fever and chills were recovered on an unknown date in May2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Extremely swollen and tender lymph nodes under left arm/in left armpit; Extremely swollen and tender lymph nodes under left arm/in left armpit; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06May2021 at 11:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 COVID-19 vaccine. The concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 15Apr2021 at 11:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 07May2021, the patient experienced extremely swollen and tender lymph nodes under left arm/in left armpit. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely swollen and tender lymph nodes under left arm/in left armpit were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Feeling abnormal, Insomnia, Night sweats
Clinical narrative: I had very bad insomnia; anxiety; extreme fatigue; brain fog for over a week after the vaccine; Later I had night sweats.; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-01) via an unspecified route of administration in the left arm on 03Apr2021 at 12:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. 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 included fexofenadine hydrochloride (ALLEGRA), vitamins (MANUFACTURER UNKNOWN) and herbs (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously did not take any drug in the past. On 03Apr2021, the patient had very bad insomnia, anxiety, extreme fatigue and brain fog for over a week after the vaccine. Later patient had night sweats. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of anxiety and included treatment with lorazepam (MANUFACTURER UNKNOWN) and homeopathic remedies. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very bad insomnia, anxiety, extreme fatigue and brain fog was recovered on an unknown date in Apr2021. The clinical outcome of the event later I had night sweats was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, SARS-CoV-2 test
Clinical narrative: Once my period started it was way worse cramps; A heavier flow than i've ever had; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 27Apr2021 at 14:15 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. 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. On 19Apr2021, the patient underwent COVID-19 test and the result was negative. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 04Apr2021 at 14:15 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. On 10May2021, once the patients period started it was way worse cramps and a heavier flow than she ever had. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events once period started it was way worse cramps and a heavier flow than she ever had was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Migraine, Nausea, Vertigo
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 21Apr2021 at 13:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve prolapse, degenerative disc disease, migraines, raynaud's disease, menopause and known allergies to penicillin. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and sennoside a+b (EX-LAX); both for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received sulfamethoxazole/trimethoprim (BACTRIM) for an unknown indication on an unknown date and experienced drug allergy. On 23Apr2021 at 01:15, within 36 hours of the first vaccine, the patient began to have vertigo and got bad enough that she could not stand or move her head. The patient became very weak and nauseous. The patient was extremely fatigued and subsequently determined that she was having complicated migraines possibly triggered by the vaccine. It had happened 3 times and the patient's second dose was due today (as reported). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vertigo, got bad enough that she could not stand or move her head, very weak, nauseous, extremely fatigued and complicated migraines possibly triggered by the vaccine was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Nausea, Periorbital swelling, Photopsia
Clinical narrative: Burning pain in joints / knees; Visual issues (flashing / swirling in peripheral); Significant chills; Significant nausea; Vomiting; Rash/swelling around eyes; Swelling around eyes; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 04May2021 at 09:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 13Apr2021 at 09:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 04May2021 at 18:00, the patient experienced burning pain in joints and knees, visual issues like flashing and swirling in peripheral, significant chills, significant nausea and vomiting, rash and swelling around eyes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events burning pain in joints and knees, visual issues like flashing and swirling in peripheral, significant chills, significant nausea and vomiting, rash and swelling around eyes were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Vomiting
Clinical narrative: Burning pain in joints / knees; Visual issues (flashing / swirling in peripheral); Significant chills; Significant nausea; Vomiting; Rash/swelling around eyes; Swelling around eyes; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 04May2021 at 09:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 13Apr2021 at 09:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 04May2021 at 18:00, the patient experienced burning pain in joints and knees, visual issues like flashing and swirling in peripheral, significant chills, significant nausea and vomiting, rash and swelling around eyes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events burning pain in joints and knees, visual issues like flashing and swirling in peripheral, significant chills, significant nausea and vomiting, rash and swelling around eyes were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Extreme fatigue for 7 days; Lightheadedness; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 03May2021 at 09:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history reported that the patient's colon removed due to ulcerated colitis in 1992. The patient had known allergies to sulfa. 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 included fish oil (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B12) and loperamide (MANUFACTURER UNKNOWN); all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 08Apr2021 at 09:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. On 03May2021 at 18:00, the patient experienced extreme fatigue for 7 days and lightheadedness. 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 results of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme fatigue for 7 days and lightheadedness was resolved on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Heart rate increased, Myalgia, Nausea
Clinical narrative: Headache; Nausea; Joint pain; Muscle pain; Tingling sensation as soon as the vaccine was received in the whole arm plus a little of swollen; Tingling sensation as soon as the vaccine was received in the whole arm plus a little of swollen; Fast heart beat rate; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration on 04May2021 at 10:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously took received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration on 13Apr2021 at 10:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 04May2021, the patient experienced a tingling sensation as soon as the vaccine was received in the whole arm plus a little of swollen and fast heart beat rate. On 05May2021 at 04:00, the patient experienced headache, nausea, joint pain, muscle pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, nausea, joint pain, muscle pain, tingling sensation, swollen arm and fast heart beat rate was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: Headache; Nausea; Joint pain; Muscle pain; Tingling sensation as soon as the vaccine was received in the whole arm plus a little of swollen; Tingling sensation as soon as the vaccine was received in the whole arm plus a little of swollen; Fast heart beat rate; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration on 04May2021 at 10:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously took received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration on 13Apr2021 at 10:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 04May2021, the patient experienced a tingling sensation as soon as the vaccine was received in the whole arm plus a little of swollen and fast heart beat rate. On 05May2021 at 04:00, the patient experienced headache, nausea, joint pain, muscle pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, nausea, joint pain, muscle pain, tingling sensation, swollen arm and fast heart beat rate was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: Vertigo/spinning; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the right arm on 03May2021 at 09:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included heart failure and kidney failure and chronic obstructive pulmonary disease (COPD). The patient had no known allergies. 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 included warfarin (MANUFACTURER UNKNOWN), allopurinol (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and "fu"; all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 08Apr2021 at 09:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. On 05May2021 at 09:30, the patient experienced vertigo, spinning followed by vomiting which happened 4 times in a 24 hour period. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vertigo/spinning and vomiting were resolved with sequelae on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional
Clinical narrative: Shortness of breath doing basic things; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 04May2021 at 13:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included seizure disorder, migraines, post-traumatic stress disorder (ptsd), depression, gastroesophageal reflux disease (gerd), over active bladder and allergic to penicillin and sulfas. 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 included oxybutynin hydrochloride (DITROPAN), fluoxetine hydrochloride (PROZAC), clonazepam (CLONOPIN), topiramate (TROKENDI XR) and gabapentin (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received silybum marianum (DILATIN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 13:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 05May2021, the patient experienced shortness of breath doing basic things. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event shortness of breath doing basic things was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Severe body aches; Headache; Fever; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06May2021 at 11:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and migraine. The patient previously received chlorpromazine (THORAZINE) and infliximab (REMICADE) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included prednisone (MANUFACTURER UNKNOWN) for an unknown indication, from an unknown start date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously 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 15Apr2021 at 11:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. On 07May2021 at 06:30, the patient experienced severe body aches, headache and fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events severe body aches, headache and fever was resolved on 07May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dry eye
Clinical narrative: This is a spontaneous report from non-contactable consumer based on the information received by Pfizer from Regulatory Authority. (Manufacturer Report Number: 2021_012780).  A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number was not reported) via an unspecified route of administration in Apr2021 (age at the time of vaccination was 63 years) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization and tolvaptan (JINARC) started on 07Mar2021 at 45 mg and 15 mg polycystic kidney disease (congenital cystic kidney disease). The patient current conditions included autosomal dominant polycystic kidney disease (congenital cystic kidney disease). The patient's concomitant medications and laboratory data were not reported. On an unspecified date in Apr2021, the patient had experienced dry eyes after vaccine. No action was taken with Jinarc in response to the event dry eyes. The outcome of the event dry eyes was unknown at the time of this report.  Reporter assessment: The event dry eyes was assessed as non-serious, and its causality with respect to Jinarc and Pfizer COVID-19 vaccine was unknown.  Regulatory Authority causality assessment: This was a male patient who experienced the event of dry eyes (Dry eye) on an unspecified date in the month of April after initiation of treatment with Jinarc at 45 mg and 15 mg, once a day for autosomal dominant polycystic kidney disease (ADPKD) from 07Mar2021. The event had been assessed as non-serious. The presence of other concomitant drug also presented as a confounding factor, but the causal rote of suspect drug could not been excluded. Moreover, in view of temporal relationship and established safety profile of the drug the event has been assessed as related to the suspect drug.   Health authority comment: Not applicable   No follow-up attempts were possible, information about lot/batch could not be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Musculoskeletal stiffness, Neck pain
Clinical narrative: Extreme fatigue; Headache; Pain at injection point; Extreme neck pain; Pain from neck and arm was so bad; Didnt sleep for another 2 days/ Unable to sleep or find relief.; Couldnt move neck; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included propranolol (MANUFACUTURER UNKNOWN), medroxyprogesterone (MANUFACUTURER UNKNOWN) and levonorgestrel (PLAN B), all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. On 04May2021, the patient experienced extreme fatigue, headache, pain at injection point, extreme neck pain. Could not move neck. Did not sleep for another 2 days. Pain from neck and arm was so bad she had been up crying every night and unable to sleep or find relief. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events extreme fatigue, headache, pain at injection point, extreme neck pain. Could not move neck. Did not sleep for another 2 days. Pain from neck and arm was so bad she had been up crying every night and unable to sleep or find relief was recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Extreme fatigue; Headache; Pain at injection point; Extreme neck pain; Pain from neck and arm was so bad; Didnt sleep for another 2 days/ Unable to sleep or find relief.; Couldnt move neck; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included propranolol (MANUFACUTURER UNKNOWN), medroxyprogesterone (MANUFACUTURER UNKNOWN) and levonorgestrel (PLAN B), all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. On 04May2021, the patient experienced extreme fatigue, headache, pain at injection point, extreme neck pain. Could not move neck. Did not sleep for another 2 days. Pain from neck and arm was so bad she had been up crying every night and unable to sleep or find relief. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events extreme fatigue, headache, pain at injection point, extreme neck pain. Could not move neck. Did not sleep for another 2 days. Pain from neck and arm was so bad she had been up crying every night and unable to sleep or find relief was recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.