chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Lymphadenopathy, Pain, Tenderness
Clinical narrative: Swelling of left lymph node in armpit near injection site; Severe throbbing for 2.5 days and tender.; Severe throbbing for 2.5 days and tender.; joint pain concentrated in kneecaps; headache; This is a spontaneous report from a contactable consumer, the patient. A 64- years old patient of an unknown gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 16Mar2021 at 15:45 as a single dose for COVID-19 immunisation. Medical history included allergic to latex. Concomitant medications included aspirin (MANUFACTURER UNKNOWN), multi-B vitamin (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), and zinc (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had not received any other vaccines within four weeks, prior to the COVID-19 vaccine. On 17Mar2021 at 03:00, patient experienced swelling of left lymph node in armpit near injection site, severe throbbing for (2.5 days), tender, headache, joint pain concentrated in the kneecaps and back for 2 days. The clinical outcome for the events lymph node swollen, headache, joint pain, tenderness and throbbing pain was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; This is a spontaneous report received from a contactable nurse, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: PF208ENG202), via an unspecified route of administration in the left arm on 17Mar2021 at 12:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included pre-type-2 diabetes mellitus, lupus and COVID-19. Concomitant medication included metformin (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN); both for unknown indications, from unknown dates. The patient previously took penicillin for unknown indication and experienced an allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021, the patient experienced swollen lymph nodes. The patient did not receive any treatment for the reported event. The clinical outcome of the event swollen lymph nodes was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Diaphragmatic spasm, Heart rate, Heart rate increased, Respiratory rate increased
Clinical narrative: Being winded; Heart rate has dramatically increased during any type of exercise (125 plus); Rapid breathing; This is a spontaneous report received from a contactable consumer, the patient. A 79 years old male patient received second dose of BNT162b2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; Lot number: EN6200] via an unspecified route of administration in left arm on 19Feb2021 at 08:00 (at the age of 79 years old), as a single dose, for COVID-19 immunisation. The patient medical history included allergy to Zocin. 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 4 weeks prior to the COVID 19 vaccine. No concomitant medication was reported. The patient previously took first dose of BNT162b2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; Lot number: El9262] via an unspecified route of administration in left arm on 29Jan2021 at 08:00 (at the age of 79 years old), as a single dose, for COVID-19 immunisation. On 28Feb2021, the patient noticed that his heart rate had dramatically increased during any type of exercise. The patients resting pulse was 74 and he was exercising on a treadmill for weeks before the second shot. The patient experienced being winded after a very short time on the treadmill with his heart rate reaching 125 plus after a very short time. This was out of patient target range and he stopped before getting to that heart rate that patient knew that something was definitely wrong. The patient also got rapid breathing when the heart rate increased. The clinical outcome of events heart rate increased, being winded and rapid breathing was not recovered. No follow up attempts are needed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Headache; Significant increase in pain; This is a spontaneous report received from a contactable consumer, patient. A 54-years-old male patient received 1st dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6955) to arm left on 17Mar2021 at 12:30 as a single dose for COVID-19 immunisation. Medical history included osteoarthritis, spinal stenosis, spinal osteophytosis, chronic pain, hypertension and obesity. Relevant past drug use included Penicillin, Tetracycline and unspecified Sulpha drugs for an unknown indication from an unknown date and experienced drug allergy. Concomitant medications included Ibuprofen (MANUFACTURER UNKNOWN) and Acetaminophen (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 17Mar2021 at 19:00, patient experienced significant increase in pain and headache. The patient stated that, he experienced a significant increase in pain in existing injuries and a headache within 7 hours of the dose and that's continued for 3 days. Pain levels were gradually decreasing at the time of the report. The patient reported that he did not receive any treatment for the events and did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. It was also reported that the patient was not diagnosed with COVID-19 prior to vaccination and since vaccination, patient was not tested for COVID-19. The clinical outcome of the events significant increase in pain and headache were resolving at the time of report. No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Livedo reticularis
Clinical narrative: Livedo Reticularis (purple veins on legs/arms, rapid heartrate, shivering, teeth chattering, pain in legs & left chest); This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202)  via an unspecified route of administration in the arm left on 25Feb2021 at 15:00 (at the age of 36-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an  unspecified route of administration in the arm left on 18Mar2021 at 10:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient medical history included multiple sclerosis. Concomitant medication included Gilenya 0.5mg (MANUFACTURER UNKNOWN), Lisinopril 10mg (MANUFACTURER UNKNOWN) and Amitriptyline 25mg (MANUFACTURER UNKNOWN) all for unknown indication. The patient had no allergies to medications, food or other products. The patient was not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the  vaccination.  On 08 Mar2021, the patient experienced livedo reticularis (purple veins on legs/arms, rapid heartrate, shivering, teeth chattering, pain in legs & left chest). The patient  had no treatment for AEs. The clinical outcome of livedo reticularis was unknown. No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy
Clinical narrative: collarbone lymphnode swollen and sore; collarbone lymphnode swollen and sore; tiredness day of vaccination; This is a spontaneous report received from a contactable patient. A 32-year-old adult non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via unspecified route of administration in her left arm on 13Mar2021 at 12:15 (at the age of 32 years) as a single dose for COVID-19 immunisation. Past medical history included obesity, sinus infection and allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medication included Amoxicillin/clavulanic acid (AUGMENTIN) for sinus infection (day 7 or 10). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has a medical history of being allergic to nitrofurantoin (MACROBID) and sulfa drugs. On the day of vaccination, on 13Mar2021, the patient experienced extreme fatigue. 5-days post vaccination, on 18Mar2021 at 2000, the patient experienced left collarbone lymph node swelling and soreness. No therapeutic measures were taken in response to the events. The clinical outcome of the event lymph node swelling and lymph node pain was not recovered and the patient recovered from the event tiredness on 14Mar2021. No follow-up attempts are needed. No further information is expected
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Extreme insomnia; This is a spontaneous report from a contactable consumer, the patient. A 35-years-old non pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: En6202) via unspecified route of administration in the left arm on 24Feb2021 at 13:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included Crohns, Ehlers-Danlos syndromes (EDS), migraines/headaches, to in the left arm on 24Feb2021 at 13:30urette's disorder. The patient was allergic to iodine contrast (reported as IV contrast). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included multiple medications (unspecified) for multiple chronic illnesses. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On 25Feb2021 at 22:00, the patient had extreme insomnia, after receiving the second dose of the vaccine. The patient was unable to sleep more than a couple broken hours per night without taking diphenhydramine; ibuprofen (ADVIL PM). The clinical outcome of the event insomnia was not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Upset stomach/diarrhea.; This is a spontaneous report from contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: En6204), via an unspecified route of administration in the left arm on 19Mar2021 at 10:15 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included diabetes. The patient was sensitive to some anti-inflammatory drugs and pseudoephedrine. Concomitant medications included metformin (MANUFACTURE UNKNOWN) and Tylenol (MANUFACTURE UNKNOWN), reported for diabetes. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021 at 19:30, the patient experienced upset stomach/diarrhea. The patient was diabetic and on metformin and also took Tylenol prior to getting the injection. No therapeutic measures were taken as a result of event. The clinical outcome of diarrhea was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Nausea, Vomiting
Clinical narrative: Chills; Nausea; Vomiting; Weakness; This is a spontaneous report from a non-contactable consumer, the patient. A 68-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in left arm on 16Mar2021 at 10:45 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. The patient did not have medical history. The patient did not have allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), lurasidone (LATUDA), bupropion (WELBUTRIN), dextroamphetamine-amphetamine (ADDERALL), valacyclovir (VALTREX) taken within last two weeks of vaccination for an unknown indication 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 left arm on 22Feb2021 at 10:45 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. The patient experienced chills, nausea, vomiting and weakness on 17Mar2021, at 10:00. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events chills, nausea, vomiting and weakness were recovered on an unknown date in Mar2021.   Information about lot/batch number cannot be obtained. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Pain in extremity
Clinical narrative: Could not smell; a very sore arm; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 17Mar2021 at 14.00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history reported was asthma. Concomitant medication included sertraline (MANUFACTURER UNKNOWN) and DAYQUIL. Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021 at 16:00, the patient could not smell and had a very sore arm. The patient did not take any treatment for the reported events. The clinical outcome for the event loss of smell and very sore arm was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anion gap, Blood calcium, Blood chloride, Blood creatinine, Blood potassium
Clinical narrative: Metabolic Alkalosis; Lethargy; Sleep16-18 hours per day; This is a spontaneous report from a contactable nurse, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207), via unspecified route administration in left arm on 11Mar2021 at 14:30 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medical history included total thyroidectomy, idiopathic intracranial hypertension (IIH), depression, ehlers-danlos syndrome, post cardiac ablation, AV-nodal reentrant tachycardia (AVNRT) on unknown date. The patient previously allergies to sulfanamide. It was unknown if the patient had diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included NEURONTIN, ATENOLOL, LEVOTHYROXINE from unknown dates for unknown indication. The patient did not receive any other vaccines within two weeks prior to the vaccination. On 12Mar2021, the patient underwent lab tests  which included blood urea nitrogen (BUN) 17, sodium (Na) 142, potassium (K) 4.5, chloride Cl 101, carbon dioxide (CO2) 31, creatinine 1.28, anion gap 10, calcium 9, glomerular filtration rate (GFR) non-AA 50 and diagnosed with metabolic alkalosis. On same day, the patient developed lethargy and sleep 16-18 hours per day. The patient did not receive any treatment for events. The clinical outcome of metabolic alkalosis, lethargy and hypersomnia was not resolved.    No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium, Blood urea, Carbon dioxide, Glomerular filtration rate, Hypersomnia
Clinical narrative: Metabolic Alkalosis; Lethargy; Sleep16-18 hours per day; This is a spontaneous report from a contactable nurse, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207), via unspecified route administration in left arm on 11Mar2021 at 14:30 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medical history included total thyroidectomy, idiopathic intracranial hypertension (IIH), depression, ehlers-danlos syndrome, post cardiac ablation, AV-nodal reentrant tachycardia (AVNRT) on unknown date. The patient previously allergies to sulfanamide. It was unknown if the patient had diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included NEURONTIN, ATENOLOL, LEVOTHYROXINE from unknown dates for unknown indication. The patient did not receive any other vaccines within two weeks prior to the vaccination. On 12Mar2021, the patient underwent lab tests  which included blood urea nitrogen (BUN) 17, sodium (Na) 142, potassium (K) 4.5, chloride Cl 101, carbon dioxide (CO2) 31, creatinine 1.28, anion gap 10, calcium 9, glomerular filtration rate (GFR) non-AA 50 and diagnosed with metabolic alkalosis. On same day, the patient developed lethargy and sleep 16-18 hours per day. The patient did not receive any treatment for events. The clinical outcome of metabolic alkalosis, lethargy and hypersomnia was not resolved.    No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Metabolic alkalosis
Clinical narrative: Metabolic Alkalosis; Lethargy; Sleep16-18 hours per day; This is a spontaneous report from a contactable nurse, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207), via unspecified route administration in left arm on 11Mar2021 at 14:30 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medical history included total thyroidectomy, idiopathic intracranial hypertension (IIH), depression, ehlers-danlos syndrome, post cardiac ablation, AV-nodal reentrant tachycardia (AVNRT) on unknown date. The patient previously allergies to sulfanamide. It was unknown if the patient had diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included NEURONTIN, ATENOLOL, LEVOTHYROXINE from unknown dates for unknown indication. The patient did not receive any other vaccines within two weeks prior to the vaccination. On 12Mar2021, the patient underwent lab tests  which included blood urea nitrogen (BUN) 17, sodium (Na) 142, potassium (K) 4.5, chloride Cl 101, carbon dioxide (CO2) 31, creatinine 1.28, anion gap 10, calcium 9, glomerular filtration rate (GFR) non-AA 50 and diagnosed with metabolic alkalosis. On same day, the patient developed lethargy and sleep 16-18 hours per day. The patient did not receive any treatment for events. The clinical outcome of metabolic alkalosis, lethargy and hypersomnia was not resolved.    No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Myalgia, Vaccination site pain
Clinical narrative: moderate to severe muscle pain; moderate to severe joint pain; increase in weakness and fatigue; chills; vaccination site pain; vaccination site swelling; This is a spontaneous report from a contactable consumer, the patient.  A 67-year-old non-pregnant female patient received second dose of BNT162b2 (COVID-19 MRNA VACCINE BIONTECH; Lot number: unknown), via an unspecified route of administration in the right arm on 13Mar2021 at 15:00 (at the age of 67-year-old) as a single dose for COVID-19 immunisation.  Medical history included chronic disabling illness like Myalgic encephalomyelitis, Fibromyalgia, Lyme disease, CFS. The patient was allergic to versed. The patient received concomitant medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (COVID-19 MRNA VACCINE BIONTECH; Lot number: unknown) via an unspecified route of administration in the right arm on 23Feb2021 at 14:30 for COVID -19 immunisation. Since the vaccination, patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. After vaccination on 14Mar2021 at 06:00 patient experienced moderate to severe muscle and joint pain all over, increase in weakness/fatigue, some chills, pain at injection site, some swelling. The patient did not receive any treatment for the reported events. The clinical outcome of all events moderates to severe muscle and joint pain all over, increase in weakness/fatigue, some chills, pain at injection site, some swellings were Recovering.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: moderate to severe muscle pain; moderate to severe joint pain; increase in weakness and fatigue; chills; vaccination site pain; vaccination site swelling; This is a spontaneous report from a contactable consumer, the patient.  A 67-year-old non-pregnant female patient received second dose of BNT162b2 (COVID-19 MRNA VACCINE BIONTECH; Lot number: unknown), via an unspecified route of administration in the right arm on 13Mar2021 at 15:00 (at the age of 67-year-old) as a single dose for COVID-19 immunisation.  Medical history included chronic disabling illness like Myalgic encephalomyelitis, Fibromyalgia, Lyme disease, CFS. The patient was allergic to versed. The patient received concomitant medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (COVID-19 MRNA VACCINE BIONTECH; Lot number: unknown) via an unspecified route of administration in the right arm on 23Feb2021 at 14:30 for COVID -19 immunisation. Since the vaccination, patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. After vaccination on 14Mar2021 at 06:00 patient experienced moderate to severe muscle and joint pain all over, increase in weakness/fatigue, some chills, pain at injection site, some swelling. The patient did not receive any treatment for the reported events. The clinical outcome of all events moderates to severe muscle and joint pain all over, increase in weakness/fatigue, some chills, pain at injection site, some swellings were Recovering.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Drainage, Fatigue, Headache
Clinical narrative: Sore throat; Sinus pain; Body aches and pain; Stomach cramping; Diarrhoea; Extreme fatigue; Headache; Swollen lymph nodes in throat; Sinus drainage; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via unspecified route of administration in left arm on 17Mar2021 at 10:15 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. On 19Mar2021 at 07:00, the patient experienced sore throat, sinus pain, drainage, swollen lymph nodes in throat, headache, body aches and pain, stomach cramping, diarrhoea and extreme fatigue. It was reported that the patient did not receive any treatment for the reported events. The clinical outcome of sore throat, sinus pain, drainage, swollen lymph nodes in throat, headache, body aches and pain, stomach cramping, diarrhoea and extreme fatigue were not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pain, Sinus pain
Clinical narrative: Sore throat; Sinus pain; Body aches and pain; Stomach cramping; Diarrhoea; Extreme fatigue; Headache; Swollen lymph nodes in throat; Sinus drainage; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via unspecified route of administration in left arm on 17Mar2021 at 10:15 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. On 19Mar2021 at 07:00, the patient experienced sore throat, sinus pain, drainage, swollen lymph nodes in throat, headache, body aches and pain, stomach cramping, diarrhoea and extreme fatigue. It was reported that the patient did not receive any treatment for the reported events. The clinical outcome of sore throat, sinus pain, drainage, swollen lymph nodes in throat, headache, body aches and pain, stomach cramping, diarrhoea and extreme fatigue were not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: 3" raised red spot at injection spot; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199) via unspecified route of administration in the left arm on 11Mar2021 at 15:45(at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient had allergies to unspecified medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 20Mar2021 at 16:45, the patient had 3 degree raised red spot at injection spot (vaccination site erythema). The patient did not receive any treatment for the event. The clinical outcome of the event 3 degree raised red spot at injection spot was not recovered at the time of this report.   No follow-up attempts are possible; No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Vaccination site pain
Clinical narrative: Sore at site; flu like symptoms; Tired; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9810) via unspecified route of administration in the left arm on 26Feb2021 at 15:00 (at the age of 67-years-old), as a single dose for COVID-19 immunisation and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number is EN6207) via unspecified route of administration in the left arm on 19Mar2021 (at the age of 67-years-old), as a single dose for COVID-19 immunisation. Medical history included heart attack. Concomitant medications included statin (unspecified) and cholesterol medication (unspecified) taken from an unknown date for unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 26Feb2021 at 18:00, the patient experienced sore at site, flu like symptoms and was tired. All the symptoms had gone in three days after both vaccinations. The patient had not received any treatment for the adverse events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room/department or urgent care. The clinical outcome of sore at site, flu like symptoms and tiredness were recovered on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus mostly in  left ear; This is a spontaneous report received from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EL8982), via an unspecified route of administration in the right arm on 21Jan2021 at 10:45 (at the age of 69-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient was allergic to sulfa based drugs. Concomitant medication included Vitamin D (MANUFACTURER UNKNOWN) within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EL8982), via an unspecified route of administration in the right arm on 30Dec2020 at 14:45 (at the age of 69-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Jan2021, the patient experienced tinnitus mostly in the left ear. The event resulted in [Doctor or other healthcare professional office/clinic visit]. The patient's ears were cleaned and given hearing specialist appointment. The clinical outcome of the event tinnitus mostly in the left ear was not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: Hives/Rash; Facial swelling; This is a spontaneous report from non-contactable consumer, the patient. A 62-years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in the left arm on 28Feb2021, as a single dose for COVID-19 immunisation. Medical history included osteoarthritis, fibrocystic breast, tonsils surgery, caesarean, myomectomy, sensitivity to dairy/some fruit, feathers/wool/pets and seasonal allergy. Concomitant medications included ALLERCLEAR; glucosamine (MANUFACTURER UNKNOWN); EMERGEN C IMMUNE PLUS; guaifenesin (MUCINEX) all from an unknown date for unknown indication. 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 03Mar2021, the patient experienced hives/rash and facial swelling. The patient was treated with methylprednisolone for all the events. The clinical outcome of hives/rash and facial swelling was resolving. No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Myalgia
Clinical narrative: Muscle pain - all muscle areas; Chills; Fever; Loss of appetite; Nausea; Pain in the arm; Pain all over body; Tiredness; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in left arm on 13Mar2021 at 09:00 (at the age of 49- year-old) as a single dose for COVID-19 immunisation. Medical history included dysfibrinogenemia. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in left arm on 19Feb2021 at 14:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within two weeks prior to the vaccination. On 13Mar2021 at 13:00, the patient had pain in arm, pain all over body, tiredness, headaches, muscle pain- all muscle areas, chills, fever, loss of appetite and nausea. Therapeutic measures were taken as a result of events pain in arm, pain all over body, tiredness, headaches, muscle pain- all muscle areas, chills, fever, loss of appetite and nausea and included treatment with tylenol on day 2 after the second dose. The clinical outcome of events pain in arm, pain all over body, tiredness, headaches, muscle pain- all muscle areas, chills, fever, loss of appetite and nausea was recovered on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Muscle pain - all muscle areas; Chills; Fever; Loss of appetite; Nausea; Pain in the arm; Pain all over body; Tiredness; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in left arm on 13Mar2021 at 09:00 (at the age of 49- year-old) as a single dose for COVID-19 immunisation. Medical history included dysfibrinogenemia. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in left arm on 19Feb2021 at 14:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within two weeks prior to the vaccination. On 13Mar2021 at 13:00, the patient had pain in arm, pain all over body, tiredness, headaches, muscle pain- all muscle areas, chills, fever, loss of appetite and nausea. Therapeutic measures were taken as a result of events pain in arm, pain all over body, tiredness, headaches, muscle pain- all muscle areas, chills, fever, loss of appetite and nausea and included treatment with tylenol on day 2 after the second dose. The clinical outcome of events pain in arm, pain all over body, tiredness, headaches, muscle pain- all muscle areas, chills, fever, loss of appetite and nausea was recovered on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Tinnitus
Clinical narrative: (Tinnitus) terrible Ear ringing in both ears; Cannot sleep.; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6205) via an unspecified route of administration on the left arm on 10Mar2021 at 13:00 (at the age of 61-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to medications, food, or other products. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine.  Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient was tested for COVID-19, since having the vaccine. On 10Mar2021 at 20:00, the patient had experienced terrible ear ringing in both ears(tinnitus) and was not able to sleep. The patient did not receive treatment for the reported events. The clinical outcome of events tinnitus and sleeplessness were not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Rash
Clinical narrative: with a severe rash; A lot of pain in all his joints; This is a spontaneous report received from a contactable consumer (patient himself) via Pfizer sponsored program. A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient reported being off Xeljanz for about 1.5 months. He was instructed by MD to stop Xeljanz while he received his covid vaccine. After he got the vaccine, he developed an adverse reaction with a severe rash. He was placed on prednisone for the rash which helped with his rheumatoid arthritis symptoms. While he was off of his Xeljanz, he reported having a lot of pain in all his joints. He has been back on Xeljanz now for about a week and his rheumatoid arthritis symptoms are back to normal. His primary MD was aware of the allergic reaction. Informed patient to update his rheumatologist when he sees them next. No additional information provided. The outcome of the events was unknown.   Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Skin infection
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable female consumer (patient) reported for self that. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 11Mar2021 as 1ST DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that she asked about the medication that her dermatologist prescribed to her after finding a skin infection at the back of her ear. She stated that she was advised to take the medication named "Doxycycline" for 10 days. However, she is concerned about the effectiveness of the vaccine since she got the 1st dose last 11Mar2021 and she is aware that she will be in the 3 weeks window before the 2nd dose on 01Apr2021. Right now, she wants to know what she can do about this so she can talk to her dermatologist and doctor at the same time. Therapeutic measures were taken because of skin infection at the back of her ear. The outcome of event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dermatologic examination, Rash, Transient acantholytic dermatosis
Clinical narrative: Grover's disease; rash is on my back, on my chest and abdomen; Grover's disease; rash is on my back, on my chest and abdomen; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ELM9810), via an intramuscular route on 04Feb2021 at 13:30 (at the age of 77-years) as 2nd dose, single in the left arm for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications included Tamsulosin tolterodine for bladder control, Multiple vitamins & mineral supplements from unknown dates and unknown if ongoing and Betamethasone, hydrocortisone (CORTIZONE) for Grover's disease rash from 04Feb2021 to 15May2021. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3249), via an intramuscular route on 14Jan2021 at 13:30 (at the age of 77-years) as 1st dose, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Feb2021, the patient experienced Grover's disease; rash is on my back, on my chest and abdomen. Patient stated that he consulted dermatologist and he identified a rash and identified it as Grover's disease rash. He noticed it was developing in February. It was diagnosed on February 18th. He did not think it might result from the vaccine but he still nursing it, it had gotten better. He suggested, patient should call just to double check. Patient wants to knew whether or not, this rash might have resulted from the vaccine. The patient underwent lab tests and procedures which included Dermatology tests for annual physical was Minor skin lesions on 18Feb2021. Patient stated that he had a blood test. It was good, no problems. Blood test was on 09Mar2021, just a part of my general physical and everything was okay. Patient stated that It's getting better but it still hadn't gone away. He was treating it with Betamethasone and not Cortisone ointment. He finished with the betamethasone and now treating it with Cortisone. The patient visited to physician office. The outcome of the event was recovering.  Follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Skin infection
Clinical narrative: Was prescribed doxycycline for skin infection; This is a spontaneous report from a Pfizer sponsored . A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), dose 1 via an unspecified route of administration on 11Mar2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, she had 1st dose of covid vaccine on 11Mar. Yesterday went to see Dermatologist. Was prescribed doxycycline for skin infection. Was reading papers with medication, said you should get vaccine while taking this medication. HCP called in prescription of Cipro and papers say same thing, not to get vaccine while taking medication. Has not started taking medication yet but wants to know if she takes medication, will it impact covid vaccine. Not clarified if appointment with Dermatologist was before or after covid vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash macular, SARS-CoV-2 antibody test, Vaccination site pruritus
Clinical narrative: Sore arm where injectionwas given.; Itching in the injection sight; Itching in neck, cheststomach back and other partsof the body.; Red blotches in the core areas.; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in left arm on 13Mar2021 at 07:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included sinus issues with sinus surgery in 2004, glute or hamstring surgeries in Oct2020. It was reported that the patient was an extremely active slim person and the glute or hamstring surgeries were healed for the most part. In Nov2020, the patient had COVID-19. The patient was tested positive for COVID-19 antibodies in Dec2020. Patient used to get the reaction at times when she gets a virus or bacterial infection for a day. Concomitant medications included diclofenac sodium (MANUFACTURER UNKNOWN), SUDAFED and supplements on unknown dates and for unknown indications. Prior to the vaccination the patient had not tested positive for COVID-19 and since the vaccination, the patient had not been tested positive for COVID-19. It is unknown if patient has allergies to food, medications or other products. On 14Mar2021, one day after vaccination, at 15:00, the patient experienced sore arm where injection was given, itching occurred in many different places such as the injection sight, neck, chest stomach back and at times other parts of the body. The patient also experienced red blotches in the core areas. The patient did not receive any treatment for the events.The clinical outcome of sore arm where injection was given, itching at the injection sight, itching on neck, chest stomach back and at times other parts of the body and red blotches were not recovered.    No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: A very strong metallic taste in mouth; This is a spontaneous report received from a non-contactable consumer, the patient. A 50-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6205) via an unspecified route of administration in left arm on 17Mar2021 (at the age of 50-years-old) at 14:00 hours as a single dose for COVID-19 immunisation. Medical history was not reported. It was reported that the patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Concomitant medication was not reported. On 17Mar2021, at 14:00 hours, the patient experienced a very strong metallic taste in mouth (taste metallic). No treatment was given for adverse event. The clinical outcome of taste metallic was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Severe dizzy ness. It felt like if I was not deliberate in my steps I might fall. Balance was off. This lasted for 5 days off and on.; This is a spontaneous report received from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL92669), via an unspecified route of administration in the right arm on 09Mar2021 for COVID-19 immunisation. Medical history included rheumatoid arthritis, high blood pressure. Concomitant medications included metoprolol tartrate (MANUFACTURER UNKNOWN), triamterene (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN) and vitamin C (MANUFACTURER UNKNOWN) were reported. The patients past drug history included Amoxycillin. Prior to 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 4 weeks prior to the vaccine. The patient experienced severe dizziness on 09Mar2021. The therapeutic measures were taken for the dizziness, which included Meclizine. The adverse event resulted in emergency room visit. The clinical outcome of the severe dizziness was resolving.  No follow-up attempts are needed. No further information is expected.