chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Dysgeusia, Feeling cold, Myalgia
Clinical narrative: Fever of 104.5; felt extremely cold; Severe pain in joints and muscles; Severe pain in joints and muscles; Strong metallic taste in mouth; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 26Mar2021 at 18:00, dose number unknown, single for COVID-19 immunization. Medical history included obesity, asthma and penicillin allergy from an unknown date and unknown if ongoing. Concomitant medication included semaglutide (OZEMPIC) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took neomycin and experienced allergy. On 27Mar2021 at 08:00 the patient experienced fever of 104.5, felt extremely cold, no amount of covers kept the patient warm, severe pain in joints and muscles and strong metallic taste in mouth. The patient did not receive treatment for the events. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 104.5; felt extremely cold; Severe pain in joints and muscles; Severe pain in joints and muscles; Strong metallic taste in mouth; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 26Mar2021 at 18:00, dose number unknown, single for COVID-19 immunization. Medical history included obesity, asthma and penicillin allergy from an unknown date and unknown if ongoing. Concomitant medication included semaglutide (OZEMPIC) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took neomycin and experienced allergy. On 27Mar2021 at 08:00 the patient experienced fever of 104.5, felt extremely cold, no amount of covers kept the patient warm, severe pain in joints and muscles and strong metallic taste in mouth. The patient did not receive treatment for the events. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Oxygen saturation, Pharyngeal erythema, Respiratory rate
Clinical narrative: redness to throat and complaint of itchy throat; redness to throat and complaint of itchy throat; This is a spontaneous report from a contactable nurse. A 51-year-old female patient received first dose of BNT162B2 intramuscular at arm right on 29Mar2021 12:45 (age at 51 years old, Batch/Lot Number: ER8732) as single dose for COVID-19 immunisation. Medical history included Cardio myopathy, multiple sclerosis (MS) and anaphylaxis to multiple meds. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine or received any other medications within 2 weeks of vaccination. It was also unknown if the patient was diagnosed with COVID-19 prior to vaccination or the patient been tested for COVID-19 since the vaccination. The patient presented with redness to throat and complaint of itchy throat on 29Mar2021 12:45. The patient was speaking in full sentences. The patient blood pressure was 110/70, pulse rate was 94, respiratory rate was 20, oxygen saturation was sat 97 %. Diphenhydramine hydrochloride (BENADRYL) oral at 25 mg given as treatment for the event and the patient was transported to ED for further evaluation. The outcome of the events was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: redness to throat and complaint of itchy throat; redness to throat and complaint of itchy throat; This is a spontaneous report from a contactable nurse. A 51-year-old female patient received first dose of BNT162B2 intramuscular at arm right on 29Mar2021 12:45 (age at 51 years old, Batch/Lot Number: ER8732) as single dose for COVID-19 immunisation. Medical history included Cardio myopathy, multiple sclerosis (MS) and anaphylaxis to multiple meds. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine or received any other medications within 2 weeks of vaccination. It was also unknown if the patient was diagnosed with COVID-19 prior to vaccination or the patient been tested for COVID-19 since the vaccination. The patient presented with redness to throat and complaint of itchy throat on 29Mar2021 12:45. The patient was speaking in full sentences. The patient blood pressure was 110/70, pulse rate was 94, respiratory rate was 20, oxygen saturation was sat 97 %. Diphenhydramine hydrochloride (BENADRYL) oral at 25 mg given as treatment for the event and the patient was transported to ED for further evaluation. The outcome of the events was unknown.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Fatigue; Slight sore arm; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the left arm on 27Mar2021 at 09:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 28Mar2021 at 07:00, the patient experienced fatigue and slight sore arm. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the adverse events. The clinical outcome of the events fatigue and slight sore arm were resolving at the time of this report.    No follow-up attempts are needed; information about lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Mobility decreased, Muscular weakness
Clinical narrative: Diarrhea; Chills; Leg weakness from being immobile for so long and day 4 still weak in right leg; Leg weakness from being immobile for so long and day 4 still weak in right leg; Headache; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: ER8732), via an unspecified route of administration administered in left arm on unspecified date in Mar2021 at 13:15 as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included multiple sclerosis and penicillin allergy, both from unspecified date. Concomitant medications included ethinylestradiol/norethisterone (VYFEMLA), omeprazole, clonazepam, natalizumab (TYSABRI), and levocetirizine dihydrochloride (XYZAL); all from unspecified date for unspecified indication. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient reported at 6 hours, the patient had chills, at 7 hours in she had diarrhea that lasted for 72 hours until she got intravenous (IV) fluids, leg weakness from being immobile for so long and at Day 4 still weak in right leg with headache; all on unspecified date in Mar2021 at 20:00. The events resulted in emergency room visit. The event diarrhea was considered medically significant. Outcome of the events was recovering.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue or tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 64-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 26Mar2021 at 08:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021, the patient had experienced fatigue or tiredness. No therapeutic measures were taken as the result of adverse events. The clinical outcome of the event fatigue or tiredness was resolved on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on right arm; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ep6955), via an unspecified route of administration in left arm on 21Mar2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and penicillin allergy. concomitant medication was not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 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 24Mar2021 at 17:00, the patient experienced a rash on the right arm. The patient did not receive treatment for the reported event. The event did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care The clinical outcome of the event rash on right arm was resolved with lasting effects on an unspecified date in Mar2021 at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Myalgia, Vomiting
Clinical narrative: Bad back aches; Muscle sore; Throwing up; This is a spontaneous report from a contactable other healthcare professional, the patient. A 63-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8730) via an unspecified route of administration in the right arm on 28Mar2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, on an unspecified date. The patient did not receive any concomitant medications within 2 weeks of the vaccine. Prior to the COVID-19 vaccination, the patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was had not been tested for COVID-19. On 29Mar2021 at 02:00, the patient experienced bad back aches, muscles sore and throwing up. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatments were not taken for the reported events. The clinical outcome of the events bad back aches, muscles sore, throwing up 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: Hypoaesthesia, Vision blurred
Clinical narrative: Numbness at the level over the skin; Vision got a little blurry/shaky; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old-non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8734) via an unspecified route of administration in the arm left on 28Mar2021 at 14:30 as a single dose (at the age of 51-years-old) for COVID-19 immunisation. The medical history of the patient was reported as migraine. The patient had strong reactions to amoxicillin and allergies to wheat, blueberries and eggplant. The patient received concomitant medications included as Naratriptan (MANUFACTURER UNKNOWN) for an unknown indication, Nortriptyline (MANUFACTURER UNKNOWN) for an unknown indication, Naproxen (MANUFACTURER UNKNOWN) for an unknown indication and the patient received within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6206) via an unspecified route of administration in the arm left on 07Mar2021 at 14:30 as a single dose for COVID-19 immunisation. 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 tested for COVID-19. On 28Mar2021 at 15:00, after 30 minutes of vaccination the patient was experienced numbness at the level over the skin and vision got a little blurry/shaky. The patient reported as numbness was beginning in the center of face about 20-30 minutes after the injection. It was speeded across the body. The numbness and vision issues dissipated by the next morning. The patient did not received treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of numbness at the level over the skin and vision got a little blurry/shaky were recovering.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Paraesthesia
Clinical narrative: Feel very warm; Arms were tingling; Felt she was going to passout and dizziness; This is a spontaneous report from a non-contactable healthcare professional. A 35-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration on 22Mar2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included vasovagal response when getting vaccines or donating blood in the past. Concomitant medications were not reported. On 22Mar2021, (during 15-minutes) the patient experienced very warm and her arms were tingling. The patient felt she was going to pass out (laid on the floor in the observation area) and dizziness. She was wheel chaired to observation bay. The patient denied rash, hives, difficulty breathing, difficulty swallowing and facial swelling. The patient received treatment for the events which included water. Follow up response to treatment was good. The patient stated she felt normal prior to discharge. She was escorted out of the facility and denied any symptoms with ambulation. The patient was discharged and was stable to go home and was asked to follow up with Primary care provider (PCP). The clinical outcome of the events began to feel very warm, arms tingling and dizziness were recovered on 22Mar2021.    No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: blood sugars elevated; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH Covid 19 mRNA Vaccine, lot number: ER8732) via an unspecified route of administration in the right arm on 26Mar2021 at 0900 (at the age of 38-years-old) for COVID-19 immunisation. Medical history includes Type 1 diabetes. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 10:00 after getting the vaccine, the patient experienced blood sugars elevated for 2 days. The patient reported that he had noticed it at night when typically they are very stable. Further it was reported that they have since come down and are manageable again. The adverse event did not result in a visit to the doctors or other healthcare professional office/ clinic visit and emergency room/ department or urgent care. The patient did not receive any treatment for the event blood sugars elevated. The clinical outcome of the event blood sugars elevated was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: Painful lymph node in left armpit.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 27Mar2021 at 13:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not available (n/a). The patient did not had allergy to any medications, food, or other products. Concomitant medications included quetiapine (MANUFACTURER UNKNOWN), MAXI-HAIR PLUS, D3 (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN), and LINZESS all taken for an unknown indication, from unknown dates. The patient previously received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203), via an unspecified route of administration in the left arm on 06Mar2021 at 13:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. 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 had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 28Mar2021 at 11:00, the patient experienced painful lymph node in the left armpit. The patient did not receive any treatment for the adverse event. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event painful lymph node in the left armpit was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Body pains; Pain at the injection site; 99.9 degrees fever; Fatigue; This is a spontaneous report from a contactable consumer via Pfizer sales/company representative. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 28Mar2021 at 09:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to food, medications, or other products. Concomitant medication included levothyroxine 75 mcg (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. 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 four weeks prior to the COVID vaccine. On 29Mar2021 at 22:00, the patient experienced body pains, pain at injection site, 99.9 degrees fever and fatigue. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events body pains, pain at injection site, 99.9 degrees fever and fatigue. The clinical outcomes of the events general body pain, vaccination site pain, fever and fatigue were recovering at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Chills, Fatigue, Hyperhidrosis
Clinical narrative: Sore throat; Achy; bones hurt; Very weak; Itchy; sweats; Fatigued; Chills; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EPB955) via an unspecified route of administration in the left arm on 23Mar2021 at 09:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Other medications received by the patient within two weeks prior to vaccination included levothyroxine sodium (MANUFACTURER UNKNOWN) and ibuprofen (MOTRIN). The patient had not received any other vaccines within four weeks prior to the vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 24Mar2021 at 01:45, sixteen hours after vaccination, the patient experienced sore throat, achy, bones hurt, very weak, fatigued, itchy, chills and sweats. Therapeutic measures were not taken as a result of sore throat, ache, bone pain , weakness, itchy, sweaty, fatigue and chills. The adverse event had not resulted in doctor or other healthcare professional office/clinic visit/ emergency visit/ department or urgent care.  The clinical outcome of the events sore throat, ache, bone pain , weakness, itchy, sweaty, fatigue and chills was recovering 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: Oropharyngeal pain, Pain, Pruritus
Clinical narrative: Sore throat; Achy; bones hurt; Very weak; Itchy; sweats; Fatigued; Chills; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EPB955) via an unspecified route of administration in the left arm on 23Mar2021 at 09:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Other medications received by the patient within two weeks prior to vaccination included levothyroxine sodium (MANUFACTURER UNKNOWN) and ibuprofen (MOTRIN). The patient had not received any other vaccines within four weeks prior to the vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 24Mar2021 at 01:45, sixteen hours after vaccination, the patient experienced sore throat, achy, bones hurt, very weak, fatigued, itchy, chills and sweats. Therapeutic measures were not taken as a result of sore throat, ache, bone pain , weakness, itchy, sweaty, fatigue and chills. The adverse event had not resulted in doctor or other healthcare professional office/clinic visit/ emergency visit/ department or urgent care.  The clinical outcome of the events sore throat, ache, bone pain , weakness, itchy, sweaty, fatigue and chills was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Headache, Oropharyngeal pain
Clinical narrative: chills; Aches; headache on right side going down to ear; red sore in back of throat that looks like a burn; red sore in back of throat that looks like a burn; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: ER8733), via an unspecified route of administration in right arm on 27Mar2021 at 11:15 (at the age of 57-year-old), at single dose for COVID-19 immunisation. Medical history included known allergy with penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included magnesium sulfate (reported as magnesium sufinate), ergocalciferol (VIT D), calcium and atorvastatin. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Starting night of 27Mar2021 at 20:00, the patient experienced temp 90, chills, aches, headache on right side going down to ear, red sore in back of throat that looked like a burn, diarrhea. All, but temp stayed to 29Mar2021: Monday. 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. The patient underwent lab test which included temp on 27Mar2021: 90. The patient did not receive treatment for the reported events. The clinical outcome of the events was recovering. This report was reported as non-serious by reporter.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pharyngeal erythema
Clinical narrative: chills; Aches; headache on right side going down to ear; red sore in back of throat that looks like a burn; red sore in back of throat that looks like a burn; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: ER8733), via an unspecified route of administration in right arm on 27Mar2021 at 11:15 (at the age of 57-year-old), at single dose for COVID-19 immunisation. Medical history included known allergy with penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included magnesium sulfate (reported as magnesium sufinate), ergocalciferol (VIT D), calcium and atorvastatin. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Starting night of 27Mar2021 at 20:00, the patient experienced temp 90, chills, aches, headache on right side going down to ear, red sore in back of throat that looked like a burn, diarrhea. All, but temp stayed to 29Mar2021: Monday. 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. The patient underwent lab test which included temp on 27Mar2021: 90. The patient did not receive treatment for the reported events. The clinical outcome of the events was recovering. This report was reported as non-serious by reporter.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Feeling abnormal, Influenza like illness, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the left arm on 24Mar2021 at 16:30 (at the age of 43-years-old), as a single dose for COVID-19 immunization. Medical history included diabetes insipidus and high blood pressure. The patient was allergic to penicillin, tramadol, Avapro, Norvasc, and clindamycin. Concomitant medications included desmopressin acetate (DDAVP), atenolol (MANUFACTURER UNKNOWN), losartan potassium (MANUFACTURER UNKNOWN) and esomeprazole magnesium (NEXIUM). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in the left arm on 03Mar2021 at 17:00 (at the age of 43-years-old), as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks, prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021, the patient experienced flu like symptoms, uneasiness, lightheadedness and feeling spaced out. The patient found it hard to focus or concentrate and felt as if she was drugged. The patient worked as a legal assistant and was struggling with performing her duties. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event flu like symptoms, uneasy (unwell), light headed, spaced out feeling and poor concentration was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Intense Headache; Mild Nausea; Pain in Arm; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6204), via an unspecified route of administration in the left arm on 09Mar2021 at 10:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to guaifenesin (MANUFACTURER UNKNOWN) and BENEDRYL. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included lansoprazole (PREVACID 30 mg), cetirizine hydrochloride (ZYRTEC) 10 mg and fluticasone propionate (FOLNASE) spray received on unspecified dates for an unknown indication. On 09Mar2021 at 17:45, the patient experienced, mild nausea, pain in arm and intense headache while driving home from office. The headache on left side to left temple was painful, different type of pain which was consistent, pain emitted from the inside out and lasted for more than six hours. The patient did not receive any treatment for the events. The clinical outcome of the events intense headache was resolved on 09Mar2021, however mild nausea and pain in arm were resolved on unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Patient developed paresthesia of the left arm; Patient developed paresthesia of the left arm and left side of face.; This is a spontaneous report received from a contactable healthcare professional, the physician. A 28-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left deltoid on 26Mar2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included herniated disc of lumbosacral spine. It was unknown if the patient had any allergies to food, medications, or other products. It was unknown if the patient received any medication within two weeks prior to the COVID-19 vaccine. It was unknown if the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. On 28Mar2021, the patient experienced paraesthesia of the left arm and left side of face and neg (negative) weakness was reported. The adverse events resulted in a visit to the doctor's or other healthcare professional office/clinic visit. The clinical outcome of the events paraesthesia of the left arm, left side of face was not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Influenza like illness, Lymphadenopathy, Oropharyngeal pain, Pyrexia
Clinical narrative: mild flu like symptoms; Mild fever; sore throat; lymph nodes; ears feel clogged; This is a spontaneous report received from a contactable consumer, the patient. A 36-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 her left arm on 26Feb2021 at 09:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis, bipolar and post-traumatic stress disorder (PTSD). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included clonazepam (KLONOPIN), lamotrigine (LAMICTAL), quetiapine fumarate (SEROQUEL) and escitalopram oxalate (LEXAPRO) all for an unknown indication and from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 26Feb2021 at 09;00, the patient experienced mild flu like symptoms every day at the same time each day, felt after the second dose, but was not nearly as symptomatic, mild fever, sore throat, swollen lymph nodes and ears feet clogged. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcomes of the events flu like symptoms, mild fever, sore throat, lymph nodes and ears feel clogged was unknown at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain
Clinical narrative: mild/mod shooting pain in right breast/nipple area, it switched to left breast with the same sensation; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old, female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via unspecified route of administration in the right arm on 17Mar2021 at 10:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included major depression, obsessive compulsive disorder (OCD), anxiety, hypothyroidism/hashimotos and Polycystic ovary syndrome (PCOS). Concomitant medication included sertraline hydrochloride (ZOLOFT), liothyronine (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and methylphenidate hydrochloride (RITALIN) for an unknown indication and from an unknown date. The patient reported being intolerant to fructose. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 06:00, the patient experienced mild/moderate shooting pain in the right breast/nipple area, which was different from lymph node soreness and after one or two days she experienced same sensation in the left breast. The pain was reported to last for several minutes on and off but as she experienced it in both breast it was moderately painful and that she wanted to let someone know. Also, the pain was most concentrated by the nipple area both times. The patient reported that the pain was still occurring and that it lasted for a few seconds and she never had breast cancer/problems. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of event breast pain was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial flutter
Clinical narrative: Atrial flutter; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 17Mar2021 at 02:45 hours as dose 2, single (at the age of 67-years-old) for covid-19 immunisation. Medical history included hypertension and caffeine allergy (both from an unknown date and unknown if ongoing). Concomitant medication(s) and other medications the patient received within 2 weeks of vaccination included amlodipine; atorvastatin calcium (Lipitor); cetirizine hydrochloride (Zyrtec); lansoprazole (Prevacid); famotidine (Pepcid). Historical vaccine included BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 17Feb2021 at 01:45 hours as dose 1, single (at the age of 67-years-old) for covid-19 immunisation. Patient was not diagnosed with COVID-19, prior to vaccination. Patient had not been tested for COVID-19, since the vaccination. On 18Mar2021, at 08:00 hours, patient had atrial flutter. Patient had a doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit. Patient received Cardizem, Xarelto and further heart testing for the event, as treatment. The outcome of the event was recovering.  Information about lot/batch number has been requested.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Night sweats, Pyrexia
Clinical narrative: Fever; Chills; Night sweats; This is a spontaneous report from a contactable other healthcare professional, the patient. A 27-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 15Mar2021 at 13:30 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. 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 13:30 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. 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. The patient had no known allergies to medications, food or other products. On 16Mar2021 at 00:00 the patient experienced fevers, chills and night sweats for two days. 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 fever, chills and night sweats was recovered on 18Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: minor arm pain; 7 days after the vaccine, I developed a red welt about 3inches in diameter.  w; It was raised off of the skin, was a defined red circle,; caused my upper arm to swell,; as hot to the touch,; was itchy.; This is a spontaneous report from a contactable consumer, the patient. A 23-years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in left arm on 20Mar2021 at 16:30 (at the age of 23-years-old) as single for COVID-19 immunisation. Medical history included asthma, environmental allergy to trees, molds, animals and attention deficit hyperactivity disorder. Concomitant medications included vyvanse (MANUFACTURER UNKNOWN), loratadine (MANUFACTURER UNKNOWN), breo ellipta (MANUFACTURER UNKNOWN) and birth control pill. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient experienced pain in arm after two days of vaccination and on 27Mar2021 at 12:00, red welt for about 3 inches in diameter after 7 days of vaccination, which was raised off from the skin around a defined red circle which caused the upper arm to swell, was hot to touch and itchy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The adverse events resulted in doctor or other health care professional or clinic visit. The patient did not receive any treatments for the adverse events. The clinical outcome of welts, skin red, swelling arm, hot dry skin, itchy were recovering at the time of the report. The clinical outcome of the pain in arm was recovered at the time of this report.   No follow-up attempts needed. No further information expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: minor arm pain; 7 days after the vaccine, I developed a red welt about 3inches in diameter.  w; It was raised off of the skin, was a defined red circle,; caused my upper arm to swell,; as hot to the touch,; was itchy.; This is a spontaneous report from a contactable consumer, the patient. A 23-years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in left arm on 20Mar2021 at 16:30 (at the age of 23-years-old) as single for COVID-19 immunisation. Medical history included asthma, environmental allergy to trees, molds, animals and attention deficit hyperactivity disorder. Concomitant medications included vyvanse (MANUFACTURER UNKNOWN), loratadine (MANUFACTURER UNKNOWN), breo ellipta (MANUFACTURER UNKNOWN) and birth control pill. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient experienced pain in arm after two days of vaccination and on 27Mar2021 at 12:00, red welt for about 3 inches in diameter after 7 days of vaccination, which was raised off from the skin around a defined red circle which caused the upper arm to swell, was hot to touch and itchy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The adverse events resulted in doctor or other health care professional or clinic visit. The patient did not receive any treatments for the adverse events. The clinical outcome of welts, skin red, swelling arm, hot dry skin, itchy were recovering at the time of the report. The clinical outcome of the pain in arm was recovered at the time of this report.   No follow-up attempts needed. No further information expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph node in the underarm area of the injection arm.; painfull lymph nodes in the underarm area of the injection arm.; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via unspecified route of administration in the right arm on 27Mar2021 at 16:15 as a single dose for COVID-19 immunisation. Medical history included lupus, blood clotting disorder, rheumatoid arthritis (RA). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via unspecified route of administration in the right arm on 03Mar2021 at 16:30 as a single dose for COVID-19 immunisation. The patient previously received adalimumab (HUMIRA) on unknown date and for unspecified indication and the patient experienced drug allergy. Concomitant medication included etanercept (ENBREL) for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 08:00, the patient experienced swollen and painful lymph node in the underarm area of the injection arm. 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 ant treatment for events. The clinical outcome of the events swollen and painful lymph node was not resolved at this time of report. No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm injection site; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN 6206) via an unspecified route of administration in the left arm on 08March2021 at 14:30 (at the age of 39-years-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER 8732) via an unspecified route of administration in the left arm on 29March2021 at 15:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 unspecified date, in Mar2021 the patient experienced sore arm at injection site (vaccination site pain). The clinical outcome of event vaccination site pain was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; unknown), via an unspecified route of administration in the right arm on 27Mar2021 at 15:15 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. Medical history included back pain, back hip pain and knees pain. The patient received unspecified medications within two weeks of vaccination. The patient previously received NAPROSYN and DILAUDID, both for an unspecified indications and experienced drug allergy. 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 COVID vaccine. On 28Mar2021 at 01:00, the patient felt really tired, run down with fever, muscle aches and headaches which was coming and going and had an overall feeling that somethings not right. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event tiredness, fever, muscle aches and headaches were unknown at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.