chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: My entire body broke out in hives. The hives started on the skull and then went to the chest.; This is a spontaneous report from a contactable consumer. A 48-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205), dose 2 via an unspecified route of administration, in right arm on 13Mar2021 at 10:15 am (at 48-years age) as 2nd dose, single for covid-19 immunisation and patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9267), dose 1 via an unspecified route of administration, in right arm on 19Feb2021 at 02:30 PM as 1st dose, single for covid-19 immunisation. Medical history included type 1 diabetes mellitus, hypothyroidism and hypertension. The patient had allergies to oxycodone, biaxin and clindamycin. Concomitant medication was not reported. Patient did not receive any other vaccine in four weeks Prior to vaccination, patient became now not diagnosed with COVID-19. On 15Mar2021 at 10:30 am patient's entire body broke out in hives. The hives started on the skull and then went to the chest. Patient visited to doctor or other healthcare professional office/clinic visit for reported adverse event. Treatment was provided with Prednisone, Benadryl and Cetirizine. Since the vaccination, the patient was not tested for COVID-19. Outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Diarrhoea, Headache, Hypersomnia-bulimia syndrome
Clinical narrative: Hives covered both lower arms; Extreme malaise; headaches; chills; body aches; Vomiting; diarrhea; Klein-Levin Syndrome episode was triggered; Klein-Levin Syndrome episode was triggered; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6200) via an unspecified route of administration, administered in left arm on 24Feb2021 at 16:00 (at the age of 40-year-old) at a single dose for covid-19 immunisation in workplace clinic. Medical history included common variable immune deficiency, mannose binding lection deficiency, ongoing klein-levin syndrome, peptic ulcer, arthritis and was allergic to Keflex, Reglan and Prilosec. The patient did not receive any other vaccines within 4 weeks. Concomitant medications included pharmacy brand 50+ year old multivitamin (within two weeks). The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: PAA156051) via an unspecified route of administration, administered in right arm on 27Jan2021 at 15:00 at a single dose for Covid-19 immunization. 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 24Feb2021 at 22:00, the patient experienced hives covered both lower arms and on an unspecified date in Feb2021, the patient experienced extreme malaise, headaches, chills, and body aches began within 12 hours, vomiting and diarrhea occurred within 36 hours and persisted for approx 18 hours and A Klein- Levin Syndrome episode was triggered 72 hours later and persisted for 17 days. No treatment was received for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain, Urticaria, Vomiting
Clinical narrative: Hives covered both lower arms; Extreme malaise; headaches; chills; body aches; Vomiting; diarrhea; Klein-Levin Syndrome episode was triggered; Klein-Levin Syndrome episode was triggered; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6200) via an unspecified route of administration, administered in left arm on 24Feb2021 at 16:00 (at the age of 40-year-old) at a single dose for covid-19 immunisation in workplace clinic. Medical history included common variable immune deficiency, mannose binding lection deficiency, ongoing klein-levin syndrome, peptic ulcer, arthritis and was allergic to Keflex, Reglan and Prilosec. The patient did not receive any other vaccines within 4 weeks. Concomitant medications included pharmacy brand 50+ year old multivitamin (within two weeks). The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: PAA156051) via an unspecified route of administration, administered in right arm on 27Jan2021 at 15:00 at a single dose for Covid-19 immunization. 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 24Feb2021 at 22:00, the patient experienced hives covered both lower arms and on an unspecified date in Feb2021, the patient experienced extreme malaise, headaches, chills, and body aches began within 12 hours, vomiting and diarrhea occurred within 36 hours and persisted for approx 18 hours and A Klein- Levin Syndrome episode was triggered 72 hours later and persisted for 17 days. No treatment was received for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Swelling face, Vaccination site pain
Clinical narrative: face swollen; mild to moderate joint pain in knees and hip; Sore arm (injection site); This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: not known), via unspecified route of administration in right arm on 15Mar2021 at 13:00 (at the age of 57-years-old), as a single dose for COVID-19 Immunisation. The Medical history included hypothyroidism. Concomitant medication included synthroid 75 ug QD for unknown indication from unknown-to-unknown date, and COVID vaccine on 22Feb2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and the patient had not been tested for COVID-19 Since having the vaccine. The patient experienced mild to moderate joint pain in knees and hip, face swollen, Sore arm (injection site) on 16Mar2021 at 6:00. No treatment was taken for the events. The clinical outcome of the pain in joint, swelling face and vaccination site pain was unknown. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: body aches; chills; 12 hours after dose, headache; 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 mRNA VACCINE; lot number: EL3247) via an unspecified route and administration, in the left arm on 15Mar2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunization. The patient's medical history included Covid-19 in Jun2020 and lymphoma. The patient was not allergic to any other medication, food or other products. Past medication included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) first dose, single via an unspecified route and administration in the left arm on 22Feb20221 at 14:30. Concomitant medication included levothyroxine started on an unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021 at 02:00 AM, 12 hours after the second dose of vaccination, the patient experienced chills, headache and body aches. The patient was diagnosed as having covid- 19. No therapeutic measures were taken as a result of the events. The clinical outcome of chills, headache and body aches were recovering at the time of reporting. No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin, Injection site mass, Pruritus, Urticaria
Clinical narrative: I am getting hives; It is just itchy, a little bit itchy not much; Raised & hard bumps; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6206), dose 1 via an unspecified route of administration on 10Mar2021 as single dose for covid-19 immunisation. Medical history included rheumatoid arthritis. Concomitant medication(s) included Xeljanz XR (TOFACITINIB CITRATE), Nabumetone: 750 mg, Metformin XR (METFORMIN) 750 mg, Glipizide: 2.5mg, Losartan, Chlorthalidone: 25 mg, Omeprazole: 40 mg daily all for unspecified indication from unknown date. The patient underwent lab tests and procedures which included haemoglobin on 01Mar2021 with unknown results. It was reported that on 11Mar2021, patient experienced getting hives, it is just itchy, a little bit itchy not much on 11Mar2021. She also reported the following day she broke out in scattered hives described as itching, raised & hard bumps. Patient is asking if it's possible to experience the same symptoms on the second vaccine. Outcome of event getting hives was not recovered while others was unknown  No follow-up attempts are possible. information on lot/batch number cannot be requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Vaccination site pain
Clinical narrative: Soreness at injection, down the arm to hand; Soreness at injection, down the arm to hand; minor headache; chills; tired; This is a spontaneous report from a contactable reporter, patient. A 58-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3247) via unspecified route of administration in the right arm on 15Mar2021at 10:45 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3247) via unspecified route of administration in the left arm on 22Feb2021 at 10:45 (at the age of 58-years-old), as a single dose for Covid-19 immunisation. The patient Medical history was not reported. Concomitant medication included ibuprofen and claritin from for unknown indication an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not diagnosed with COVID-19 and the Patient has not tested positive for COVID-19, since having the vaccine. The facility where the most recent COVID-19 vaccine administered was at a Workplace clinic. The patient experienced soreness at injection, down the arm to hand, minor headache, some chills, tired and arm soreness on 15Mar2021 at 11:00. No treatment was receive for reported events. The clinical outcome of the vaccination site pain, tired, headache, pain in arm, chills was recovering. No follow-up attempts are needed. No further information is expected
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Dizziness, Ear pain, Eye swelling
Clinical narrative: Head congestion; Left ear pain; Arm soreness; Chills; Blurred vision; Dehydration; Malaise; Sinus pain in left side; Dizziness/lightheaded; Left side of face swelling; Lips and tip of tongue numb; Itchy around injection site; Swollen throat; Left eye discomfort/swelling; Tension pain in left side of neck; This is a spontaneous report from a contactable Consumer, a patient. A 28-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: EL9266), via an unspecified route of administration in the Left arm on 20Feb2021 at 10:00 (at the age of 28-years-old) as a single dose for COVID 19 immunisation. The patient's medical history included Asthma. The patients' concomitant medications were not reported. She 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 and not tested for COVID-19 since the vaccination. On 20Feb2021 the patient experienced arm soreness, blurred vision, chills, dehydration, dizziness/ lightheaded, head congestion, itchy around injection site, left ear pain, left eye discomfort/ swelling, left side of face swelling, lips and tip of tongue numb, malaise, sinus pain in left side, swollen throat, tension pain in left side of neck. The patient did not receive any treatment for the events. The clinical outcome for the events arm soreness, blurred vision, chills, dehydration, dizziness/ lightheaded, head congestion, itchy around injection site, left ear pain, left eye discomfort/ swelling, left side of face swelling, lips and tip of tongue numb, malaise, sinus pain in left side, swollen throat, tension pain in left side of neck was recovered. No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Hypoaesthesia oral, Injection site pruritus, Malaise, Myalgia
Clinical narrative: Head congestion; Left ear pain; Arm soreness; Chills; Blurred vision; Dehydration; Malaise; Sinus pain in left side; Dizziness/lightheaded; Left side of face swelling; Lips and tip of tongue numb; Itchy around injection site; Swollen throat; Left eye discomfort/swelling; Tension pain in left side of neck; This is a spontaneous report from a contactable Consumer, a patient. A 28-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: EL9266), via an unspecified route of administration in the Left arm on 20Feb2021 at 10:00 (at the age of 28-years-old) as a single dose for COVID 19 immunisation. The patient's medical history included Asthma. The patients' concomitant medications were not reported. She 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 and not tested for COVID-19 since the vaccination. On 20Feb2021 the patient experienced arm soreness, blurred vision, chills, dehydration, dizziness/ lightheaded, head congestion, itchy around injection site, left ear pain, left eye discomfort/ swelling, left side of face swelling, lips and tip of tongue numb, malaise, sinus pain in left side, swollen throat, tension pain in left side of neck. The patient did not receive any treatment for the events. The clinical outcome for the events arm soreness, blurred vision, chills, dehydration, dizziness/ lightheaded, head congestion, itchy around injection site, left ear pain, left eye discomfort/ swelling, left side of face swelling, lips and tip of tongue numb, malaise, sinus pain in left side, swollen throat, tension pain in left side of neck was recovered. No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pharyngeal swelling, Sinus pain, Swelling face, Vision blurred
Clinical narrative: Head congestion; Left ear pain; Arm soreness; Chills; Blurred vision; Dehydration; Malaise; Sinus pain in left side; Dizziness/lightheaded; Left side of face swelling; Lips and tip of tongue numb; Itchy around injection site; Swollen throat; Left eye discomfort/swelling; Tension pain in left side of neck; This is a spontaneous report from a contactable Consumer, a patient. A 28-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: EL9266), via an unspecified route of administration in the Left arm on 20Feb2021 at 10:00 (at the age of 28-years-old) as a single dose for COVID 19 immunisation. The patient's medical history included Asthma. The patients' concomitant medications were not reported. She 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 and not tested for COVID-19 since the vaccination. On 20Feb2021 the patient experienced arm soreness, blurred vision, chills, dehydration, dizziness/ lightheaded, head congestion, itchy around injection site, left ear pain, left eye discomfort/ swelling, left side of face swelling, lips and tip of tongue numb, malaise, sinus pain in left side, swollen throat, tension pain in left side of neck. The patient did not receive any treatment for the events. The clinical outcome for the events arm soreness, blurred vision, chills, dehydration, dizziness/ lightheaded, head congestion, itchy around injection site, left ear pain, left eye discomfort/ swelling, left side of face swelling, lips and tip of tongue numb, malaise, sinus pain in left side, swollen throat, tension pain in left side of neck was recovered. No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Rash small red spots on face 4 days after second shot.; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received BNT162B2(PFIZER BIONTECH mRNA COVID-19 mRNA VACCINE; Lot no. EN6206), 2nd dose single on the right arm via an unspecified route of administration on 09Mar2021 as single dose for COVID-19 vaccination. Medical history included Arthritis and Hypothyroidism. Concomitant medication included bupropion (MANUFACTURER UNKNOWN), Metoporaltrx (MANUFACTURE UNKNOWN) Levothyroxine (MANUFACTURER UNKNOWN), Estradiol (MANUFACTURER UNKNOWN). The patient was allergic to Penicillin, Demerol. It was unknown whether patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not enrolled in clinical trial. The patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. On 12Mar2021 at 10:00, the patient experienced rash small red spots on face 4 days after second shot. It is unknown whether the patient received any treatment for the event. The clinical outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: painful in the arm pit; This is a spontaneous report received from a contactable consumer, the patient. A 68-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via unspecified route of administration in left arm on 04Mar2021 at 01:30 PM as a single dose for COVID-19 immunization. Medical history included Stent in artery five and half years ago, minor kidney, heart condition (event clarification needed) at the time of reporting. Since the vaccination, the patient had not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient reported he was allergic to penicillin. Concomitant medications included amlodipine, aspirin 81mg, lovastatin, metoprolol (MANUFACTURE UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. Patient experienced very sore under right arm pit on 09Mar2021, right side of chest, right arm tricep area and right shoulder blade. Patient explained that when he tried to move right arm, it was painful in the arm pit and surrounding areas. This was continued till march 16 and the area described above is still sore. Patient explained he was Not sure if from the COVID shot but he never had an issue like this. The patient did not receive any treatment for the event. The clinical outcome of the event painful in the arm pit was reported as not recovered/not resolved at the time of report. No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Twitching below right eye on right cheek; This is a spontaneous report from a contactable consumer, the patient. A 51 years old non-pregnant female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Batch/lot Number: EN6200) via an unspecified route of administration on left arm as single dose on 02Mar2021 at 19:30 (at the age of 51-years-old) for COVID-19 immunization. The patient's medical history included chronic migraine, twitching on eye and Gastroesophageal reflux disease (GERD). The patient previously took penicillin, codeine and Diflucan, and developed allergy to all the three drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications include Famvir, Celebrex, Wellbutrin, atenolol, and Emgality. On 03Mar2021, the patient experienced twitching below right eye on right cheek, which would come and go. The patient felt like she was having a transcutaneous electrical nerve stimulation (TENS) unit on her face. The patient also felt it was very different to a twitch she would get on her eye. The patient did not receive any treatment for the event. The event twitching below right eye on right cheek was not resolved. No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Bone Aches; headache; Muscle Aches; chills; fatigue; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route of administration in the left arm, on 07Mar2021 14:30 (at 02:30 PM) (Lot number: EN6205), at the age of 52-years-old, as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took ondansetron (ZOFRAN) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19. On 10Mar2021 12:00 PM, the patient experienced muscle aches, bone aches, chills, headache, and fatigue. The patient did not received any treatment for the events. The clinical outcome of muscle aches, bone aches, chills, headache, fatigue were recovering.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up is being submitted to amend previously reported information: in corresponding data fields, patient age was added, stop date of BNT162B2 was populated as 07Mar2021 14:30, reporter details (first and last name and email address) were updated, past drug Zofran was coded appropriately and suspect vaccine BNT162B2 was recoded as a company product.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Asthma, Chills, Fatigue, Headache
Clinical narrative: no energy; Sore arm; spike of asthma; chills; tiredness; fever; body ache; headache; nausea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Lot /Batch Number: EN6205), Dose 2 via an unspecified route of administration on left arm on 04Mar2021 at 10:15 (at the age of 60 years) as a single dose for COVID-19 immunization. Medical history included heart attack, diabetes, obesity, asthma and Sulfa allergic. The patient's past medical history included BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot/Batch Number: EN6201) dose 1 on 13Feb2021 at 10:00 as a single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient took Nasal swab test for COVID-19 and was tested negative at 04Feb2021. Concomitant medications include Meloxicam ER (Manufacturer Unknown), Metformin (Manufacturer Unknown), Spironolac (Manufacturer Unknown), Pantoprazole (Manufacturer Unknown), Metoprolol tartrate (MANUFACTURER UNKNOWN), Atorvastatin (Manufacturer Unknown), Clopidogrel (Manufacturer Unknown), Losartan (Manufacturer Unknown), Montelukast (Manufacturer Unknown). The patient experienced no other adverse event except for sore arm until 11Mar2021. On 11Mar2021 around 03:30am it started with chills but moved on and would cycle through between chills, fevers up to 102.4, headaches, body aches, tiredness, spikes in asthma, nausea, and just an overall feeling of feeling bad and 6 days later the patient feels ok, just no energy. Patient not taken any treatment for reported events. Therapeutic outcome of reported events was recovering at the time of report. No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: no energy; Sore arm; spike of asthma; chills; tiredness; fever; body ache; headache; nausea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Lot /Batch Number: EN6205), Dose 2 via an unspecified route of administration on left arm on 04Mar2021 at 10:15 (at the age of 60 years) as a single dose for COVID-19 immunization. Medical history included heart attack, diabetes, obesity, asthma and Sulfa allergic. The patient's past medical history included BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot/Batch Number: EN6201) dose 1 on 13Feb2021 at 10:00 as a single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient took Nasal swab test for COVID-19 and was tested negative at 04Feb2021. Concomitant medications include Meloxicam ER (Manufacturer Unknown), Metformin (Manufacturer Unknown), Spironolac (Manufacturer Unknown), Pantoprazole (Manufacturer Unknown), Metoprolol tartrate (MANUFACTURER UNKNOWN), Atorvastatin (Manufacturer Unknown), Clopidogrel (Manufacturer Unknown), Losartan (Manufacturer Unknown), Montelukast (Manufacturer Unknown). The patient experienced no other adverse event except for sore arm until 11Mar2021. On 11Mar2021 around 03:30am it started with chills but moved on and would cycle through between chills, fevers up to 102.4, headaches, body aches, tiredness, spikes in asthma, nausea, and just an overall feeling of feeling bad and 6 days later the patient feels ok, just no energy. Patient not taken any treatment for reported events. Therapeutic outcome of reported events was recovering at the time of report. No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Hyperhidrosis
Clinical narrative: Sweating; Dizziness; Racing Heart beats; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EU6202; first dose via unspecified route of administration in the left arm on 13Mar2021 at 11:15 (at the age of 58-year-old at vaccination) as a single dose for COVID-19 immunisation. Medical history of the patient included Lactose intolerance, Osteo and Rheumatoid arthritis, HBP (High Blood Pressure) and Apnea. The patient was allergic to drugs Irbesartan and Naproxen. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Losartan 100 mg and Hydrochlorothiazide 25 mg from an unknown date, indication and ongoing treatment unknown. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 15Mar2021 at 20:45, the patient experienced racing heartbeat, dizziness and sweating. The patient received treatment as sit up, Aspirin 325 two tablets, dinner meal and fluids. The clinical outcome of the events racing heartbeat, dizziness and sweating was recovering. Since vaccination, the patient was not tested with COVID-19. No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Very nauseous and dizzy for 2 days; Very nauseous and dizzy for 2 days; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6199) via unspecified route of administration in the left arm on 05Mar2021 01:00 PM (age at the time of vaccination 39 year). as a single dose for COVID-19 immunisation. Medical history included Ehlers Danlos syndrome, compromised immune system. Patient allergies include Penicillin allergy. She has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination she was not diagnosed with COVID-19. Since the vaccination she has not been tested for COVID-19. Concomitant medications reported included Gabepentin, Vyvanse, Cymbalta, quintepine, rosarum all taken for unknown indication on unknown date. On 15Mar2021, the patient experienced very nauseous and dizzy for 2 days. Patient not received treatment for the reported events. The clinical outcome of the events Very nauseous and dizzy for 2 days was not recovered and is ongoing. No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain
Clinical narrative: right eye pain for the last 3 days / viralconjunctivitis symptoms; This is a spontaneous report received from a contactable healthcare professional (pharmacist). A 36-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en9581) via unspecified route of administration in left arm on 06Mar2021 (at the age of 36-years) as a single dose for COVID-19 Immunisation. Past medication included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en5318) via intramuscular route of administration in left arm as a single dose on 18Feb2021 for COVID 19 immunisation. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not have any medical history. The patient was allergic to codeine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other medications within 2 weeks of vaccination. On 13Mar2021, the patient experienced right eye pain which was one of viral conjunctivitis (not diagnosed) symptoms. The patient had right eye pain for the last 3 days. The adverse event resulted in doctor or other healthcare professional office/clinic. The patient did not receive any treatment for the event. At the time of this report, the patient was not recovered from the event right eye pain. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: had an immediate reactions of hives; This is a spontaneous report received from consumer reported for herself. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6200, Expiration date: not provided) dose 1 via an unspecified route of administration on an unknown date as 1 ST DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  It was reported that on unspecified date Immediately after the first dose, the patient had reactions of hives.  She was given an intramuscular injection of Benadryl and the hives resolved.  She stated that she had side effects that occur afterward that she was not concerned about and were normal, however she was concerned about the immediate hives.  She reported that it was an immediate non severe reaction.  She enquired if she could get the second dose. She was referred to HCP to determine if her reaction was a severe allergic reaction or not and if she should receive a second dose of the vaccine. The outcome of event was recovered.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Based on the temporal relationship, A possible contributory role of the suspect product to the development of Urticaria cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cognitive disorder, Fatigue, Pain in extremity, Pruritus
Clinical narrative: Hives forming on face near ears; itchy skin on arms and legs; Tired; weak mildly achy limbs; weak mildly achy limbs; cognitively slower; This is a spontaneous report from a contactable consumer, the patient. A 54-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in left arm on 11Mar2021 13:00 (at the age of 54-years-old) as a single dose for covid-19 immunization. Medical history included dry inflamed eyes and MGD of eyes (Meibomian gland dysfunction), thyroidectomy, thyroid cancer, pulmonary sarcoidosis, lymphedema and hypertension. The patient previously took ciprofloxacin and experienced drug hypersensitivity and food allergy (sulfa drugs, tree nuts, raw orchard fruits). Concomitant medication(s) included levothyroxine, liothyronine, losartan, clonazepam. The patient had no other vaccine within four weeks. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. On 11Mar2021 21:00, the patient had hives forming on face near ears, itchy skin on arms and legs, tired, weak mildly achy limbs, cognitively slower. The patient received treatment for the events. Outcome of the events was not recovered, at the time of this report. No follow-up attempts are Possible. Information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives forming on face near ears; itchy skin on arms and legs; Tired; weak mildly achy limbs; weak mildly achy limbs; cognitively slower; This is a spontaneous report from a contactable consumer, the patient. A 54-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in left arm on 11Mar2021 13:00 (at the age of 54-years-old) as a single dose for covid-19 immunization. Medical history included dry inflamed eyes and MGD of eyes (Meibomian gland dysfunction), thyroidectomy, thyroid cancer, pulmonary sarcoidosis, lymphedema and hypertension. The patient previously took ciprofloxacin and experienced drug hypersensitivity and food allergy (sulfa drugs, tree nuts, raw orchard fruits). Concomitant medication(s) included levothyroxine, liothyronine, losartan, clonazepam. The patient had no other vaccine within four weeks. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. On 11Mar2021 21:00, the patient had hives forming on face near ears, itchy skin on arms and legs, tired, weak mildly achy limbs, cognitively slower. The patient received treatment for the events. Outcome of the events was not recovered, at the time of this report. No follow-up attempts are Possible. Information about lot/batch number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash, SARS-CoV-2 test
Clinical narrative: Rash around the injection site was mostly red; Injection site slightly painful; Injection site was slightly itchy; Injection site raised bumps and did not spread; Rash around the injection site; This is a spontaneous report received from a contactable consumer, the patient. A 21-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 left arm on 01Mar2021 at 12:00 (at the age of 21 years), as 1st single dose for COVID-19 immunisation. The patient's medical history included exercise-induced asthma. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures, which included COVID-19 Virus test on 08Mar202, the result was negative and COVID-19 Virus test on 16Mar2021, the result was negative. On 03Mar2021 at 21:00, the patient experienced rash around the injection site which lasted about 3 days and was slightly itchy and slightly painful, and the rash was mostly red, raised bumps and did not spread. No therapeutic measures were taken as a result of adverse events. The clinical outcome of the events vaccination site rash, red rash, itchy rash and painful rash was recovered on unknown date. No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash around the injection site was mostly red; Injection site slightly painful; Injection site was slightly itchy; Injection site raised bumps and did not spread; Rash around the injection site; This is a spontaneous report received from a contactable consumer, the patient. A 21-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 left arm on 01Mar2021 at 12:00 (at the age of 21 years), as 1st single dose for COVID-19 immunisation. The patient's medical history included exercise-induced asthma. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures, which included COVID-19 Virus test on 08Mar202, the result was negative and COVID-19 Virus test on 16Mar2021, the result was negative. On 03Mar2021 at 21:00, the patient experienced rash around the injection site which lasted about 3 days and was slightly itchy and slightly painful, and the rash was mostly red, raised bumps and did not spread. No therapeutic measures were taken as a result of adverse events. The clinical outcome of the events vaccination site rash, red rash, itchy rash and painful rash was recovered on unknown date. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Insomnia; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: not provided) on left arm via an unspecified route of administration on 10Mar2021 at 14:30PM as a first dose single for COVID-19 immunization. The patient's medical history was 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. The patient did not receive any mediations within 2 weeks of vaccination. On 12Mar2021 the patient experienced Insomnia. The patient did not receive any other vaccines four weeks prior to the COVID vaccine. Since the vaccine, the patient did have not been tested positive for COVID-19. No therapeutic measures were taken for the events. The clinical outcome of insomnia was not recovered at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site pruritus
Clinical narrative: Colorless, itchy hives under the injection site, which I noticed 53 hours after injection.; Colorless, itchy hives under the injection site, which I noticed 53 hours after injection.; This is a spontaneous report from a contactable other hcp. A 32-years-old male patient received first dose of PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 12Mar2021 15:30 single dose for COVID-19 immunization. Medical history included Known allergies to Penicillin. Concomitant medications (other medications in two weeks) included escitalopram (ESCITALOPRAM) and trazodone (TRAZODONE) from an unspecified date and unknown if ongoing. The patient had no COVID prior vaccination not tested for COVID post vaccination.  On 14Mar2021 at 09:30 PM the patient experienced colorless, itchy hives under the injection site, which he noticed 53 hours after injection. No treatment received for the event. The outcome of event was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Pain
Clinical narrative: complete exhaustion; tailbone headache/migraine; body aches; This is a spontaneous report from a non-contactable consumer, the patient. An adult non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: Unknown) via an unspecified route of administration in the left arm on 14Mar2021 at 09:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported and concomitant medications taken within 2 weeks of vaccination were numerous (Unspecified). Patient was allergic to penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID 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 as well. The patient experienced complete exhaustion, body aches, tailbone headache/ migraine. The patient did not receive any treatment for adverse events. The clinical outcome of the events of complete exhaustion, body aches, tailbone headache/migraine was not recovered at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Hypoaesthesia oral, Viral test
Clinical narrative: this is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot/batch number: SDPHO EN6206), Dose: 1 via an unspecified route of administration in the left arm on 11Mar2021 at 11:00 AM (at the age of 34-years-old), as a single dose for COVID-19 Immunization. The patient was allergic to latex, curry, nickel and other alloys. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient was not receiving any concomitant medications. The patient did not receive any vaccine within 4 weeks prior to the COVID-19 vaccine. On 11Mar2021 at 21:00, the patient experienced new loss of taste and tongue numbness. The patient underwent lab test on 15Mar2021 which included polymerase chain reaction via a nasal swab and the test result was negative. The patient did not receive any treatment for the adverse events. The clinical outcome of new loss of taste and tongue numbness was recovering. No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Non stop diarrhea and vomiting; Non stop diarrhea and vomiting; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot/batch number: EN6198) via an unspecified route of administration, in left arm on 16Mar2021 at 12:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included liver auto immune disease. The patient previously took synthetic iodone  and experienced  allergic. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 and the patient had not been tested for COVID-19, Since the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient experienced non stop diarreah and vomiting on 17Mar2021 . The adverse event resulted in doctor or healthcare professional office/clinic visit and no treatments were taken for the events. The clinical outcome of the events diarrhoea and vomiting was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Left ear tinnitus; This is a spontaneous report from a contactable Consumer (Patient). A 39-Year-old Male patient received first dose of BNT162B2 (Pfizer BioNTech Covid 19 MRNA VACCINE BIONTECH) (Lot/batch no: EP7534) via an unspecified route, administered in to Left Arm on 2 16Mar2021, 12:30 PM as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant drugs were taken, but the medications prescribed were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 and didn't had a COVID-19 test since vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine and he is not Allergic to medications, food, or other products. The patient experienced Left ear tinnitus on 16Mar2021, 10:00 PM. No therapeutic measures were taken for the event. The clinical outcome of the Left ear tinnitus was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Skin exfoliation, Throat tightness
Clinical narrative: Extremely dry skin; Throat closing increasing; Flaking skin; This is a spontaneous report from a contactable pharmacist. A 66-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Not known) via an intramuscular route in the left arm on 25Feb2021 at 19:30 (at the age of 66-years-old) for COVID-19 immunisation. The patient's medical history included asthma. The patient had Hydromorphone allergic reaction to first Shingrex 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 Asthma inhalers (MANUFACTURER UNKNOWN) for unknown indications from unknown dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 07Mar2021, the patient had extremely dry flaking skin, throat closing increasing over 3-day period. The patient was treated with oral prednisone 20 mg twice in a day for asthma attack. The clinical outcome of the events, extremely dry flaking skin, throat closing was resolving. Information about lot/batch number cannot be obtained. No further information is expected.