chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Brain natriuretic peptide increased, Cardiac failure, Cerebral artery occlusion, Computerised tomogram head abnormal, Dysarthria
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA: patient with generalized weakness since immunization. Two days after vaccination became dysarthric. Three days after vaccination became minimally responsive and brought to emergency department (ED) by ambulance. On arrival patient had right lower extremity weakness, right upper extremity mild drift, and severe dysarthria. Patient underwent thrombectomy and did not have residual neurologic deficits. Initiated on antiplatelet agent, anticoagulation, and cholesterol-lowering agent. Patient also experienced NSTEMI and newly diagnosed with heart failure and initiated medications for management. Patient discharged medically stable. Three days later patient admitted for atrial fibrillation with rapid ventricular response and worsening ischemia: initiated antiarrhythmic medications and patient improved and discharged medically stable.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Full blood count normal, Hypoperfusion, Ischaemia, Magnetic resonance imaging head abnormal
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA: patient with generalized weakness since immunization. Two days after vaccination became dysarthric. Three days after vaccination became minimally responsive and brought to emergency department (ED) by ambulance. On arrival patient had right lower extremity weakness, right upper extremity mild drift, and severe dysarthria. Patient underwent thrombectomy and did not have residual neurologic deficits. Initiated on antiplatelet agent, anticoagulation, and cholesterol-lowering agent. Patient also experienced NSTEMI and newly diagnosed with heart failure and initiated medications for management. Patient discharged medically stable. Three days later patient admitted for atrial fibrillation with rapid ventricular response and worsening ischemia: initiated antiarrhythmic medications and patient improved and discharged medically stable.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, SARS-CoV-2 test negative, Sinus tachycardia, Subdural haematoma, Thrombectomy
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA: patient with generalized weakness since immunization. Two days after vaccination became dysarthric. Three days after vaccination became minimally responsive and brought to emergency department (ED) by ambulance. On arrival patient had right lower extremity weakness, right upper extremity mild drift, and severe dysarthria. Patient underwent thrombectomy and did not have residual neurologic deficits. Initiated on antiplatelet agent, anticoagulation, and cholesterol-lowering agent. Patient also experienced NSTEMI and newly diagnosed with heart failure and initiated medications for management. Patient discharged medically stable. Three days later patient admitted for atrial fibrillation with rapid ventricular response and worsening ischemia: initiated antiarrhythmic medications and patient improved and discharged medically stable.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid mass, Troponin increased, Upper motor neurone lesion
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA: patient with generalized weakness since immunization. Two days after vaccination became dysarthric. Three days after vaccination became minimally responsive and brought to emergency department (ED) by ambulance. On arrival patient had right lower extremity weakness, right upper extremity mild drift, and severe dysarthria. Patient underwent thrombectomy and did not have residual neurologic deficits. Initiated on antiplatelet agent, anticoagulation, and cholesterol-lowering agent. Patient also experienced NSTEMI and newly diagnosed with heart failure and initiated medications for management. Patient discharged medically stable. Three days later patient admitted for atrial fibrillation with rapid ventricular response and worsening ischemia: initiated antiarrhythmic medications and patient improved and discharged medically stable.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Nausea
Clinical narrative: Nausea; Lightheadedness; Patient felt SOB after vaccine.  No significant medical history, seen by EMS with no intervention needed.  Released to self care.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Echocardiogram abnormal, Transient ischaemic attack
Clinical narrative: Two weeks after receiving my vaccine, I had a mini stroke while driving. I was able to get to my destination safely thank goodness. A friend took me immediately to the Er where I was admitted for 4 days. I experienced another stroke somewhat similar as the first but less intense  2 days after the first one.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Condition aggravated, Throat tightness, Wheezing
Clinical narrative: Chest pain, wheezing, throat closing sensation, autoimmune flare up that lasted three weeks until the next shot.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Dyspnoea, Pleural effusion
Clinical narrative: About 2 weeks after receiving the vaccine, the patient started developing progressive shortness of breath. He obtained a CT chest which showed bilateral pleural effusions and congestive heart failure. Patient was evaluated in emergency room at hospital and treated with IV lasix for acute on chronic heart failure. However, his symptoms were progressing. Currently, he is hospitalized with suspicion of myocarditis / cardiomyopathy.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Mild seizure type activity.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis type symptoms at injection site.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Mobility decreased, Pain in extremity
Clinical narrative: Received the first and second doses at Pharmacy.  Second vaccine shot was on Friday, May 14, 2021, in the left arm.  On Saturday, May 15, 2021, I wasn't feeling well.  Then later in the evening I developed a bulge under the left arm.  The lympth node increased in size; my left arm would ache, especially if I would stretch to reach for something.  I have been applying cold packs.  This situation has now continued for two weeks.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Erythema
Clinical narrative: Red skin bumps with blisters on shins and tops of feet.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Nausea; Dizziness. EMS at bedside.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Menstruation irregular
Clinical narrative: Irregular periods. I had a normal period Feb 10 (after 1st dose) which was 30 days after previous period which was normal cycle for me since recovering from covid but did not have normal cycle again until April 25, and cycles now seem to be 35 days long. Blood work and monitoring done by OBGYN, has not yet resolved.  Also experience hair loss similar to experience after having covid but less intense. Still experiencing.
Age: 48.0
Sex: F
Vaccine: DTAPIPVHIB, MMR
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Swollen red sight of injection hot to touch , headaches , bumps on body
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Movement disorder, Skin discolouration
Clinical narrative: Patient reports week-long, not yet resolved, numbness in fingers, pain in elbow of injected arm.  Also ?hard to bend? and injected arm ?darker than other arm?
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheadedness; EMS at side.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Very achy "vaccine" arm one week after second shot. Painful enough to wake me up in the middle of the night
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; EMS at side.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Lymphadenopathy, Pain in extremity
Clinical narrative: After receiving my first dose of the Pfizer vaccine I got arm pain, headache, armpit pain and fatigue. Eight days later I developed 2 small lymph nodes; one behind my left ear and one on the back of my head.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Reaction to preservatives
Clinical narrative: Heart rate got up to 214 five hours after the vaccine. Called 911 and they came to get me. When I got there, they had me rear down and my heart rate decreased and they took me to the hospital. The hospital ran test and everything was normal. They discharged me after the IV fluid bag was done.   I followed up with my cardiologist 2 weeks later and had a stress test and ekg. All tests were normal.   The doctor thinks it was an adverse reactions to the vaccine.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Ear pain, Tinnitus
Clinical narrative: Within 15 minutes, ringing in left ear, inner ear canal pain, loss of hearing left ear.  Ringing ended in 3-4 hours, ear pain and loss of hearing lasted around 2 days.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Nausea
Clinical narrative: Nausea; Anxiety; EMS with the patient.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Lightheadedness; Collapsing or losing consciousness.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, Chest X-ray normal, Chest discomfort, Chest pain, Echocardiogram normal
Clinical narrative: Diagnosis: acute pericarditis and acute myocarditis.   Patient received Moderna  Covid19 vaccine 1st dose 4/21/2021  LOT 037A21B to left arm. Stated he had sore arm. Patient received Moderna Covid19 vaccine 2nd dose on Tuesday, 5/25/2021 LOT 044B21A to right arm. Tuesday afternoon he developed a fever but did not take his temperature. On Thursday morning (May 27) he was at rest and stated that's when he first felt chest pressure. Chest pain got worse since yesterday, prompting  a visit to urgent care then urgent care sent patient to ED. Denies shortness of breath, dizziness, cough, or other associated symptoms. complains of anterior chest pain, does not radiate.  non smoker.   trop 3.79, CRP 35.4; sed rate 17, EKG . ED physician consulted with cardiologist. Patient given ibuprofen  600 mg PO x1 in ED and discharged on ibuprofen and will be following up with cardiologist. discharge dx by ED doc: acute pericarditis and acute myocarditis
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Injection site pain, Myocarditis, Non-tobacco user, Pericarditis
Clinical narrative: Diagnosis: acute pericarditis and acute myocarditis.   Patient received Moderna  Covid19 vaccine 1st dose 4/21/2021  LOT 037A21B to left arm. Stated he had sore arm. Patient received Moderna Covid19 vaccine 2nd dose on Tuesday, 5/25/2021 LOT 044B21A to right arm. Tuesday afternoon he developed a fever but did not take his temperature. On Thursday morning (May 27) he was at rest and stated that's when he first felt chest pressure. Chest pain got worse since yesterday, prompting  a visit to urgent care then urgent care sent patient to ED. Denies shortness of breath, dizziness, cough, or other associated symptoms. complains of anterior chest pain, does not radiate.  non smoker.   trop 3.79, CRP 35.4; sed rate 17, EKG . ED physician consulted with cardiologist. Patient given ibuprofen  600 mg PO x1 in ED and discharged on ibuprofen and will be following up with cardiologist. discharge dx by ED doc: acute pericarditis and acute myocarditis
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Troponin
Clinical narrative: Diagnosis: acute pericarditis and acute myocarditis.   Patient received Moderna  Covid19 vaccine 1st dose 4/21/2021  LOT 037A21B to left arm. Stated he had sore arm. Patient received Moderna Covid19 vaccine 2nd dose on Tuesday, 5/25/2021 LOT 044B21A to right arm. Tuesday afternoon he developed a fever but did not take his temperature. On Thursday morning (May 27) he was at rest and stated that's when he first felt chest pressure. Chest pain got worse since yesterday, prompting  a visit to urgent care then urgent care sent patient to ED. Denies shortness of breath, dizziness, cough, or other associated symptoms. complains of anterior chest pain, does not radiate.  non smoker.   trop 3.79, CRP 35.4; sed rate 17, EKG . ED physician consulted with cardiologist. Patient given ibuprofen  600 mg PO x1 in ED and discharged on ibuprofen and will be following up with cardiologist. discharge dx by ED doc: acute pericarditis and acute myocarditis
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: Fever, sweats chills, arm soreness, aches, dizzy treated with acetaminophen
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, sweats chills, arm soreness, aches, dizzy treated with acetaminophen
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RVX
Symptoms: Pyrexia
Clinical narrative: Had Fever for 2 days, no other  symptoms.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Thigh redness & swelling to double the size with Kinrix site.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: 10 mn post vaccination pt complains of heaviness to the (L) arm. Was assessed by EMS. Vital stable 118/56 - 120/80 P88 O2 sat 100%. Was picked at 1225PM and transported to Hosp.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Acne, Allergy alert test negative, Arthralgia, Chills, Injection site pain
Clinical narrative: On 4/29/21 client had a very sore arm@ injection site an sore joints. These resolved by the next day. On 5/8/21 client developed chills, no wheezing, no difficulty breathing, swelling @injection site, wrist, and thumb on left side. She developed a rash of small to larger bump (1mm-8mm), red and itchy with white fluid (like head of a pimple) inside. Many were joint areas like elbow and knee. This rash spread to her entire body, showing up in patches. She saw an allergist and testing showed no allergies to vaccine ingredients. The rask has continued to come and go since it began on 5/8/21
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site swelling, Rash, Rash erythematous, Rash pruritic
Clinical narrative: On 4/29/21 client had a very sore arm@ injection site an sore joints. These resolved by the next day. On 5/8/21 client developed chills, no wheezing, no difficulty breathing, swelling @injection site, wrist, and thumb on left side. She developed a rash of small to larger bump (1mm-8mm), red and itchy with white fluid (like head of a pimple) inside. Many were joint areas like elbow and knee. This rash spread to her entire body, showing up in patches. She saw an allergist and testing showed no allergies to vaccine ingredients. The rask has continued to come and go since it began on 5/8/21
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain, Pain in extremity
Clinical narrative: Patient recieved Moderna dose #2 at 1034. Left location and returned to vaccination site at 1540 with ccomplaints of "nerve pain shooting down my arm to my fingertips". States that she felt a "zing" down her arm when injected with vaccine. Patient stating she has pain when moving arm, hand and fingers along with when rotating hand into supine position. Patient appears to be bracing/guarding her right arm when moving .Vaccination site at right deltoid within normal limits, no swelling, no redness, no bruising noted. Patient has been taking Ibuprofen and using cold compresses at site before coming in to site. Recommended to the patient that she needs to be assessed and seen at the urgent care or the ER for follow up.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Erythema, Fatigue, Headache
Clinical narrative: Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 post-injection.; Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 post-injection.; Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 post-injection.; Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 post-injection.; This is a spontaneous report from a contactable consumer(patient). This 60-year-old (non pregnant) female Patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: unknown), via an unspecified route of administration in the left arm, on 26Jan2021 at 08:00 (at the age of 60-year-old), as single dose, for COVID-19 immunization, in the hospital. Medical history included Penicillin allergy from an unknown date and unknown if ongoing. Patient had no other known illnesses. The first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number EK5730, Expiration date was not reported), received via an unspecified route of administration, administered in left arm on 05Jan2021 at 13:00 for COVID-19 immunization. Concomitant medication was not reported. Prior the vaccination, was not diagnosis with COVID-19.post vaccination, no COVID test was performed. On 29Jan2021 at 6:00, patient experienced Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 postinjection. No treatment was received for the events. The outcome of the events was reported as not recovered.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site reaction, Malaise, Pain, Pyrexia, Rash
Clinical narrative: Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 post-injection.; Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 post-injection.; Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 post-injection.; Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 post-injection.; This is a spontaneous report from a contactable consumer(patient). This 60-year-old (non pregnant) female Patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: unknown), via an unspecified route of administration in the left arm, on 26Jan2021 at 08:00 (at the age of 60-year-old), as single dose, for COVID-19 immunization, in the hospital. Medical history included Penicillin allergy from an unknown date and unknown if ongoing. Patient had no other known illnesses. The first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number EK5730, Expiration date was not reported), received via an unspecified route of administration, administered in left arm on 05Jan2021 at 13:00 for COVID-19 immunization. Concomitant medication was not reported. Prior the vaccination, was not diagnosis with COVID-19.post vaccination, no COVID test was performed. On 29Jan2021 at 6:00, patient experienced Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 postinjection. No treatment was received for the events. The outcome of the events was reported as not recovered.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site papule, Vaccination site rash
Clinical narrative: Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 post-injection.; Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 post-injection.; Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 post-injection.; Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 post-injection.; This is a spontaneous report from a contactable consumer(patient). This 60-year-old (non pregnant) female Patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: unknown), via an unspecified route of administration in the left arm, on 26Jan2021 at 08:00 (at the age of 60-year-old), as single dose, for COVID-19 immunization, in the hospital. Medical history included Penicillin allergy from an unknown date and unknown if ongoing. Patient had no other known illnesses. The first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number EK5730, Expiration date was not reported), received via an unspecified route of administration, administered in left arm on 05Jan2021 at 13:00 for COVID-19 immunization. Concomitant medication was not reported. Prior the vaccination, was not diagnosis with COVID-19.post vaccination, no COVID test was performed. On 29Jan2021 at 6:00, patient experienced Raised, slightly painful, red rash about 3 cm inferior to the injection site on the left arm. The rash is triangular in shape and measures approximately 4.5 x 7 cm, present on day #3 postinjection. No treatment was received for the events. The outcome of the events was reported as not recovered.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Metatarsalgia, Neuroma, Pain in extremity, Peripheral swelling
Clinical narrative: my feet had been a bit sore from working so much lately; on the second day after the vaccine swelling in both feet began and worsened throughout the week; This is a spontaneous report from a contactable consumer (himself). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Formulation: Solution for injection,Batch/Lot number: not reported), via an unspecified route of administration, administered in Arm Left on 23Jan2021 15:15 (age at vaccination 68-year-old) as 1st dose, single for covid-19 immunization in School/ Student Health Clinic. The patient medical history was not reported. No allergies to medications, food, or other products. 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 and not tested for COVID-19 since vaccination. Concomitant medication(s) included glucosamine (GLUCOSAMINE), vitamin d nos (VITAMIN D NOS) taken for an unspecified indication and from unknown dates and unknown if ongoing. Patient received other medications Multivitamin/ Glucosamine/ vitamin D within 2 weeks of vaccination. On 25Jan2021, the patient's feet had been a bit sore from working so much lately, on the second day after the vaccine swelling in both feet began and worsened throughout the week. Therapeutic measures taken as a result of the events were prednisone. The outcome of events were recovering.   Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: my feet had been a bit sore from working so much lately; on the second day after the vaccine swelling in both feet began and worsened throughout the week; This is a spontaneous report from a contactable consumer (himself). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Formulation: Solution for injection,Batch/Lot number: not reported), via an unspecified route of administration, administered in Arm Left on 23Jan2021 15:15 (age at vaccination 68-year-old) as 1st dose, single for covid-19 immunization in School/ Student Health Clinic. The patient medical history was not reported. No allergies to medications, food, or other products. 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 and not tested for COVID-19 since vaccination. Concomitant medication(s) included glucosamine (GLUCOSAMINE), vitamin d nos (VITAMIN D NOS) taken for an unspecified indication and from unknown dates and unknown if ongoing. Patient received other medications Multivitamin/ Glucosamine/ vitamin D within 2 weeks of vaccination. On 25Jan2021, the patient's feet had been a bit sore from working so much lately, on the second day after the vaccine swelling in both feet began and worsened throughout the week. Therapeutic measures taken as a result of the events were prednisone. The outcome of events were recovering.   Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: dizziness 48 h after injection; This is a spontaneous report from a contactable other hcp (herself). A 77-year-old non pregnant female patient received (patient was not pregnant at the time of vaccination) BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EL9265, Expiration Date was not reported), via an unspecified route of administration on 30Jan2021 (at the age of 77-year-old) as single dose for covid-19 immunisation. Medical history included hypertension, cholesterol elevation. The patient previously took aleve and experienced allergy (drug hypersensitivity). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Feb2021, 48 hours after injection, the patient experienced, dizziness. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. No treatment was received for the adverse event. The adverse event resulted Doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Nausea, Pyrexia
Clinical narrative: Fever bet. 100 and 101 for 4 days; nausea; chills; loss of appetite; slept a lot; diarhhea; This is a spontaneous report from a contactable consumer or other non hcp.  A 75-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 28Jan2021 at 10:30 (Batch/Lot Number: EL 9262) as 2nd dose, single for covid-19 immunization.The patient medical history and concomitant medications were not reported. Patient had no known allergies. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 07Jan2021 at 10:30 am (Batch/Lot Number: EL3246) as 1st dose, single for covid-19 immunization. The patient did not receive any other vaccine in four weeks. Patient received other unspecified medications in two weeks. Prior to vaccination, the patient did not had Covid. The Patient did not test for Covid post vaccination. On 28Jan2021 at 12:30 pm the patient experienced fever between 100 and 101 for 4 days, nausea, diarrhea, chills, loss of appetite and slept a lot. Lab test included body temperature was between 100 and 101 for 4 days. No treatment was received for the events. Outcome of the events were recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: Fever bet. 100 and 101 for 4 days; nausea; chills; loss of appetite; slept a lot; diarhhea; This is a spontaneous report from a contactable consumer or other non hcp.  A 75-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 28Jan2021 at 10:30 (Batch/Lot Number: EL 9262) as 2nd dose, single for covid-19 immunization.The patient medical history and concomitant medications were not reported. Patient had no known allergies. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 07Jan2021 at 10:30 am (Batch/Lot Number: EL3246) as 1st dose, single for covid-19 immunization. The patient did not receive any other vaccine in four weeks. Patient received other unspecified medications in two weeks. Prior to vaccination, the patient did not had Covid. The Patient did not test for Covid post vaccination. On 28Jan2021 at 12:30 pm the patient experienced fever between 100 and 101 for 4 days, nausea, diarrhea, chills, loss of appetite and slept a lot. Lab test included body temperature was between 100 and 101 for 4 days. No treatment was received for the events. Outcome of the events were recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Diarrhoea, Hypersomnia
Clinical narrative: Fever bet. 100 and 101 for 4 days; nausea; chills; loss of appetite; slept a lot; diarhhea; This is a spontaneous report from a contactable consumer or other non hcp.  A 75-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 28Jan2021 at 10:30 (Batch/Lot Number: EL 9262) as 2nd dose, single for covid-19 immunization.The patient medical history and concomitant medications were not reported. Patient had no known allergies. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 07Jan2021 at 10:30 am (Batch/Lot Number: EL3246) as 1st dose, single for covid-19 immunization. The patient did not receive any other vaccine in four weeks. Patient received other unspecified medications in two weeks. Prior to vaccination, the patient did not had Covid. The Patient did not test for Covid post vaccination. On 28Jan2021 at 12:30 pm the patient experienced fever between 100 and 101 for 4 days, nausea, diarrhea, chills, loss of appetite and slept a lot. Lab test included body temperature was between 100 and 101 for 4 days. No treatment was received for the events. Outcome of the events were recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever bet. 100 and 101 for 4 days; nausea; chills; loss of appetite; slept a lot; diarhhea; This is a spontaneous report from a contactable consumer or other non hcp.  A 75-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 28Jan2021 at 10:30 (Batch/Lot Number: EL 9262) as 2nd dose, single for covid-19 immunization.The patient medical history and concomitant medications were not reported. Patient had no known allergies. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 07Jan2021 at 10:30 am (Batch/Lot Number: EL3246) as 1st dose, single for covid-19 immunization. The patient did not receive any other vaccine in four weeks. Patient received other unspecified medications in two weeks. Prior to vaccination, the patient did not had Covid. The Patient did not test for Covid post vaccination. On 28Jan2021 at 12:30 pm the patient experienced fever between 100 and 101 for 4 days, nausea, diarrhea, chills, loss of appetite and slept a lot. Lab test included body temperature was between 100 and 101 for 4 days. No treatment was received for the events. Outcome of the events were recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Electrocardiogram, Injection site swelling, Laboratory test, Pain
Clinical narrative: Stinging whelps and hives on injection; Stinging whelps and hives on injection; bump arose 3 inches approximately from injection; throat swelling; nausea; diarrhea; itching; headaches; chills; dizziness; weakness; congestion; exhaustion; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL 12B3) via intramuscular route of administration in left arm on 14Jan2021 at 12:00 PM as single dose for COVID-19 immunization. The patient medical history included hypothyroidism, hypertension, allergies year round and allergies ciprofloxacin, penicillin, peaches, bananas, strawberry, cockroaches, trees, grass, dander, dust, mold, cats and dogs. The patient did not receive any other vaccine within 4 weeks of COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications received within 2 weeks of vaccination included, levothyroxine, amlodipine, setraline, losartan and women multivitamin. On 14Jan2021 at 12:15 PM, the patient experienced stinging whelps and hives on injection site with swelling, bump arose 3 inches approximately from injection, throat swelling, nausea, diarrhea, itching, headaches, chills, dizziness, congestion, weakness and exhaustion. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Benadryl. The case was considered as non-serious by the reporter. Since the vaccination, the patient had been tested for COVID-19 including nasal swab test on 15Jan2021 with result: negative and throat swab test on 29Jan2021 with result: negative. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Pruritus, Rash
Clinical narrative: Stinging whelps and hives on injection; Stinging whelps and hives on injection; bump arose 3 inches approximately from injection; throat swelling; nausea; diarrhea; itching; headaches; chills; dizziness; weakness; congestion; exhaustion; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL 12B3) via intramuscular route of administration in left arm on 14Jan2021 at 12:00 PM as single dose for COVID-19 immunization. The patient medical history included hypothyroidism, hypertension, allergies year round and allergies ciprofloxacin, penicillin, peaches, bananas, strawberry, cockroaches, trees, grass, dander, dust, mold, cats and dogs. The patient did not receive any other vaccine within 4 weeks of COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications received within 2 weeks of vaccination included, levothyroxine, amlodipine, setraline, losartan and women multivitamin. On 14Jan2021 at 12:15 PM, the patient experienced stinging whelps and hives on injection site with swelling, bump arose 3 inches approximately from injection, throat swelling, nausea, diarrhea, itching, headaches, chills, dizziness, congestion, weakness and exhaustion. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Benadryl. The case was considered as non-serious by the reporter. Since the vaccination, the patient had been tested for COVID-19 including nasal swab test on 15Jan2021 with result: negative and throat swab test on 29Jan2021 with result: negative. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Stinging whelps and hives on injection; Stinging whelps and hives on injection; bump arose 3 inches approximately from injection; throat swelling; nausea; diarrhea; itching; headaches; chills; dizziness; weakness; congestion; exhaustion; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL 12B3) via intramuscular route of administration in left arm on 14Jan2021 at 12:00 PM as single dose for COVID-19 immunization. The patient medical history included hypothyroidism, hypertension, allergies year round and allergies ciprofloxacin, penicillin, peaches, bananas, strawberry, cockroaches, trees, grass, dander, dust, mold, cats and dogs. The patient did not receive any other vaccine within 4 weeks of COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications received within 2 weeks of vaccination included, levothyroxine, amlodipine, setraline, losartan and women multivitamin. On 14Jan2021 at 12:15 PM, the patient experienced stinging whelps and hives on injection site with swelling, bump arose 3 inches approximately from injection, throat swelling, nausea, diarrhea, itching, headaches, chills, dizziness, congestion, weakness and exhaustion. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Benadryl. The case was considered as non-serious by the reporter. Since the vaccination, the patient had been tested for COVID-19 including nasal swab test on 15Jan2021 with result: negative and throat swab test on 29Jan2021 with result: negative. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Nausea, Pain, Pharyngeal swelling
Clinical narrative: Stinging whelps and hives on injection; Stinging whelps and hives on injection; bump arose 3 inches approximately from injection; throat swelling; nausea; diarrhea; itching; headaches; chills; dizziness; weakness; congestion; exhaustion; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL 12B3) via intramuscular route of administration in left arm on 14Jan2021 at 12:00 PM as single dose for COVID-19 immunization. The patient medical history included hypothyroidism, hypertension, allergies year round and allergies ciprofloxacin, penicillin, peaches, bananas, strawberry, cockroaches, trees, grass, dander, dust, mold, cats and dogs. The patient did not receive any other vaccine within 4 weeks of COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications received within 2 weeks of vaccination included, levothyroxine, amlodipine, setraline, losartan and women multivitamin. On 14Jan2021 at 12:15 PM, the patient experienced stinging whelps and hives on injection site with swelling, bump arose 3 inches approximately from injection, throat swelling, nausea, diarrhea, itching, headaches, chills, dizziness, congestion, weakness and exhaustion. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Benadryl. The case was considered as non-serious by the reporter. Since the vaccination, the patient had been tested for COVID-19 including nasal swab test on 15Jan2021 with result: negative and throat swab test on 29Jan2021 with result: negative. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, SARS-CoV-2 test, Skin disorder, Urticaria
Clinical narrative: Stinging whelps and hives on injection; Stinging whelps and hives on injection; bump arose 3 inches approximately from injection; throat swelling; nausea; diarrhea; itching; headaches; chills; dizziness; weakness; congestion; exhaustion; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL 12B3) via intramuscular route of administration in left arm on 14Jan2021 at 12:00 PM as single dose for COVID-19 immunization. The patient medical history included hypothyroidism, hypertension, allergies year round and allergies ciprofloxacin, penicillin, peaches, bananas, strawberry, cockroaches, trees, grass, dander, dust, mold, cats and dogs. The patient did not receive any other vaccine within 4 weeks of COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications received within 2 weeks of vaccination included, levothyroxine, amlodipine, setraline, losartan and women multivitamin. On 14Jan2021 at 12:15 PM, the patient experienced stinging whelps and hives on injection site with swelling, bump arose 3 inches approximately from injection, throat swelling, nausea, diarrhea, itching, headaches, chills, dizziness, congestion, weakness and exhaustion. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Benadryl. The case was considered as non-serious by the reporter. Since the vaccination, the patient had been tested for COVID-19 including nasal swab test on 15Jan2021 with result: negative and throat swab test on 29Jan2021 with result: negative. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives / Urticaria - lower back and between shoulder blades. Came on about 1 day after the vaccination. Remained for over 1 week; This is a spontaneous report from a contactable consumer or other non hcp. A 81-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 14Feb2021 11:15 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took trazodone, sulfites and had allergies. No other vaccines in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. On 15Feb2021, the patient experienced hives/urticaria - lower back and between shoulder blades came on about 1 day after the vaccination and remained for over 1 week. The outcome of the events was not recovered.  Information on Lot/Batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Hives / Urticaria - lower back and between shoulder blades. Came on about 1 day after the vaccination. Remained for over 1 week; This is a spontaneous report from a contactable consumer or other non hcp. A 81-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 14Feb2021 11:15 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took trazodone, sulfites and had allergies. No other vaccines in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. On 15Feb2021, the patient experienced hives/urticaria - lower back and between shoulder blades came on about 1 day after the vaccination and remained for over 1 week. The outcome of the events was not recovered.  Information on Lot/Batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer. A 69-years-old female (non-pregnant) patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration, administered in right arm on 25Feb2021 11:00 at a single dose (1ST DOSE, SINGLE) for covid-19 immunisation. The patient medical history was not reported. No known allergies reported. Concomitant medications included tetanus vaccine (TETANUS VACCINE) first dose on 20Feb2021 on left arm and amoxicillin trihydrate, clavulanate potassium (AMOXICILLIN CLAVULANIC ACID). No covid prior vaccination. No covid tested post vaccination. The patient experienced headache on 26Feb2021 at 14:00. No treatment was received for the event. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.