chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin hyperpigmentation
Clinical narrative: Sudden Hyperpigmentation in legs; This is a spontaneous report from a contactable other hcp (patient). A 37-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9269) dose 2 intramuscular, administered in the left arm on 04Feb2021 03:30 as dose 2, single for COVID-19 immunization at hospital. Patient was not pregnant at time of vaccination. Medical history included keratoconus. Patient had no known allergies. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3246) dose 1 intramuscular, administered in the left arm on 14Jan2021 02:45 as dose 1, single for COVID-19 immunization. The patient concomitant medication was not reported. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 08Feb2021 the patient experienced sudden hyperpigmentation in legs. Adverse event resulted physician office visit. No treatment was given. The clinical outcome of the event was reported as not recovered.  Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Musculoskeletal discomfort, Musculoskeletal stiffness, Myalgia
Clinical narrative: very sore hip; This is a spontaneous report from a contactable consumer, the patient. A 75-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection,Lot number and Expiry date was not reported), via an unspecified route of administration on an unspecified date (Age at vaccination 75-years-old) as dose 2, single for covid-19 immunisation; The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation and experience very sore neck, neck was so stiff that it hurt to turn her head, discomfort in her shoulder and stiffness, stiffness in neck on both sides very painful to turn head; sore muscle around her neck. . On an unspecified date, the patient experienced very sore hip. The patient did not receive any other product that were taken together with those indicated. Patient took paracetamol (TYLENOL), via an unspecified route of administration from 21Feb2021 (Lot Number: PCA085) to 21Feb2021, at 325 mg as treatment. The outcome of event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: very sore hip; This is a spontaneous report from a contactable consumer, the patient. A 75-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection,Lot number and Expiry date was not reported), via an unspecified route of administration on an unspecified date (Age at vaccination 75-years-old) as dose 2, single for covid-19 immunisation; The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation and experience very sore neck, neck was so stiff that it hurt to turn her head, discomfort in her shoulder and stiffness, stiffness in neck on both sides very painful to turn head; sore muscle around her neck. . On an unspecified date, the patient experienced very sore hip. The patient did not receive any other product that were taken together with those indicated. Patient took paracetamol (TYLENOL), via an unspecified route of administration from 21Feb2021 (Lot Number: PCA085) to 21Feb2021, at 325 mg as treatment. The outcome of event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Musculoskeletal discomfort, Peripheral swelling
Clinical narrative: Rash on most of body, with concentration on feet, lower back, and back of thighs/very itchy, with bumps and blisters; Rash on most of body, with concentration on feet, lower back, and back of thighs/very itchy, with bumps and blisters; Rash on most of body, with concentration on feet, lower back, and back of thighs/very itchy, with bumps and blisters; Feet and lower back swelling; Feet and lower back swelling; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6202), via an unspecified route of administration in the right arm on 29Mar2021 at 18:30 (at the age of 57-year-old), dose 1, single for COVID-19 immunisation. The patient had no medical history and there were no concomitant medications. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. On 30Mar2021 at 12:00, the patient experienced rash on most of body, with concentration on feet, lower back, and back of thighs. It was very itchy, with bumps and blisters. The patient also had feet and lower back swelling. The event was reported as non-serious and resulted in doctor or other healthcare professional office/clinic visit. The patient received prescription for prednisone, and, hydroxyzine for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible; No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Rash on most of body, with concentration on feet, lower back, and back of thighs/very itchy, with bumps and blisters; Rash on most of body, with concentration on feet, lower back, and back of thighs/very itchy, with bumps and blisters; Rash on most of body, with concentration on feet, lower back, and back of thighs/very itchy, with bumps and blisters; Feet and lower back swelling; Feet and lower back swelling; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6202), via an unspecified route of administration in the right arm on 29Mar2021 at 18:30 (at the age of 57-year-old), dose 1, single for COVID-19 immunisation. The patient had no medical history and there were no concomitant medications. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. On 30Mar2021 at 12:00, the patient experienced rash on most of body, with concentration on feet, lower back, and back of thighs. It was very itchy, with bumps and blisters. The patient also had feet and lower back swelling. The event was reported as non-serious and resulted in doctor or other healthcare professional office/clinic visit. The patient received prescription for prednisone, and, hydroxyzine for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible; No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Peripheral swelling, Rash papular, Rash pruritic, Rash vesicular, Swelling
Clinical narrative: Rash on most of body, with concentration on feet, lower back, and back of thighs/very itchy, with bumps and blisters; Rash on most of body, with concentration on feet, lower back, and back of thighs/very itchy, with bumps and blisters; Rash on most of body, with concentration on feet, lower back, and back of thighs/very itchy, with bumps and blisters; Feet and lower back swelling; Feet and lower back swelling; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6202), via an unspecified route of administration in the right arm on 29Mar2021 at 18:30 (at the age of 57-year-old), dose 1, single for COVID-19 immunisation. The patient had no medical history and there were no concomitant medications. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. On 30Mar2021 at 12:00, the patient experienced rash on most of body, with concentration on feet, lower back, and back of thighs. It was very itchy, with bumps and blisters. The patient also had feet and lower back swelling. The event was reported as non-serious and resulted in doctor or other healthcare professional office/clinic visit. The patient received prescription for prednisone, and, hydroxyzine for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible; No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: After the 2nd vaccine within 24 hours, I had hives pretty much from waste and up on my chest, face, back, arms, and I was very itchy and it was painful hives. I went to urgent care because my doctor couldn?t see me quickly and they weren?t really sure what to do so I was prescribed oral steroids and I got a shot of steroids at my next visit two days later and some topical ointments. My PCP said it appeared to be an allergic reaction w/o anaphylaxis, they just basically said to deal with It. This lasted about three weeks.  I also had Covid and my Symptoms started on 09/02/2021 and tested positive the same day. I had Cough, Congestion, Loss of smell, bad headache. This lasted about a week. It was a mild case because I was vaccinated.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anosmia, COVID-19, Cough, Headache, Hypersensitivity
Clinical narrative: After the 2nd vaccine within 24 hours, I had hives pretty much from waste and up on my chest, face, back, arms, and I was very itchy and it was painful hives. I went to urgent care because my doctor couldn?t see me quickly and they weren?t really sure what to do so I was prescribed oral steroids and I got a shot of steroids at my next visit two days later and some topical ointments. My PCP said it appeared to be an allergic reaction w/o anaphylaxis, they just basically said to deal with It. This lasted about three weeks.  I also had Covid and my Symptoms started on 09/02/2021 and tested positive the same day. I had Cough, Congestion, Loss of smell, bad headache. This lasted about a week. It was a mild case because I was vaccinated.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pruritus, Respiratory tract congestion, SARS-CoV-2 test positive, Urticaria
Clinical narrative: After the 2nd vaccine within 24 hours, I had hives pretty much from waste and up on my chest, face, back, arms, and I was very itchy and it was painful hives. I went to urgent care because my doctor couldn?t see me quickly and they weren?t really sure what to do so I was prescribed oral steroids and I got a shot of steroids at my next visit two days later and some topical ointments. My PCP said it appeared to be an allergic reaction w/o anaphylaxis, they just basically said to deal with It. This lasted about three weeks.  I also had Covid and my Symptoms started on 09/02/2021 and tested positive the same day. I had Cough, Congestion, Loss of smell, bad headache. This lasted about a week. It was a mild case because I was vaccinated.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Incorrect product formulation administered, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer. A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6207, Expiry date: unknown), via intramuscular route of administration, administered in Arm Left on 16Mar2021 as dose 1, single for COVID-19 immunisation (Age at Vaccination was 68 years) for Covid-19 immunisation. Patient received mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE, Batch/Lot number and Expiry date: unknown), via an unspecified route of administration on 08Apr2021 as dose 2, single for COVID-19 immunisation. The patient medical history included ongoing high blood pressure. Concomitant medications included ongoing Metformin, Apixaban (ELIQUIS), Lisinopril, Finasteride (PROPECIA), Saxagliptin hydrochloride (ONGLYZA), Tamsulosin hydrochloride (FLOMAX RELIEF), and Atorvastatin (LIPITOR (ATORVASTATIN)). Patient did not visit the emergency room or physician office as a result of events. On 08Apr2021, the patient experienced received Moderna COVID-19 vaccine after receiving the first dose of the Pfizer COVID-19 vaccine. On an unspecified date, the patient experienced headache and fever. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Pyrexia, Wrong product administered
Clinical narrative: This is a spontaneous report from a contactable consumer. A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6207, Expiry date: unknown), via intramuscular route of administration, administered in Arm Left on 16Mar2021 as dose 1, single for COVID-19 immunisation (Age at Vaccination was 68 years) for Covid-19 immunisation. Patient received mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE, Batch/Lot number and Expiry date: unknown), via an unspecified route of administration on 08Apr2021 as dose 2, single for COVID-19 immunisation. The patient medical history included ongoing high blood pressure. Concomitant medications included ongoing Metformin, Apixaban (ELIQUIS), Lisinopril, Finasteride (PROPECIA), Saxagliptin hydrochloride (ONGLYZA), Tamsulosin hydrochloride (FLOMAX RELIEF), and Atorvastatin (LIPITOR (ATORVASTATIN)). Patient did not visit the emergency room or physician office as a result of events. On 08Apr2021, the patient experienced received Moderna COVID-19 vaccine after receiving the first dose of the Pfizer COVID-19 vaccine. On an unspecified date, the patient experienced headache and fever. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Diarrhoea, Nausea, Vomiting
Clinical narrative: This is a spontaneous report from a contactable other hcp. A 48-year- old non-pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EW0169), via an unspecified route of administration, administered in Arm Left on 17Apr2021 18:30 (at the age of 48-year-old) as dose 1, single for COVID-19 immunisation. Medical history included endometriosis. Patient did not receive other vaccine in four weeks. Patient did not had covid prior to vaccination. Concomitant medication(s) included Vit D, multivitamin and krill oil. On 17Apr2021 18:45, the patient experienced severe abdominal pain, diarrhea, vomiting. Severe abdominal pain 24 hours after vaccination resulting in diarrhea, and vomiting X2. The outcome of all the events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Diarrhoea, Vomiting
Clinical narrative: This is a spontaneous report from a contactable other hcp. A 48-year- old non-pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EW0169), via an unspecified route of administration, administered in Arm Left on 17Apr2021 18:30 (at the age of 48-year-old) as dose 1, single for COVID-19 immunisation. Medical history included endometriosis. Patient did not receive other vaccine in four weeks. Patient did not had covid prior to vaccination. Concomitant medication(s) included Vit D, multivitamin and krill oil. On 17Apr2021 18:45, the patient experienced severe abdominal pain, diarrhea, vomiting. Severe abdominal pain 24 hours after vaccination resulting in diarrhea, and vomiting X2. The outcome of all the events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Angiogram pulmonary abnormal, Anti factor Xa assay normal, Anticoagulant therapy, Atelectasis
Clinical narrative: pulmonary embolism (venous thrombo-embolism)
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Brain natriuretic peptide normal, C-reactive protein increased, Chest X-ray abnormal, Chest pain, Chills
Clinical narrative: pulmonary embolism (venous thrombo-embolism)
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram normal, Electrocardiogram normal, Fibrin D dimer increased, Hiatus hernia, Laboratory test abnormal
Clinical narrative: pulmonary embolism (venous thrombo-embolism)
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Leukocytosis, Ophthalmic migraine, Pain, Palpitations, Pleural effusion
Clinical narrative: pulmonary embolism (venous thrombo-embolism)
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pleural thickening, Pleuritic pain, Pulmonary embolism, Pulmonary infarction, Pulmonary mass
Clinical narrative: pulmonary embolism (venous thrombo-embolism)
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Respiratory viral panel, SARS-CoV-2 test negative, Systolic dysfunction, Tachycardia
Clinical narrative: pulmonary embolism (venous thrombo-embolism)
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tachypnoea, Thrombocytopenia, Tricuspid valve incompetence, Troponin normal, Ultrasound Doppler normal
Clinical narrative: pulmonary embolism (venous thrombo-embolism)
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White blood cell count increased
Clinical narrative: pulmonary embolism (venous thrombo-embolism)
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Embolism venous, Fibrin D dimer, Pulmonary embolism
Clinical narrative: pulmonary embolism (venous thrombo-embolism)
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Arthritis, COVID-19, Decreased appetite, Drug ineffective
Clinical narrative: pain and inflammation in the joints of the ankles, knees and her jaw; pain and inflammation in the joints of the ankles, knees and her jaw; pain and inflammation in the joints of the ankles, knees and her jaw; pain and inflammation in the joints of the ankles, knees and her jaw; This is a spontaneous report from a contactable consumer (patient) received via medical information team. An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included COVID-19 (she was infected with the COVID-19 virus on January). The patient's concomitant medications were not reported. The patient experienced pain and inflammation in the joints of the ankles, knees, and her jaw on an unspecified date. The patient reported that the inflammation in the jaw was making difficult to eat and chew. The patient reported that she was managing these symptoms with Tylenol and she has not visited her Physician for more information and management. Outcome of events was unknown. The patient reported that she has an appointment for the administration of the second dose of the COVID-19 vaccine on 22Apr2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021372685 Same reporter/drug/event, different patient.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mastication disorder
Clinical narrative: pain and inflammation in the joints of the ankles, knees and her jaw; pain and inflammation in the joints of the ankles, knees and her jaw; pain and inflammation in the joints of the ankles, knees and her jaw; pain and inflammation in the joints of the ankles, knees and her jaw; This is a spontaneous report from a contactable consumer (patient) received via medical information team. An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included COVID-19 (she was infected with the COVID-19 virus on January). The patient's concomitant medications were not reported. The patient experienced pain and inflammation in the joints of the ankles, knees, and her jaw on an unspecified date. The patient reported that the inflammation in the jaw was making difficult to eat and chew. The patient reported that she was managing these symptoms with Tylenol and she has not visited her Physician for more information and management. Outcome of events was unknown. The patient reported that she has an appointment for the administration of the second dose of the COVID-19 vaccine on 22Apr2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021372685 Same reporter/drug/event, different patient.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Arthritis, Osteitis, Pain in jaw
Clinical narrative: pain and inflammation in the joints of the ankles, knees and her jaw; pain and inflammation in the joints of the ankles, knees and her jaw; pain and inflammation in the joints of the ankles, knees and her jaw; pain and inflammation in the joints of the ankles, knees and her jaw; This is a spontaneous report from a contactable consumer (patient) received via medical information team. An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included COVID-19 (she was infected with the COVID-19 virus on January). The patient's concomitant medications were not reported. The patient experienced pain and inflammation in the joints of the ankles, knees, and her jaw on an unspecified date. The patient reported that the inflammation in the jaw was making difficult to eat and chew. The patient reported that she was managing these symptoms with Tylenol and she has not visited her Physician for more information and management. Outcome of events was unknown. The patient reported that she has an appointment for the administration of the second dose of the COVID-19 vaccine on 22Apr2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021372685 Same reporter/drug/event, different patient.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: I've developed a rash on the back of my knees and face/The rash is itchy and uncomfortable; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 04Apr2021 the patient experienced I've developed a rash on the back of my knees and face/the rash is itchy and uncomfortable. The outcome of the event rash pruritic was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic
Clinical narrative: I've developed a rash on the back of my knees and face/The rash is itchy and uncomfortable; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 04Apr2021 the patient experienced I've developed a rash on the back of my knees and face/the rash is itchy and uncomfortable. The outcome of the event rash pruritic was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diplopia, Muscular weakness
Clinical narrative: generalized myasthenia gravis and pernicious anemia
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Diplopia, Dysphagia, Magnetic resonance imaging, Mastication disorder
Clinical narrative: generalized myasthenia gravis and pernicious anemia
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Myasthenia gravis
Clinical narrative: generalized myasthenia gravis and pernicious anemia
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antiacetylcholine receptor antibody, Antibody test positive, Intrinsic factor antibody, Myasthenia gravis, Pernicious anaemia
Clinical narrative: generalized myasthenia gravis and pernicious anemia
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vitamin B12 decreased
Clinical narrative: generalized myasthenia gravis and pernicious anemia
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Cardiac monitoring, Cerebrovascular accident, Computerised tomogram head abnormal, Electrocardiogram
Clinical narrative: brain inflammation; This is a spontaneous report from a contactable consumer. An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 02Mar2021 10:00 (Batch/Lot Number: EN6199) as dose 1, single; via an unspecified route of administration, administered in Arm Left on 23Mar2021 (Batch/Lot Number: ER8732) as dose 2, single for COVID-19 immunization. Medical history included COPD and diabetes. The patient had no known allergies. The patient had no other vaccine in four weeks. The patient had other concomitant medications in two weeks. In Mar2021, the patient suffered two episodes of brain inflammation, each occurring within a week of receiving the vaccines which resulted to hospitalization for 51 days, disability, ER and physician visit. The patient had no COVID prior vaccination and has not been tested post vaccination. No treatment was given for the event. The patient underwent lab tests and procedures which included nasal swab: negative on Aug2021. The outcome of the event was not recovered.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head abnormal
Clinical narrative: brain inflammation; This is a spontaneous report from a contactable consumer. An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 02Mar2021 10:00 (Batch/Lot Number: EN6199) as dose 1, single; via an unspecified route of administration, administered in Arm Left on 23Mar2021 (Batch/Lot Number: ER8732) as dose 2, single for COVID-19 immunization. Medical history included COPD and diabetes. The patient had no known allergies. The patient had no other vaccine in four weeks. The patient had other concomitant medications in two weeks. In Mar2021, the patient suffered two episodes of brain inflammation, each occurring within a week of receiving the vaccines which resulted to hospitalization for 51 days, disability, ER and physician visit. The patient had no COVID prior vaccination and has not been tested post vaccination. No treatment was given for the event. The patient underwent lab tests and procedures which included nasal swab: negative on Aug2021. The outcome of the event was not recovered.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Noninfective encephalitis, SARS-CoV-2 test
Clinical narrative: brain inflammation; This is a spontaneous report from a contactable consumer. An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 02Mar2021 10:00 (Batch/Lot Number: EN6199) as dose 1, single; via an unspecified route of administration, administered in Arm Left on 23Mar2021 (Batch/Lot Number: ER8732) as dose 2, single for COVID-19 immunization. Medical history included COPD and diabetes. The patient had no known allergies. The patient had no other vaccine in four weeks. The patient had other concomitant medications in two weeks. In Mar2021, the patient suffered two episodes of brain inflammation, each occurring within a week of receiving the vaccines which resulted to hospitalization for 51 days, disability, ER and physician visit. The patient had no COVID prior vaccination and has not been tested post vaccination. No treatment was given for the event. The patient underwent lab tests and procedures which included nasal swab: negative on Aug2021. The outcome of the event was not recovered.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Chest discomfort, Cough, Dizziness, Dyspnoea
Clinical narrative: Difficulty breathing, episodic shortness of breath; rapid or irregular heartbeat; chest pain; very low blood oxygen levels; coughing; lightheaded; weakness/very low energy; brain fog (equilibrium off); inability to focus and react in timely manner; fatigue; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose via an unspecified route of administration, administered in Arm Right on 06May2021 14:15 (Lot Number: ER8735, expiration date unknown) at age of 53 years old as a single dose for covid-19 immunisation.  Medical history included no Prior Health Problems or Issues and no past drugs. There were no concomitant medications. The patient previously received 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 15Apr2021 14:00 (Lot Number: ER8734, expiration date unknown) at age of 53 years old as a single dose for covid-19 immunisation. The patient experienced difficulty breathing, episodic shortness of breath, rapid or irregular heartbeat, chest pain, very low blood oxygen levels, coughing, lightheaded, weakness/very low energy, brain fog (equilibrium off), inability to focus and react in timely manner, fatigue, all on 06May2021 20:30.  The outcome of the events was not recovered. The patient underwent lab tests and procedures which included blood oxygen level: very low blood oxygen levels (oximeter) on 06May2021, COVID 19 test: negative on 11May2021 Nasal Swab, negative on 25May2021 Blood test. Treatment received for events was unknown. The adverse events result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient was no known allergies. The report was reported as serious for being life threatening and disabling/incapacitating. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram normal, Heart rate increased, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Difficulty breathing, episodic shortness of breath; rapid or irregular heartbeat; chest pain; very low blood oxygen levels; coughing; lightheaded; weakness/very low energy; brain fog (equilibrium off); inability to focus and react in timely manner; fatigue; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose via an unspecified route of administration, administered in Arm Right on 06May2021 14:15 (Lot Number: ER8735, expiration date unknown) at age of 53 years old as a single dose for covid-19 immunisation.  Medical history included no Prior Health Problems or Issues and no past drugs. There were no concomitant medications. The patient previously received 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 15Apr2021 14:00 (Lot Number: ER8734, expiration date unknown) at age of 53 years old as a single dose for covid-19 immunisation. The patient experienced difficulty breathing, episodic shortness of breath, rapid or irregular heartbeat, chest pain, very low blood oxygen levels, coughing, lightheaded, weakness/very low energy, brain fog (equilibrium off), inability to focus and react in timely manner, fatigue, all on 06May2021 20:30.  The outcome of the events was not recovered. The patient underwent lab tests and procedures which included blood oxygen level: very low blood oxygen levels (oximeter) on 06May2021, COVID 19 test: negative on 11May2021 Nasal Swab, negative on 25May2021 Blood test. Treatment received for events was unknown. The adverse events result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient was no known allergies. The report was reported as serious for being life threatening and disabling/incapacitating. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chest pain, Cough, Disturbance in attention, Dizziness
Clinical narrative: Difficulty breathing, episodic shortness of breath; rapid or irregular heartbeat; chest pain; very low blood oxygen levels; coughing; lightheaded; weakness/very low energy; brain fog (equilibrium off); inability to focus and react in timely manner; fatigue; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose via an unspecified route of administration, administered in Arm Right on 06May2021 14:15 (Lot Number: ER8735, expiration date unknown) at age of 53 years old as a single dose for covid-19 immunisation.  Medical history included no Prior Health Problems or Issues and no past drugs. There were no concomitant medications. The patient previously received 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 15Apr2021 14:00 (Lot Number: ER8734, expiration date unknown) at age of 53 years old as a single dose for covid-19 immunisation. The patient experienced difficulty breathing, episodic shortness of breath, rapid or irregular heartbeat, chest pain, very low blood oxygen levels, coughing, lightheaded, weakness/very low energy, brain fog (equilibrium off), inability to focus and react in timely manner, fatigue, all on 06May2021 20:30.  The outcome of the events was not recovered. The patient underwent lab tests and procedures which included blood oxygen level: very low blood oxygen levels (oximeter) on 06May2021, COVID 19 test: negative on 11May2021 Nasal Swab, negative on 25May2021 Blood test. Treatment received for events was unknown. The adverse events result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient was no known allergies. The report was reported as serious for being life threatening and disabling/incapacitating. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Heart rate irregular, Oxygen saturation
Clinical narrative: Difficulty breathing, episodic shortness of breath; rapid or irregular heartbeat; chest pain; very low blood oxygen levels; coughing; lightheaded; weakness/very low energy; brain fog (equilibrium off); inability to focus and react in timely manner; fatigue; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose via an unspecified route of administration, administered in Arm Right on 06May2021 14:15 (Lot Number: ER8735, expiration date unknown) at age of 53 years old as a single dose for covid-19 immunisation.  Medical history included no Prior Health Problems or Issues and no past drugs. There were no concomitant medications. The patient previously received 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 15Apr2021 14:00 (Lot Number: ER8734, expiration date unknown) at age of 53 years old as a single dose for covid-19 immunisation. The patient experienced difficulty breathing, episodic shortness of breath, rapid or irregular heartbeat, chest pain, very low blood oxygen levels, coughing, lightheaded, weakness/very low energy, brain fog (equilibrium off), inability to focus and react in timely manner, fatigue, all on 06May2021 20:30.  The outcome of the events was not recovered. The patient underwent lab tests and procedures which included blood oxygen level: very low blood oxygen levels (oximeter) on 06May2021, COVID 19 test: negative on 11May2021 Nasal Swab, negative on 25May2021 Blood test. Treatment received for events was unknown. The adverse events result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient was no known allergies. The report was reported as serious for being life threatening and disabling/incapacitating. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation decreased, SARS-CoV-2 test
Clinical narrative: Difficulty breathing, episodic shortness of breath; rapid or irregular heartbeat; chest pain; very low blood oxygen levels; coughing; lightheaded; weakness/very low energy; brain fog (equilibrium off); inability to focus and react in timely manner; fatigue; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose via an unspecified route of administration, administered in Arm Right on 06May2021 14:15 (Lot Number: ER8735, expiration date unknown) at age of 53 years old as a single dose for covid-19 immunisation.  Medical history included no Prior Health Problems or Issues and no past drugs. There were no concomitant medications. The patient previously received 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 15Apr2021 14:00 (Lot Number: ER8734, expiration date unknown) at age of 53 years old as a single dose for covid-19 immunisation. The patient experienced difficulty breathing, episodic shortness of breath, rapid or irregular heartbeat, chest pain, very low blood oxygen levels, coughing, lightheaded, weakness/very low energy, brain fog (equilibrium off), inability to focus and react in timely manner, fatigue, all on 06May2021 20:30.  The outcome of the events was not recovered. The patient underwent lab tests and procedures which included blood oxygen level: very low blood oxygen levels (oximeter) on 06May2021, COVID 19 test: negative on 11May2021 Nasal Swab, negative on 25May2021 Blood test. Treatment received for events was unknown. The adverse events result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient was no known allergies. The report was reported as serious for being life threatening and disabling/incapacitating. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Testicular pain
Clinical narrative: intense pain in his testes; general pain and inflammation throughout his body and head; general pain and inflammation throughout his body and head; general pain and inflammation throughout his body and head; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8736), via an unspecified route of administration, administered in left arm on 14May2021 11:30 (at 54-year-old) as dose 1, single for COVID-19 immunization. Medical history included borderline hypertension. Prior to vaccination, the patient was not diagnosed with COVID-19. No known drug allergies. Concomitant medication included losartan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14May2021 at 11:45 PM the patient felt intense pain in his testes, off and on all evening throughout his 8.5 hours sleep cycle, from 12 am to 8:30 am. This, along with the expected general pain and inflammation throughout his body and head. The events did not result in emergency room visit or physician office visit. No treatment was received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Inflammation, Pain, Testicular pain
Clinical narrative: intense pain in his testes; general pain and inflammation throughout his body and head; general pain and inflammation throughout his body and head; general pain and inflammation throughout his body and head; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8736), via an unspecified route of administration, administered in left arm on 14May2021 11:30 (at 54-year-old) as dose 1, single for COVID-19 immunization. Medical history included borderline hypertension. Prior to vaccination, the patient was not diagnosed with COVID-19. No known drug allergies. Concomitant medication included losartan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14May2021 at 11:45 PM the patient felt intense pain in his testes, off and on all evening throughout his 8.5 hours sleep cycle, from 12 am to 8:30 am. This, along with the expected general pain and inflammation throughout his body and head. The events did not result in emergency room visit or physician office visit. No treatment was received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiovascular evaluation, Computerised tomogram, Concussion, Haemorrhage, Loss of consciousness
Clinical narrative: muscle aches; extremely nauseous; passed out; broken nose; a huge bump on her forehead; concussion; I felt a little sore in my arm; This is a spontaneous report from a contactable Other Health Professional (patient). A 19-year-old female patient (no pregnant) received the second dose of bnt162b2 on 04May2021 at 14:30 (lot number: unknown) (at the age of 19-years-old) via unknown route of administration in left arm at single dose for COVID-19 immunization. Medical history included Concussions; Tachycardia; anxiety; adhd; known allergies: Sulfa. Concomitant medications included sertraline; amphetamine; dextroamphetamine hydrochloride. Historical vaccine included the first dose of bnt162b2 on unknown date in left arm at single dose for COVID-19 immunization. There was no other vaccine in four weeks. Patient did not have covid prior vaccination. Patient was not tested covid post vaccination. Patient received the second dose of the Pfizer vaccine on 04May2021 around 2:30-3 in the afternoon. She then went home and took some Tylenol just in case she had symptoms and she continued to study for her finals. That night she felt a little sore in her arm but nothing crazy and decided she had to sleep in the next morning so that she would be ready for tests and sleep of the vaccine. Patient woke up the next morning on 05May around 12:30 and went to take a shower feeling normal except for slight muscle aches but nothing flu like; but as she went to turn on the shower she got extremely nauseous so patient sat on the toilet. A few seconds later she woke up in a pile of her own blood with the nose in the bathroom floor. Patient cleaned up the blood and went to call her Roommate and as she was walking to the room she passed out again. Patient then spent the next 12 hours in the ER all with what looked to be a broken nose and a huge bump on her forehead. The doctor 2 days later determined she had a suffered 10th concussion. Patient received treatment including Neurologist, cardiologist, cranial sacrum. The outcome of the events was not recovered. The events resulted in physician office visit, Emergency room visit, Disability.  The lot number for [BNT162B2] was not requested and will be requested during follow-up.