chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Brain natriuretic peptide normal, Computerised tomogram, Dyspnoea, Hypoxia
Clinical narrative: severe bilateral pneumonia; hypoxia; shortness of breath; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (severe bilateral pneumonia) and HYPOXIA (hypoxia) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tobacco user since an unknown date, Hyperlipidemia since an unknown date, Chronic pancreatitis since an unknown date, Hypertension since an unknown date and Diabetes mellitus since an unknown date. Concomitant products included INSULIN GLARGINE (LANTUS), INSULIN LISPRO (HUMALOG), METFORMIN, OMEPRAZOLE, ESCITALOPRAM OXALATE (LEXAPRO), ASA, PROPRANOLOL and OXYCODONE for an unknown indication.    On 04-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced DYSPNOEA (shortness of breath). On 10-Apr-2021, the patient experienced PNEUMONIA (severe bilateral pneumonia) (seriousness criteria hospitalization and medically significant) and HYPOXIA (hypoxia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 10-Apr-2021 due to HYPOXIA and PNEUMONIA. At the time of the report, PNEUMONIA (severe bilateral pneumonia), HYPOXIA (hypoxia) and DYSPNOEA (shortness of breath) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal wbc 17.3 with 79% neutrophils and 1.2 lymphocytes.. On an unknown date, Brain natriuretic peptide normal: normal normal. On an unknown date, Computerized tomogram: abnormal chest with collapse of the left upper lobe with dense consolidation with possible mass like density occupying much of the left upper lobe bronchus, diffuse ground glass opacities throughout the left lung are seen and ground glass opacities of the right upper lobe and right lower lobe are seen infectious/inflammatory. there is also mediastinal and hilar lymphadenopathy seen.. On an unknown date, Influenza: negative negative. On an unknown date, Procalcitonin: normal normal. On an unknown date, Productive cough: normal normal. On an unknown date, SARS-CoV-2 test: negative negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza, Pneumonia, Procalcitonin, Productive cough, SARS-CoV-2 test
Clinical narrative: severe bilateral pneumonia; hypoxia; shortness of breath; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (severe bilateral pneumonia) and HYPOXIA (hypoxia) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tobacco user since an unknown date, Hyperlipidemia since an unknown date, Chronic pancreatitis since an unknown date, Hypertension since an unknown date and Diabetes mellitus since an unknown date. Concomitant products included INSULIN GLARGINE (LANTUS), INSULIN LISPRO (HUMALOG), METFORMIN, OMEPRAZOLE, ESCITALOPRAM OXALATE (LEXAPRO), ASA, PROPRANOLOL and OXYCODONE for an unknown indication.    On 04-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced DYSPNOEA (shortness of breath). On 10-Apr-2021, the patient experienced PNEUMONIA (severe bilateral pneumonia) (seriousness criteria hospitalization and medically significant) and HYPOXIA (hypoxia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 10-Apr-2021 due to HYPOXIA and PNEUMONIA. At the time of the report, PNEUMONIA (severe bilateral pneumonia), HYPOXIA (hypoxia) and DYSPNOEA (shortness of breath) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal wbc 17.3 with 79% neutrophils and 1.2 lymphocytes.. On an unknown date, Brain natriuretic peptide normal: normal normal. On an unknown date, Computerized tomogram: abnormal chest with collapse of the left upper lobe with dense consolidation with possible mass like density occupying much of the left upper lobe bronchus, diffuse ground glass opacities throughout the left lung are seen and ground glass opacities of the right upper lobe and right lower lobe are seen infectious/inflammatory. there is also mediastinal and hilar lymphadenopathy seen.. On an unknown date, Influenza: negative negative. On an unknown date, Procalcitonin: normal normal. On an unknown date, Productive cough: normal normal. On an unknown date, SARS-CoV-2 test: negative negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy, Off label use
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). This 49-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 26Mar2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (lot number unknown) on 12Mar2021 at 11:00 (at the age of 49-years-old) in the right arm for COVID-19 immunization. The patient reported experiencing swollen lymph nodes in both armpits, groin, and abdomen on 27Mar2021 at 06:00. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the event. The clinical outcome of swollen lymph nodes in both armpits, groin, and abdomen was not recovered, the clinical outcome of second dose administered on 26Mar2021 was recovered on 26Mar2021 at 14:00. It was also reported that the patient had not been tested for COVID-19 since vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling; Facial numbness on left side face; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number 588727) via an unspecified route of administration on 25Mar2021 at 08:00 (at the age of 48-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine the patient was not diagnosed with COVID-19. Concomitant medications include fexofenadine (reported as "generic ALLEGRA") from an unknown date for an unknown indication. The patient did not have any allergies to medications, food, or other products. In the afternoon on the day of vaccine on 25Mar2021 at 14:30, the patient experienced facial numbness on left side face. She felt it more in cheek. As of 28Mar2021 the patient improved by still had numbness and tingling. The event was reported as non-serious. The patient was not hospitalized for the event. It was unknown if the patient received any treatment for the event. The outcome of facial numbness on left side face and tingling was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: constant headaches starting the day after shot was administered; This is a spontaneous report received from a contactable consumer, the patient. This 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 24Mar2021 18:30 (at the age of 40-year-old) as single dose for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. Medical history included a head cold the week prior to the vaccination (Mar2021). Concomitant medications included pantoprazole and escitalopram. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 14:00, the patient experienced constant headaches starting the day after shot was administered. No treatment was received for the adverse event. The clinical outcome of the "constant headaches" was not resolved.    The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast tenderness, Fatigue
Clinical narrative: Tenderness, burning and hurtful left breast; Tenderness, burning and hurtful left breast.; Really run down and tired as expected.; This is a spontaneous report from a contactable consumer, the patient. This 54-year-old non-pregnant female patient reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) via unspecified route in the left arm on 23Mar2021 at 15:15 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Medical history included overweight. The patient had no allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination,  the patient was not diagnosed with COVID-19. There were no concomitant medications. On 24Mar2021 at 12:00 AM, the patient experienced tenderness, burning and hurtful left breast, especially around the of the breast almost as if touching a splinter on the breast. The patient also reported she was really run down and tired as expected. There was no treatment received for tenderness, burning and hurtful left breast, run down and tired. The clinical outcomes of tenderness, burning and hurtful left breast, run down and tired was not recovered. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pustule, Vaccination site swelling
Clinical narrative: the site was swollen and red, draining pus; the site was swollen and red, draining pus; the site was swollen and red, draining pus; This is a spontaneous report from a contactable consumer, the patient. A 61-years-old non-pregnant female patient received the first does of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 16Mar2021 13:15 (Batch/Lot Number: EN6204) (at the age of 61-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, spinal neuropathy and allergy to latex. Concomitant medication included atenolol taken for an unspecified indication, start and stop date were not reported. Past drug history included the patient had allergy to acetylsalicylic acid (ASPIRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the site was swollen and red, draining pus and she cleansed the area and it was size of a walnut. The area opened on its own with a moderate amount pus. The patient had no fever. She had been cleansing and keeping the area clean and dry. She kept applying antibiotic and cove. It was red but no drainage. It had not spread. The patient had no other symptoms. The outcome of events, the site was swollen and red, draining pus was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Nausea
Clinical narrative: This is a spontaneous report received a contactable consumer, the patient. A 53-year-old adult [non-pregnant] female received the second dose of BNT162B2 (solution for injection; Lot provided as unknown and expiry information not reported) via unspecified route in the right arm on 18Mar2021 at 12:00 (at 53-years-old), for COVID-19 immunization. Relevant medical history included hypothyroid, Chiari malformation, hemicrania continua, depression, allergic rhinitis, sulfonamide allergy, and food allergy (pineapple and hot peppers). Concomitant medications included riboflavin (VITAMIN B 2), cetirizine hydrochloride (ZYRTEC ALLERGY), levothyroxine, fluoxetine hydrochloride (PROZAC), and indomethacin (INDOMETHACIN). The patient previously received COVID-19 immunization with the first dose of BNT162b2 (Lot unknown) in the right arm on 25Feb2021 at 11:30 (at 53-years-old). The patient previously received treatment for unspecified indications with codeine, morphine, and capsaicin and experienced allergy with each. The denied being diagnosed with COVID-19 prior to the vaccine, the patient was not pregnant at time of vaccination, and the patient denied receiving any other vaccine within four weeks of this vaccine. On 25Mar2021 at 16:30 the patient developed swollen right inside of throat, joint pain entire body, nausea, chills, diarrhea, and headache; which the reporter considered non-serious. The patient denied being tested for COVID-19 since the vaccine. There was no treatment received for the events. The outcome of the events, swollen right inside of throat, joint pain entire body, nausea, chills, diarrhea, and headache, was recovering. No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: This is a spontaneous report received a contactable consumer, the patient. A 53-year-old adult [non-pregnant] female received the second dose of BNT162B2 (solution for injection; Lot provided as unknown and expiry information not reported) via unspecified route in the right arm on 18Mar2021 at 12:00 (at 53-years-old), for COVID-19 immunization. Relevant medical history included hypothyroid, Chiari malformation, hemicrania continua, depression, allergic rhinitis, sulfonamide allergy, and food allergy (pineapple and hot peppers). Concomitant medications included riboflavin (VITAMIN B 2), cetirizine hydrochloride (ZYRTEC ALLERGY), levothyroxine, fluoxetine hydrochloride (PROZAC), and indomethacin (INDOMETHACIN). The patient previously received COVID-19 immunization with the first dose of BNT162b2 (Lot unknown) in the right arm on 25Feb2021 at 11:30 (at 53-years-old). The patient previously received treatment for unspecified indications with codeine, morphine, and capsaicin and experienced allergy with each. The denied being diagnosed with COVID-19 prior to the vaccine, the patient was not pregnant at time of vaccination, and the patient denied receiving any other vaccine within four weeks of this vaccine. On 25Mar2021 at 16:30 the patient developed swollen right inside of throat, joint pain entire body, nausea, chills, diarrhea, and headache; which the reporter considered non-serious. The patient denied being tested for COVID-19 since the vaccine. There was no treatment received for the events. The outcome of the events, swollen right inside of throat, joint pain entire body, nausea, chills, diarrhea, and headache, was recovering. No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes (underarm) on side of injection; This is a spontaneous report from a contactable consumer, patient. A 30-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Lot Number: ER2613) via an unspecified route of administration, administered in the right arm on 26Mar2021 at 15:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient has no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162b2 on 05Mar2021 at 15:45 (Lot Number: EN6205; at age of 30-years-old) via an unspecified route of administration in the left arm for COVID-19 immunisation. The patient experienced swollen lymph nodes (underarm) on side of injection on 28Mar2021 at 08:00. No treatment was provided for the event. The patient had not recovered from the event, swollen lymph nodes (underarm) on side of injection.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Skin reaction, Stevens-Johnson syndrome
Clinical narrative: a bad skin reaction after that like Stevens-Johnson syndrome (SJS) only less severe; a bad skin reaction after that like Stevens-Johnson syndrome (SJS) only less severe; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 18Dec2019 (Batch/Lot number was not reported) as a single dose for immunization.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced: a bad skin reaction after that like Stevens-Johnson Syndrome (SJS) only less severe (medically significant). On 18Dec2019, the patient received the pneumococcal 13-val conj vac (dipht crm197 protein) vaccine. The patient had a bad skin reaction after that, which was like Stevens-Johnson syndrome (SJS) only less severe. The patient still had some skin problems left. "The second exposure to a similar medication would cause a more severe reaction" (as reported). The patient stated, "I wonder if I should worry about receiving the second dose of the Pfizer vaccine. The first vaccination by Pfizer vaccine went uneventful. The composition of Prevnar13 is well known, the composition of Pfizer vaccine is known only to you and your scientists. Can they compare the vaccines and let me know if I am at a higher risk? " The clinical outcome of the events was not recovered.  The batch/lot numbers for the vaccine, pneumococcal 13-val conj vac (dipht crm197 protein), were not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nephrolithiasis
Clinical narrative: developed kidney stone; This is a spontaneous report from a contactable nurse (who is also the patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0150), via an unspecified route of administration in the left arm, on 31Mar2021, as single dose, for COVID-19 immunisation. There were no medical history and concomitant medications. On 06Apr2021, 6 days after the vaccination, the patient developed kidney stone which was a 6x2 mm stone. The patient stated that she never had a history of stone. She was wondering if anything has been reported like this and mentioned that she was unsure if this could be a side effect. The patient was recovering from the event. The patient reported the event as serious (medically significant).; Sender's Comments: The event kidney stone is considered unrelated to suspect vaccine BNT162B2 as there is no known plausible mechanism. The reported event most likely represented intercurrent medical condition. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging, Nerve injury, SARS-CoV-2 test, Spinal disorder
Clinical narrative: lesions on my spinal cord which may result in permanent nerve damage; lesions on my spinal cord which may result in permanent nerve damage; numbness which is increasing day by day; This is a spontaneous report from a contactable consumer (patient).  A 40-year old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: ER8732), via an unspecified route of administration, administered in the left arm on 25Mar2021 11:00 (at the age of 40 years-old) as single dose for covid-19 immunisation.  Medical history included penicillin allergy and shingles outbreak. Patient previously received bnt162b2 (lot number: EN6200) on 01Mar2021 at 09:00 in the left arm for covid-19 immunization and experienced shingles outbreak. Concomitant medication included doxycycline monohydrate taken for an unspecified indication, start and stop date were not reported.  The patient was now (Mar2021) experiencing numbness which was increasing day by day. She had an MRI scan last week (Mar2021) and it's showing lesions on her spinal cord which may result in permanent nerve damage. She will be speaking with a neurologist this week and doing additional test/scans. The patient underwent other lab tests and procedures on 07Apr2021 which included Nasal Swab (for sars-cov-2 test) with negative result.  the outcome of events was reported as not recovered. It was unknown whether treatment was received. The events were considered as serious,involving persistent or significant disability or incapacity.   No follow-up attempts possible. No further information expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blindness transient, Diarrhoea, Hyperhidrosis, Nausea
Clinical narrative: even to the point of near blindness; suddenly begin to sweat profusely; feeling weak/felt weak; nauseous; my vision becomes extremely blurry; spent much of that time in the bathroom with diarrhea; This is a spontaneous report from a contactable consumer. A 33-year-old male patient received first dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 31Mar2021 at 13:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included Seasonal allergies (trees, grass) and related fruits (apples/cherries/peaches). Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient reported "Received the shot and waited in the parking lot for the 15 minutes. No negative effects whatsoever during the 15 minutes, and I was cleared to leave. As I am driving out of the parking lot, suddenly begin to sweat profusely, feeling weak/nauseous, and my vision becomes extremely blurry, even to the point of near blindness. I stopped the car and sat for about 30 seconds/1 minute until my vision returned sufficiently to drive back to the waiting area where I requested water. I immediately felt better with the water, and the staff also gave me benadryl although I don't think it had any impact. I felt weak for an additional 30 minutes or so and spent much of that time in the bathroom with diarrhea. I felt fine to drive after this 30 minutes and have had no side effects since." Therapeutic measures were taken as a result of even to the point of near blindness, suddenly begin to sweat profusely, feeling weak/felt weak, nauseous and my vision becomes extremely blurry. No treatment was reported for the event spent much of that time in the bathroom with diarrhea. Outcome of the events was recovered on 31Mar2021.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: even to the point of near blindness; suddenly begin to sweat profusely; feeling weak/felt weak; nauseous; my vision becomes extremely blurry; spent much of that time in the bathroom with diarrhea; This is a spontaneous report from a contactable consumer. A 33-year-old male patient received first dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 31Mar2021 at 13:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included Seasonal allergies (trees, grass) and related fruits (apples/cherries/peaches). Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient reported "Received the shot and waited in the parking lot for the 15 minutes. No negative effects whatsoever during the 15 minutes, and I was cleared to leave. As I am driving out of the parking lot, suddenly begin to sweat profusely, feeling weak/nauseous, and my vision becomes extremely blurry, even to the point of near blindness. I stopped the car and sat for about 30 seconds/1 minute until my vision returned sufficiently to drive back to the waiting area where I requested water. I immediately felt better with the water, and the staff also gave me benadryl although I don't think it had any impact. I felt weak for an additional 30 minutes or so and spent much of that time in the bathroom with diarrhea. I felt fine to drive after this 30 minutes and have had no side effects since." Therapeutic measures were taken as a result of even to the point of near blindness, suddenly begin to sweat profusely, feeling weak/felt weak, nauseous and my vision becomes extremely blurry. No treatment was reported for the event spent much of that time in the bathroom with diarrhea. Outcome of the events was recovered on 31Mar2021.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Myasthenia gravis
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 72-years-old via an unspecified route of administration, administered in arm left on 08Feb2021 09:30 (Batch/Lot Number: EM9810) as single dose for covid-19 immunisation.  Medical history included high blood pressure, diabetes, Stage 3 Kidney Disease; from an unknown date and unknown if ongoing. Concomitant medication included amlodipine; levothyroxine, tamsulosin; taken for an unspecified indication, start and stop date were not reported. The patient experienced thirteen days after receiving the second Covid shot, his right eyelid started closing (also reported as 10Mar2021). Eight days later he was diagnosed with Myasthenia Gravis. The event resulted to doctor or other healthcare professional office/visit and emergency room department or urgent care. The patient was hospitalized due to the event for 5 days. No treatment was received for the event. The patient was recovering from the event.  No follow up attempts are possible. No further information is expected
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: it was the arthritis/ it was the rheumatoid arthritis/additional swelling in her knees; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 12Mar2021 (Lot Number: EN6204, expiry date not reported) as single dose for COVID-19 immunization. Medical history included rheumatoid arthritis from Jan2021 and ongoing (Verbatim: Rheumatoid arthritis/She says she just got diagnosed with arthritis in Jan2021), ongoing chronic obstructive pulmonary disease, breast cancer female from 2006 to 2006 (Verbatim: Breast cancer survivor), and bone density abnormal from an unknown date and unknown if ongoing. Concomitant medications included methotrexate taken for rheumatoid arthritis from 06Feb2021 to an unspecified stop date; cortisone taken for an unspecified indication from 01Feb2021 to 01Feb2021; denosumab (PROLIA) taken for bone density abnormal from 16Mar2021 to an unspecified stop date; and cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for an unspecified indication from 16Mar2021 to an unspecified stop date.  The patient experienced it was the arthritis/ it was the rheumatoid arthritis/swelling in her knees on 24Mar2021. The patient had a rheumatoid arthritis and after she took the first dose of the Pfizer-BioNTech COVID-19 Vaccine shot, about 12 days later she noticed additional swelling in her knees. She had preexisting condition of Rheumatoid arthritis prior to any Pfizer-BioNTech COVID-19 Vaccine. Prior to onset of this event, with her rheumatoid arthritis, she did not have any rheumatoid arthritis problems in her knees. With the rheumatoid arthritis, it has always been in her hands and arms. She was taking Methotrexate for Rheumatoid arthritis. Rheumatologist told her that additional swelling in her knees event was rheumatoid arthritis. She went to the Rheumatologist for the swelling in her knees and they told her it was the arthritis/rheumatoid arthritis. She had second dose of Pfizer-BioNTech COVID-19 Vaccine shot on 08Apr2021. On 11Apr2021 she noticed additional swelling around her waist. She asked if these swelling events are a side effect of the Pfizer-BioNTech COVID-19 Vaccine, or in combination with her rheumatoid arthritis. Clinical outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Anal haemorrhage, Colonoscopy, Diverticulitis, Haemoglobin, Haemoglobin decreased
Clinical narrative: This is a spontaneous report from a contactable consumer. A 52-year-old male patient received the first dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization, and to Prevent getting COVID. Medical history included sickle cell trait, diabetes and was obesity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  On 06Apr2021, the patient experienced bleeding from the anus. Did colonoscopy and found that he had diverticulitis, sent home after 3 days in the hospital. On 11Apr2021, patient was bleeding from anus again where he went to ER that day and was admitted to the hospital. Basically, they haven't made any progress but his hemoglobin was 7 (hospital was talking about a blood transfusion). He had sickle cell trait, the hospital was fixed on diverticulitis. It was reported that patient was due to have another shot and was afraid it's going to start over again. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fatigue, Feeling abnormal, Nausea
Clinical narrative: She was 'bouncing off the walls'.; unsteadiness; Nausea; extreme dizziness; fatigue/bad enough that for 3 days she couldn't work; This is spontaneous report received from Pfizer Sponsored Program Support from a contactable consumer (patient). This 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in upper left arm on 15Mar2021 09:30 (Lot Number: EN6207) as single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were none.  The patient experienced nausea on 15Mar2021 18:00, extreme dizziness on 15Mar2021 18:00, fatigue/bad enough that for 3 days she couldn't work on 15Mar2021 18:00, she was 'bouncing off the walls' on an unspecified date, unsteadiness on an unspecified date. She went on 15Mar2021 to get her first shot and then she was went for her second vaccine this past Saturday. Patient stated they denied giving her the 2nd dose of the covid vaccine after hearing about her side effects form the 1st one. She would like to know whether she needs to get the 2nd dose. She had pretty bad reactions to the first shot. She got the shot around 09:30 in the morning and by 6 pm she felt the reactions. Patient reported the following side effects form the 1st dose of the covid vaccine: nausea, extreme dizziness and fatigue, bad enough that for 3 days she couldn't work. She was 'bouncing off the walls', unsteadiness and spent the next three days in bed due to fatigue. There was no event require a visit to emergency room and physician office. There was no prior vaccination (within 4 weeks) and no adverse event following prior vaccinations. The outcome of event nausea was recovered on 16Mar2021, extreme dizziness and fatigue/bad enough that for 3 days she couldn't work was recovered on 18Mar2021, She was 'bouncing off the walls' was recovered on an unspecified date, unsteadiness was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypothyroidism, Narcolepsy
Clinical narrative: fell asleep, and experienced narcolepsy for the next three weeks; hypothyroid; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered at the left arm on 24Mar2021 13:00 (Lot number and expiry date not reported) as single dose for COVID-19 immunization. Medical history included asthma, chronic kidney disease, hypertension, drug hypersensitivity (penicillin allergy) from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included benazepril taken for an unspecified indication, start and stop date were not reported; venlafaxine hydrochloride (EFEXOR) taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; and allopurinol taken for an unspecified indication, start and stop date were not reported.  Historical vaccine included first dose of BNT162B2 for COVID-19 immunization on 03Mar2021 13:00 at left arm (age at vaccination was 57 years) for COVID-19 immunization. The patient previously took morphine, iodine, levaquin, lisinopril and gabapentin experienced drug hypersensitivity. On 27Mar2021, the patient experienced fell asleep, and experienced narcolepsy for the next three weeks and had hypothyroid with outcome of recovering. Therapeutic measures were taken as a result of the events.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Loss of consciousness
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0158 and expiration date not provided), via an unspecified route of administration administered in the right arm on 11Apr2021 14:00 as  a single dose for COVID-19 immunization. Medical history included Crohns Disease. The patient is not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient has no known allergies. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 12Apr2021 01:45, about 12 hours after the first dose, the patient passed out and then broke out in a cold sweat, multiple times. No treatment was given in response to the events.  The outcome of the events was recovering. The patient has not been tested for COVID post vaccination.; Sender's Comments: Based on the plausible temporal association and product safety profile, the reported events are possibly related to the vaccine BNT162B2. administration. This case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Lethargy, Muscle swelling, Rheumatoid arthritis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 52-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm right on 19Mar2021 09:45 (batch/lot number EN6204 and expiry date not reported) at 52 years of age as single dose for covid-19 immunization in a hospital facility. Medical history included rheumatoid arthritis, ovarian cancer and had 6 chemo treatments, Sjogren's disease, obesity. The patient had no Covid prior vaccination. Concomitant medications included meloxicam (MOBIC); venlafaxine hydrochloride (EFFEXOR); hydroxychloroquine phosphate (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]); pantoprazole; biotin; fish oil (OMEGA 3 [FISH OIL]); all taken for an unspecified indication, start and stop date were not reported. The patient previously took Remicade, Mucinex DM and fast acting cortisol shot; all experienced allergies. The patient had no other vaccine in four weeks. The patient informed that on 19Mar2021 16:30, her rheumatoid arthritis started acting up; it started in her right shoulder and spread to almost all her joints, every joint hurt except her back, neck, and jaw; then her bones started hurting, the patient informed that she had 6 chemo treatments and it felt just like a chemo treatment, hurting deep inside the bone marrow; she also had swelling in some of the muscles that were affected with rheumatoid arthritis; she felt lethargic and tired; she also had a welt at the injection site, it was 2 inches wide and wrapped halfway around her arm. The patient took all weekend for it to go down. The patient informed that it lasted till Sunday night (unspecified date). The patient was not Covid tested post vaccination. The patient received no treatment for the events. The outcome of the events was recovered.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 52-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm right on 19Mar2021 09:45 (batch/lot number EN6204 and expiry date not reported) at 52 years of age as single dose for covid-19 immunization in a hospital facility. Medical history included rheumatoid arthritis, ovarian cancer and had 6 chemo treatments, Sjogren's disease, obesity. The patient had no Covid prior vaccination. Concomitant medications included meloxicam (MOBIC); venlafaxine hydrochloride (EFFEXOR); hydroxychloroquine phosphate (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]); pantoprazole; biotin; fish oil (OMEGA 3 [FISH OIL]); all taken for an unspecified indication, start and stop date were not reported. The patient previously took Remicade, Mucinex DM and fast acting cortisol shot; all experienced allergies. The patient had no other vaccine in four weeks. The patient informed that on 19Mar2021 16:30, her rheumatoid arthritis started acting up; it started in her right shoulder and spread to almost all her joints, every joint hurt except her back, neck, and jaw; then her bones started hurting, the patient informed that she had 6 chemo treatments and it felt just like a chemo treatment, hurting deep inside the bone marrow; she also had swelling in some of the muscles that were affected with rheumatoid arthritis; she felt lethargic and tired; she also had a welt at the injection site, it was 2 inches wide and wrapped halfway around her arm. The patient took all weekend for it to go down. The patient informed that it lasted till Sunday night (unspecified date). The patient was not Covid tested post vaccination. The patient received no treatment for the events. The outcome of the events was recovered.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Tiredness; Chills; Fever; Doesn't feel good, weak; Lymph node swollen, hurts, can't touch it; Nauseous; Headache; This is a spontaneous report from a contactable consumer (Patient). A 61-year-old female patient received the second dose of BNT162B2 (COMIRNATY Formulation: Solution for injection) via unspecified route of administration as a SINGLE DOSE on 07Apr2021 02:35PM for COVID-19 immunization. The patient had no relevant medical history and family history. Patient received historical vaccine of first dose BNT162B2 (COMIRNATY) via unspecified route of administration in left arm on 17Mar2021 02:35 PM for COVID-19 immunization. Medical history and concomitant medication was not reported. No family history. Patient reported as does not think her medications had anything to do with the events. she takes all the same medications and didn't have any events with the first vaccine. On 07Apr2021 at 14:35 after second vaccine she got headache right after that and still ongoing. On 08Apr2021 lymph node under arm swollen hurts and she can't touch it and still ongoing, she was nauseous around 5 or 6 in evening. On 08Apr2021 2:00 AM she had chills, tiredness, doesn't feel good weak and fever was 100.5 then it went higher and lower. Second shot on Wednesday and she really sick was 25 percent better today. No Prior Vaccinations (within 4 weeks). The outcome of event recovered for Chills, Fever on 09Apr2021, Nauseous on 08Apr0221 and not recovered for Tiredness, Headache, Doesn't feel good, weak, Lymph node swollen, hurts, can't touch it.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Tiredness; Chills; Fever; Doesn't feel good, weak; Lymph node swollen, hurts, can't touch it; Nauseous; Headache; This is a spontaneous report from a contactable consumer (Patient). A 61-year-old female patient received the second dose of BNT162B2 (COMIRNATY Formulation: Solution for injection) via unspecified route of administration as a SINGLE DOSE on 07Apr2021 02:35PM for COVID-19 immunization. The patient had no relevant medical history and family history. Patient received historical vaccine of first dose BNT162B2 (COMIRNATY) via unspecified route of administration in left arm on 17Mar2021 02:35 PM for COVID-19 immunization. Medical history and concomitant medication was not reported. No family history. Patient reported as does not think her medications had anything to do with the events. she takes all the same medications and didn't have any events with the first vaccine. On 07Apr2021 at 14:35 after second vaccine she got headache right after that and still ongoing. On 08Apr2021 lymph node under arm swollen hurts and she can't touch it and still ongoing, she was nauseous around 5 or 6 in evening. On 08Apr2021 2:00 AM she had chills, tiredness, doesn't feel good weak and fever was 100.5 then it went higher and lower. Second shot on Wednesday and she really sick was 25 percent better today. No Prior Vaccinations (within 4 weeks). The outcome of event recovered for Chills, Fever on 09Apr2021, Nauseous on 08Apr0221 and not recovered for Tiredness, Headache, Doesn't feel good, weak, Lymph node swollen, hurts, can't touch it.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Feeling abnormal
Clinical narrative: Tiredness; Chills; Fever; Doesn't feel good, weak; Lymph node swollen, hurts, can't touch it; Nauseous; Headache; This is a spontaneous report from a contactable consumer (Patient). A 61-year-old female patient received the second dose of BNT162B2 (COMIRNATY Formulation: Solution for injection) via unspecified route of administration as a SINGLE DOSE on 07Apr2021 02:35PM for COVID-19 immunization. The patient had no relevant medical history and family history. Patient received historical vaccine of first dose BNT162B2 (COMIRNATY) via unspecified route of administration in left arm on 17Mar2021 02:35 PM for COVID-19 immunization. Medical history and concomitant medication was not reported. No family history. Patient reported as does not think her medications had anything to do with the events. she takes all the same medications and didn't have any events with the first vaccine. On 07Apr2021 at 14:35 after second vaccine she got headache right after that and still ongoing. On 08Apr2021 lymph node under arm swollen hurts and she can't touch it and still ongoing, she was nauseous around 5 or 6 in evening. On 08Apr2021 2:00 AM she had chills, tiredness, doesn't feel good weak and fever was 100.5 then it went higher and lower. Second shot on Wednesday and she really sick was 25 percent better today. No Prior Vaccinations (within 4 weeks). The outcome of event recovered for Chills, Fever on 09Apr2021, Nauseous on 08Apr0221 and not recovered for Tiredness, Headache, Doesn't feel good, weak, Lymph node swollen, hurts, can't touch it.  No follow-up attempts are needed. No further information is expected.