chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Inappropriate schedule of product administration
Clinical narrative: More than 35 days second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days second dose). On 03-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) no antibodies.         The patient received first dose in late 2020. When doctor recently ran a test on him, he did not have any antibodies.  No concomitant medications were provided by the reporter  No treatment information were provided by the reporter. Patient received his booster shot on 22 Oct 2021 of 0.25 mL.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2021, the patient experienced BACK PAIN (Back pain). The patient was treated with HYDROCODONE for Back pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (Back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Patient is under treatment for a condition of unknown onset; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient is under treatment for a condition of unknown onset) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient is under treatment for a condition of unknown onset). At the time of the report, VACCINATION COMPLICATION (Patient is under treatment for a condition of unknown onset) outcome was unknown.            No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter   Reporter did not allow further contact
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 patients were administered doses of a vial 4 days after the 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients were administered doses of a vial 4 days after the 30-day Use By Date) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients were administered doses of a vial 4 days after the 30-day Use By Date). On 14-Dec-2021, EXPIRED PRODUCT ADMINISTERED (4 patients were administered doses of a vial 4 days after the 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date when the vial was initially stored in the refrigerator: 10 Nov 2021.  No treatment information was reported.   This case was linked to MOD-2021-413275, MOD-2021-413238, MOD-2021-413267 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2021: Significant Follow-up : Reporter address updated, patient Information added and batch/Lot information added. On 14-Dec-2021: Follow-up contains no new information.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included TRIAMCINOLONE ACETONIDE from 25-Oct-2021 to an unknown date, MUPIROCIN from 25-Oct-2021 to an unknown date and IBUPROFEN from 25-Oct-2021 to 25-Oct-2021 for an unknown indication.    On 25-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-413222 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Asthenia, Fatigue, Feeling abnormal, Pain
Clinical narrative: Hardball pain; Bruising on her arm; Swelling; Feels bad; Really weak and tired; Continued severe allergic reaction; Severe pain; Red area of 5 by 4 inches; Fells exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Hardball pain), VACCINATION SITE BRUISING (Bruising on her arm), SWELLING (Swelling), FEELING ABNORMAL (Feels bad) and ASTHENIA (Really weak and tired) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 016B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Hardball pain), VACCINATION SITE BRUISING (Bruising on her arm), SWELLING (Swelling), FEELING ABNORMAL (Feels bad), ASTHENIA (Really weak and tired), ALLERGY TO VACCINE (Continued severe allergic reaction), VACCINATION SITE PAIN (Severe pain), VACCINATION SITE ERYTHEMA (Red area of 5 by 4 inches) and FATIGUE (Fells exhausted). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Hardball pain), VACCINATION SITE BRUISING (Bruising on her arm), SWELLING (Swelling), FEELING ABNORMAL (Feels bad), ASTHENIA (Really weak and tired), ALLERGY TO VACCINE (Continued severe allergic reaction), VACCINATION SITE PAIN (Severe pain), VACCINATION SITE ERYTHEMA (Red area of 5 by 4 inches) and FATIGUE (Fells exhausted) outcome was unknown.            Treatment details include ice, pain medication and observing her. Concomitant medications include not reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site bruising, Vaccination site erythema, Vaccination site pain
Clinical narrative: Hardball pain; Bruising on her arm; Swelling; Feels bad; Really weak and tired; Continued severe allergic reaction; Severe pain; Red area of 5 by 4 inches; Fells exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Hardball pain), VACCINATION SITE BRUISING (Bruising on her arm), SWELLING (Swelling), FEELING ABNORMAL (Feels bad) and ASTHENIA (Really weak and tired) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 016B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Hardball pain), VACCINATION SITE BRUISING (Bruising on her arm), SWELLING (Swelling), FEELING ABNORMAL (Feels bad), ASTHENIA (Really weak and tired), ALLERGY TO VACCINE (Continued severe allergic reaction), VACCINATION SITE PAIN (Severe pain), VACCINATION SITE ERYTHEMA (Red area of 5 by 4 inches) and FATIGUE (Fells exhausted). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Hardball pain), VACCINATION SITE BRUISING (Bruising on her arm), SWELLING (Swelling), FEELING ABNORMAL (Feels bad), ASTHENIA (Really weak and tired), ALLERGY TO VACCINE (Continued severe allergic reaction), VACCINATION SITE PAIN (Severe pain), VACCINATION SITE ERYTHEMA (Red area of 5 by 4 inches) and FATIGUE (Fells exhausted) outcome was unknown.            Treatment details include ice, pain medication and observing her. Concomitant medications include not reported.
Sex: F
Vaccine: PNC13
Symptoms: Adverse reaction, Rash
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "history of skin rash" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (non-serious), outcome "unknown", described as "had a history of skin rash that lasted 8 years and returned with the Prevnar 13 pneumonia vaccine"; RASH (non-serious), outcome "unknown", described as "skin rash ".   Additional information: The patient had a history of skin rash that lasted 8 years and returned with the Prevnar 13 pneumonia vaccine years later; caller states that is all the information she has regarding the Prevnar 13.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Fever at 101 degree Fahrenheit overnight; Still have fever; Lot of chills; Really weak like unwell; Really weak like unwell; Arm hurts, where I have the shot it's hurting me and bothering me a little bit; Arm hurts, where I have the shot it's hurting me and bothering me a little bit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 20Aug2021 (Lot number: FD8448) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 21Aug2021 01:00, outcome "not recovered", described as "Fever at 101 degree Fahrenheit overnight; Still have fever"; CHILLS (non-serious) with onset 21Aug2021 01:00, outcome "unknown", described as "Lot of chills"; ASTHENIA (non-serious), MALAISE (non-serious) all with onset 21Aug2021 01:00, outcome "unknown" and all described as "Really weak like unwell"; PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 21Aug2021 01:00, outcome "unknown" and all described as "Arm hurts, where I have the shot it's hurting me and bothering me a little bit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, asthenia, malaise, pain in extremity, vaccination site pain. Additional information: Report was related to a study or programme. Consumer stated, had a lot of chills all night, still have fever right now, feel like really weak like unwell and arm hurts, think that was normal where she has the shot it was hurting her and bothering a little bit. But concern was this if she feels this way do anybody get sick, herself or if any problems, if she can drink something to lower her fever, have not done anything because she was scared to do anything. Consumer was informed about the role of Pfizer Drug Safety and requested to probe. Consumer stated, just wanted an answer about what to do. Okay, you can go ahead. Started feeling them last night at around would say 1 o'clock in the morning. Her age was 56. Start date of events, consumer stated, 21Aug2021 (21Aug2021) it was after 1 o'clock so it was today. It was just being the same all night lots of chills, the fever and the fever was not going away. So she does not know. Treatment: have not taken anything. Consumer stated, her question was what should she, should she isolate from people or can be next to other people that will be fine or not. Consumer was informed about Pfizer Medical Information.  Follow-up attempts are completed. No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fever at 101 degree Fahrenheit overnight; Still have fever; Lot of chills; Really weak like unwell; Really weak like unwell; Arm hurts, where I have the shot it's hurting me and bothering me a little bit; Arm hurts, where I have the shot it's hurting me and bothering me a little bit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 20Aug2021 (Lot number: FD8448) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 21Aug2021 01:00, outcome "not recovered", described as "Fever at 101 degree Fahrenheit overnight; Still have fever"; CHILLS (non-serious) with onset 21Aug2021 01:00, outcome "unknown", described as "Lot of chills"; ASTHENIA (non-serious), MALAISE (non-serious) all with onset 21Aug2021 01:00, outcome "unknown" and all described as "Really weak like unwell"; PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 21Aug2021 01:00, outcome "unknown" and all described as "Arm hurts, where I have the shot it's hurting me and bothering me a little bit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, asthenia, malaise, pain in extremity, vaccination site pain. Additional information: Report was related to a study or programme. Consumer stated, had a lot of chills all night, still have fever right now, feel like really weak like unwell and arm hurts, think that was normal where she has the shot it was hurting her and bothering a little bit. But concern was this if she feels this way do anybody get sick, herself or if any problems, if she can drink something to lower her fever, have not done anything because she was scared to do anything. Consumer was informed about the role of Pfizer Drug Safety and requested to probe. Consumer stated, just wanted an answer about what to do. Okay, you can go ahead. Started feeling them last night at around would say 1 o'clock in the morning. Her age was 56. Start date of events, consumer stated, 21Aug2021 (21Aug2021) it was after 1 o'clock so it was today. It was just being the same all night lots of chills, the fever and the fever was not going away. So she does not know. Treatment: have not taken anything. Consumer stated, her question was what should she, should she isolate from people or can be next to other people that will be fine or not. Consumer was informed about Pfizer Medical Information.  Follow-up attempts are completed. No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ankylosing spondylitis, Fatigue, Headache, Injection site pruritus, Pain in extremity
Clinical narrative: Injection site itching; Pain in arm; Welts; Itchy; Headache; Spondylitis ankylosing aggravated; Fatigue; This is a solicited report based on the information received by Pfizer from a company (Mfr. Control No. 21K-163-4057970-00). A contactable 42-year-old female consumer reported that she received bnt162b2 (COVD-19 VACCINE, solution for injection), intramuscular on 01Apr2021 (at the age of 42-year-old) at dose 1, single for COVID-19 immunization and adalimumab (HUMIRA) subcutaneous from an unknown date to ongoing at an unknown dose and frequency for ankylosing spondylitis. Medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown dates, the patient experienced itch at injection site and sore arm. On an unspecified date in 2021, the patient experienced fatigue, headache, Spondylitis ankylosing aggravated, itch and welts. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. Action taken in response to the events for suspect drug Humira was dose not changed. Outcome of the event Injection site itching was not resolved whereas for other events was unknown.  The reporter's causality for the events of fatigue, Itchy, spondylitis ankylosing aggravated and sore arm with Humira (Adalimumab) was no reasonable possibility, for event itch at injection site was a reasonable possibility and for events headache, welts was not reported. The reporter's causality for events fatigue, headache was probable, for event sore arm and itch at injection site, itchy, spondylitis ankylosing aggravated, welts with Pfizer Biontech Covid-19 Vaccine was not related.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up(03Dec2021) This is a Follow-up solicited report based on the information received by Pfizer from a company (MFR Control No. 21K-163-4181817-00). Case upgraded to serious. New information included: Suspect drug (vaccination date was updated for dose 1), new events (Itchy, Welts and Spondylitis ankylosing aggravated), onset date of event (fatigue and headache) and narrative updated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of fatigue, itch at injection site, headache and sore arm, Itchy, Welts and Spondylitis ankylosing aggravated. "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: 42.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pruritus, Urticaria
Clinical narrative: Injection site itching; Pain in arm; Welts; Itchy; Headache; Spondylitis ankylosing aggravated; Fatigue; This is a solicited report based on the information received by Pfizer from a company (Mfr. Control No. 21K-163-4057970-00). A contactable 42-year-old female consumer reported that she received bnt162b2 (COVD-19 VACCINE, solution for injection), intramuscular on 01Apr2021 (at the age of 42-year-old) at dose 1, single for COVID-19 immunization and adalimumab (HUMIRA) subcutaneous from an unknown date to ongoing at an unknown dose and frequency for ankylosing spondylitis. Medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown dates, the patient experienced itch at injection site and sore arm. On an unspecified date in 2021, the patient experienced fatigue, headache, Spondylitis ankylosing aggravated, itch and welts. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. Action taken in response to the events for suspect drug Humira was dose not changed. Outcome of the event Injection site itching was not resolved whereas for other events was unknown.  The reporter's causality for the events of fatigue, Itchy, spondylitis ankylosing aggravated and sore arm with Humira (Adalimumab) was no reasonable possibility, for event itch at injection site was a reasonable possibility and for events headache, welts was not reported. The reporter's causality for events fatigue, headache was probable, for event sore arm and itch at injection site, itchy, spondylitis ankylosing aggravated, welts with Pfizer Biontech Covid-19 Vaccine was not related.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up(03Dec2021) This is a Follow-up solicited report based on the information received by Pfizer from a company (MFR Control No. 21K-163-4181817-00). Case upgraded to serious. New information included: Suspect drug (vaccination date was updated for dose 1), new events (Itchy, Welts and Spondylitis ankylosing aggravated), onset date of event (fatigue and headache) and narrative updated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of fatigue, itch at injection site, headache and sore arm, Itchy, Welts and Spondylitis ankylosing aggravated. "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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body height decreased, Dizziness, Electrocardiogram, Malaise, Tachycardia
Clinical narrative: fast heartbeat; got dizzy; not feeling well; Used to be 6 feet 4 inches, is now 6 feet 3 inches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administration date 24Mar2021 11:00 (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "He smoked for 35 years" (unspecified if ongoing), notes: He smoked for 35 years, but clarifies he hasn't had a cigarette in about 4 years.; "macular degeneration" (unspecified if ongoing), notes: he has macular degeneration and can't see well.; "dizzy", start date: 2021 (unspecified if ongoing); "fast heart beat", start date: 2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, from being in the hospital and in an emergency., Time: 11:00), administration date: 03Mar2021, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "fast heart beat", "he couldn't walk/had trouble going upstairs", "dizzy", "blood pressure was a little high", "sweating", "room was spinning", "feeling abnormal"; Bnt162b2 (First dose, Time: 11:00), administration date: 03Mar2021, when the patient was 67 years old, for COVID-19 immunisation, reaction(s): "he thought he had a heart attack", "Couldn't remember exactly when he had gone to the ER", "only nauseous when he was dizzy", "eyes were not that good while reading the paperwork from the ER", "Out of breath", "Falling all over the place"; Pneumonia (he was also inoculated for pneumonia), for immunisation; Hep a (he was inoculated for Hep A, Hep B, chicken pox, and stuff as kids.), for immunization; Hep b (he was inoculated for Hep A, Hep B, chicken pox, and stuff as kids.), for immunization; Chicken pox (he was inoculated for Hep A, Hep B, chicken pox, and stuff as kids.), for immunization. The following information was reported: TACHYCARDIA (hospitalization) with onset 2021, outcome "unknown", described as "fast heartbeat"; DIZZINESS (hospitalization) with onset 2021, outcome "unknown", described as "got dizzy"; MALAISE (hospitalization) with onset 2021, outcome "unknown", described as "not feeling well"; BODY HEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "Used to be 6 feet 4 inches, is now 6 feet 3 inches". The patient reported he had not had problems after his second vaccine dose. After he got the second dose, he was not feeling well. Three days after, got dizzy and taken to the hospital where he was experiencing a fast heartbeat. The patient underwent the following laboratory tests and procedures: electrocardiogram: came out perfect, notes: His EKG came out perfect; unknown result. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Heart rate, Hypoaesthesia, Paraesthesia, Sinus bradycardia
Clinical narrative: new parasthesias/tingling; new numbness; Fluctuating sinus bradycardia to tachycardia (45-190) for 4 months starting immediately after vaccine; Fluctuating sinus bradycardia to tachycardia (45-190) for 4 months starting immediately after vaccine; exercise intolerance; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 37-year-old male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) at the age of 37 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "Pre-diabetes" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE. The following information was reported: SINUS BRADYCARDIA (non-serious), SINUS TACHYCARDIA (non-serious) all with onset Mar2021, outcome "not recovered" and all described as "Fluctuating sinus bradycardia to tachycardia (45-190) for 4 months starting immediately after vaccine"; EXERCISE TOLERANCE DECREASED (non-serious) with onset Mar2021, outcome "not recovered", described as "exercise intolerance"; PARAESTHESIA (non-serious) with onset May2021, outcome "not recovered", described as "new parasthesias/tingling"; HYPOAESTHESIA (non-serious) with onset May2021, outcome "not recovered", described as "new numbness". The events "fluctuating sinus bradycardia to tachycardia (45-190) for 4 months starting immediately after vaccine", "fluctuating sinus bradycardia to tachycardia (45-190) for 4 months starting immediately after vaccine", "exercise intolerance", "new parasthesias/tingling" and "new numbness" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of sinus bradycardia, sinus tachycardia, exercise tolerance decreased, paraesthesia, hypoaesthesia. Additional information: Patient did not have known allergies. Patient did not have other vaccine in four weeks. Patient did not have COVID-19 prior vaccination. It was unknown if patient had COVID-19 tested post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus tachycardia
Clinical narrative: new parasthesias/tingling; new numbness; Fluctuating sinus bradycardia to tachycardia (45-190) for 4 months starting immediately after vaccine; Fluctuating sinus bradycardia to tachycardia (45-190) for 4 months starting immediately after vaccine; exercise intolerance; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 37-year-old male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) at the age of 37 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "Pre-diabetes" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE. The following information was reported: SINUS BRADYCARDIA (non-serious), SINUS TACHYCARDIA (non-serious) all with onset Mar2021, outcome "not recovered" and all described as "Fluctuating sinus bradycardia to tachycardia (45-190) for 4 months starting immediately after vaccine"; EXERCISE TOLERANCE DECREASED (non-serious) with onset Mar2021, outcome "not recovered", described as "exercise intolerance"; PARAESTHESIA (non-serious) with onset May2021, outcome "not recovered", described as "new parasthesias/tingling"; HYPOAESTHESIA (non-serious) with onset May2021, outcome "not recovered", described as "new numbness". The events "fluctuating sinus bradycardia to tachycardia (45-190) for 4 months starting immediately after vaccine", "fluctuating sinus bradycardia to tachycardia (45-190) for 4 months starting immediately after vaccine", "exercise intolerance", "new parasthesias/tingling" and "new numbness" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of sinus bradycardia, sinus tachycardia, exercise tolerance decreased, paraesthesia, hypoaesthesia. Additional information: Patient did not have known allergies. Patient did not have other vaccine in four weeks. Patient did not have COVID-19 prior vaccination. It was unknown if patient had COVID-19 tested post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic fatigue syndrome, Condition aggravated, Post viral fatigue syndrome, Vaccination site pain
Clinical narrative: I have ME/CFS/ my condition has been exacerbated; I have ME/CFS/ my condition has been exacerbated; I have ME/CFS/ my condition has been exacerbated; normal soreness around injection site for a few days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date May2021 (Batch/Lot number: unknown) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ME/CFS" (unspecified if ongoing), notes: ME/CFS; "ME/CFS" (unspecified if ongoing), notes: ME/CFS; "Reactivated Epstein-Barr", start date: 2020 (unspecified if ongoing), notes: reactivated Epstein-Barr (non contagious), also have had reactivated EBV for over a year. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 01, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: POST VIRAL FATIGUE SYNDROME (non-serious), CHRONIC FATIGUE SYNDROME (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 2021, outcome "recovering" and all described as "I have ME/CFS/ my condition has been exacerbated"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered with sequelae" (2021), described as "normal soreness around injection site for a few days". Therapeutic measures were not taken as a result of post viral fatigue syndrome, chronic fatigue syndrome, condition aggravated, vaccination site pain.  Additional information: Prior to vaccination the patient had not been diagnosed with COVID-19. The patient reported the events were not serious and did not require hospitalization. The patient reported that the vaccine itself was fine; only minor extra tiredness for a day or two after second dose and normal soreness around injection site for a few days. The patient was thrilled it went so well, but wanted to report she had ME/CFS, and while she was still glad she got the Pfizer mRNA vaccine, her condition had been exacerbated starting about a week after her second dose. She had much more inflammation and tiredness than usual, with some days really weak. Now about 4 months later, she thought it was starting to ease up but was not sure. Since vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Pyrexia, Vaccination site erythema, Vaccination site warmth
Clinical narrative: My arm is very red and warm about 4 inches around the injection site; arm is very warm about 4 inches around the injection site; Fever of 101.4; Dizzy; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Sep2021 15:45 (Lot number: FC3183) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 15Sep2021 16:00, outcome "not recovered", described as "My arm is very red and warm about 4 inches around the injection site"; VACCINATION SITE WARMTH (non-serious) with onset 15Sep2021 16:00, outcome "not recovered", described as "arm is very warm about 4 inches around the injection site"; PYREXIA (non-serious) with onset 15Sep2021 16:00, outcome "not recovered", described as "Fever of 101.4"; DIZZINESS (non-serious) with onset 15Sep2021 16:00, outcome "not recovered", described as "Dizzy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site warmth, pyrexia, dizziness. Additional information: Patient did not have known allergies or other medical history. Patient did not have other vaccine in four weeks. Events did not result to visit physician office or emergency room. Patient did not have COVID-19 tested post vaccination.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Retinal exudates
Clinical narrative: MEWDS in my right eye; This is a spontaneous report received from contactable reporter (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm left, administration date 07May2021 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Long COVID" (unspecified if ongoing); "known allergies: Cruciferous Vegetables" (unspecified if ongoing); "covid prior to vaccination" (unspecified if ongoing). Concomitant medications included: BUDESONIDE; ALBUTEROL [SALBUTAMOL]. The patient did not receive any other vaccines with 4 weeks prior to the COVID vaccine. Vaccination history included: BNT162B2 (1st dose, Anatomical Location: Arm Right), for COVID-19 immunization. The following information was reported: RETINAL EXUDATES (medically significant) with onset 12Sep2021, outcome "not recovered", described as "MEWDS in my right eye". The event "mewds in my right eye" was evaluated at the physician office visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of retinal exudates. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the prolonged onset latency and the etiology of the condition, it appears unlikely that BNT162B2 contributed to the event MEWDS in the right eye. The event could've been caused by "long covid" prior to vaccination. This case will be reassessed if additional information becomes available. 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Lymphadenopathy
Clinical narrative: swollen lymph node; Painful lump in left armpit; Painful lump in left armpit; This is a spontaneous report from a contactable consumer (Patient). A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Oct2021 at 12:00 (Lot number: 32030801) at the age of 48 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "depression" (unspecified if ongoing); "acne" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII, administration date 13Sep2021; ESCITALOPRAM taken for depression (ongoing); WIXELA INHUB taken for asthma (ongoing); PROAIR DIGIHALER taken for asthma (ongoing); SPIRONOLACTONE taken for acne (ongoing). Vaccination history included: Bnt162b2 (Dose, 1st dose, Date:04Mar2021, Anatomical site of injection: left arm, Route of Administration: Intramuscular, Batch/Lot number: EJ1685), administration date: 04Mar2021, when the patient was 48 years old, for Covid-19 immunization; Bnt162b2 (Dose, 2nd dose, Date:25Apr2021, Anatomical site of injection: left arm, Route of Administration: Intramuscular, Batch/Lot number: EK5730), administration date: 25Apr2021, when the patient was 48 years old, for Covid-19 immunization; Flu (Vaccine Name: Flu, Manufacturer: Unknown, Batch/Lot#: Unknown, Route: IM, Anatomical site of injection: left arm, No of previous doses: Unknown, Date:23Sep2021), administration date: 23Sep2021.The following information was reported: PAIN (non-serious), AXILLARY MASS (non-serious) all with onset 25Oct2021 08:00, outcome "not recovered" and all described as "Painful lump in left armpit"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph node". Therapeutic measures were not taken as a result of pain, axillary mass.  Additional information: facility type vaccine: Pharmacy or Drug Store. if other vaccine in four weeks: Yes. other vaccine 4weeks details: other vaccine 4weeks product=Flu vaccine. adverse event: Painful lump in left armpit. adverse event: start date 25Oct2021. adverse events start time: 08:00 AM. adverse event country: US. ae resulted in: [None of the above]. if patient recovered: Not recovered. if treatment ae: No. if COVID prior vaccination: No. if COVID tested post vaccination: No. known allergies: No. other medical history: Asthma. I experienced a painful lump in my left armpit (presumably swollen lymph node) for two days after vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Dyskinesia, Musculoskeletal stiffness, Myalgia
Clinical narrative: Back pain; In the mornings he is stiff and cant move; In the mornings he is stiff and cant move; Joint and Muscle Pain; Joint and Muscle Pain; I now have consent Pain. The level increases and decreases; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101732327 (PFIZER).  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Mar2021 10:00 (Lot number: EN6198) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Iodine, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Pfizer, Inc EN5318, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 14Feb2021, for Covid-19 immunization, reaction(s): "back pain". The following information was reported: ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 07Mar2021, outcome "not recovered" and all described as "Joint and Muscle Pain"; PAIN (non-serious) with onset 07Mar2021, outcome "not recovered", described as "I now have consent Pain. The level increases and decreases"; BACK PAIN (non-serious), outcome "unknown", described as "Back pain"; DYSKINESIA (non-serious), outcome "recovering", MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown" and all described as "In the mornings he is stiff and cant move". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of arthralgia, myalgia, pain.  Additional information: Since the Vaccine patient experienced the following: Joint and Muscle Pain. The level increases and decreases. The pain is constant from a 2-10. By the end of the day it can be a 10. Patient wake up it is a 3-5. Patient thought it would diminish as time goes on but it not. After getting first and second dose he had side effects of muscle pain and back pain and he can barely go in or out of the bed. muscle pain and back pain. These began at first and he was tossing it off, it was probably a week or 7 days after his second dose. AE outcome: Patient says he would say slowly it has gotten worse now, it has leveled off to bad. AE treatment: says he has done nothing other than take Advil or Aleve for a week, he was taking probably 8 a day of Aleve and 4-5 a day of Advil, basically 8 a day of whatever had gel caps or the little round ones. Caller doesn't clarify dosage of those medications. Since his second vaccine he has experienced ongoing muscle and back pain. Per caller if he has a whole day of work he can barely straighten up & move. In the mornings he is stiff and cant move, but as the day goes on it loosens up. Physical activity makes it worst.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain assessment
Clinical narrative: Back pain; In the mornings he is stiff and cant move; In the mornings he is stiff and cant move; Joint and Muscle Pain; Joint and Muscle Pain; I now have consent Pain. The level increases and decreases; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101732327 (PFIZER).  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Mar2021 10:00 (Lot number: EN6198) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Iodine, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Pfizer, Inc EN5318, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 14Feb2021, for Covid-19 immunization, reaction(s): "back pain". The following information was reported: ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 07Mar2021, outcome "not recovered" and all described as "Joint and Muscle Pain"; PAIN (non-serious) with onset 07Mar2021, outcome "not recovered", described as "I now have consent Pain. The level increases and decreases"; BACK PAIN (non-serious), outcome "unknown", described as "Back pain"; DYSKINESIA (non-serious), outcome "recovering", MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown" and all described as "In the mornings he is stiff and cant move". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of arthralgia, myalgia, pain.  Additional information: Since the Vaccine patient experienced the following: Joint and Muscle Pain. The level increases and decreases. The pain is constant from a 2-10. By the end of the day it can be a 10. Patient wake up it is a 3-5. Patient thought it would diminish as time goes on but it not. After getting first and second dose he had side effects of muscle pain and back pain and he can barely go in or out of the bed. muscle pain and back pain. These began at first and he was tossing it off, it was probably a week or 7 days after his second dose. AE outcome: Patient says he would say slowly it has gotten worse now, it has leveled off to bad. AE treatment: says he has done nothing other than take Advil or Aleve for a week, he was taking probably 8 a day of Aleve and 4-5 a day of Advil, basically 8 a day of whatever had gel caps or the little round ones. Caller doesn't clarify dosage of those medications. Since his second vaccine he has experienced ongoing muscle and back pain. Per caller if he has a whole day of work he can barely straighten up & move. In the mornings he is stiff and cant move, but as the day goes on it loosens up. Physical activity makes it worst.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mass, Swelling
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Oct2021 12:20 (Lot number: FH8027) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 2), administration date: 2021, when the patient was 63 years old, for Covid-19 immunization; Bnt162b2 (dose 1), administration date: 2021, when the patient was 63 years old, for Covid-19 immunization. The following information was reported: MASS (non-serious), SWELLING (non-serious) all with onset 26Oct2021, outcome "unknown" and all described as "Lump on my neck, on my left side, on my clavicula right around that area; It moves, like a little ball, when I touch; it is a little swollen, nothing too much"; LYMPHADENOPATHY (non-serious) with onset 26Oct2021, outcome "unknown", described as "swollen lymph node". Therapeutic measures were not taken as a result of mass, swelling, lymphadenopathy. No follow-up attempts are possible. No further information is expected.