chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19-2, COVID19-2, FLU4
Symptoms: Angiogram pulmonary abnormal, Blood HIV RNA below assay limit, Blood culture negative, Blood immunoglobulin G normal, Blood immunoglobulin M
Clinical narrative: Vaccinated for flu and covid on 10/5.  Had symptoms of fever and fatigue on 10/6 and 10/7 which are typical for patient after covid vaccines (this was his 5th dose).  He is high risk because of obesity.  On saturday, 10/8 he started having a rash and shortness of breath and he sought care at an urgent care who transferred him to an ED.  HE was found to have orthopnea, LE edema, and DOE with elevated troponin (200s).  Cardiac MRI was recommended but couldn't be done in a timely manner so he was transferred to our ED and admitted for myocarditis.  Troponins were already decreasing and CRP was >100.  Rash was present and thought to be more typical of viral exanthem but all viral studies were negative (see below).  He remained febrile until 10/13 and defervesce and rash began to fade. He was also digressed and treated for hypertension.   trops and crp were decreasing and patient was less symptomatic.  he was d/ced home.
Age: 37.0
Sex: M
Vaccine: COVID19-2, COVID19-2, FLU4
Symptoms: Borrelia test negative, Cardiac dysfunction, Cardiac imaging procedure abnormal, Chest pain, Chills
Clinical narrative: Vaccinated for flu and covid on 10/5.  Had symptoms of fever and fatigue on 10/6 and 10/7 which are typical for patient after covid vaccines (this was his 5th dose).  He is high risk because of obesity.  On saturday, 10/8 he started having a rash and shortness of breath and he sought care at an urgent care who transferred him to an ED.  HE was found to have orthopnea, LE edema, and DOE with elevated troponin (200s).  Cardiac MRI was recommended but couldn't be done in a timely manner so he was transferred to our ED and admitted for myocarditis.  Troponins were already decreasing and CRP was >100.  Rash was present and thought to be more typical of viral exanthem but all viral studies were negative (see below).  He remained febrile until 10/13 and defervesce and rash began to fade. He was also digressed and treated for hypertension.   trops and crp were decreasing and patient was less symptomatic.  he was d/ced home.
Age: 37.0
Sex: M
Vaccine: COVID19-2, COVID19-2, FLU4
Symptoms: Computerised tomogram thorax, Cytomegalovirus test negative, Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased
Clinical narrative: Vaccinated for flu and covid on 10/5.  Had symptoms of fever and fatigue on 10/6 and 10/7 which are typical for patient after covid vaccines (this was his 5th dose).  He is high risk because of obesity.  On saturday, 10/8 he started having a rash and shortness of breath and he sought care at an urgent care who transferred him to an ED.  HE was found to have orthopnea, LE edema, and DOE with elevated troponin (200s).  Cardiac MRI was recommended but couldn't be done in a timely manner so he was transferred to our ED and admitted for myocarditis.  Troponins were already decreasing and CRP was >100.  Rash was present and thought to be more typical of viral exanthem but all viral studies were negative (see below).  He remained febrile until 10/13 and defervesce and rash began to fade. He was also digressed and treated for hypertension.   trops and crp were decreasing and patient was less symptomatic.  he was d/ced home.
Age: 37.0
Sex: M
Vaccine: COVID19-2, COVID19-2, FLU4
Symptoms: Epstein-Barr virus test negative, Fatigue, Gynaecomastia, HIV antibody negative, HIV antigen negative
Clinical narrative: Vaccinated for flu and covid on 10/5.  Had symptoms of fever and fatigue on 10/6 and 10/7 which are typical for patient after covid vaccines (this was his 5th dose).  He is high risk because of obesity.  On saturday, 10/8 he started having a rash and shortness of breath and he sought care at an urgent care who transferred him to an ED.  HE was found to have orthopnea, LE edema, and DOE with elevated troponin (200s).  Cardiac MRI was recommended but couldn't be done in a timely manner so he was transferred to our ED and admitted for myocarditis.  Troponins were already decreasing and CRP was >100.  Rash was present and thought to be more typical of viral exanthem but all viral studies were negative (see below).  He remained febrile until 10/13 and defervesce and rash began to fade. He was also digressed and treated for hypertension.   trops and crp were decreasing and patient was less symptomatic.  he was d/ced home.
Age: 37.0
Sex: M
Vaccine: COVID19-2, COVID19-2, FLU4
Symptoms: Hepatitis viral test negative, Imaging procedure artifact, Left ventricular dysfunction, Lung opacity, Mycoplasma test
Clinical narrative: Vaccinated for flu and covid on 10/5.  Had symptoms of fever and fatigue on 10/6 and 10/7 which are typical for patient after covid vaccines (this was his 5th dose).  He is high risk because of obesity.  On saturday, 10/8 he started having a rash and shortness of breath and he sought care at an urgent care who transferred him to an ED.  HE was found to have orthopnea, LE edema, and DOE with elevated troponin (200s).  Cardiac MRI was recommended but couldn't be done in a timely manner so he was transferred to our ED and admitted for myocarditis.  Troponins were already decreasing and CRP was >100.  Rash was present and thought to be more typical of viral exanthem but all viral studies were negative (see below).  He remained febrile until 10/13 and defervesce and rash began to fade. He was also digressed and treated for hypertension.   trops and crp were decreasing and patient was less symptomatic.  he was d/ced home.
Age: 37.0
Sex: M
Vaccine: COVID19-2, COVID19-2, FLU4
Symptoms: Night sweats, Nodule, Oral disorder, Oropharyngeal pain, Pain in extremity
Clinical narrative: Vaccinated for flu and covid on 10/5.  Had symptoms of fever and fatigue on 10/6 and 10/7 which are typical for patient after covid vaccines (this was his 5th dose).  He is high risk because of obesity.  On saturday, 10/8 he started having a rash and shortness of breath and he sought care at an urgent care who transferred him to an ED.  HE was found to have orthopnea, LE edema, and DOE with elevated troponin (200s).  Cardiac MRI was recommended but couldn't be done in a timely manner so he was transferred to our ED and admitted for myocarditis.  Troponins were already decreasing and CRP was >100.  Rash was present and thought to be more typical of viral exanthem but all viral studies were negative (see below).  He remained febrile until 10/13 and defervesce and rash began to fade. He was also digressed and treated for hypertension.   trops and crp were decreasing and patient was less symptomatic.  he was d/ced home.
Age: 37.0
Sex: M
Vaccine: COVID19-2, COVID19-2, FLU4
Symptoms: Parvovirus B19 test negative, Pleural effusion, Productive cough, Pulmonary oedema, Pulmonary septal thickening
Clinical narrative: Vaccinated for flu and covid on 10/5.  Had symptoms of fever and fatigue on 10/6 and 10/7 which are typical for patient after covid vaccines (this was his 5th dose).  He is high risk because of obesity.  On saturday, 10/8 he started having a rash and shortness of breath and he sought care at an urgent care who transferred him to an ED.  HE was found to have orthopnea, LE edema, and DOE with elevated troponin (200s).  Cardiac MRI was recommended but couldn't be done in a timely manner so he was transferred to our ED and admitted for myocarditis.  Troponins were already decreasing and CRP was >100.  Rash was present and thought to be more typical of viral exanthem but all viral studies were negative (see below).  He remained febrile until 10/13 and defervesce and rash began to fade. He was also digressed and treated for hypertension.   trops and crp were decreasing and patient was less symptomatic.  he was d/ced home.
Age: 37.0
Sex: M
Vaccine: COVID19-2, COVID19-2, FLU4
Symptoms: Pyrexia, Rash, SARS-CoV-2 test negative, Scan with contrast abnormal, Sensitive skin
Clinical narrative: Vaccinated for flu and covid on 10/5.  Had symptoms of fever and fatigue on 10/6 and 10/7 which are typical for patient after covid vaccines (this was his 5th dose).  He is high risk because of obesity.  On saturday, 10/8 he started having a rash and shortness of breath and he sought care at an urgent care who transferred him to an ED.  HE was found to have orthopnea, LE edema, and DOE with elevated troponin (200s).  Cardiac MRI was recommended but couldn't be done in a timely manner so he was transferred to our ED and admitted for myocarditis.  Troponins were already decreasing and CRP was >100.  Rash was present and thought to be more typical of viral exanthem but all viral studies were negative (see below).  He remained febrile until 10/13 and defervesce and rash began to fade. He was also digressed and treated for hypertension.   trops and crp were decreasing and patient was less symptomatic.  he was d/ced home.
Age: 37.0
Sex: M
Vaccine: COVID19-2, COVID19-2, FLU4
Symptoms: Sputum discoloured, Streptococcus test negative, Tachycardia, Troponin increased, Vomiting
Clinical narrative: Vaccinated for flu and covid on 10/5.  Had symptoms of fever and fatigue on 10/6 and 10/7 which are typical for patient after covid vaccines (this was his 5th dose).  He is high risk because of obesity.  On saturday, 10/8 he started having a rash and shortness of breath and he sought care at an urgent care who transferred him to an ED.  HE was found to have orthopnea, LE edema, and DOE with elevated troponin (200s).  Cardiac MRI was recommended but couldn't be done in a timely manner so he was transferred to our ED and admitted for myocarditis.  Troponins were already decreasing and CRP was >100.  Rash was present and thought to be more typical of viral exanthem but all viral studies were negative (see below).  He remained febrile until 10/13 and defervesce and rash began to fade. He was also digressed and treated for hypertension.   trops and crp were decreasing and patient was less symptomatic.  he was d/ced home.
Age: 37.0
Sex: M
Vaccine: COVID19-2, COVID19-2, FLU4
Symptoms: Adenovirus test, Blood HIV RNA, Borrelia test positive, C-reactive protein increased, Chest X-ray abnormal
Clinical narrative: Vaccinated for flu and covid on 10/5.  Had symptoms of fever and fatigue on 10/6 and 10/7 which are typical for patient after covid vaccines (this was his 5th dose).  He is high risk because of obesity.  On saturday, 10/8 he started having a rash and shortness of breath and he sought care at an urgent care who transferred him to an ED.  HE was found to have orthopnea, LE edema, and DOE with elevated troponin (200s).  Cardiac MRI was recommended but couldn't be done in a timely manner so he was transferred to our ED and admitted for myocarditis.  Troponins were already decreasing and CRP was >100.  Rash was present and thought to be more typical of viral exanthem but all viral studies were negative (see below).  He remained febrile until 10/13 and defervesce and rash began to fade. He was also digressed and treated for hypertension.   trops and crp were decreasing and patient was less symptomatic.  he was d/ced home.
Age: 37.0
Sex: M
Vaccine: COVID19-2, COVID19-2, FLU4
Symptoms: Cytomegalovirus test negative, Dyspnoea, Dyspnoea exertional, Echocardiogram, Echovirus test negative
Clinical narrative: Vaccinated for flu and covid on 10/5.  Had symptoms of fever and fatigue on 10/6 and 10/7 which are typical for patient after covid vaccines (this was his 5th dose).  He is high risk because of obesity.  On saturday, 10/8 he started having a rash and shortness of breath and he sought care at an urgent care who transferred him to an ED.  HE was found to have orthopnea, LE edema, and DOE with elevated troponin (200s).  Cardiac MRI was recommended but couldn't be done in a timely manner so he was transferred to our ED and admitted for myocarditis.  Troponins were already decreasing and CRP was >100.  Rash was present and thought to be more typical of viral exanthem but all viral studies were negative (see below).  He remained febrile until 10/13 and defervesce and rash began to fade. He was also digressed and treated for hypertension.   trops and crp were decreasing and patient was less symptomatic.  he was d/ced home.
Age: 37.0
Sex: M
Vaccine: COVID19-2, COVID19-2, FLU4
Symptoms: Enterovirus test negative, Epstein-Barr virus test negative, Fatigue, Hepatitis viral test negative, Hypertension
Clinical narrative: Vaccinated for flu and covid on 10/5.  Had symptoms of fever and fatigue on 10/6 and 10/7 which are typical for patient after covid vaccines (this was his 5th dose).  He is high risk because of obesity.  On saturday, 10/8 he started having a rash and shortness of breath and he sought care at an urgent care who transferred him to an ED.  HE was found to have orthopnea, LE edema, and DOE with elevated troponin (200s).  Cardiac MRI was recommended but couldn't be done in a timely manner so he was transferred to our ED and admitted for myocarditis.  Troponins were already decreasing and CRP was >100.  Rash was present and thought to be more typical of viral exanthem but all viral studies were negative (see below).  He remained febrile until 10/13 and defervesce and rash began to fade. He was also digressed and treated for hypertension.   trops and crp were decreasing and patient was less symptomatic.  he was d/ced home.
Age: 37.0
Sex: M
Vaccine: COVID19-2, COVID19-2, FLU4
Symptoms: Immunology test, Laboratory test, Left ventricular dysfunction, Legionella test, Measles antibody negative
Clinical narrative: Vaccinated for flu and covid on 10/5.  Had symptoms of fever and fatigue on 10/6 and 10/7 which are typical for patient after covid vaccines (this was his 5th dose).  He is high risk because of obesity.  On saturday, 10/8 he started having a rash and shortness of breath and he sought care at an urgent care who transferred him to an ED.  HE was found to have orthopnea, LE edema, and DOE with elevated troponin (200s).  Cardiac MRI was recommended but couldn't be done in a timely manner so he was transferred to our ED and admitted for myocarditis.  Troponins were already decreasing and CRP was >100.  Rash was present and thought to be more typical of viral exanthem but all viral studies were negative (see below).  He remained febrile until 10/13 and defervesce and rash began to fade. He was also digressed and treated for hypertension.   trops and crp were decreasing and patient was less symptomatic.  he was d/ced home.
Age: 37.0
Sex: M
Vaccine: COVID19-2, COVID19-2, FLU4
Symptoms: Mycoplasma test positive, Myocarditis, Oedema peripheral, Orthopnoea, Parvovirus B19 test positive
Clinical narrative: Vaccinated for flu and covid on 10/5.  Had symptoms of fever and fatigue on 10/6 and 10/7 which are typical for patient after covid vaccines (this was his 5th dose).  He is high risk because of obesity.  On saturday, 10/8 he started having a rash and shortness of breath and he sought care at an urgent care who transferred him to an ED.  HE was found to have orthopnea, LE edema, and DOE with elevated troponin (200s).  Cardiac MRI was recommended but couldn't be done in a timely manner so he was transferred to our ED and admitted for myocarditis.  Troponins were already decreasing and CRP was >100.  Rash was present and thought to be more typical of viral exanthem but all viral studies were negative (see below).  He remained febrile until 10/13 and defervesce and rash began to fade. He was also digressed and treated for hypertension.   trops and crp were decreasing and patient was less symptomatic.  he was d/ced home.
Age: 37.0
Sex: M
Vaccine: COVID19-2, COVID19-2, FLU4
Symptoms: Pyrexia, Rash, Rubella antibody negative, Streptococcus test negative, Troponin increased
Clinical narrative: Vaccinated for flu and covid on 10/5.  Had symptoms of fever and fatigue on 10/6 and 10/7 which are typical for patient after covid vaccines (this was his 5th dose).  He is high risk because of obesity.  On saturday, 10/8 he started having a rash and shortness of breath and he sought care at an urgent care who transferred him to an ED.  HE was found to have orthopnea, LE edema, and DOE with elevated troponin (200s).  Cardiac MRI was recommended but couldn't be done in a timely manner so he was transferred to our ED and admitted for myocarditis.  Troponins were already decreasing and CRP was >100.  Rash was present and thought to be more typical of viral exanthem but all viral studies were negative (see below).  He remained febrile until 10/13 and defervesce and rash began to fade. He was also digressed and treated for hypertension.   trops and crp were decreasing and patient was less symptomatic.  he was d/ced home.
Age: 37.0
Sex: M
Vaccine: COVID19-2, COVID19-2, FLU4
Symptoms: Viral test negative
Clinical narrative: Vaccinated for flu and covid on 10/5.  Had symptoms of fever and fatigue on 10/6 and 10/7 which are typical for patient after covid vaccines (this was his 5th dose).  He is high risk because of obesity.  On saturday, 10/8 he started having a rash and shortness of breath and he sought care at an urgent care who transferred him to an ED.  HE was found to have orthopnea, LE edema, and DOE with elevated troponin (200s).  Cardiac MRI was recommended but couldn't be done in a timely manner so he was transferred to our ED and admitted for myocarditis.  Troponins were already decreasing and CRP was >100.  Rash was present and thought to be more typical of viral exanthem but all viral studies were negative (see below).  He remained febrile until 10/13 and defervesce and rash began to fade. He was also digressed and treated for hypertension.   trops and crp were decreasing and patient was less symptomatic.  he was d/ced home.
Age: 1.17
Sex: F
Vaccine: COVID19, COVID19-2, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given the adult dose of bivalent and not the child dose
Age: 1.17
Sex: F
Vaccine: COVID19, COVID19-2, COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient was given the adult dose of bivalent and not the child dose
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Prostatic specific antigen, Suspected COVID-19
Clinical narrative: PSA increase; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 18Oct2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 Immunization, reaction(s): "every time I got a vaccine or a booster, my PSA readings go up"; Bnt162b2 (Dose 2, Single), for COVID-19 Immunization, reaction(s): "every time I got a vaccine or a booster, my PSA readings go up". The following information was reported: PROSTATIC SPECIFIC ANTIGEN INCREASED (non-serious), outcome "unknown", described as "PSA increase". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter mentioned that he already 2 doses of the Pfizer Covid-19 Vaccine and the booster dose. He took Paxlovid as well. He wanted to know if there is correlations between Paxlovid and Pfizer Covid-19 Vaccine with his PSA increase. Reporter stated "he read several things saying they've been test and show high PSA levels, he had 2 vaccines and 2 boosters and then the paxlovid, because he contracted Covid 19, he have a chart showing when he was taken the vaccine and when he got back my PSA readings back and every time he got a vaccine or a booster, his PSA readings go up. He also heard that they go up when you contract Covid 19, but there's no information about Paxlovid because it was so new, but when you have covid 19 and you feel terrible, anything that helps is considered. He was curious, he mentioned this to urologist, but he wanted to know if there's a correlation that you've heard about, with Paxlovid and the vaccine and the booster. He mentioned he didn't know if he received the bivalent or monovalent formulation, he received it when it just came out and his most recent booster was on 25Mar2022. He took Paxlovid took 2 months ago, on 12Aug2022. He wanted to know if the chemical make up of Paxlovid was the same as the booster and the vaccine. He also read in case studies that if you contract covid, that also elevates the PSA, there's a test, 91 people PSA levels went from 1.58 to 4.34 on average, he was wondering if you heard anything about that. he figured you might have heard about it. Patient had a phone meeting with his urologist.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen increased
Clinical narrative: PSA increase; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 18Oct2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 Immunization, reaction(s): "every time I got a vaccine or a booster, my PSA readings go up"; Bnt162b2 (Dose 2, Single), for COVID-19 Immunization, reaction(s): "every time I got a vaccine or a booster, my PSA readings go up". The following information was reported: PROSTATIC SPECIFIC ANTIGEN INCREASED (non-serious), outcome "unknown", described as "PSA increase". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter mentioned that he already 2 doses of the Pfizer Covid-19 Vaccine and the booster dose. He took Paxlovid as well. He wanted to know if there is correlations between Paxlovid and Pfizer Covid-19 Vaccine with his PSA increase. Reporter stated "he read several things saying they've been test and show high PSA levels, he had 2 vaccines and 2 boosters and then the paxlovid, because he contracted Covid 19, he have a chart showing when he was taken the vaccine and when he got back my PSA readings back and every time he got a vaccine or a booster, his PSA readings go up. He also heard that they go up when you contract Covid 19, but there's no information about Paxlovid because it was so new, but when you have covid 19 and you feel terrible, anything that helps is considered. He was curious, he mentioned this to urologist, but he wanted to know if there's a correlation that you've heard about, with Paxlovid and the vaccine and the booster. He mentioned he didn't know if he received the bivalent or monovalent formulation, he received it when it just came out and his most recent booster was on 25Mar2022. He took Paxlovid took 2 months ago, on 12Aug2022. He wanted to know if the chemical make up of Paxlovid was the same as the booster and the vaccine. He also read in case studies that if you contract covid, that also elevates the PSA, there's a test, 91 people PSA levels went from 1.58 to 4.34 on average, he was wondering if you heard anything about that. he figured you might have heard about it. Patient had a phone meeting with his urologist.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 61.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Nail ridging
Clinical narrative: She would also have some mild chest pain for 3-4 times per day; Some pain with lifting her left arm up or forward for 8 months; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (She would also have some mild chest pain for 3-4 times per day) and PAIN (Some pain with lifting her left arm up or forward for 8 months) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 041L20A) for COVID-19 prophylaxis.     She has no history of myocarditis or pericarditis.  Concurrent medical conditions included AFib (Saw her cardiologist 1.5 months after these symptoms concluded). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (She would also have some mild chest pain for 3-4 times per day) and PAIN (Some pain with lifting her left arm up or forward for 8 months). At the time of the report, CHEST PAIN (She would also have some mild chest pain for 3-4 times per day) outcome was unknown and PAIN (Some pain with lifting her left arm up or forward for 8 months) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Heart rate: Elevated from 45bpm to 55bpm.         Concomitant medication also reported that, patient took about 6 other vaccines over the past year and a half.  After the second dose of the vaccine patient noticed her heart rate was elevated from 45bpm to 55bpm for approximately 3.5 months. During this time she would also have some mild chest pain for 3-4 times per day.  She does have a history of Afib and saw her cardiologist 1.5 months after these symptoms concluded. During this visit patient had an echocardiogram and received a 2 week patch heart monitor. There was no official diagnosis following this visit. She is also extremely active does, yoga and walks 6 miles a day.   Following the second dose, patient also had some pain with lifting her left arm up or forward for 8 months.  The lab test also included, On an unspecified date, echocardiogram.  No treatment medications was reported.   This case was linked to MOD-2022-661856 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Heart rate, Pain
Clinical narrative: She would also have some mild chest pain for 3-4 times per day; Some pain with lifting her left arm up or forward for 8 months; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (She would also have some mild chest pain for 3-4 times per day) and PAIN (Some pain with lifting her left arm up or forward for 8 months) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 041L20A) for COVID-19 prophylaxis.     She has no history of myocarditis or pericarditis.  Concurrent medical conditions included AFib (Saw her cardiologist 1.5 months after these symptoms concluded). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (She would also have some mild chest pain for 3-4 times per day) and PAIN (Some pain with lifting her left arm up or forward for 8 months). At the time of the report, CHEST PAIN (She would also have some mild chest pain for 3-4 times per day) outcome was unknown and PAIN (Some pain with lifting her left arm up or forward for 8 months) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Heart rate: Elevated from 45bpm to 55bpm.         Concomitant medication also reported that, patient took about 6 other vaccines over the past year and a half.  After the second dose of the vaccine patient noticed her heart rate was elevated from 45bpm to 55bpm for approximately 3.5 months. During this time she would also have some mild chest pain for 3-4 times per day.  She does have a history of Afib and saw her cardiologist 1.5 months after these symptoms concluded. During this visit patient had an echocardiogram and received a 2 week patch heart monitor. There was no official diagnosis following this visit. She is also extremely active does, yoga and walks 6 miles a day.   Following the second dose, patient also had some pain with lifting her left arm up or forward for 8 months.  The lab test also included, On an unspecified date, echocardiogram.  No treatment medications was reported.   This case was linked to MOD-2022-661856 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Back disorder, Hypoaesthesia, Hypovitaminosis, Neuropathy peripheral, Pain
Clinical narrative: tinnitus, mostly in left ear - 3 days after vaccine neuropathy, pain and tingling all over - 4 days after vaccine numbness - started in right foot, slowly progressed to left foot my  One Medical doctor confirmed my diagnosis and then when my numbness started, my doctor sent me to the emergency room. ER at denied any connection to the vaccine, focusing instead on vitamin deficiency possibilities and my poor back/neck spine issues. However, they ruled out the back/neck as causes and sent me home with no treatment, focusing on vitamin deficiencies. Vitamin lab results have returned and are just fine, so it's not vitamin related. Neurology in the ER totally denied that the vaccine would cause this, so all I have now is low dose gaabapentin prescribed by my internist, and it's providing very little relief. Quite frustrating
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Paraesthesia, Spinal disorder, Tinnitus
Clinical narrative: tinnitus, mostly in left ear - 3 days after vaccine neuropathy, pain and tingling all over - 4 days after vaccine numbness - started in right foot, slowly progressed to left foot my  One Medical doctor confirmed my diagnosis and then when my numbness started, my doctor sent me to the emergency room. ER at denied any connection to the vaccine, focusing instead on vitamin deficiency possibilities and my poor back/neck spine issues. However, they ruled out the back/neck as causes and sent me home with no treatment, focusing on vitamin deficiencies. Vitamin lab results have returned and are just fine, so it's not vitamin related. Neurology in the ER totally denied that the vaccine would cause this, so all I have now is low dose gaabapentin prescribed by my internist, and it's providing very little relief. Quite frustrating
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: 2nd booster 4/18/2022 COVID  7/5/2022 (breakthrough)
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: wrong vaccine was administered to the patient. Patient was only 11.5 years old but received Pfizer bivalent 12+ instead of kids bivalent 5-11
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait inability, Magnetic resonance imaging, Muscle disorder, Poor peripheral circulation
Clinical narrative: Muscle and tissue breakdown, poor circulation, extreme constant dizziness, becoming unable to walk
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypertension
Clinical narrative: Hypertension with values increasing systolic by 40 mmhg and increase in diastolic by 30 mmhg for 10 days after immunization occurred. Prior to the immunization, blood pressure was 120/80 consistently! We were so relieved after 10 days that it returned to normal. No meds for hypertension were changed during this event.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: I got the vaccine on 9/28/22 about 48 to 72 hours later I developed soreness to my right arm. As days passed the pain got worse and ROM became an issue. Went to ER got medrol dose pack have appointment with work comp dr on 11/04/2022
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Exposure during pregnancy, Fatigue, Oropharyngeal pain, Pain in extremity
Clinical narrative: Currently 7 months pregnant, received vaccine around 1pm and started having reaction around 4:30pm. I also had previous reaction during my last pregnancy (2 years ago).   Side effects: fever (101 at the highest, sore throat, dizziness, fatigue and standard sore arm)
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Currently 7 months pregnant, received vaccine around 1pm and started having reaction around 4:30pm. I also had previous reaction during my last pregnancy (2 years ago).   Side effects: fever (101 at the highest, sore throat, dizziness, fatigue and standard sore arm)
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Adverse reaction, Back pain, Bedridden, Dysstasia, Erectile dysfunction
Clinical narrative: Adverse reaction began the next morning after vaccine with extreme lower right hip Sciatica extending through the hip and down right leg.  Later that day and evening could barely walk from severe pain.  Never before experienced anything like this so severe.  Mild headache.  The following day, 2nd day after vaccine, mostly lower back pain, fatigue and head 'thickness'.  The next day, 3rd day after vaccine, most severe Transverse Myelitis and bed ridden all day.  Could not stand up due to intense torso pain.  The next day, 4th day after vaccine, mild neck pain and generalized body aches and fatigue.   Sciatica and Myelitis have subsided leaving only mild discomfort. The following days up though today, 18 days after vaccine, developed mild, itchy skin rash around neck and shoulders.  Continue mild headache, head 'thickness',  and mild body aches and fatigue.  Also have developed Erectile Dysfunction.  No erections during sleep or early morning as is usually the case.    This sequence of symptoms is reminiscent of similar symptoms I felt enduring Viral Meningitis over 40 years ago at 27 years of age.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Gait disturbance, Head discomfort, Headache, Myelitis transverse
Clinical narrative: Adverse reaction began the next morning after vaccine with extreme lower right hip Sciatica extending through the hip and down right leg.  Later that day and evening could barely walk from severe pain.  Never before experienced anything like this so severe.  Mild headache.  The following day, 2nd day after vaccine, mostly lower back pain, fatigue and head 'thickness'.  The next day, 3rd day after vaccine, most severe Transverse Myelitis and bed ridden all day.  Could not stand up due to intense torso pain.  The next day, 4th day after vaccine, mild neck pain and generalized body aches and fatigue.   Sciatica and Myelitis have subsided leaving only mild discomfort. The following days up though today, 18 days after vaccine, developed mild, itchy skin rash around neck and shoulders.  Continue mild headache, head 'thickness',  and mild body aches and fatigue.  Also have developed Erectile Dysfunction.  No erections during sleep or early morning as is usually the case.    This sequence of symptoms is reminiscent of similar symptoms I felt enduring Viral Meningitis over 40 years ago at 27 years of age.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Neck pain, Pain, Rash, Rash pruritic, Sciatica
Clinical narrative: Adverse reaction began the next morning after vaccine with extreme lower right hip Sciatica extending through the hip and down right leg.  Later that day and evening could barely walk from severe pain.  Never before experienced anything like this so severe.  Mild headache.  The following day, 2nd day after vaccine, mostly lower back pain, fatigue and head 'thickness'.  The next day, 3rd day after vaccine, most severe Transverse Myelitis and bed ridden all day.  Could not stand up due to intense torso pain.  The next day, 4th day after vaccine, mild neck pain and generalized body aches and fatigue.   Sciatica and Myelitis have subsided leaving only mild discomfort. The following days up though today, 18 days after vaccine, developed mild, itchy skin rash around neck and shoulders.  Continue mild headache, head 'thickness',  and mild body aches and fatigue.  Also have developed Erectile Dysfunction.  No erections during sleep or early morning as is usually the case.    This sequence of symptoms is reminiscent of similar symptoms I felt enduring Viral Meningitis over 40 years ago at 27 years of age.
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Chills, Decreased appetite, Diarrhoea, Injection site pain
Clinical narrative: I got the Pfizer bivalent booster. This was my 4th Pfizer shot (2-dose primary, 1 booster shot). I got the shot at 4pm, and around 12am I had pretty severe abdominal pain, followed by flu-like diarrhea and nausea. The next morning I felt very achy,  feverish, chilled, and lack of appetite.  Also had arm pain at injection site through all of this.
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: I got the Pfizer bivalent booster. This was my 4th Pfizer shot (2-dose primary, 1 booster shot). I got the shot at 4pm, and around 12am I had pretty severe abdominal pain, followed by flu-like diarrhea and nausea. The next morning I felt very achy,  feverish, chilled, and lack of appetite.  Also had arm pain at injection site through all of this.
Age: 61.0
Sex: M
Vaccine: COVID19, FLU4, COVID19-2
Symptoms: Pustule, Rash, Rash pruritic
Clinical narrative: PATIENT STOPPED BY PHARMACY TO REPORT RASHES ON BOTH ARMS AND UPPER BODY AFTER VACCINATION.
Age: 61.0
Sex: M
Vaccine: COVID19, FLU4, COVID19-2
Symptoms: Rash
Clinical narrative: PATIENT STOPPED BY PHARMACY TO REPORT RASHES ON BOTH ARMS AND UPPER BODY AFTER VACCINATION.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine. no symptoms, signs, no treatment
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; Improperly stored vaccine was administered to a patient; This spontaneous report was received from a nurse referring to a patient of unspecified age and gender. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 26-SEP-2022, the patient was administered an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (dose, route of administration, and vaccine scheme were not reported; lot number W017567 has been verified to be valid, expiration date reported as 29-DEC-2023 but upon internal verification was established as 29-NOV-2023) for prophylaxis.  The vaccine was exposed to a temperature excursion of minus 11.8 degrees Celsius during a time frame of 1 hour and 45 minutes (product storage error). No additional adverse event was reported (no adverse event).
Sex: M
Vaccine: BCG
Symptoms: Abdominal pain, Acid fast bacilli infection, Amoebiasis, Biopsy colon abnormal, Colitis
Clinical narrative: Patient diagnosed with extrapulmonary tuberculosis; Positive Quantiferon gold (thought to be secondary to BCG vaccine); Information has been received from the authors in the published literature article entitled as stated below, referring to a 48-year-old male with a history of type 1 diabetes complicated by end-stage renal disease status post kidney and pancreas transplants (performed on an unspecified date reported as 5 years ago). The patient's concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with bcg live (manufacturer unknown) administered for tuberculosis bladder (strength, lot #, expiry date, and route of administration were not provided).  On an unspecified date, the patient had taken a Quantiferon gold test that resulted positive and was thought to be secondary to bcg live (manufacturer unknown) vaccine. Afterwards, on an unspecified date (reported as for the past 7 months), the patient experienced chronic diarrhea, abdominal pain, and weight loss, so he was admitted to hospital. Initial infectious work-up was positive for norovirus and entamoeba histolytica. On an unknown date (reported as hospital day 3), he developed fevers and hemorrhagic shock, and an urgent colonoscopy revealed multi-focal large ulcers throughout the colon evidencing pan-colitis. Additional biopsies showed granulomas, positive acid-fast bacilli (AFB) stain for AFB, and positive mycobacterium bovis on AFB culture. Finally, the patient was diagnosed with extrapulmonary tuberculosis (TB) and started anti-TB therapy with rifabutin, isoniazid, pyrazinamide, and ethambutol. He initially improved, but subsequently had multiple complications including transaminitis concerning for hepatoxicity and worsening renal function from hemorrhagic shock caused by a bleeding mesenteric artery; therefore, the anti-TB regimen was held. The reproted complications significantly impacted drug levels as well as the dosing of anti-TB medications and immunosuppressants. After clinical stabilization, improvement in renal function and transaminitis, he was re-started on anti-TB medications in a step-wise approach. According to the authors, the patient improved with anti-TB treatment. Pulmonary TB was ruled out with AFB sputum and mycobacterium tuberculosis (MTB) polymerase chain reaction (PCR). The patient was eventually discharged on anti-TB medications and close follow-up.  The reporting authors of the article described extrapulmonary tuberculosis diagnosis in the context of a previous bcg live (manufacturer unknown) vaccine administration.  Upon internal review, extrapulmonary tuberculosis was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.  Literature report:
Sex: M
Vaccine: BCG
Symptoms: Colonoscopy abnormal, Culture positive, Diarrhoea, Extrapulmonary tuberculosis, Granuloma
Clinical narrative: Patient diagnosed with extrapulmonary tuberculosis; Positive Quantiferon gold (thought to be secondary to BCG vaccine); Information has been received from the authors in the published literature article entitled as stated below, referring to a 48-year-old male with a history of type 1 diabetes complicated by end-stage renal disease status post kidney and pancreas transplants (performed on an unspecified date reported as 5 years ago). The patient's concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with bcg live (manufacturer unknown) administered for tuberculosis bladder (strength, lot #, expiry date, and route of administration were not provided).  On an unspecified date, the patient had taken a Quantiferon gold test that resulted positive and was thought to be secondary to bcg live (manufacturer unknown) vaccine. Afterwards, on an unspecified date (reported as for the past 7 months), the patient experienced chronic diarrhea, abdominal pain, and weight loss, so he was admitted to hospital. Initial infectious work-up was positive for norovirus and entamoeba histolytica. On an unknown date (reported as hospital day 3), he developed fevers and hemorrhagic shock, and an urgent colonoscopy revealed multi-focal large ulcers throughout the colon evidencing pan-colitis. Additional biopsies showed granulomas, positive acid-fast bacilli (AFB) stain for AFB, and positive mycobacterium bovis on AFB culture. Finally, the patient was diagnosed with extrapulmonary tuberculosis (TB) and started anti-TB therapy with rifabutin, isoniazid, pyrazinamide, and ethambutol. He initially improved, but subsequently had multiple complications including transaminitis concerning for hepatoxicity and worsening renal function from hemorrhagic shock caused by a bleeding mesenteric artery; therefore, the anti-TB regimen was held. The reproted complications significantly impacted drug levels as well as the dosing of anti-TB medications and immunosuppressants. After clinical stabilization, improvement in renal function and transaminitis, he was re-started on anti-TB medications in a step-wise approach. According to the authors, the patient improved with anti-TB treatment. Pulmonary TB was ruled out with AFB sputum and mycobacterium tuberculosis (MTB) polymerase chain reaction (PCR). The patient was eventually discharged on anti-TB medications and close follow-up.  The reporting authors of the article described extrapulmonary tuberculosis diagnosis in the context of a previous bcg live (manufacturer unknown) vaccine administration.  Upon internal review, extrapulmonary tuberculosis was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.  Literature report:
Sex: M
Vaccine: BCG
Symptoms: Hypertransaminasaemia, Immunosuppressant drug therapy, Laboratory test abnormal, Large intestinal ulcer, Mesenteric haemorrhage
Clinical narrative: Patient diagnosed with extrapulmonary tuberculosis; Positive Quantiferon gold (thought to be secondary to BCG vaccine); Information has been received from the authors in the published literature article entitled as stated below, referring to a 48-year-old male with a history of type 1 diabetes complicated by end-stage renal disease status post kidney and pancreas transplants (performed on an unspecified date reported as 5 years ago). The patient's concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with bcg live (manufacturer unknown) administered for tuberculosis bladder (strength, lot #, expiry date, and route of administration were not provided).  On an unspecified date, the patient had taken a Quantiferon gold test that resulted positive and was thought to be secondary to bcg live (manufacturer unknown) vaccine. Afterwards, on an unspecified date (reported as for the past 7 months), the patient experienced chronic diarrhea, abdominal pain, and weight loss, so he was admitted to hospital. Initial infectious work-up was positive for norovirus and entamoeba histolytica. On an unknown date (reported as hospital day 3), he developed fevers and hemorrhagic shock, and an urgent colonoscopy revealed multi-focal large ulcers throughout the colon evidencing pan-colitis. Additional biopsies showed granulomas, positive acid-fast bacilli (AFB) stain for AFB, and positive mycobacterium bovis on AFB culture. Finally, the patient was diagnosed with extrapulmonary tuberculosis (TB) and started anti-TB therapy with rifabutin, isoniazid, pyrazinamide, and ethambutol. He initially improved, but subsequently had multiple complications including transaminitis concerning for hepatoxicity and worsening renal function from hemorrhagic shock caused by a bleeding mesenteric artery; therefore, the anti-TB regimen was held. The reproted complications significantly impacted drug levels as well as the dosing of anti-TB medications and immunosuppressants. After clinical stabilization, improvement in renal function and transaminitis, he was re-started on anti-TB medications in a step-wise approach. According to the authors, the patient improved with anti-TB treatment. Pulmonary TB was ruled out with AFB sputum and mycobacterium tuberculosis (MTB) polymerase chain reaction (PCR). The patient was eventually discharged on anti-TB medications and close follow-up.  The reporting authors of the article described extrapulmonary tuberculosis diagnosis in the context of a previous bcg live (manufacturer unknown) vaccine administration.  Upon internal review, extrapulmonary tuberculosis was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.  Literature report: