chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (My hair started falling out. It's gotten worse in last month, or so./unusual loss of hair. About 3 month after my last shot , it is still going on) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 008B21A and 014M20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Amoxicillin), Drug allergy (Atorvastatin), Drug allergy (Ditropan), Penicillin allergy (all penicillins), Sinusitis (causes on set and pets) and Asthma (Asthma since child).Concomitant products included ROSUVASTATIN and LISINOPRIL for an unknown indication.On 28-Feb-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 28-Mar-2021 at 12:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 02-Nov-2021 at 2:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, the patient experienced ALOPECIA (My hair started falling out. It's gotten worse in last month, or so./unusual loss of hair. About 3 month after my last shot , it is still going on). At the time of the report, ALOPECIA (My hair started falling out. It's gotten worse in last month, or so./unusual loss of hair. About 3 month after my last shot , it is still going on) had not resolved.    The patient had Multivitamin at the vaccination or at the time of the adverse event.This case was linked to MOD-2021-395776, MOD-2021-395763, MOD-2021-395825 (Patient Link).Most recent FOLLOW-UP information incorporated above includes:On 14-Jan-2022: Follow-up reeived: Patient demographic details added, allergic condition added, medical history added, concomitants added, event outcome updated.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Dysgeusia, Electrocardiogram, Pericarditis
Clinical narrative: PERICARDITIS; TASTED METAL AND SALTY IN MOUTH; This spontaneous report received from a patient concerned a 46-year-old male of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, alcohol user (very rarely), and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and the patient did not abuse drug or illicit drug usage.  The patient experienced flu like symptoms when treated with influenza vaccine, so he stopped getting the flu shot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, 1 total administered to left arm on 17-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-SEP-2021, immediately after the vaccination the patient had metal taste (a salty taste) in his mouth. He experienced chest burning and chest pressure within a day (on 18-Sep-2021). The patient stated that it was hard to breathe, was fatigued and short of breath. On an unspecified date in SEP-2021, after 1 week, he went to hospital, laboratory test included blood work, chest X-ray and EKG (electrocardiography) and everything was normal. He said the hospital was useless. Then he saw his PCP (primary care provider). His PCP assumed pericarditis and he treated him with prednisone (a course of 5 days) and he felt better but once the medication was out he felt miserable again. He also saw a cardiologist and the cardiologist said that his heart was okay. He mentioned that his PCP wants him to take Pulmicort but he could not afford it. On an unspecified date the patient visited emergency room. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pericarditis, and the outcome of tasted metal and salty in mouth was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20220133399-COVID-19 VACCINE AD26.COV2.S-Pericarditis. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cardiac arrest, Dyspepsia, SARS-CoV-2 test positive
Clinical narrative: Hospitalized with COVID 19 breakthrough infection. Updating previous VAERS report E #780118. Patient expired 1/22/2022. PRINCIPAL DIAGNOSIS: Arrest Cardiac (HCC). SECONDARY DIAGNOSES: Principal Problem: Arrest Cardiac (HCC). Active Problems: ST Elevation Myocardial Infarction Involving Left Main Coronary Artery (HCC), Atherosclerotic Heart Disease Native Coronary Artery With Other Forms Angina Pectoris (Angina Equivalent) (HCC), Respiratory Failure With Hypoxia (HCC), Regurgitation Aortic, Hyperkalemia, Shock Cardiogenic (HCC), ST Elevation Myocardial Infarction Of Unspecified Site (HCC), COVID-19 Infection, Pneumonia Community Acquired.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Anginal equivalent, Aortic valve incompetence, Arteriosclerosis coronary artery, COVID-19
Clinical narrative: Hospitalized with COVID 19 breakthrough infection. Updating previous VAERS report E #780118. Patient expired 1/22/2022. PRINCIPAL DIAGNOSIS: Arrest Cardiac (HCC). SECONDARY DIAGNOSES: Principal Problem: Arrest Cardiac (HCC). Active Problems: ST Elevation Myocardial Infarction Involving Left Main Coronary Artery (HCC), Atherosclerotic Heart Disease Native Coronary Artery With Other Forms Angina Pectoris (Angina Equivalent) (HCC), Respiratory Failure With Hypoxia (HCC), Regurgitation Aortic, Hyperkalemia, Shock Cardiogenic (HCC), ST Elevation Myocardial Infarction Of Unspecified Site (HCC), COVID-19 Infection, Pneumonia Community Acquired.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Cardiogenic shock, Death, Hyperkalaemia, Pneumonia
Clinical narrative: Hospitalized with COVID 19 breakthrough infection. Updating previous VAERS report E #780118. Patient expired 1/22/2022. PRINCIPAL DIAGNOSIS: Arrest Cardiac (HCC). SECONDARY DIAGNOSES: Principal Problem: Arrest Cardiac (HCC). Active Problems: ST Elevation Myocardial Infarction Involving Left Main Coronary Artery (HCC), Atherosclerotic Heart Disease Native Coronary Artery With Other Forms Angina Pectoris (Angina Equivalent) (HCC), Respiratory Failure With Hypoxia (HCC), Regurgitation Aortic, Hyperkalemia, Shock Cardiogenic (HCC), ST Elevation Myocardial Infarction Of Unspecified Site (HCC), COVID-19 Infection, Pneumonia Community Acquired.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Respiratory failure, Vaccine breakthrough infection
Clinical narrative: Hospitalized with COVID 19 breakthrough infection. Updating previous VAERS report E #780118. Patient expired 1/22/2022. PRINCIPAL DIAGNOSIS: Arrest Cardiac (HCC). SECONDARY DIAGNOSES: Principal Problem: Arrest Cardiac (HCC). Active Problems: ST Elevation Myocardial Infarction Involving Left Main Coronary Artery (HCC), Atherosclerotic Heart Disease Native Coronary Artery With Other Forms Angina Pectoris (Angina Equivalent) (HCC), Respiratory Failure With Hypoxia (HCC), Regurgitation Aortic, Hyperkalemia, Shock Cardiogenic (HCC), ST Elevation Myocardial Infarction Of Unspecified Site (HCC), COVID-19 Infection, Pneumonia Community Acquired.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in the arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 013A21A) for COVID-19 vaccination. Concurrent medical conditions included Sjogren's (Sjogren's (kind of a lupus) unknown onset but caller confirmed it was prior to the vaccine.).On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in the arm). At the time of the report, PAIN IN EXTREMITY (soreness in the arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.The  concomitant medications on use were not provided.No treatment information was provided.This case was linked to MOD-2022-456733, MOD-2022-456752 (Patient Link).Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2022: Added reporter information.
Age: 51.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Feeling hot, Injection site infection, Pain, Pruritus
Clinical narrative: L upper extremity swelling, heat, pain and induration 1.5 weeks after vaccine administration
Age: 51.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Swelling
Clinical narrative: L upper extremity swelling, heat, pain and induration 1.5 weeks after vaccine administration
Age: 51.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Induration, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: L upper extremity swelling, heat, pain and induration 1.5 weeks after vaccine administration
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Adenoidal hypertrophy, C-reactive protein increased, Febrile convulsion, Nasal congestion, Pyrexia
Clinical narrative: FEBRILE CONVULSION; ADENOIDAL HYPERTROPHY; PYREXIA; C-REACTIVE PROTEIN INCREASED; NASAL CONGESTION; A spontaneous report has been received from a consumer via the regulatory authority concerning a 2 year old female patient.    No medical history was reported. No concomitant products were reported.    On 07-Dec-2021, the patient started receiving a treatment with Fluenz Tetra (influenza vaccine live reassort 4v) 1 df daily, via nasal route. No malfunction has been reported for Fluenz Tetra.    On 08-Dec-2021, the patient experienced febrile convulsion (preferred term: Febrile convulsion), adenoidal hypertrophy (preferred term: Adenoidal hypertrophy), pyrexia (preferred term: Pyrexia), c-reactive protein increased (preferred term: C-reactive protein increased) and nasal congestion (preferred term: Nasal congestion).     It was unknown if any action was taken with Fluenz Tetra.  At the time of reporting, the event of febrile convulsion, adenoidal hypertrophy, pyrexia, c-reactive protein increased and nasal congestion was ongoing.     The events were considered serious (hospitalised) by the reporter.    Device Information:     Combination Product Report: Yes    Product As Reported: FLUENZ TETRA  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect; Sender's Comments: Febrile convulsion, adenoidal hypertrophy and C-reactive protein increased are not listed in company core data sheet of Quadrivalent live attenuated influenza vaccine (Q/LAIV). Pyrexia has been associated with use of LAIV in children but not in adults. This case concerns a 2year old female patient with reported event of pyrexia in association with use of Quadrivalent live attenuated influenza vaccine (Q/LAIV). Pyrexia could be contributory factor for the event febrile convulsion which could be in association with C-reactive protein increased. Due to limited information on exact circumstances leading to the event, treatment provided, concomitant medications, risk factors(allergy, infection), relevant medical and family history, concomitant diseases, detailed etiological and diagnostic workup (complete blood count, allergy work up, infection workup), the evaluation did not find evidence to suggest a reasonable possibility of a causal relationship between the events and Quadrivalent live attenuated influenza vaccine (Q/LAIV).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE or PQC reported; administration of expired VARlVAX to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.  On 04-JAN-2022, the patient was vaccinated with expired varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml (lot #S032357, expiration date: 14-OCT-2021) (strength and route of administration were not provided) for prophylaxis (expired product administered). There was no additional adverse event (AE) or product quality complaint (PQC) reported (no adverse event).
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no other AE occurred; The caller said they have a patient who inadvertently received an extra dose of PEDVAX HIB on 12/30/2021; patient who inadvertently received an extra dose of PEDVAX HIB on 12/30/2021/The patient was due for the meningiococcal B vaccine, Bexsero; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was first vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported). On 30-DEC-2021, the patient inadvertently received an extra dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 1 dose (lot # S021458, and expiration date 27-FEB-2022) for prophylaxis (route of administration, vaccination scheme frequency, and anatomical location were not reported) (incorrect dose administered). The caller said the patient was due for meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO) (wrong product administered). No other adverse event (AE) occurred.
Sex: F
Vaccine: VARCEL
Symptoms: COVID-19
Clinical narrative: infected with COVID-19 virus; This spontaneous report has been received from a pharmacist referring to a female of unknown age.  The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.  On an unknown date, the patient received the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (formulation, lot#, expiration date, strength, dose, frequency and route of administration were not reported) for prophylaxis.   After the first dose, on an unknown date, the patient was infected with coronavirus disease 2019 (COVID-19) virus. On an unknown date, the patient recovered from the event. The patient did not receive the second dose yet.  The causal relationship between the event and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.
Age: 23.0
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Contraindicated product administered, Exposure during pregnancy, No adverse event
Clinical narrative: no additional information provided/ the pregnant patient did not have a clinical adverse event; a pregnant patient was administered a third dose of VARlVAX on 5 JAN 2022; a pregnant patient was administered a third dose of VARlVAX on 5 JAN 2022; This spontaneous prospective pregnancy report has been received from a physician referring to a 23-year-old female patient. The patient's pertinent medical history was not reported. There were no known drug allergies. Historical vaccine included varicella virus vaccine live (Oka/Merck) (VARIVAX). Concomitant vaccine included flu vaccine.  On 05-JAN-2022, the pregnant patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 mL (lot# U008180, expiration date 12-MAR-2023; strength was not reported) and sterile diluent (strength, dose, lot#, and expiration date were not reported) subcutaneously for prophylaxis (exposure during pregnancy, contraindicated product administered). The reporter stated that the patient was in her second trimester but could not provide any further details on pregnancy gestation. The last menstrual period (LMP) and estimated due date (EDD) were not known. It was reported that the patient was required to be vaccinated in order to obtain an immigration medical clearance. The patient had not sought medical attention. No treatment was given. No additional information or adverse event (AE) was reported. The patient did not have a clinical AE.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional information provided; patient was administered a third dose of Varivax on 5JAN2022; she received her 1st dose of Varivax on 18 OCT 2007, and second dose on 26 NOV 2007; This spontaneous report has received from a physician referring to a 9-year-old female patient. Concomitant medication and pertinent medical history were not reported. There were no known drug allergies.  On 18-OCT-2007, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 mL subcutaneously for prophylaxis (strength, lot#, and expiration date were not reported).   On 26-NOV-2007, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, lot#, and expiration date were not reported) (inappropriate schedule of product administration). On 05-JAN-2022, the patient was vaccinated with the third dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot# U008180, expiration date 12-MAR-2023; strength was not reported) (extra dose administered). No additional information or adverse event (AE) was reported.; Sender's Comments:  US-009507513-2201USA003547:
Age: 33.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event reported; Patient was administered an expired dose of MMRII; This spontaneous report has been received from a medical assistant concerning a 33-year-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant therapies were not reported.   On 18-JAN-2022, the patient was vaccinated with 1 dose of a Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) vaccine (exact dose, route of administration, anatomical location and vaccine scheme were not provided; lot number S035354 has been verified to be a valid lot number, expiration date was reported and established on 05-NOV-2021), as prophylaxis (expired product administered). The patient did not have any other adverse events.
Sex: U
Vaccine: VARZOS
Symptoms: Allergy to vaccine
Clinical narrative: allergic to some or all of the ingredients; This case was reported by a consumer via interactive digital media and described the occurrence of allergy to vaccine in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergy to vaccine. On an unknown date, the outcome of the allergy to vaccine was unknown.   It was unknown if the reporter considered the allergy to vaccine to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient experienced severe side effect from the Shingrix shot. The patient stated that he/she must be allergic to some or all of the ingredients. The patient asked that what were the ingredients. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: have them, got both shingles vaccines/Suspected Vaccination failure; have them; I'm miserable; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling miserable. On an unknown date, the outcome of the vaccination failure and feeling miserable were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine and Shingles vaccine.  Addition details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had shingles right now at the time of reporting for the 2nd time, and he/she got both Shingles vaccines. The patient was miserable. The follow up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 21.0
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia, Asthenia, Cold sweat, Disorientation, Dizziness
Clinical narrative: heart arrhythmia, two separate episodes of syncope, lasted hours, tachycardia low blood pressure dizziness, disorientation, weakness, blurry vision, clammy, overheating
Age: 21.0
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Hypotension, Syncope, Tachycardia, Vision blurred
Clinical narrative: heart arrhythmia, two separate episodes of syncope, lasted hours, tachycardia low blood pressure dizziness, disorientation, weakness, blurry vision, clammy, overheating
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I?m 1/21/22 I developed a sore throat and fever, and chills. I?m 1/23/22 I tested positive for Covid-19.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Streptococcus test negative
Clinical narrative: I?m 1/21/22 I developed a sore throat and fever, and chills. I?m 1/23/22 I tested positive for Covid-19.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Addition details were provided as follows: The case was reported by the patient's family member. The age at vaccination was not reported. The patient got the Shingles vaccine and then got shingles that week. The follow-up would not possible as no contact details were available.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenitis, Pyrexia, Tonsillitis
Clinical narrative: Chills, lymph nodes flared up, tonsillitis, and fever
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Sleep disorder, Urticaria
Clinical narrative: I received my booster dose on November 30 and 11 days after I started getting rashes and urticaria crisis. I never encounter any allergies before. Since I keep getting crisis, every day randomly and all over my body. Those rashes can last for 30 minutes than disappear sometimes by themself or  I need to take antihistaminique meds to help to calm. It sometimes also wake me up during the night. I read articles about the fact that this could be a side effect of recovering from Covid but I didn?t get it at that time. I also read a lot of forums were people got the exact same rashes than me between 9 to 12 days after the booster shot so I was wondering if there was any infos about it.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Blood pressure increased, Cough, Dyspnoea, Respiratory disorder
Clinical narrative: I was getting ready for work on Sept. 24th, 2021 and then I started to get pains in my heart and my blood pressure went up to 194 over 190. The pains in my heart persistent. I called my nurse friend,  for help to take me to the doctor or hospital.She is an LPN. She kept taking my blood pressure and tired to calm me down. We were going to go to the hospital, then my heart stopped hurting after a couple of hours. She thought since I have so many allergies, that I was allergic to something in the vaccine.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angina pectoris, Arthralgia, Blood test normal, Chest discomfort, Chest pain
Clinical narrative: After 3rd dose, later in the day started feeling aching on left side of chest/shoulder. This quickly moved directly around heart area and included sharp pain around heart. Heart felt very tight and was aching. Kept getting worse throughout week. Left arm went numb 6 days after vaccine. Went to ER on day 6 once arm numbness started. They took EKG, blood work and xray. Found nothing immediately wrong. Gave anti-inflammatory shot and 5 day anti-inflammatory prescription. A few days after prescription ended chest pain kicked up again, being very tight and painful at times. Would take ibuprofen to help pain. Started taking quercetin, vitamin c and zinc daily which seems to b helping. A month later has gotten better but still aches and feels like a cramp around heart from time to time.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram normal, Hypoaesthesia, Muscle spasms, X-ray normal
Clinical narrative: After 3rd dose, later in the day started feeling aching on left side of chest/shoulder. This quickly moved directly around heart area and included sharp pain around heart. Heart felt very tight and was aching. Kept getting worse throughout week. Left arm went numb 6 days after vaccine. Went to ER on day 6 once arm numbness started. They took EKG, blood work and xray. Found nothing immediately wrong. Gave anti-inflammatory shot and 5 day anti-inflammatory prescription. A few days after prescription ended chest pain kicked up again, being very tight and painful at times. Would take ibuprofen to help pain. Started taking quercetin, vitamin c and zinc daily which seems to b helping. A month later has gotten better but still aches and feels like a cramp around heart from time to time.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hive accrued over 3 weeks (still continue)
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Arrhythmia, Chest pain, Dyspnoea, Fatigue
Clinical narrative: Chest Pains, Trouble Sleeping, Trouble Breathing, Fatigue, Insomnia, Anxiety, Immense Pain, Possible Arythmias, Fainting
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pain, Syncope
Clinical narrative: Chest Pains, Trouble Sleeping, Trouble Breathing, Fatigue, Insomnia, Anxiety, Immense Pain, Possible Arythmias, Fainting
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got first shot, still had an outbreak; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received a dose of shingles vaccine and experienced shingles outbreak few months later. The patient was hopeful that after second dose it would never happen. Consent to follow up was not possible as no contact details were available.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Angiogram normal, Blood test abnormal, Chest pain, Dyspnoea
Clinical narrative: SOB that is still lingering, Sharp pain in lungs and heart, dull chest pain that is still persistent. Lung infection.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Fibrin D dimer increased, Pain, Pneumonia, Pulmonary pain
Clinical narrative: SOB that is still lingering, Sharp pain in lungs and heart, dull chest pain that is still persistent. Lung infection.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dysstasia, Fatigue, Feeling abnormal, Gait disturbance
Clinical narrative: After the 1st & 2nd dose within 10-15 minutes of it being administered I  had sweats, chills, fever, nausea, tiredness, headache, tingling in my body, muscle weakness and extreme fatigue. I felt like I had got hit by a bus for over a week. After an hour I could barely bare weight and stand up. Walking was very hard. I still have numbness and tingling in my legs from the waist down. I have headaches that hav gradually turned into everyday ones and migraines. I have had delayed menstrual cycle and inconsistent periods. Some of which have small blood clots.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hyperhidrosis, Hypoaesthesia, Menstruation delayed, Menstruation irregular
Clinical narrative: After the 1st & 2nd dose within 10-15 minutes of it being administered I  had sweats, chills, fever, nausea, tiredness, headache, tingling in my body, muscle weakness and extreme fatigue. I felt like I had got hit by a bus for over a week. After an hour I could barely bare weight and stand up. Walking was very hard. I still have numbness and tingling in my legs from the waist down. I have headaches that hav gradually turned into everyday ones and migraines. I have had delayed menstrual cycle and inconsistent periods. Some of which have small blood clots.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Muscular weakness, Nausea, Paraesthesia, Pyrexia
Clinical narrative: After the 1st & 2nd dose within 10-15 minutes of it being administered I  had sweats, chills, fever, nausea, tiredness, headache, tingling in my body, muscle weakness and extreme fatigue. I felt like I had got hit by a bus for over a week. After an hour I could barely bare weight and stand up. Walking was very hard. I still have numbness and tingling in my legs from the waist down. I have headaches that hav gradually turned into everyday ones and migraines. I have had delayed menstrual cycle and inconsistent periods. Some of which have small blood clots.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis, Weight bearing difficulty
Clinical narrative: After the 1st & 2nd dose within 10-15 minutes of it being administered I  had sweats, chills, fever, nausea, tiredness, headache, tingling in my body, muscle weakness and extreme fatigue. I felt like I had got hit by a bus for over a week. After an hour I could barely bare weight and stand up. Walking was very hard. I still have numbness and tingling in my legs from the waist down. I have headaches that hav gradually turned into everyday ones and migraines. I have had delayed menstrual cycle and inconsistent periods. Some of which have small blood clots.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Goitre, Inflammation, Pain, Vaccine positive rechallenge
Clinical narrative: enlarged and inflamed under arm thyroid. very painful. lasts many days
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Burning sensation, Feeling abnormal
Clinical narrative: Burned like the booster; Kicked my but; This case was reported by a consumer via interactive digital media and described the occurrence of burning sensation in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and Flu vaccine. On an unknown date, unknown after receiving Shingles vaccine and Flu vaccine, the patient experienced burning sensation and feeling abnormal. On an unknown date, the outcome of the burning sensation and feeling abnormal were unknown.   It was unknown if the reporter considered the burning sensation and feeling abnormal to be related to Shingles vaccine and Flu vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The reporter stated just got the shot the other day and wait 2 to 3 month for the 2nd. The reporter stated that not going to lie, burned like the booster plus got the flu shot in the same arm. The reporter further stated that it kicked her but. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Malaise, Vaccination failure
Clinical narrative: had both shingles vaccines, had shingles three times/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had both shingles vaccines and had shingles three times since the vaccines.  This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The patient further stated unfortunately, he/she was in the small percentage of people who became sick from the vaccine injections but the vaccines did not deter thee infections. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR011001:same reporter (invalid case)
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: got sick from the 1st shot; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got so sick from the 1st shot. The pharmacy said most people did not get any side affects but the paperwork she gave me after he/she got it said 1 in 6 would people. The follow-up would not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: dose two less than 4 weeks after dose one; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose two of Shingrix doses less than 4 weeks after dose one, which led to shortening of vaccination schedule. The reporter did not wish to complete report. The reporter did not provide lot number or expiration date. The reporter did not consent to follow-up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness at the injection site; Itchiness at the injection site; Pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2022, the patient received the 1st dose of Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site itching and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching and injection site pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's husband. The patient received the Shingrix vaccine in the left arm and at the time of reporting, she was experiencing redness, itching and pain at the injection site. The reporter was referred to healthcare professional.  The reporter provided limited information. The reporter gave consent to follow up with pharmacy.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: itching; redness; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced pruritus and erythema. On an unknown date, the outcome of the pruritus and erythema were recovered/resolved.   It was unknown if the reporter considered the pruritus and erythema to be related to Shingrix.   Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got her 1st Shingrix vaccine in an unknown arm.  The patient had itching and redness for over a week until it resolved. The reporter did not consent to follow-up.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Angiogram abnormal, COVID-19, COVID-19 pneumonia, Computerised tomogram
Clinical narrative: COVID-19 PNEUMONIA; MEDIASTINAL DISORDER; COVID-19; COUGH; HILAR LYMPHADENOPATHY; ANGIOGRAM ABNORMAL; This spontaneous report received from a health care professional by a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS ID private) and concerned an 88 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980 and expiry: Unknown) dose was not reported, dose number in series was 1, 01 total administered in left arm on 02-APR-2021 for an unknown indication. No concomitant medications were reported.  On 07-NOV-2021 patient experienced corona virus disease pneumonia (COVID -19 pneumonia) and was hospitalized for 16 days, discharge information was not reported. She was given supportive care and remained stable on 3 to 5 liter nasal cannula (oxygen), while hospitalized her main complaint was cough so she was started on Mucinex (guaifenesin) and her Tessalon Perles (benzonatate) was increased. During her hospitalization her oxygen level had been ranging from 3 to 5 liters nasal cannula and was stable, mediastinal (mediastinal disorder) and hilar lymph node enlargement (hilar lymphadenopathy) were found on computed tomography angiography (CTA) and likely secondary to COVID -19 infection (dose number in series was 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the angiogram abnormal, covid-19, COVID -19 pneumonia, cough, hilar lymphadenopathy and mediastinal disorder was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000209403. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information was received from Central Complaint Vigilance department on 19-JAN-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.  Upon review following information was amended: Suspected clinical vaccination failure event removed.; Sender's Comments: V2: Additional information updated : Product quality complaint investigation result. Upon review following information was amended: Suspected clinical vaccination failure event removed. 20211255822-COVID-19 VACCINE AD26.COV2.S- angiogram abnormal, covid-19, covid-19 pneumonia, cough, hilar lymphadenopathy, mediastinal disorder. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Hilar lymphadenopathy, Mediastinal disorder, Oxygen saturation
Clinical narrative: COVID-19 PNEUMONIA; MEDIASTINAL DISORDER; COVID-19; COUGH; HILAR LYMPHADENOPATHY; ANGIOGRAM ABNORMAL; This spontaneous report received from a health care professional by a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS ID private) and concerned an 88 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980 and expiry: Unknown) dose was not reported, dose number in series was 1, 01 total administered in left arm on 02-APR-2021 for an unknown indication. No concomitant medications were reported.  On 07-NOV-2021 patient experienced corona virus disease pneumonia (COVID -19 pneumonia) and was hospitalized for 16 days, discharge information was not reported. She was given supportive care and remained stable on 3 to 5 liter nasal cannula (oxygen), while hospitalized her main complaint was cough so she was started on Mucinex (guaifenesin) and her Tessalon Perles (benzonatate) was increased. During her hospitalization her oxygen level had been ranging from 3 to 5 liters nasal cannula and was stable, mediastinal (mediastinal disorder) and hilar lymph node enlargement (hilar lymphadenopathy) were found on computed tomography angiography (CTA) and likely secondary to COVID -19 infection (dose number in series was 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the angiogram abnormal, covid-19, COVID -19 pneumonia, cough, hilar lymphadenopathy and mediastinal disorder was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000209403. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information was received from Central Complaint Vigilance department on 19-JAN-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.  Upon review following information was amended: Suspected clinical vaccination failure event removed.; Sender's Comments: V2: Additional information updated : Product quality complaint investigation result. Upon review following information was amended: Suspected clinical vaccination failure event removed. 20211255822-COVID-19 VACCINE AD26.COV2.S- angiogram abnormal, covid-19, covid-19 pneumonia, cough, hilar lymphadenopathy, mediastinal disorder. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Nasal cyst, SARS-CoV-2 test
Clinical narrative: NASAL CYST; HARD TIME BREATHING; ANXIETY; This spontaneous report received from a patient concerned a 47 year old, male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and smoker (started smoking heavily in JAN-2022, a pack per week, after quitting for two years). The patient had no known allergies, no history of drug abuse or illicit drug usage. The patient was healthy was not sick for many years before the vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total administered to right arm on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in JAN-2022, the patient experienced to have a little hard time breathing. The patient mentioned to have sick people in his household and were confirmed to not have covid-19 but were symptomatic. The patient was tested negative for covid-19 done via nasal swab at the hospital before he underwent the procedure of surgical drainage of nasal cyst. The patient was at the hospital for two hours and was prescribed with amoxicillin to take after the procedure for one week and he mentioned to have finished the antibiotic course. The patient further stated that hard time breathing symptoms could be from returning to smoke or anxiety related or might be a side effect from amoxicillin. The patient had then slowed down on smoking and described his hard time breathing to be not to the point where he cannot breath or needs to go to the hospital. The patient has an appointment booked to receive the booster shot of Janssen COVID-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nasal cyst on 11-JAN-2022, had not recovered from hard time breathing, and the outcome of anxiety was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  20220133751 -Covid-19 vaccine ad26.cov2.s- Nasal cyst. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: SORE THROAT; RUNNY NOSE; COUGH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: UNKNOWN) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JAN-2022, the patient experienced sore throat, runny nose, and cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore throat, runny nose, and cough. This report was non-serious.