chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Swelling
Clinical narrative: little knot on the backside, like a big area; fever in it; a little red; back of the neck is sore and hurting; still has the knot, which is swollen and sore; It is swollen and itchy / which is swollen and sore; knot was itchy; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (little knot on the backside, like a big area), SKIN WARM (fever in it), ERYTHEMA (a little red), NECK PAIN (back of the neck is sore and hurting) and BACK PAIN (still has the knot, which is swollen and sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 052B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Diabetes.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced SKIN MASS (little knot on the backside, like a big area), SKIN WARM (fever in it), ERYTHEMA (a little red), NECK PAIN (back of the neck is sore and hurting), BACK PAIN (still has the knot, which is swollen and sore), SWELLING (It is swollen and itchy / which is swollen and sore) and PRURITUS (knot was itchy). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN MASS (little knot on the backside, like a big area), BACK PAIN (still has the knot, which is swollen and sore) and SWELLING (It is swollen and itchy / which is swollen and sore) had not resolved and SKIN WARM (fever in it), ERYTHEMA (a little red), NECK PAIN (back of the neck is sore and hurting) and PRURITUS (knot was itchy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The patient had several medication but did not have the list.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral disorder, Death
Clinical narrative: Died after booster shot; she had something in the brain; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died after booster shot) and CEREBRAL DISORDER (she had something in the brain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (Died after booster shot) (seriousness criteria death, hospitalization and medically significant) and CEREBRAL DISORDER (she had something in the brain) (seriousness criterion hospitalization). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, CEREBRAL DISORDER (she had something in the brain) outcome was unknown.            Company comment: This is a spontaneous case concerning a female patient of an unknown age with no reported medical history, who experienced the serious  unexpected event cerebral disorder and death. The events occurred on an unknown date after the booster dose of mRNA-1273.  It is not clear if cerebral disorder (she had something in the brain) refers to a previous medical history or is an event. No information was provided regarding medical history and events. Further information has been requested.The benefit-risk relationship of mRNA-1273 is not affected by this report.  It was stated that the reporter don't know if Patient had underlying health conditions. Reporter was not certain if the booster dose was a Moderna shot. No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2022-452712, MOD-2022-452729 (Patient Link).; Sender's Comments: Company comment: This is a spontaneous case concerning a female patient of an unknown age with no reported medical history, who experienced the serious  unexpected event cerebral disorder and death. The events occurred on an unknown date after the booster dose of mRNA-1273.  It is not clear if cerebral disorder (she had something in the brain) refers to a previous medical history or is an event. No information was provided regarding medical history and events. Further information has been requested.The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Anxiety, Arthralgia, Chills, Condition aggravated
Clinical narrative: All outlined in my VSafe health checkin today. Injection site pain.  Chills, headache, joint pain, fever, muscle aches, fatigue, nausea, vomiting, diarrhea, abdominal pain, fibromyalgia flare up, anxiety and depression. Started around 6pm on 1/18 and began to ease up on 1/23 in the evening.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Diarrhoea, Fatigue, Fibromyalgia, Headache
Clinical narrative: All outlined in my VSafe health checkin today. Injection site pain.  Chills, headache, joint pain, fever, muscle aches, fatigue, nausea, vomiting, diarrhea, abdominal pain, fibromyalgia flare up, anxiety and depression. Started around 6pm on 1/18 and began to ease up on 1/23 in the evening.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: All outlined in my VSafe health checkin today. Injection site pain.  Chills, headache, joint pain, fever, muscle aches, fatigue, nausea, vomiting, diarrhea, abdominal pain, fibromyalgia flare up, anxiety and depression. Started around 6pm on 1/18 and began to ease up on 1/23 in the evening.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Daughter at 3 months, experienced swelling and pain in her legs at the sites where injections were administered.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination site pain
Clinical narrative: fever; pain at the left arm injection site.; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), VACCINATION SITE PAIN (pain at the left arm injection site.) and HEADACHE (headache) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 043120A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced PYREXIA (fever), VACCINATION SITE PAIN (pain at the left arm injection site.) and HEADACHE (headache). At the time of the report, PYREXIA (fever), VACCINATION SITE PAIN (pain at the left arm injection site.) and HEADACHE (headache) had resolved.            Patient received third Moderna COVID-19 vaccine on 27OCT2021 ,lot number DDLC21A.  Patient received booster dose in his left arm. Patient had no adverse reactions.   No Concomitant medication were reported by the reporter.  NO Treatment Medication were reported by the reporter.   This case was linked to MOD-2022-455759 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2022: Follow up received contains, No New Information.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Lacrimation increased
Clinical narrative: shot really hurt, it brought tears to my eyes; tears to my eyes; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In January 2022, the patient received the 1st dose of Shingles vaccine. In January 2022, immediately after receiving Shingles vaccine, the patient experienced injection site pain and eyes tearing. On an unknown date, the outcome of the injection site pain and eyes tearing were unknown.   It was unknown if the reporter considered the injection site pain and eyes tearing to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age ta vaccination was not reported. The patient got the 1st part of Shingles vaccination on Wednesday the 13th. That shot really hurt, it brought tears to his/her eyes. But the patient promised that on one would regret getting it, because from what the patient heard about the pain from Shingles, the shot was no comparison.  The patient would take the next part in six months. Note - Discrepancy in reported dates as reported received vaccination Wednesday with date 13th but the date on Wednesday was 12th January 2022.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID-19; This spontaneous report received from a consumer concerned a 24 year old male. 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: 204A21A and expiry: 21-SEP-2022) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JAN-2022, the patient experienced tested positive for covid-19. Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Death, Thrombosis
Clinical narrative: DEAD; DEVELOPED BLOOD CLOTS; COUPLE STROKES; This spontaneous report received from a patient via a company representative via social media concerned a female of unspecified age, race and ethnicity. 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, and batch number were not reported) dose, start therapy date were not reported, 1 total, for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, she developed blood clots followed by a couple strokes, now she dead (cause unknown). It was not reported if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots and strokes was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20220136326-COVID-19 VACCINE AD26.COV2.S-Dead,Developed blood clots,couple strokes 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Heart rate, Pneumonia, Pyrexia, Respiratory rate
Clinical narrative: Pneumonia; Fast heart beat/Patients Heart Rate was 110 beats per minute; respiratory rate was 40 bpm; high fever of 100.6 degrees Farenheight.; This spontaneous case was reported by a pharmacist and describes the occurrence of PNEUMONIA (Pneumonia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant), TACHYCARDIA (Fast heart beat/Patients Heart Rate was 110 beats per minute), TACHYPNOEA (respiratory rate was 40 bpm) and PYREXIA (high fever of 100.6 degrees Farenheight.). At the time of the report, PNEUMONIA (Pneumonia), TACHYCARDIA (Fast heart beat/Patients Heart Rate was 110 beats per minute), TACHYPNOEA (respiratory rate was 40 bpm) and PYREXIA (high fever of 100.6 degrees Farenheight.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.6 (High) 100.6. On an unknown date, Heart rate: 110 bpm (High) 110 bpm. On an unknown date, Respiratory rate: 40bpm (High) 40bpm.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported.Treatment information was not provided.  Hospital lists a reason for admission that is different from the vaccine side effect. Company Comment: This is a spontaneous case concerning male patient of unknown age with no medical history reported, who experienced the unexpected serious event of pneumonia, that led to hospitalization. The event occurred at an unknown time after the second dose of mRNA-1273 vaccine. The patient also experienced tachycardia, Tachypnoea and pyrexia, however it is not reported if these symptoms were temporally related to pneumonia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and hospitalization.; Sender's Comments: This is a spontaneous case concerning male patient of unknown age with no medical history reported, who experienced the unexpected serious event of pneumonia, that led to hospitalization. The event occurred at an unknown time after the second dose of mRNA-1273 vaccine. The patient also experienced tachycardia, Tachypnoea and pyrexia, however it is not reported if these symptoms were temporally related to pneumonia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and hospitalization.
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia, Tachypnoea
Clinical narrative: Pneumonia; Fast heart beat/Patients Heart Rate was 110 beats per minute; respiratory rate was 40 bpm; high fever of 100.6 degrees Farenheight.; This spontaneous case was reported by a pharmacist and describes the occurrence of PNEUMONIA (Pneumonia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant), TACHYCARDIA (Fast heart beat/Patients Heart Rate was 110 beats per minute), TACHYPNOEA (respiratory rate was 40 bpm) and PYREXIA (high fever of 100.6 degrees Farenheight.). At the time of the report, PNEUMONIA (Pneumonia), TACHYCARDIA (Fast heart beat/Patients Heart Rate was 110 beats per minute), TACHYPNOEA (respiratory rate was 40 bpm) and PYREXIA (high fever of 100.6 degrees Farenheight.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.6 (High) 100.6. On an unknown date, Heart rate: 110 bpm (High) 110 bpm. On an unknown date, Respiratory rate: 40bpm (High) 40bpm.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported.Treatment information was not provided.  Hospital lists a reason for admission that is different from the vaccine side effect. Company Comment: This is a spontaneous case concerning male patient of unknown age with no medical history reported, who experienced the unexpected serious event of pneumonia, that led to hospitalization. The event occurred at an unknown time after the second dose of mRNA-1273 vaccine. The patient also experienced tachycardia, Tachypnoea and pyrexia, however it is not reported if these symptoms were temporally related to pneumonia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and hospitalization.; Sender's Comments: This is a spontaneous case concerning male patient of unknown age with no medical history reported, who experienced the unexpected serious event of pneumonia, that led to hospitalization. The event occurred at an unknown time after the second dose of mRNA-1273 vaccine. The patient also experienced tachycardia, Tachypnoea and pyrexia, however it is not reported if these symptoms were temporally related to pneumonia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and hospitalization.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Painful respiration
Clinical narrative: pain when she breath deeply; not feeling well; body aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAINFUL RESPIRATION (pain when she breath deeply), MALAISE (not feeling well), MYALGIA (body aches) and HEADACHE (headaches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066h21a, 046a21a and 023m21a) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2022, the patient experienced PAINFUL RESPIRATION (pain when she breath deeply). 18-Jan-2022, the patient experienced MALAISE (not feeling well), MYALGIA (body aches) and HEADACHE (headaches). At the time of the report, PAINFUL RESPIRATION (pain when she breath deeply), MALAISE (not feeling well), MYALGIA (body aches) and HEADACHE (headaches) had not resolved.            No concomitant medication information provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2022: Follow-up received contained no new information.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Vaccination site pain
Clinical narrative: pretty severe pain in his shoulder and neck; it is not just at the injection site; pretty severe pain in his shoulder and neck; This spontaneous case was reported by a pharmacist and describes the occurrence of NECK PAIN (pretty severe pain in his shoulder and neck), VACCINATION SITE PAIN (it is not just at the injection site) and ARTHRALGIA (pretty severe pain in his shoulder and neck) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (pretty severe pain in his shoulder and neck), VACCINATION SITE PAIN (it is not just at the injection site) and ARTHRALGIA (pretty severe pain in his shoulder and neck). At the time of the report, NECK PAIN (pretty severe pain in his shoulder and neck), VACCINATION SITE PAIN (it is not just at the injection site) and ARTHRALGIA (pretty severe pain in his shoulder and neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.  Patient stated events occurred 2 days after vaccination.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received  Moderna dose after receiving Janssen; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received  Moderna dose after receiving Janssen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Janssen COVID-19 vaccine (as primary series) on 22-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen COVID-19 vaccine.    On 25-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received  Moderna dose after receiving Janssen). On 25-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received  Moderna dose after receiving Janssen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided.   This case was linked to MOD-2022-456266 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered more than 12 hours post puncture for 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered more than 12 hours post puncture for 2nd dose) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A and 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022 at 12:40 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2022 at 12:40 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered more than 12 hours post puncture for 2nd dose). On 20-Jan-2022 at 12:40 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered more than 12 hours post puncture for 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs were reported.   It was reported that the vial was initially stored in refrigerator on around 09-Jan-2022 and was first punctured on 19-Jan-2022 at 08:50 AM. The patient received expired vaccine beyond 12 hours post puncture on 20-Jan-2022 at 12:40 PM. The vial was stored at room temperature post puncture and did not undergo any temperature excursions. The vial was exposed to room temperature for 28 hours.  No treatment drugs were reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A lot pain on the arm/pain affected the whole left arm, from the shoulder blade and neck till the fingers.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A lot pain on the arm/pain affected the whole left arm, from the shoulder blade and neck till the fingers.) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-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 (A lot pain on the arm/pain affected the whole left arm, from the shoulder blade and neck till the fingers.). In December 2021, PAIN IN EXTREMITY (A lot pain on the arm/pain affected the whole left arm, from the shoulder blade and neck till the fingers.) had resolved.            Patient  had to take pain medications and steroids Patient state they do not take any medications regularly   This case was linked to MOD-2022-456263 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Colonoscopy, Lymphadenopathy
Clinical narrative: Severe swelling of neck glands requiring emergency room visit.  Steroid and Toradol shot - swelling went down in 45 minutes
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Haemorrhage, Nausea, Vomiting
Clinical narrative: my wife had her booster of moderna vaccine and the next day reported bleeding and loss of pregnancy. she had previously tested positive for pregnancy a few weeks before so it was pretty early on during her pregnancy. Unsure if it was related to the vaccine. she had also had nausea and vomiting a few days leading up the event which she thought was morning sickness. I had read about people having irregular periods and a few others reported miscarriages on a pharmacy group page so i though i'd report it.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Pyrexia
Clinical narrative: Migraine, light fever for about two days
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Inflammation, Muscle atrophy
Clinical narrative: Extreme inflamation with muscle loss and inability to consume calories to maintain weight due to inflamation
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Computerised tomogram, Endoscopy, Hypophagia, Inflammation
Clinical narrative: Extreme inflamation with muscle loss and inability to consume calories to maintain weight due to inflamation
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle atrophy, Pain, Weight decreased
Clinical narrative: Extreme inflamation with muscle loss and inability to consume calories to maintain weight due to inflamation
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Inflammation, Muscle atrophy
Clinical narrative: Same as last shot. Extreme inflamation in abdomin. Unable to consume enough caloris to maintain body weight. Patient lost over 50% muscle mass. Muscles seem to be disolving and due to pain in joints patient cannot exorcise enough to build back muscle mass lost. Patient has gone from 220lbs to 160 with no attenpt to lose weight. At this time patient has painfull swollen inflamed insides and is unable to consume more that 800- 1200 calories
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Computerised tomogram, Endoscopy, Hypophagia, Inflammation
Clinical narrative: Same as last shot. Extreme inflamation in abdomin. Unable to consume enough caloris to maintain body weight. Patient lost over 50% muscle mass. Muscles seem to be disolving and due to pain in joints patient cannot exorcise enough to build back muscle mass lost. Patient has gone from 220lbs to 160 with no attenpt to lose weight. At this time patient has painfull swollen inflamed insides and is unable to consume more that 800- 1200 calories
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle atrophy, Pain, Weight decreased
Clinical narrative: Same as last shot. Extreme inflamation in abdomin. Unable to consume enough caloris to maintain body weight. Patient lost over 50% muscle mass. Muscles seem to be disolving and due to pain in joints patient cannot exorcise enough to build back muscle mass lost. Patient has gone from 220lbs to 160 with no attenpt to lose weight. At this time patient has painfull swollen inflamed insides and is unable to consume more that 800- 1200 calories
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Vaccination failure
Clinical narrative: It hurts; Burns; I had the two shots two years ago now have shingles/ suspected vaccination failiure; Have shingles right now; 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 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In January 2022, between 1 and 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced suspected vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain and burning sensation. On an unknown date, the outcome of the suspected vaccination failure, pain and burning sensation were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the suspected vaccination failure, shingles, pain and burning sensation to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2 shots of Shingles vaccine 2 years ago from reporting date and had shingles right now. Less than 2 years after vaccination, the patient also experienced hurts and burns. Consent to follow up was not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got two doses of vaccine and I have them again/ Suspected vaccination failure; Shingles; hurt; 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.   The patient's past medical history included shingles (had shingles in November 2020).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced suspected vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the suspected vaccination failure and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the suspected vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2 doses of Shingles vaccine and had shingles again now  The patient stated that the shingles hurt so bad. Consent to follow up was not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19, Cerebrovascular accident, Immediate post-injection reaction, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Stroke; test positive for the COVID; 102 fever; This case was reported by a consumer and described the occurrence of stroke in a patient who received Herpes zoster (Shingles vaccine) (batch number 27PAS, expiry date unknown) for prophylaxis.   In August 2021, the patient received Shingles vaccine. In August 2021, immediately after receiving Shingles vaccine, the patient experienced fever. In January 2022, the patient experienced covid-19. On an unknown date, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke, covid-19 and fever were unknown.   It was unknown if the reporter considered the stroke, covid-19 and fever to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingles vaccine and started running 102 degree F fever immediately after vaccination. The patient also had stroke 4 days later. Between 4 and 6 months after receiving the vaccination, the patient was now (in January 2022) tested positive for the Covid vaccine which he/she did not had.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a parent concerned a male of unspecified age, race and ethnicity. 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, and batch number were not reported) dose was not reported, 1 total, administered on 20-MAR-2021 for prophylactic vaccination. The Batch number was not reported and has been requested. No concomitant medications were reported.  On 06-JAN-2022, the patient tested positive for Covid-19 via Polymerase chain reaction (PCR) test (confirmed clinical vaccination failure, and confirmed covid-19 infection) and he experienced a fever, cough and body aches.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220139528. This report was associated with a product quality complaint: 90000213267.; Sender's Comments: V0:20220139639 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: TINNITUS WAS 50 FOLD SINCE GOT THE VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: tinnitus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced tinnitus was 50 fold since got the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus was 50 fold since got the vaccine. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: sore shoulder/shoulder was extremely sore; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of ARTHRALGIA (sore shoulder/shoulder was extremely sore) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (sore shoulder/shoulder was extremely sore) and HEADACHE (Headache). At the time of the report, ARTHRALGIA (sore shoulder/shoulder was extremely sore) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment information was provided  This is a spontaneous case concerning  a patient of unknown age and gender with no relevant medical history, who experienced the expected non serious events of arthralgia and headache. The events occurred on an unknown  day after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events outcome  was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning  a patient of unknown age and gender with no relevant medical history, who experienced the expected non serious events of arthralgia and headache. The events occurred on an unknown  day after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events outcome  was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Feeling abnormal
Clinical narrative: Left ear is 100% deaf after vaccination; Very unhappy with the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Left ear is 100% deaf after vaccination) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced DEAFNESS UNILATERAL (Left ear is 100% deaf after vaccination) (seriousness criterion medically significant) and FEELING ABNORMAL (Very unhappy with the Moderna vaccine). At the time of the report, DEAFNESS UNILATERAL (Left ear is 100% deaf after vaccination) and FEELING ABNORMAL (Very unhappy with the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided. No treatment information was provided. The patient reported that, she was very unhappy with the Moderna vaccine that she received. Per ENT her left ear was 100% deaf after vaccination. She stated that, she did not have a medical history of hearing issues. Company Comment: This spontaneous case concerns a 47-year-old female patient with no relevant medical history reported, experienced serious unexpected AESI event of Deafness unilateral after receiving the first dose of mRNA-1373. The event occurred on an unknown date but within the same month of vaccination in August 2021. Patient did not have any medical history of hearing issues. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report; Sender's Comments: This spontaneous case concerns a 47-year-old female patient with no relevant medical history reported, experienced serious unexpected AESI event of Deafness unilateral after receiving the first dose of mRNA-1373. The event occurred on an unknown date but within the same month of vaccination in August 2021. Patient did not have any medical history of hearing issues. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: difficulty lifting her right arm up; sore right arm 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (difficulty lifting her right arm up) and PAIN IN EXTREMITY (sore right arm 2nd dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 007M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (she had a high fever (up and down) for 10 days with COVID-19 infection.14 days to recover from COVID-19) on 16-Aug-2020, Physical therapy and Pain management (on her neck due to COVID-19 infection). Concurrent medical conditions included Sulfonamide allergy and Adhesive tape allergy (adhesive tape).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced LIMB DISCOMFORT (difficulty lifting her right arm up) and PAIN IN EXTREMITY (sore right arm 2nd dose). At the time of the report, LIMB DISCOMFORT (difficulty lifting her right arm up) and PAIN IN EXTREMITY (sore right arm 2nd dose) outcome was unknown.            No Concomitant Drug details were reported.  No Treatment information was provided.   This case was linked to MOD-2022-456401, MOD-2022-456431 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (tle temperature located in the area /  arm a little warm,), PRURITUS (Itchy) and RASH (rash in the arm after dose 2) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, Cardiac disorder NOS, Adhesive tape allergy (rash) and Adhesive tape allergy (EKG adhesive plugs-rash).On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 06-Apr-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 VACCINATION SITE WARMTH (tle temperature located in the area /  arm a little warm,), PRURITUS (Itchy) and RASH (rash in the arm after dose 2). At the time of the report, VACCINATION SITE WARMTH (tle temperature located in the area /  arm a little warm,), PRURITUS (Itchy) and RASH (rash in the arm after dose 2) outcome was unknown. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.This case was linked to MOD-2022-456504 (Patient Link). Reporter did not allow further contact.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Illness, Influenza like illness, Insomnia
Clinical narrative: did not sleep; Pain; It feels like she has a bad case of the flu; She has never been this sick since she can remember; had diarrhea; terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (did not sleep), PAIN (Pain), INFLUENZA LIKE ILLNESS (It feels like she has a bad case of the flu), ILLNESS (She has never been this sick since she can remember) and DIARRHOEA (had diarrhea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (did not sleep), PAIN (Pain), INFLUENZA LIKE ILLNESS (It feels like she has a bad case of the flu), ILLNESS (She has never been this sick since she can remember), DIARRHOEA (had diarrhea) and HEADACHE (terrible headache). At the time of the report, INSOMNIA (did not sleep), PAIN (Pain), INFLUENZA LIKE ILLNESS (It feels like she has a bad case of the flu), ILLNESS (She has never been this sick since she can remember), DIARRHOEA (had diarrhea) and HEADACHE (terrible headache) outcome was unknown.            Concomitant medications details were not reported by the reporter. Patient might be taking ibuprofen as a treatment drug.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: did not sleep; Pain; It feels like she has a bad case of the flu; She has never been this sick since she can remember; had diarrhea; terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (did not sleep), PAIN (Pain), INFLUENZA LIKE ILLNESS (It feels like she has a bad case of the flu), ILLNESS (She has never been this sick since she can remember) and DIARRHOEA (had diarrhea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (did not sleep), PAIN (Pain), INFLUENZA LIKE ILLNESS (It feels like she has a bad case of the flu), ILLNESS (She has never been this sick since she can remember), DIARRHOEA (had diarrhea) and HEADACHE (terrible headache). At the time of the report, INSOMNIA (did not sleep), PAIN (Pain), INFLUENZA LIKE ILLNESS (It feels like she has a bad case of the flu), ILLNESS (She has never been this sick since she can remember), DIARRHOEA (had diarrhea) and HEADACHE (terrible headache) outcome was unknown.            Concomitant medications details were not reported by the reporter. Patient might be taking ibuprofen as a treatment drug.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A, 042L20A and 029A21A) for COVID-19 vaccination. No Medical History information was reported.On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant medications details were not reported by the reporter.Treatment details was not reported by the reporter.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: BECAME BLIND AFTER RECEIVING THE VACCINE
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Oligomenorrhoea, Vaginal haemorrhage
Clinical narrative: Severe ovarian cramping, spot bleeding; menstrual cycle lasts 14 days; prior to vax was 3 days...