chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected Vaccination failure; diagnosed with shingles. Because I did get the shot it is a much milder case; somewhat painful; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows The patient reported for him/herself. The age at vaccination was not reported. The patient got the shingles shot less than a year ago and the patient was just diagnosed with shingles.  The patient stated because he or she did get the shot it was a much milder case but still somewhat painful. The patient's doctor said to the patient that the patient was his first breakthrough case. The still patient recommend getting the shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset and laboratory confirmation were not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; got the shingles shot and he gave it to him; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving 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.  Additional details were provided as follows The reporter was the patient's friend. The age at vaccination was not reported. After receiving shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact
Clinical narrative: during the administration of Shingrix to a patient the vaccine leak on the arm; during the administration of Shingrix to a patient the vaccine leak on the arm; during the administration of Shingrix to a patient the vaccine leak on the arm; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.  Additional details provided were as follows: The pharmacist reported that during the administration of Shingrix to a patient the vaccine leak on the arm which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. No adverse event was reported. No patient identifiers were reported. No vaccination date was provided. No product complaint was reported. No lot number and expiry date was provided. Reporter consented to follow-up.
Sex: F
Vaccine: HIBV
Symptoms: Intercepted product prescribing error
Clinical narrative: 65 years old has a prescription to receive Hiberix.; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 65-year-old female patient who received Hib (Hiberix) for prophylaxis.   Concurrent medical conditions included asthma, obesity, acute pharyngitis, type ii diabetes mellitus and skin cancer.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.  Additional details were provided are as follows: The age at vaccination was not applicable for this report. The female patient 65 years old had a prescription to receive Hiberix, which led to intercepted drug prescribing error. The reporter mentioned that, vaccination had not occurred yet. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first shot of Engerix-B one year ago/her second shot on the 19th July, 2021; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 41-year-old female patient who received HBV (Engerix B) (batch number 74EM4, expiry date 20th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (1st dose of Engerix B one year ago in 2020).   On 19th July 2021, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 19th July 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: This case was reported by the pharmacy intern. The patient received her second shot on the 19th July 2021, later than the recommended interval, which led to lengthening of the vaccine schedule. The patient did not specify the exact day or lot number because the patient was vaccinated in another facility. No further events were reported at the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: dose 1 in October 2020/ dose#2 a month later/ did not get the third dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 32-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B adult (received 1st dose in October 2020) and Engerix B adult (patient believes she received 2nd dose a month later in 2020).   On an unknown date, the patient received the 3rd dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by the patient for herself. The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive the 3rd dose of Engerix B adult, which led to incomplete course of vaccination. No further information was reported. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021158159:possible same patient
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose/administrated more than a year ago/No 2nd dose/administrated; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose of Shingrix received more than a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. No patient's identifiers, lot number and expiration date was provided.  No vaccination date provided for the first dose. No further information was reported. The reporter consented to follow up.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Vomiting / unable to keep any fluids down, due to the vomiting; Experience nausea; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th July 2021, the patient received the 1st dose of Shingrix. In July 2021, less than a week after receiving Shingrix, the patient experienced vomiting and nausea. On an unknown date, the outcome of the vomiting and nausea were not recovered/not resolved.   It was unknown if the reporter considered the vomiting and nausea to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient. The patient received first dose of Shingrix. After getting the shot, he experienced nausea and vomiting and was unable to keep any fluids down, due to the vomiting.  The symptoms had not yet resolved, patient advised to speak with health care professional. No further information was available. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: didn´t received second dose / at time / first dose was given / during 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting,the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Feeling abnormal, Impaired work ability, Pain
Clinical narrative: back is hurting severely; body aches; feels horrible; This case was reported by a consumer via call center representative and described the occurrence of back pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2021, the patient received the 1st dose of Shingrix. In July 2021, less than a week after receiving Shingrix, the patient experienced back pain, general body pain and feels awful. On an unknown date, the outcome of the back pain, general body pain and feels awful were not recovered/not resolved.   The reporter considered the back pain, general body pain and feels awful to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced body aches, back was hurting severely and was unable to go to work because she felt horrible.
Age: 57.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: adult patient received/ pediatric dose of Havrix.; adult patient received/ pediatric dose of Havrix.; This case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 57-year-old male patient who received HAV (Havrix pediatric) (batch number ZJ3G3, expiry date 12th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th July 2021, the patient received the 1st dose of Havrix pediatric and Havrix Pre-Filled Syringe Device. On 14th July 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: It was reported that an adult patient received a pediatric dose instead of adult dose of Havrix, which led to adult use of a child product and underdose. Nurse wanted to know if the patient should  start over with adult dose schedule or complete the schedule with pediatric dose. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Death
Clinical narrative: DEATH; FEEL SIDE EFFECTS/SYMPTOMS; This spontaneous report received from a consumer concerned a 49 year old male an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient was healthy. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown; expiry date: Unknown) dose, start therapy date were not reported 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date (1 day after receiving vaccine), the patient experienced side effects/symptoms. Four day later, he passed away. It was not reported, if the autopsy was performed or not. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of feel side effects/symptoms was not reported. This report was serious (Death). This case is linked to 20210608311 (same reporter).; Sender's Comments: V0 - 20210745184-Covid-19 vaccine ad26.cov2.s-Death. 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: F
Vaccine: COVID19, UNK
Symptoms: Hypoaesthesia
Clinical narrative: Numbness; This spontaneous report received from a health care professional concerned a 42 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received (solution for injection, subcutaneous, batch number: Unknown) 45 mg, frequency was not reported, from 29-SEP-2018 for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-MAY-2021, the patient experienced numbness, and was hospitalized for 3 days in the early MAY-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with ustekinumab was not reported. The outcome of numbness was not reported. The reporter provided no causality assessment, the company causality between ustekinumab and numbness was not related. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V:20210749072-covid-19 vaccine ad26.cov2.s-numbness. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure fluctuation, Blood pressure measurement, Choking sensation, Cough
Clinical narrative: ISCHAEMIA IN THE HEART; BLOOD PRESSURE WENT UP AND THEN DOWN; COUGH WHEN TAKES A DEEP BREATH; FEELS LIKE CHOKING; DULL PAIN IN LEFT SHOULDER BLADE; ARM (INOCULATION SITE) HURT; This spontaneous report received from a patient concerned a 53 year old female of unknown ethnicity. The patient's height, and weight were not reported.  The patient's concurrent conditions included brain aneurysm, non alcohol user, non smoker, penicillin allergy, and sulfa allergy, and other pre-existing medical conditions included the patient had no history of heart disease or blood pressure. The patient experienced drug allergy when treated with codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: 07-AUG-2021) dose was not reported, 1 total, administered to left arm on 21-MAY-2021 for prophylactic vaccination.   Concomitant medications included losartan for brain aneurysm, acetylsalicylic acid, escitalopram oxalate, gabapentin, and glyceryl trinitrate.  On 22-MAY-2021, the patient experienced nausea, then sweating started 3 to 4 days later. The patient arm (inoculation site) hurt for 2 weeks, patient also experienced heaviness on the chest, blood pressure goes up and then down and face started to sweat with any minor activity. Patient felt dull pain in left shoulder blade, tends to cough when taken deep breaths and felt like choking sometimes. After performing electrocardiography patient was diagnosed with ischaemia in the heart (part of heart not getting oxygen that could be due to clot/embolism).   On 16-JUL-2021, Laboratory data included: EKG (NR: not provided) Ischemia in heart. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) not reported (went up and then down). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm (inoculation site) hurt, and had not recovered from ischaemia in the heart, and the outcome of blood pressure went up and then down, cough when takes a deep breath, dull pain in left shoulder blade and feels like choking was not reported. This report was serious (Life Threatening).; Sender's Comments: V0:20210752777-COVID-19 VACCINE AD26.COV2.S-Ischaemia in the heart. 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Injection site pain, Myocardial ischaemia
Clinical narrative: ISCHAEMIA IN THE HEART; BLOOD PRESSURE WENT UP AND THEN DOWN; COUGH WHEN TAKES A DEEP BREATH; FEELS LIKE CHOKING; DULL PAIN IN LEFT SHOULDER BLADE; ARM (INOCULATION SITE) HURT; This spontaneous report received from a patient concerned a 53 year old female of unknown ethnicity. The patient's height, and weight were not reported.  The patient's concurrent conditions included brain aneurysm, non alcohol user, non smoker, penicillin allergy, and sulfa allergy, and other pre-existing medical conditions included the patient had no history of heart disease or blood pressure. The patient experienced drug allergy when treated with codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: 07-AUG-2021) dose was not reported, 1 total, administered to left arm on 21-MAY-2021 for prophylactic vaccination.   Concomitant medications included losartan for brain aneurysm, acetylsalicylic acid, escitalopram oxalate, gabapentin, and glyceryl trinitrate.  On 22-MAY-2021, the patient experienced nausea, then sweating started 3 to 4 days later. The patient arm (inoculation site) hurt for 2 weeks, patient also experienced heaviness on the chest, blood pressure goes up and then down and face started to sweat with any minor activity. Patient felt dull pain in left shoulder blade, tends to cough when taken deep breaths and felt like choking sometimes. After performing electrocardiography patient was diagnosed with ischaemia in the heart (part of heart not getting oxygen that could be due to clot/embolism).   On 16-JUL-2021, Laboratory data included: EKG (NR: not provided) Ischemia in heart. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) not reported (went up and then down). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm (inoculation site) hurt, and had not recovered from ischaemia in the heart, and the outcome of blood pressure went up and then down, cough when takes a deep breath, dull pain in left shoulder blade and feels like choking was not reported. This report was serious (Life Threatening).; Sender's Comments: V0:20210752777-COVID-19 VACCINE AD26.COV2.S-Ischaemia in the heart. 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: U
Vaccine: COVID19
Symptoms: Drug ineffective, Illness
Clinical narrative: VERY SICK; VACCINE IS NOT EFFECTIVE AGAINST THE VARIANT; 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. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced very sick, and vaccine is not effective against the variant. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the very sick and vaccine is not effective against the variant was not reported. This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Joint dislocation, Myalgia, Seizure
Clinical narrative: massive seizure; Shoulder popped out; light headed; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (massive seizure), JOINT DISLOCATION (Shoulder popped out) and DIZZINESS (light headed) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced SEIZURE (massive seizure) (seriousness criteria hospitalization prolonged and medically significant), JOINT DISLOCATION (Shoulder popped out) (seriousness criterion hospitalization prolonged) and DIZZINESS (light headed) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced MYALGIA (sore arm). The patient was hospitalized from 02-May-2021 to 05-May-2021 due to SEIZURE, then for 4 days due to DIZZINESS and JOINT DISLOCATION. On 05-May-2021, SEIZURE (massive seizure) had resolved. At the time of the report, JOINT DISLOCATION (Shoulder popped out), DIZZINESS (light headed) and MYALGIA (sore arm) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided. It was noted that the patient never experienced a seizure before. He was treated with Physical therapy and undergone surgery.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Diarrhoea, Helicobacter infection, Helicobacter test
Clinical narrative: Helicobacter pylori; felt that he pushed the needle too far into her arm almost like it hit bone.; diarrhea; Tiredness; worse not better; This spontaneous case was reported by a nurse and describes the occurrence of HELICOBACTER INFECTION (Helicobacter pylori) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BIFIDOBACTERIUM INFANTIS (ALIGN) for Diarrhea.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced DIARRHOEA (diarrhea), ASTHENIA (Tiredness) and CONDITION AGGRAVATED (worse not better). On an unknown date, the patient experienced HELICOBACTER INFECTION (Helicobacter pylori) (seriousness criterion medically significant) and VACCINATION SITE REACTION (felt that he pushed the needle too far into her arm almost like it hit bone.). At the time of the report, HELICOBACTER INFECTION (Helicobacter pylori), VACCINATION SITE REACTION (felt that he pushed the needle too far into her arm almost like it hit bone.), DIARRHOEA (diarrhea), ASTHENIA (Tiredness) and CONDITION AGGRAVATED (worse not better) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Helicobacter test: negative (Negative) testing negative for H Pylori.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other Concomitant Medication provided was Immodium. Treatment medication not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding this events has been provided at this time. No further information is expected at this time.   This case was linked to MOD-2021-264344 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding this events has been provided at this time. No further information is expected at this time
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Helicobacter pylori; felt that he pushed the needle too far into her arm almost like it hit bone.; diarrhea; Tiredness; worse not better; This spontaneous case was reported by a nurse and describes the occurrence of HELICOBACTER INFECTION (Helicobacter pylori) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BIFIDOBACTERIUM INFANTIS (ALIGN) for Diarrhea.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced DIARRHOEA (diarrhea), ASTHENIA (Tiredness) and CONDITION AGGRAVATED (worse not better). On an unknown date, the patient experienced HELICOBACTER INFECTION (Helicobacter pylori) (seriousness criterion medically significant) and VACCINATION SITE REACTION (felt that he pushed the needle too far into her arm almost like it hit bone.). At the time of the report, HELICOBACTER INFECTION (Helicobacter pylori), VACCINATION SITE REACTION (felt that he pushed the needle too far into her arm almost like it hit bone.), DIARRHOEA (diarrhea), ASTHENIA (Tiredness) and CONDITION AGGRAVATED (worse not better) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Helicobacter test: negative (Negative) testing negative for H Pylori.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other Concomitant Medication provided was Immodium. Treatment medication not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding this events has been provided at this time. No further information is expected at this time.   This case was linked to MOD-2021-264344 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding this events has been provided at this time. No further information is expected at this time
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Granulomatosis with polyangiitis
Clinical narrative: Wegener's granulomatosis; This spontaneous case was reported by a consumer and describes the occurrence of GRANULOMATOSIS WITH POLYANGIITIS (Wegener's granulomatosis) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GRANULOMATOSIS WITH POLYANGIITIS (Wegener's granulomatosis) (seriousness criterion medically significant). At the time of the report, GRANULOMATOSIS WITH POLYANGIITIS (Wegener's granulomatosis) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  No treatment information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked (Dose 2) (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Chest discomfort, Condition aggravated, Granulomatosis with polyangiitis, Heart rate
Clinical narrative: Wegener's granulomatosis; after the second dose that the symptoms got worst; Pressure on the chest/pressure like feeling off and on continuously; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of GRANULOMATOSIS WITH POLYANGIITIS (Wegener's granulomatosis) in a 25-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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GRANULOMATOSIS WITH POLYANGIITIS (Wegener's granulomatosis) (seriousness criterion medically significant), CONDITION AGGRAVATED (after the second dose that the symptoms got worst), CHEST DISCOMFORT (Pressure on the chest/pressure like feeling off and on continuously) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, GRANULOMATOSIS WITH POLYANGIITIS (Wegener's granulomatosis), CONDITION AGGRAVATED (after the second dose that the symptoms got worst), CHEST DISCOMFORT (Pressure on the chest/pressure like feeling off and on continuously) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, C-reactive protein: 3900 (abnormal) abnormal. In 2021, Heart rate: 100 (High) High.         It was reported that the patient got electrocardiogram (ECG) and blood work done, the results for which were not provided. No treatment information was provided.  No relevant concomitant medications were reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-265463 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Wegener's granulomatosis; after the second dose that the symptoms got worst; Pressure on the chest/pressure like feeling off and on continuously; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of GRANULOMATOSIS WITH POLYANGIITIS (Wegener's granulomatosis) in a 25-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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GRANULOMATOSIS WITH POLYANGIITIS (Wegener's granulomatosis) (seriousness criterion medically significant), CONDITION AGGRAVATED (after the second dose that the symptoms got worst), CHEST DISCOMFORT (Pressure on the chest/pressure like feeling off and on continuously) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, GRANULOMATOSIS WITH POLYANGIITIS (Wegener's granulomatosis), CONDITION AGGRAVATED (after the second dose that the symptoms got worst), CHEST DISCOMFORT (Pressure on the chest/pressure like feeling off and on continuously) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, C-reactive protein: 3900 (abnormal) abnormal. In 2021, Heart rate: 100 (High) High.         It was reported that the patient got electrocardiogram (ECG) and blood work done, the results for which were not provided. No treatment information was provided.  No relevant concomitant medications were reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-265463 (Patient Link).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Deep vein thrombosis, Pulmonary embolism, Thrombosis, Ultrasound Doppler
Clinical narrative: a month and a half after receiving the vaccine, I developed blood clots in legs; I was diagnosed with DVT; it travelled to the lungs; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (a month and a half after receiving the vaccine, I developed blood clots in legs), DEEP VEIN THROMBOSIS (I was diagnosed with DVT) and PULMONARY EMBOLISM (it travelled to the lungs) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced THROMBOSIS (a month and a half after receiving the vaccine, I developed blood clots in legs) (seriousness criteria hospitalization and medically significant), DEEP VEIN THROMBOSIS (I was diagnosed with DVT) (seriousness criteria hospitalization and medically significant) and PULMONARY EMBOLISM (it travelled to the lungs) (seriousness criteria hospitalization and medically significant). The patient was treated with APIXABAN (ELIQUIS) in March 2021 for Deep vein thrombosis, at a dose of UNK dosage form. At the time of the report, THROMBOSIS (a month and a half after receiving the vaccine, I developed blood clots in legs), DEEP VEIN THROMBOSIS (I was diagnosed with DVT) and PULMONARY EMBOLISM (it travelled to the lungs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: he was diagnosed as having deep vein thrombosis (abnormal) CT scan of his lungs. He was diagnosed as having Deep Vein Thrombosis (DVT). In 2021, Ultrasound Doppler: he was diagnosed as having deep vein thrombosis (abnormal) An ultrasound of his heart and legs. He was diagnosed as having Deep Vein Thrombosis (DVT).         Patient reports having to be hospitalized overnight, one month after vaccination. He stated that he was previously a healthy male with no underlying health conditions.   Concomitant medications were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Lumbar puncture, Multiple sclerosis
Clinical narrative: MS; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (MS) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029K20A) for COVID-19 vaccination.     The patient's past medical history included insomnia. Concurrent medical conditions included Cholesterol and Hyperthyroidism.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced MULTIPLE SCLEROSIS (MS) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 26-Apr-2021 due to MULTIPLE SCLEROSIS. The patient was treated with TERIFLUNOMIDE (AUBAGIO) ongoing since an unknown date for MS, at a dose of 1 dosage form. At the time of the report, MULTIPLE SCLEROSIS (MS) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Computerised tomogram: positive (Positive) Positive: diagnosed with MS. On 28-Apr-2021, Lumbar puncture: positive (Positive) Positive: diagnosed with MS.         Concomitant medication included medicines for cholesterol, hyperthyroidism and insomnia.  The patient reports that she was given unknown IV steroids for 7 days during her hospital stay for MS. On 13-JUN-2021 she got more of IV steroids while at ER visit. Two days later she visited MS specialist who prescribed her with IVIG and steroids for 5 days.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information has been reported at this time. Onset time of; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information has been reported at this time. Onset time of
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Nerve injury, Pain, Tremor
Clinical narrative: 1st Vaccine:   I was in Menopause for over 2 years.   The vaccine included a period. 1st Vaccine:   I began having uncontrollable  neck and head tremors after the vaccine which have not subsided and continue every day.  It appears to have caused permeant nerve damage and cervical dystonia which did not exist before the shot. 1st Vaccine:   Covid Arm to the extreme and flu like symptoms, exhaustion and pain for several days. 2nd Vaccine:  Extreme, Intense and excruciating pain as if my body was being torn apart from the inside out (the most pain I've ever felt in my life)  Lasted the entire night of the vaccine 6-10 hours and then subsided.   The nerve damage and tremors continue.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder, Ocular hyperaemia, Pain in extremity
Clinical narrative: -Arm pain for 2 to 3 days  -Right eye bloodshot   -Menstrual period started 11 days early for the 2nd time this month. Very painful cramps and chunky discharge.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort, Respiratory rate increased
Clinical narrative: Dizziness, fulness in head, rapid breathing.  Client complained of dizziness, fullness of the head and rapid breathing.  Client assessed by onsite paramedic.  Vital signs assessed.  Client states feels much better, no further symptoms and previous symptoms resolved.  Client assessed for an additional 15 mins.  No further symptoms and client informed to, instructed to f/u with medical assistance should any further symptoms arise.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient felt lightheaded for about 20 seconds while sitting down in chair. Patient states she is afraid of needles and hates shots prior to vaccine. NO Anaphylaxis, no epi pen use, no benadryl use. Patient felt fine afterwards about 20 seconds.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills, headache, body aches, some fatigue
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Feeling hot, Nervousness, Somnolence
Clinical narrative: Nervousness, c/o feeling hot, sleepy.  EMT on site-client assessed.  No sob, BP 90/50, r 18, P 70, O2Sat 99, BP 80/50. Client observed for additional 15 minutes.  Denies further c/o previous or any symptoms.  BP retaken by EMT 110/70, P 70, R 12.  Client and client's mother instructed to follow up or seek medical assistance for any further symptoms or change.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Pt received benadryl and tongue and lip tingling resolved
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: CDC recommends using single-use vials of normal saline to dilute to each vial of the Pfizer vaccine.  Staff member incorrectly used 100 ml bottles of normal saline to reconstitute multiple vials of vaccine each day.  Staff member used a new bottle per day, however, and used the correct amount of normal saline to dilute each vial (1.8 ml per vial). We have since corrected this error and also notified local health authorities.  Patient has not reported any adverse events to health clinic where error occurred.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Error: Wrong Route (SC, IM, etc.)-
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Flushing, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Systemic: Chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Systemic: Chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: injection site immediately became a hard knot and red and hot. ice give to pt and observed for 30minutes, rxn did not progess any further. advised pt of emergency protocol and told we will f/u with her tomorrow since we are closing in 30minutes after she left
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone normal, Heavy menstrual bleeding, Ultrasound uterus abnormal, Uterine leiomyoma
Clinical narrative: In June, 2021, my menstral cycle started at day 37.  The bleeding was slow to come, but once it came, it did not stop.    Today is July 27, 2021.  I am only able to control bleeding through using ibuprofen.