chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: my left "shoulder and everything" was stiff; the lymph node was / painful / I can still feel the soreness; my lymph nodes under my (left) armpit were swollen out of proportion / big time swollen; This case was reported by a consumer via call center representative and described the occurrence of stiffness shoulder in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 1st February 2021). Concomitant products included COVID 19 VACCINE and COVID 19 VACCINE.   On 4th May 2021, the patient received the 2nd dose of Shingrix (intramuscular). In May 2021, less than a week after receiving Shingrix, the patient experienced stiffness shoulder, lymph node pain and axillary lymph nodes enlarged. On an unknown date, the outcome of the stiffness shoulder and axillary lymph nodes enlarged were recovered/resolved and the outcome of the lymph node pain was not recovered/not resolved.   It was unknown if the reporter considered the stiffness shoulder, lymph node pain and axillary lymph nodes enlarged to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The patient wanted to know if it was normal for Shingrix to cause lymph nodes to swell.  The patient did not want to provide her date of birth but did provide her age. She also did not want to provide her MD contact information. The patient stated that, she had received the second Shingrix shot intramuscularly a few days ago in her left shoulder deltoid and her left shoulder and everything was stiff. The patient did not had the paperwork from the pharmacy to check for the lot/expiry date. She was concerned because her lymph nodes under her left armpit were swollen out of proportion. At the time of reporting, the shoulder was no longer stiff, she was worried about the armpit, underneath the armpit, the lymph node was swollen big time and painful the whole time and it just calmed down but she could still feel the soreness. The patient did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the 1st dose of Shingrix about a year ago / is late for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date one year ago prior to reporting).   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 information was provided as follows:  The age at vaccination was not applicable for 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 symptoms were was reported. The HCP stated that the patient received the vaccine at a different pharmacy just before the pandemic hit. The HCP does not have the lot and expiration date. The reporter consented to follow up. This case has been linked with US2021100491, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021100491:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st dose of Shingrix 2.5 to 3 years ago / is late for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date 2.5-3 years prior to reporting).   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 information was provided as follows:  The age at vaccination was not applicable for 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 symptoms were was reported. The healtcare professional (HCP) stated that the patient received 1st dose of the vaccine at a his doctor's office. The HCP did not have the lot and expiration date. The reporter consented to follow up. This case has been linked with US2021100489, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021100489:same reporter
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: administered an expired (3/26/21) Pediarix / received dose on 3/31/21.; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 53HA4, expiry date 26th March 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st March 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 31st March 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 reported as follows: The patient received an expired Pediarix dose, which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster
Clinical narrative: had a mild case of Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included tozinameran (Covid 19 Vaccine Pfizer) for covid-19 prophylaxis.   Concomitant products included tozinameran (Covid 19 Vaccine Pfizer).   In November 2020, the patient received the 1st dose of Shingrix (intramuscular). In March 2021, the patient started Covid 19 Vaccine Pfizer at an unknown dose and frequency. On 1st April 2021, between 4 and 5 months after receiving Shingrix, the patient experienced shingles. The action taken with Covid 19 Vaccine Pfizer was unknown. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 72 or 73 years. The patient got both Pfizer COVID-19 shots in March 2021. It was unknown if the reporter considered the shingles to be related to Covid 19 Vaccine Pfizer. The patient experienced mild case of Shingles after Shingrix vaccination. The patient recovered from above event. The patient did not receive the second Shingrix shot but was still within timeframe for second shot. The patient did not consent to follow up.
Age: 2.0
Sex: U
Vaccine: FLU4, HEPA
Symptoms: Product storage error
Clinical narrative: administered  frozen vaccine/ranging -8.2 to  -13.4 C for 7 hrs; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 2-year-old patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis and flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th May 2021, the patient received Havrix, Havrix Pre-Filled Syringe Device, FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On 6th May 2021, unknown after receiving Havrix, Havrix Pre-Filled Syringe Device, FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 follow: The patient was administered with frozen vaccine Flulaval Quadrivalent and Havrix which was kept on temperature ranging from negative 8.2 to negative 13.4 Celsius for 7 hours, which led to incorrect storage of drug. The mobile cooler went too cold. The medical assistant wanted to know, if the patient could be re-vaccinated. Vaccine details were available for this patient. The reporter consented to follow up. This case is one of the several cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021100517:same reporter US-GLAXOSMITHKLINE-US2021100514:same reporter US-GLAXOSMITHKLINE-US2021100518:same reporter US-GLAXOSMITHKLINE-US2021100515:same reporter US-GLAXOSMITHKLINE-US2021100519:same reporter US-GLAXOSMITHKLINE-US2021100521:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: had her first vaccine in January, 2021 / now has COVID; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 1st dose of Shingrix (intramuscular). In May 2021, between 3 and 5 months after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was not recovered/not resolved.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The reporter reported that the patient had her first vaccine and now had COVID. The reporter requested to remain anonymous and did not contribute information. All information was not available. The reporter did not consent to follow up.
Age: 3.0
Sex: U
Vaccine: FLU4, HEPA
Symptoms: Product storage error
Clinical narrative: inadvertently administered frozen vaccine / frozen temp ranging -8.2 to -13.4 C for 7 hrs; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis and hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th May 2021, the patient received FluLaval Tetra 2020-2021 season, Flulaval Tetra Pre-Filled Syringe Device, Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2020-2021 season, Flulaval Tetra Pre-Filled Syringe Device, Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. The action taken with Flulaval Tetra Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the incorrect storage of drug 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 reported as follows: The nurse reported that patient was inadvertently administered with frozen flulaval tetra and havrix vaccines (frozen temperature ranging  minus 8.2 to minus 13.4 degrees Celsius for 7 hours), which led to incorrect storage of drug. The mobile cooler went too cold. The reporter asked whether there was need to revaccinate the patient. No other patient or vaccine details were available. The reporter consented to follow up. This is 1 of the 7 cases, reported by same reporter. Note:As per information reported in source document suspect field, vaccination date was captured as 6th May 2021, and clarification has been raised for the same.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021100518:same reporter US-GLAXOSMITHKLINE-US2021100521:same reporter US-GLAXOSMITHKLINE-US2021100519:same reporter US-GLAXOSMITHKLINE-US2021100517:same reporter US-GLAXOSMITHKLINE-US2021100510:same reporter US-GLAXOSMITHKLINE-US2021100515:same reporter
Age: 1.0
Sex: U
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Product storage error
Clinical narrative: inadvertently administered frozen vaccine / frozen temp ranging -8.2 to -13.4 C for 7 hrs; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis and hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th May 2021, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Havrix and Havrix Pre-Filled Syringe Device. On 6th May 2021, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 follow: The patient was administered with frozen vaccine Pediarix and Havrix which was kept on temperature ranging from 8.2 to 13.4 Celsius for 7 hours, which led to incorrect storage of drug. The mobile cooler went too cold. The medical assistant wanted to know, if the patient could be re-vaccinated. The vaccine details were available. The reporter consented to follow up. This is 1 of the 7 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021100521:same reporter US-GLAXOSMITHKLINE-US2021100518:same reporter US-GLAXOSMITHKLINE-US2021100519:same reporter US-GLAXOSMITHKLINE-US2021100510:same reporter US-GLAXOSMITHKLINE-US2021100514:same reporter US-GLAXOSMITHKLINE-US2021100515:same reporter
Age: 2.0
Sex: U
Vaccine: DTAP
Symptoms: Product storage error
Clinical narrative: nurse inadvertently administered frozen infanrix to patient.; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 2-year-old patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th May 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 follow: The patient was administered with frozen vaccine Infanrix which was kept on temp ranging from 8.2 to 13.4 Celsius for 7 hours, which led to incorrect storage of drug. The mobile cooler went too cold. The medical assistant wanted to know, if the patient could be re-vaccinated. The vaccine details were available. The reporter consented to follow up. This case is one of the several cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021100519:same reporter US-GLAXOSMITHKLINE-US2021100514:same reporter US-GLAXOSMITHKLINE-US2021100517:same reporter US-GLAXOSMITHKLINE-US2021100518:same reporter US-GLAXOSMITHKLINE-US2021100515:same reporter US-GLAXOSMITHKLINE-US2021100510:same reporter
Age: 2.0
Sex: U
Vaccine: FLU4, HEPA
Symptoms: Product storage error
Clinical narrative: Nurse inadvertently administered frozen Havrix, flulaval to patient.; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 2-year-old patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis and flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th May 2021, the patient received Havrix, Havrix Pre-Filled Syringe Device, FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On 6th May 2021, unknown after receiving Havrix, Havrix Pre-Filled Syringe Device, FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 follow: The patient was administered with frozen vaccine Havrix and FluLaval Quadrivalent season 2020- 2021, which was kept on temperature ranging from negative 8.2 to negative 13.4 Celsius for 7 hours, which led to incorrect storage of drug. The mobile cooler went too cold. The medical assistant wanted to know, if the patient could be re-vaccinated. The vaccine details were available. The reporter consented to follow up. This case is one of the several cases reported by the same nurse.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021100514:same reporter US-GLAXOSMITHKLINE-US2021100517:same reporter US-GLAXOSMITHKLINE-US2021100518:same reporter US-GLAXOSMITHKLINE-US2021100515:same reporter US-GLAXOSMITHKLINE-US2021100510:same reporter US-GLAXOSMITHKLINE-US2021100521:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose was administered 1 month after the 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional information was provided as follows:  The age at vaccination was not reported. The patient received 2nd dose of Shingrix, less than the recommended interval, which led to shortening of vaccination schedule. The patient received 2nd dose 1 month after the 1st dose. No further details were reported at the time of call. No lot number or expiration date nor patients details were provided. The reporter consented to follow up.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Cough, Dizziness
Clinical narrative: DIFFICULTY IN BREATHING; WENT FROM CHILLS TO HOT; SLIGHT FEVER; NAUSEOUS; LEFT DELTIOD INJECTION SITE PAIN; FATIGUE; HEADAHES; MUSCLE ACHES; LIGHTHEADED; LEFT SIDE WAS ACHING; DRY COUGH; LEFT MUSCLE TIGHTNESS; ALL JOINTS ALL OVER BODY WAS HURTING; CHILLS; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included gastro issues, and hypothyroid, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 at 09:30 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced left muscle tightness. On 13-MAR-2021, the subject experienced left deltiod injection site pain. On 13-MAR-2021, the subject experienced muscle aches. On 13-MAR-2021 14:00, the subject experienced lightheaded. On 13-MAR-2021 14:00, the subject experienced nauseous. On 13-MAR-2021 14:00, the subject experienced fatigue. On 13-MAR-2021 16:00, the subject experienced chills. On 13-MAR-2021 16:00, the subject experienced headahes. On 13-MAR-2021 18:00, the subject experienced left side was aching. On 13-MAR-2021 18:00, the subject experienced dry cough. On 13-MAR-2021 18:00, the subject experienced all joints all over body was hurting. On 14-MAR-2021, Laboratory data included: Body temperature 100.1 deg. On 14-MAR-2021 02:00, the subject experienced went from chills to hot. On 14-MAR-2021 02:00, the subject experienced slight fever. On 14-MAR-2021 10:00, the subject experienced difficulty in breathing. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills, and slight fever on 14-MAR-2021, was recovering from left side was aching, went from chills to hot, difficulty in breathing, and muscle aches, had not recovered from fatigue, lightheaded, nauseous, dry cough, and headahes, and the outcome of left deltiod injection site pain, all joints all over body was hurting and left muscle tightness was not reported. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling hot, Headache, Injection site pain
Clinical narrative: DIFFICULTY IN BREATHING; WENT FROM CHILLS TO HOT; SLIGHT FEVER; NAUSEOUS; LEFT DELTIOD INJECTION SITE PAIN; FATIGUE; HEADAHES; MUSCLE ACHES; LIGHTHEADED; LEFT SIDE WAS ACHING; DRY COUGH; LEFT MUSCLE TIGHTNESS; ALL JOINTS ALL OVER BODY WAS HURTING; CHILLS; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included gastro issues, and hypothyroid, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 at 09:30 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced left muscle tightness. On 13-MAR-2021, the subject experienced left deltiod injection site pain. On 13-MAR-2021, the subject experienced muscle aches. On 13-MAR-2021 14:00, the subject experienced lightheaded. On 13-MAR-2021 14:00, the subject experienced nauseous. On 13-MAR-2021 14:00, the subject experienced fatigue. On 13-MAR-2021 16:00, the subject experienced chills. On 13-MAR-2021 16:00, the subject experienced headahes. On 13-MAR-2021 18:00, the subject experienced left side was aching. On 13-MAR-2021 18:00, the subject experienced dry cough. On 13-MAR-2021 18:00, the subject experienced all joints all over body was hurting. On 14-MAR-2021, Laboratory data included: Body temperature 100.1 deg. On 14-MAR-2021 02:00, the subject experienced went from chills to hot. On 14-MAR-2021 02:00, the subject experienced slight fever. On 14-MAR-2021 10:00, the subject experienced difficulty in breathing. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills, and slight fever on 14-MAR-2021, was recovering from left side was aching, went from chills to hot, difficulty in breathing, and muscle aches, had not recovered from fatigue, lightheaded, nauseous, dry cough, and headahes, and the outcome of left deltiod injection site pain, all joints all over body was hurting and left muscle tightness was not reported. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: DIFFICULTY IN BREATHING; WENT FROM CHILLS TO HOT; SLIGHT FEVER; NAUSEOUS; LEFT DELTIOD INJECTION SITE PAIN; FATIGUE; HEADAHES; MUSCLE ACHES; LIGHTHEADED; LEFT SIDE WAS ACHING; DRY COUGH; LEFT MUSCLE TIGHTNESS; ALL JOINTS ALL OVER BODY WAS HURTING; CHILLS; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included gastro issues, and hypothyroid, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 at 09:30 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced left muscle tightness. On 13-MAR-2021, the subject experienced left deltiod injection site pain. On 13-MAR-2021, the subject experienced muscle aches. On 13-MAR-2021 14:00, the subject experienced lightheaded. On 13-MAR-2021 14:00, the subject experienced nauseous. On 13-MAR-2021 14:00, the subject experienced fatigue. On 13-MAR-2021 16:00, the subject experienced chills. On 13-MAR-2021 16:00, the subject experienced headahes. On 13-MAR-2021 18:00, the subject experienced left side was aching. On 13-MAR-2021 18:00, the subject experienced dry cough. On 13-MAR-2021 18:00, the subject experienced all joints all over body was hurting. On 14-MAR-2021, Laboratory data included: Body temperature 100.1 deg. On 14-MAR-2021 02:00, the subject experienced went from chills to hot. On 14-MAR-2021 02:00, the subject experienced slight fever. On 14-MAR-2021 10:00, the subject experienced difficulty in breathing. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills, and slight fever on 14-MAR-2021, was recovering from left side was aching, went from chills to hot, difficulty in breathing, and muscle aches, had not recovered from fatigue, lightheaded, nauseous, dry cough, and headahes, and the outcome of left deltiod injection site pain, all joints all over body was hurting and left muscle tightness was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Deep vein thrombosis
Clinical narrative: DEEP VEIN THROMBOSIS; NON-ST-ELEVATION MYOCARDIAL INFARCTION.; This spontaneous report received from a patient concerned a 63 year white (Not Hispanic or Latino) old female. The patient's height, and weight were not reported. The patient's past medical history included coronary artery bypass grafting (CABG), and concurrent conditions included chronic coronary artery disease (CAD). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total dose administered on 23-APR-2021 for prophylactic vaccination in right arm. Concomitant medications included valsartan for unknown indication.  On 30-APR-2021, the patient developed deep vein thrombosis and was admitted in the hospital. On APR-2021, she also had developed possible non-ST-elevation myocardial infarction (NSTEMI). She was prescribed with ticagrelor (Brillinta) 60 bid and acetylsalicylic acid (Aspirin)  The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from deep vein thrombosis on 30-APR-2021, and the outcome of non-st-elevation myocardial infarction. was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210502029-covid-19 vaccine ad26.cov2.s- Deep vein thrombosis  - This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.  V0- 20210502029-covid-19 vaccine ad26.cov2.s- Non-ST-elevation myocardial infarction-. 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: MEDICAL HISTORY - chronic coronary artery disease (CAD)
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered
Clinical narrative: POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a health care professional concerned a 41 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no illness at the time of vaccination and no history of allergy to vaccine, drug or food. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, expiry: 23-JUN-2021) .5 ml, administered on 03-MAY-2021 11:20 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021 11:20, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of poor quality drug administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210503927 and 20210504498.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a health care professional concerned a 41 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no illness at the time of vaccination and no history of allergy to vaccine, drug or food. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, expiry: 23-JUN-2021) .5 ml, administered on 03-MAY-2021 11:20 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021 11:20, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of poor quality drug administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210503927 and 20210504498.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced confirmed immunological vaccine failure. Laboratory data (dates unspecified) included: SARS-CoV-2 antibody test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed immunological vaccine failure. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Feeling abnormal, Headache
Clinical narrative: STOMACH PAIN (RIGHT-SIDE); HEADACHE; TIREDNESS; FOGGY; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and have no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced foggy. On MAY-2021, the subject experienced tiredness. On 03-MAY-2021, the subject experienced stomach pain (right-side). On 03-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foggy, and tiredness on MAY-2021, and stomach pain (right-side) on 04-MAY-2021, and had not recovered from headache. This report was non-serious. This case, from the same reporter is linked to 20210506681.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a physician concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included prednisone.  On 2021, 6-8 weeks after covid-19 vaccination antibodies tests came up negative (coded to confirmed immunological vaccination failure). Laboratory data included: Antibody test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccination failure was not reported. This report was serioQus (Other Medically Important Condition).; Sender's Comments: V0 : 20210506571- COVID-19 VACCINE AD26.COV2.S -Confirmed immunological vaccine failure. This event is considered not related. The event 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 than the drug. Specifically: -OTHER SUSPECT DRUGS, SPECIAL SITUATIONS
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dyspnoea, Epistaxis, Fatigue, Injection site pain
Clinical narrative: EXTREMELY TIRED; UNABLE TO STAY AWAKE; WOBBLINESS; SHORTNESS OF BREATH; PAIN AT INJECTION SITE; NOSEBLEED; LETHARGIC; This spontaneous report received from a patient concerned a 77 year male. The patient's height, and weight were not reported. The patient's concurrent conditions included Chronic obstructive pulmonary disease (COPD). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802070 expiry: Unknown) dose was not reported, 1 total dose, administered on 06-APR-2021 for prophylactic vaccination in left arm. No concomitant medications were reported.  On 06-APR-2021 (evening), the patient experienced extremely tired and lethargic. On 07-APR-2021 (the day after), he developed nosebleeds. For a long period of time, he felt extremely tired, and he was unable to stay awake. Later, he developed wobbliness. On 17-APR-2021, he was taken to emergency room (ER) and was admitted to the hospital for couple of days. His all tests and assessments were performed which came out clear. He also experienced shortness of breath, and pain at injection site. On an unspecified date, he experienced shortness of breath, and pain at injection site. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nosebleed, had not recovered from extremely tired, wobbliness, lethargic, and unable to stay awake, and the outcome of shortness of breath and pain at injection site was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 2021506688-Covid 19 Vaccine-Unable to stay awake, Wobbliness. 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). 2021506688-Covid 19 Vaccine-Extremely tired. This event is labeled per RSI and is therefore considered potentially related.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Lethargy, Somnolence
Clinical narrative: EXTREMELY TIRED; UNABLE TO STAY AWAKE; WOBBLINESS; SHORTNESS OF BREATH; PAIN AT INJECTION SITE; NOSEBLEED; LETHARGIC; This spontaneous report received from a patient concerned a 77 year male. The patient's height, and weight were not reported. The patient's concurrent conditions included Chronic obstructive pulmonary disease (COPD). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802070 expiry: Unknown) dose was not reported, 1 total dose, administered on 06-APR-2021 for prophylactic vaccination in left arm. No concomitant medications were reported.  On 06-APR-2021 (evening), the patient experienced extremely tired and lethargic. On 07-APR-2021 (the day after), he developed nosebleeds. For a long period of time, he felt extremely tired, and he was unable to stay awake. Later, he developed wobbliness. On 17-APR-2021, he was taken to emergency room (ER) and was admitted to the hospital for couple of days. His all tests and assessments were performed which came out clear. He also experienced shortness of breath, and pain at injection site. On an unspecified date, he experienced shortness of breath, and pain at injection site. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nosebleed, had not recovered from extremely tired, wobbliness, lethargic, and unable to stay awake, and the outcome of shortness of breath and pain at injection site was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 2021506688-Covid 19 Vaccine-Unable to stay awake, Wobbliness. 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). 2021506688-Covid 19 Vaccine-Extremely tired. This event is labeled per RSI and is therefore considered potentially related.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Thrombosis, Ultrasound scan
Clinical narrative: BLOOD CLOTS IN BOTH LOWER LEGS; LEG CRAMPS; This spontaneous report received from a patient concerned a 58 year old white non-Hispanic or Latino female. The patients weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, frequency 1 total, administered on 18-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the patient started experienced leg cramps.  On 22-MAR-2021, the patient diagnosed with blood clots in both lower legs by ultrasound. Patient was put on unspecified  blood thinner and started RX on 23-Mar-2021 Laboratory data included: Diagnostic ultrasound (NR: not provided) Positive for bilateral blood clots in lower legs. On 04-Apr-2021 patient went to ER for severe leg cramps, Patient got RX for Soma and started taking on 05-Apr-2021. Treatment medications (dates unspecified) included: carisoprodol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots, lower extremities, and leg cramps. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210506805 - Covid-19 vaccine ad26.cov2.s-Blood clots in both lower legs. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: PASSED AWAY; This spontaneous report received from a consumer via social media concerned a female patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number and expiry were unknown) dose, start therapy date were not reported, 1 total, administered 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 (a couple of days after vaccination), the patient passed away. The cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210508328.; Sender's Comments: V0: 20210506934 -COVID-19 VACCINE AD26.COV2.S - Passed Away. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES ON RIGHT SIDE RIBS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A/201A2117 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced shingles on right side ribs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles on right side ribs was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: SORENESS; CHILLS; NAUSEA; SPLITTING HEADACHE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced soreness. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced nausea. On MAY-2021, the subject experienced splitting headache. On MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, nausea, splitting headache, chills, and soreness. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Discomfort, Epistaxis, Fibromyalgia, Nasopharyngitis
Clinical narrative: FIBROMYALGIA; BLEEDING NOSE; COLD; SORE AFTER RADIO FREQUENCY PROCEDURE; This spontaneous report received from a patient via a company representative concerned a 47 year old female. The patients height, and weight were not reported. The patients concurrent conditions included rheumatoid arthritis. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, intramuscular, batch number was not reported) dose, administered on 2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. Concomitant medications included adalimumab for rheumatoid arthritis. On 2021, the patient experienced fibromyalgia, bleeding nose about a week and a half, cold about a week, and sore after radio frequency procedure. In Mar 2021 patient had a radio frequency procedure completed on lower back and was sore afterwards The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from bleeding nose, and cold, had not recovered from fibromyalgia, and the outcome of sore after radio frequency procedure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210508103- COVID-19 VACCINE AD26.COV2.S -Fibromyalgia. 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: UNDERLYING DISEASE
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: BLURRED VISION; This spontaneous report received from a physician concerned a 53 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-MAY-2021, the subject experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blurred vision was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.