chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Myalgia, Nausea
Clinical narrative: muscles are sore; nausea; Been sick; This case was reported by a consumer and described the occurrence of muscle soreness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced muscle soreness, nausea and sickness. On an unknown date, the outcome of the muscle soreness and nausea were unknown and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the muscle soreness, nausea and sickness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient got the 1st shingle shots and had a lot side effects, all muscles was sore, nausea and been sick for two days so far, this was awful.  The patient still need to get the second vaccine
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Herpes zoster, Incomplete course of vaccination
Clinical narrative: shingles; trouble breathing; didn't get 2nd dose; This case was reported by a consumer and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles, difficulty breathing and incomplete course of vaccination. On an unknown date, the outcome of the shingles, difficulty breathing and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles and difficulty breathing to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by reporter for his/her father. The age at vaccination was not reported. The patient received dose and had adverse reaction (trouble breathing). The patient also experienced mild case of shingles. The patient didn't get the 2nd dose, which led to incomplete course of vaccination
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 patient had reported for him/herself. The age at vaccination was not reported. The patient received Shingles vaccine but still 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: Incomplete course of vaccination
Clinical narrative: 2nd vaccine is 3 months overdue; This case was reported by a consumer via media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   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 stated that, 2nd dose was due in May 2021 (6 months), and was 3 month overdue.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Interchange of vaccine products, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered Kinrix for a child aged 2yr, 5mo; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Dtap+IPV (received on 10th July 2019) and Dtap+IPV (received on 16th September 2019).   On 20th August 2021, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 20th August 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 health care provider mistakenly administered Kinrix for a child aged 2 years and 5 months old patient, which led to inappropriate age at vaccine administration. The reporter stated that, the patient had been delayed by caregivers. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: patient did not receive the full dose due to the syringe leaking; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number KF4T7, expiry date 14th November 2022) for prophylaxis.   On 24th August 2021, the patient received the 1st dose of Shingrix. On 24th August 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional case details were reported as follows: The pharmacist stated that she was administered the 1st dose of Shingrix to a patient and the patient did not receive the full dose due to the syringe leaking which led to accidental underdose.  The reporter suspected the patient received about 90 percent of the medication. The reporter consented to follow up.
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Pain, Product administered at inappropriate site, Tendon disorder
Clinical narrative: administered in the hip; This case was reported by a consumer via call center representative and described the occurrence of vaccine administered at inappropriate site in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Fluad with an associated reaction of tendon injury (received on 10th September 2019 (National Drug Code: 70461-0019-03)). Concomitant products included VIRAL VACCINES (COVID VACCINE (NOS)).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site was unknown.  Additional details were provided as follows: The patient reported the case for herself (reporter was a massage therapist). The patient received the Fluad 2019-2020 syringe flu shot was given at a pharmacy by a pharmacist and the patient believed that the pharmacist injected her too high on the upper arm/deltoid. This resulted in a visit to the emergency room and 7 months of severe pain and the use of prescription pain medications due to tendon damage. Since then patient had requested that all of her immunizations to be done in non-deltoid shots such as thigh or hip. The patient got a subsequent unspecified flu shot in the hip rather than the deltoid to avoid the risk of having the same shoulder tendon problem occur again, which led to vaccine administered at inappropriate site and her Covid shot(s) in the thigh. The reporter provided limited information
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: on Jan 16th 2021 patient received first dose and never gets the second shot; 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 (1st dose received on 16th January 2021).   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 did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in 2018  and had not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   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. At the moment of the call the health care professional was not in the work facility were they could find further information on the dose that was administrated. No further events were reported. Health care professional agreed to be contacted through email or phone number to be able to inform exact date of the first dose, expiration date and lot number of the vaccine. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix series greater than 2 years ago / never returned for second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received greater than 2 years 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 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 stated that, the patient did not remember date of first dose and pharmacist unable to find it in state database. The pharmacist did not have lot number or expiration date of first dose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the 1st dose of Shingrix "5 years ago" and 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 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 5 years 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 for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No symptoms reported. The reporter stated that, the patient did not know the extact date of 1st dose vaccination. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982) dose was not reported,1 total, administered on APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, the patient was sick with covid-19 infection (suspected covid-19 infection) (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000191144 This case, from the same reporter is linked to 20210854979 and 20210855254.  Additional information was received from Central Complaint Vigilance  on 27-AUG-2021. The following information was updated and incorporated into the case narrative: Updated the batch number & Product Quality number.; Sender's Comments: V1: This follow up adds Product quality number and batch no. This new information does not change prior causality assessment. 20210855235- covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 64 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. It was reported that the patient was 64 years and rarely got sick. She was previously treated with rubella vaccine for prophylactic vaccination (it did not stick with her).  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown and expiry date: unknown) dose was not reported, 1 total administered in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-AUG-2021, the patient developed the symptoms of Covid-19 infection for first time that included feeling aches, cough and fatigue (suspected clinical vaccination failure). The symptoms lasted for about a week or two, but she still felt fatigue at time of reporting. She did not receive medical help but had bed rest for 2 weeks. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected Covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210857250- Covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Exposure during pregnancy, Fatigue, Illness, Pain
Clinical narrative: VACCINE EXPOSURE DURING 24 WEEKS OF PREGNANCY; TERRIBLY SICK/GENERALLY FEELING SICK/UNBELIEVABLY SICK; ACHES; FEVER; EXHAUSTION; WEAK; This spontaneous pregnancy report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was pregnant at the time of reporting. It was not reported whether the patient had been pregnant before. 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 patient experienced vaccine exposure during 24 weeks of pregnancy, terribly sick/generally feeling sick/unbelievably sick, aches, fever, exhaustion, and weak. The date of the patient's last menstrual period and expected delivery date were not reported. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, aches, exhaustion, weak, vaccine exposure during 24 weeks of pregnancy and terribly sick/generally feeling sick/unbelievably sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: VACCINE EXPOSURE DURING 24 WEEKS OF PREGNANCY; TERRIBLY SICK/GENERALLY FEELING SICK/UNBELIEVABLY SICK; ACHES; FEVER; EXHAUSTION; WEAK; This spontaneous pregnancy report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was pregnant at the time of reporting. It was not reported whether the patient had been pregnant before. 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 patient experienced vaccine exposure during 24 weeks of pregnancy, terribly sick/generally feeling sick/unbelievably sick, aches, fever, exhaustion, and weak. The date of the patient's last menstrual period and expected delivery date were not reported. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, aches, exhaustion, weak, vaccine exposure during 24 weeks of pregnancy and terribly sick/generally feeling sick/unbelievably sick was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DVT IN BOTH LOWER LEGS; This spontaneous report received from a patient via a company representative concerned a 40-year-old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was otherwise healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) 1 total, dose and start therapy date (on an unspecified Friday) were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  On an unspecified date, on Monday the patient sent a photo to his doctor of what was happening with his legs (redness) and on an unspecified date (Tuesday) he was diagnosed with Deep Vein Thrombosis (DVT) in each lower leg. The patient was seen at a hospital (unknown date). The patient was being treated with Xarelto (rivaroxaban). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of DVT in both lower legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210857658-COVID-19 VACCINE AD26.COV2.S - DVT 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.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Paraesthesia, Peripheral vascular disorder, Skin discolouration
Clinical narrative: RIGHT HAND MIDDLE FINGER TURNING BLUE/PURPLE; 3 LITTLE ROUND DOTS/SPOTS OF BLOOD AROUND SITE OF INJECTION; LOST ALL CIRCULATION IN FINGER; TINGLING AND NUMBNESS IN RIGHT HAND MIDDLE FINGER; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included: bad fall, and concurrent conditions included: high blood pressure, low thyroid, penicillin allergy, latex allergy, allergy to sulfate drugs, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient have no drug abuse or illicit drug usage. The patient takes anti-hypertensive medication to prevent stroke, no history of stroke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-AUG-2021, the patient experienced right hand middle finger turning blue/purple. On 06-AUG-2021, the patient experienced 3 little round dots/spots of blood around site of injection. On 06-AUG-2021, the patient experienced lost all circulation in finger. On 06-AUG-2021, the patient experienced tingling and numbness in right hand middle finger. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right hand middle finger turning blue/purple, lost all circulation in finger, and tingling and numbness in right hand middle finger on 09-AUG-2021, and 3 little round dots/spots of blood around site of injection on 20-AUG-2021. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Decreased appetite
Clinical narrative: NAUSEA; VOMITING; EVERYTHING TASTES BAD; LOSS OF APPETITE/CAN'T REALLY EAT; CHILLS; ALL OVER WEAKNESS/FEELING WEAK/LACK OF ENERGY; FEVER; HEADACHES; JOINT PAIN; TIRED; DIARRHEA; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included: aneurysm, stroke, breast cancer, and double mastectomy, and concurrent conditions included: non alcohol user, non-smoker, and pre-diabetes, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use and no known allergies. The patient is on blood thinners, cholesterol, blood pressure medications and on a pill for pre-diabetes and not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced diarrhea. On AUG-2021, the patient experienced tired. Laboratory data included: COVID-19 virus test (NR: not provided) negative, negative. On 13-AUG-2021, the patient experienced chills. On 13-AUG-2021, the patient experienced joint pain. On 13-AUG-2021, the patient experienced all over weakness/feeling weak/lack of energy. On 13-AUG-2021, the patient experienced fever. On 13-AUG-2021, the patient experienced headaches. Laboratory data included: Body temperature (NR: not provided) not reported. On 14-AUG-2021, the patient experienced everything tastes bad. On 14-AUG-2021, the patient experienced loss of appetite/can't really eat. On 17-AUG-2021, the patient experienced vomiting. On 17-AUG-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 27-AUG-2021, vomiting, and nausea on 21-AUG-2021, and joint pain, was recovering from all over weakness/feeling weak/lack of energy, and headaches, had not recovered from everything tastes bad, diarrhea, and tired, and the outcome of loss of appetite/can't really eat was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: NAUSEA; VOMITING; EVERYTHING TASTES BAD; LOSS OF APPETITE/CAN'T REALLY EAT; CHILLS; ALL OVER WEAKNESS/FEELING WEAK/LACK OF ENERGY; FEVER; HEADACHES; JOINT PAIN; TIRED; DIARRHEA; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included: aneurysm, stroke, breast cancer, and double mastectomy, and concurrent conditions included: non alcohol user, non-smoker, and pre-diabetes, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use and no known allergies. The patient is on blood thinners, cholesterol, blood pressure medications and on a pill for pre-diabetes and not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced diarrhea. On AUG-2021, the patient experienced tired. Laboratory data included: COVID-19 virus test (NR: not provided) negative, negative. On 13-AUG-2021, the patient experienced chills. On 13-AUG-2021, the patient experienced joint pain. On 13-AUG-2021, the patient experienced all over weakness/feeling weak/lack of energy. On 13-AUG-2021, the patient experienced fever. On 13-AUG-2021, the patient experienced headaches. Laboratory data included: Body temperature (NR: not provided) not reported. On 14-AUG-2021, the patient experienced everything tastes bad. On 14-AUG-2021, the patient experienced loss of appetite/can't really eat. On 17-AUG-2021, the patient experienced vomiting. On 17-AUG-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 27-AUG-2021, vomiting, and nausea on 21-AUG-2021, and joint pain, was recovering from all over weakness/feeling weak/lack of energy, and headaches, had not recovered from everything tastes bad, diarrhea, and tired, and the outcome of loss of appetite/can't really eat was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Taste disorder, Vomiting
Clinical narrative: NAUSEA; VOMITING; EVERYTHING TASTES BAD; LOSS OF APPETITE/CAN'T REALLY EAT; CHILLS; ALL OVER WEAKNESS/FEELING WEAK/LACK OF ENERGY; FEVER; HEADACHES; JOINT PAIN; TIRED; DIARRHEA; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included: aneurysm, stroke, breast cancer, and double mastectomy, and concurrent conditions included: non alcohol user, non-smoker, and pre-diabetes, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use and no known allergies. The patient is on blood thinners, cholesterol, blood pressure medications and on a pill for pre-diabetes and not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced diarrhea. On AUG-2021, the patient experienced tired. Laboratory data included: COVID-19 virus test (NR: not provided) negative, negative. On 13-AUG-2021, the patient experienced chills. On 13-AUG-2021, the patient experienced joint pain. On 13-AUG-2021, the patient experienced all over weakness/feeling weak/lack of energy. On 13-AUG-2021, the patient experienced fever. On 13-AUG-2021, the patient experienced headaches. Laboratory data included: Body temperature (NR: not provided) not reported. On 14-AUG-2021, the patient experienced everything tastes bad. On 14-AUG-2021, the patient experienced loss of appetite/can't really eat. On 17-AUG-2021, the patient experienced vomiting. On 17-AUG-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 27-AUG-2021, vomiting, and nausea on 21-AUG-2021, and joint pain, was recovering from all over weakness/feeling weak/lack of energy, and headaches, had not recovered from everything tastes bad, diarrhea, and tired, and the outcome of loss of appetite/can't really eat was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Malaise, Pain in extremity
Clinical narrative: MINOR SORE ARM; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; DONT FEEL GOOD FOR 24 HOURS; 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: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included mrna 1273 for prophylactic vaccination. On 26-AUG-2021, the patient experienced dont feel good for 24 hours. On 27-AUG-2021, the patient experienced inappropriate schedule of vaccine administered. On an unspecified date, the patient experienced minor sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dont feel good for 24 hours, and the outcome of minor sore arm and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature, Chest discomfort, Chills, Decreased appetite
Clinical narrative: FELT LIKE ALMOST LITERALLY BIT THE BULLET/INABILITY TO GET COMFORTABLE; UNABLE TO SLEEP; CONSTANT URGE TO STRETCH; NO APPETITE; SICK; ACHES; DISCOMFORT; UNCOMFORTABLE ACHY GUT; ENTIRE AREA WAS LIKE BAD MENSTRUAL CRAMPS; TIGHTNESS IN CHEST; MOSTLY BILE; LEGS WERE VERY WEAK; CHILLS; FEVER 99.5 TEMPERATURE; HEADACHE; This spontaneous report received from a patient concerned a 66 year old female. 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 was not reported, administered on 26-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced felt like almost literally bit the bullet/inability to get comfortable. On AUG-2021, the patient experienced unable to sleep. On AUG-2021, the patient experienced constant urge to stretch. On AUG-2021, the patient experienced no appetite. On AUG-2021, the patient experienced sick. On AUG-2021, the patient experienced aches. On AUG-2021, the patient experienced discomfort. On AUG-2021, the patient experienced uncomfortable achy gut. On AUG-2021, the patient experienced entire area was like bad menstrual cramps. On AUG-2021, the patient experienced tightness in chest. On AUG-2021, the patient experienced mostly bile. On AUG-2021, the patient experienced legs were very weak. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced fever 99.5 temperature. On AUG-2021, the patient experienced headache. Treatment medications included: acetylsalicylic acid. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.5 temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt like almost literally bit the bullet/inability to get comfortable, unable to sleep, constant urge to stretch, discomfort, uncomfortable achy gut, entire area was like bad menstrual cramps, tightness in chest, fever 99.5 temperature, headache, legs were very weak, chills, aches, sick, no appetite and mostly bile was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Gastrointestinal pain, Headache, Illness
Clinical narrative: FELT LIKE ALMOST LITERALLY BIT THE BULLET/INABILITY TO GET COMFORTABLE; UNABLE TO SLEEP; CONSTANT URGE TO STRETCH; NO APPETITE; SICK; ACHES; DISCOMFORT; UNCOMFORTABLE ACHY GUT; ENTIRE AREA WAS LIKE BAD MENSTRUAL CRAMPS; TIGHTNESS IN CHEST; MOSTLY BILE; LEGS WERE VERY WEAK; CHILLS; FEVER 99.5 TEMPERATURE; HEADACHE; This spontaneous report received from a patient concerned a 66 year old female. 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 was not reported, administered on 26-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced felt like almost literally bit the bullet/inability to get comfortable. On AUG-2021, the patient experienced unable to sleep. On AUG-2021, the patient experienced constant urge to stretch. On AUG-2021, the patient experienced no appetite. On AUG-2021, the patient experienced sick. On AUG-2021, the patient experienced aches. On AUG-2021, the patient experienced discomfort. On AUG-2021, the patient experienced uncomfortable achy gut. On AUG-2021, the patient experienced entire area was like bad menstrual cramps. On AUG-2021, the patient experienced tightness in chest. On AUG-2021, the patient experienced mostly bile. On AUG-2021, the patient experienced legs were very weak. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced fever 99.5 temperature. On AUG-2021, the patient experienced headache. Treatment medications included: acetylsalicylic acid. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.5 temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt like almost literally bit the bullet/inability to get comfortable, unable to sleep, constant urge to stretch, discomfort, uncomfortable achy gut, entire area was like bad menstrual cramps, tightness in chest, fever 99.5 temperature, headache, legs were very weak, chills, aches, sick, no appetite and mostly bile was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Muscle tightness, Muscular weakness, Pain, Pyrexia
Clinical narrative: FELT LIKE ALMOST LITERALLY BIT THE BULLET/INABILITY TO GET COMFORTABLE; UNABLE TO SLEEP; CONSTANT URGE TO STRETCH; NO APPETITE; SICK; ACHES; DISCOMFORT; UNCOMFORTABLE ACHY GUT; ENTIRE AREA WAS LIKE BAD MENSTRUAL CRAMPS; TIGHTNESS IN CHEST; MOSTLY BILE; LEGS WERE VERY WEAK; CHILLS; FEVER 99.5 TEMPERATURE; HEADACHE; This spontaneous report received from a patient concerned a 66 year old female. 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 was not reported, administered on 26-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced felt like almost literally bit the bullet/inability to get comfortable. On AUG-2021, the patient experienced unable to sleep. On AUG-2021, the patient experienced constant urge to stretch. On AUG-2021, the patient experienced no appetite. On AUG-2021, the patient experienced sick. On AUG-2021, the patient experienced aches. On AUG-2021, the patient experienced discomfort. On AUG-2021, the patient experienced uncomfortable achy gut. On AUG-2021, the patient experienced entire area was like bad menstrual cramps. On AUG-2021, the patient experienced tightness in chest. On AUG-2021, the patient experienced mostly bile. On AUG-2021, the patient experienced legs were very weak. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced fever 99.5 temperature. On AUG-2021, the patient experienced headache. Treatment medications included: acetylsalicylic acid. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.5 temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt like almost literally bit the bullet/inability to get comfortable, unable to sleep, constant urge to stretch, discomfort, uncomfortable achy gut, entire area was like bad menstrual cramps, tightness in chest, fever 99.5 temperature, headache, legs were very weak, chills, aches, sick, no appetite and mostly bile was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: FELT LIKE ALMOST LITERALLY BIT THE BULLET/INABILITY TO GET COMFORTABLE; UNABLE TO SLEEP; CONSTANT URGE TO STRETCH; NO APPETITE; SICK; ACHES; DISCOMFORT; UNCOMFORTABLE ACHY GUT; ENTIRE AREA WAS LIKE BAD MENSTRUAL CRAMPS; TIGHTNESS IN CHEST; MOSTLY BILE; LEGS WERE VERY WEAK; CHILLS; FEVER 99.5 TEMPERATURE; HEADACHE; This spontaneous report received from a patient concerned a 66 year old female. 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 was not reported, administered on 26-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced felt like almost literally bit the bullet/inability to get comfortable. On AUG-2021, the patient experienced unable to sleep. On AUG-2021, the patient experienced constant urge to stretch. On AUG-2021, the patient experienced no appetite. On AUG-2021, the patient experienced sick. On AUG-2021, the patient experienced aches. On AUG-2021, the patient experienced discomfort. On AUG-2021, the patient experienced uncomfortable achy gut. On AUG-2021, the patient experienced entire area was like bad menstrual cramps. On AUG-2021, the patient experienced tightness in chest. On AUG-2021, the patient experienced mostly bile. On AUG-2021, the patient experienced legs were very weak. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced fever 99.5 temperature. On AUG-2021, the patient experienced headache. Treatment medications included: acetylsalicylic acid. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.5 temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt like almost literally bit the bullet/inability to get comfortable, unable to sleep, constant urge to stretch, discomfort, uncomfortable achy gut, entire area was like bad menstrual cramps, tightness in chest, fever 99.5 temperature, headache, legs were very weak, chills, aches, sick, no appetite and mostly bile was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anti-erythrocyte antibody, Coombs direct test
Clinical narrative: ANTIBODIES ATTACHED TO HER RED CELLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced antibodies attached to her red cells. Laboratory data (dates unspecified) included: Direct Coombs test (NR: not provided) Antibodies, but they have attached to red cells. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of antibodies attached to her red cells was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Therapeutic response unexpected
Clinical narrative: GUILLAIN BARRE IS BETTER; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included: right breast tumour, and concurrent conditions included: no alcohol use, non-smoker, sulfa drug allergy, flu shot reaction, ovarian tumour that spread to the uterus, and guillain-barre syndrome, and other pre-existing medical conditions included: Patient has no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced guillain barre is better. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Always high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of guillain barre is better was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Eye ulcer, Nasal congestion
Clinical narrative: CONGESTION THAT TAKES TOO LONG TO GET BETTER; EYE ULCER VIRUS (HERPES AND SHINGLES RELATED OF WHICH PATIENT DON'T HAVE NONE); This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 patient experienced congestion that takes too long to get better, and eye ulcer virus (herpes and shingles related of which patient don't have none). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from congestion that takes too long to get better, and eye ulcer virus (herpes and shingles related of which patient don't have none). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Feeling hot, Headache, Hypoaesthesia
Clinical narrative: BRIGHT LIGHTS HURT EYES; PAIN INTO ARMPITS, LEFT BREAST, CHEST, NECK AND JAW; FELT HOT; FELT COLD; ARM STILL HURTS/PAIN IN INJECTED ARM FROM SHOULDER TO WRIST; TINGLING SENSATION INTO ARMPITS, LEFT BREAST, CHEST, NECK AND JAW; NUMBNESS  INTO ARMPITS, LEFT BREAST, CHEST, NECK AND JAW; SHIVERS/CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and dye in ultrasound contrast, and other pre-existing medical conditions included: The patient was currently taking Vitamins. The patient experienced lump that has not gone in 30 years when treated with influenza vaccine for drug used for unknown indication, and drug allergy when treated with metronidazole. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. Concomitant medications included lisinopril, and rosuvastatin calcium. On 28-AUG-2021, the patient experienced bright lights hurt eyes. On 28-AUG-2021, the patient experienced pain into armpits, left breast, chest, neck and jaw. On 28-AUG-2021, the patient experienced felt hot. On 28-AUG-2021, the patient experienced felt cold. On 28-AUG-2021, the patient experienced arm still hurts/pain in injected arm from shoulder to wrist. On 28-AUG-2021, the patient experienced tingling sensation into armpits, left breast, chest, neck and jaw. On 28-AUG-2021, the patient experienced numbness into armpits, left breast, chest, neck and jaw. On 28-AUG-2021, the patient experienced shivers/chills. On 28-AUG-2021, the patient experienced headache. On 28-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain into armpits, left breast, chest, neck and jaw, felt hot, felt cold, tingling sensation into armpits, left breast, chest, neck and jaw, numbness into armpits, left breast, chest, neck and jaw, shivers/chills, and fever on AUG-2021, and had not recovered from headache, arm still hurts/pain in injected arm from shoulder to wrist, and bright lights hurt eyes. This report was non-serious.