chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose / on 5/26/21 / not received any further doses; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 26th May 2021).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. No additional information provided. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: had  shot dose #1 in August 2020 has not yet received shot #2 AFTER the Shingrix shot she received her covid-19 shot(s); This case was reported by a consumer via call center representative and described the occurrence of social problem in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2020,1 intramuscularly in unspecified upper arm). Concomitant products included covid-19 vaccine and prednisone.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of shingrix, due to covid-19 shot, which led to social problem. The reporter did not have the exact date of the shot or the lot/exp but did provide the contact information for the pharmacy who administered it. The medical director said did not have an internist and had been without one for years. The reporter stated that, the patient received  prednisone tablets in January or February 2021. The reporter stated that, an unspecified time after the Shingrix shot, the patient received covid-19 shot(s).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: two doses administered on  07/20 and 08/17; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 17th August 2021, the patient received the 2nd dose of Shingrix. On 17th August 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The nurse reported that, the patient received 2nd dose of Shingrix early than the recommended time interval, which led to shortening of vaccination schedule. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received dose 1 on june 2018. Never got 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in June 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. No information on vaccine available. The reporter stated that, did not receive in the same facility. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Only first dose was administrated on 2019; 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 on 2nd March 2019, batch number 4g58x, expiry date 9th July 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. No adverse event was reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Genital herpes
Clinical narrative: genital herpes outbreak; This case was reported by a consumer via call center representative and described the occurrence of genital herpes in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included genital herpes (one and half year before reporting date). Previously administered products included Covid vaccine (1st and 2nd shot received on unknown date) and Acyclovir (genital herpes treated with acyclovir).   On 15th August 2021, the patient received the 2nd dose of Shingrix. In August 2021, less than a week after receiving Shingrix, the patient experienced genital herpes. On an unknown date, the outcome of the genital herpes was not recovered/not resolved.   It was unknown if the reporter considered the genital herpes to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The age at vaccination was not reported. The patient refused to provide her last name or phone number. The patient received the 2nd dose of Shingrix on sunday and less than a week after the vaccination the patient experienced genital herpes outbreak which was getting worse. The patient did not want an answer any further questions. The reporter did not consent to follow up. The patient did not want an answer any further questions therefore reporter did not ask her MD (doctor of medicine) contact information.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received his first dose on 4-November-2020; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 91-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th November 2020, 0.5 ml, intramuscularly).   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. The VAERS details were reported for 1st dose of Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: On 19Jul2021,received first dose, on 20Aug2021, received the second dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 20th August 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 20th August 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccinaation was not reported. The patient received dose of Shingrix in the left deltoid. The reporter stated that, the patient received 2nd dose of Shingrix, which led to shortening of vaccination schedule. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: third dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) (batch number kb97c, expiry date 13th November 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On 19th August 2021, the patient received the 3rd dose of Shingrix. On 19th August 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that, the patient received 3rd dose of Shingrix, which led to extra dose administered. No further events were reported.  The health care professional agreed to be contacted only via email for follow-up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood count abnormal, Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: Suspected vaccination failure; diagnosed with shingles; first Shingrix dose on March 8, 2018 and the second dose on December 1, 2018; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 8th March 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st December 2018, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On 27th July 2021, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the vaccination failure and drug dose administration interval too long were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The case was reported by the patient. At the time of reporitng, the age of the patient was 75 years. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of the vaccine schedule. On 27th July 2021, 969 days after receiving the 2nd dose and 1237 days after receiving the 1st dose, the patient was diagnosed with shingles. The patient was prescribed with Valacyclovir and that cause vomiting and went to the emergency room for the vomiting, refer case US2021AMR177242. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR177242:same reproter, same patient, different product (valacyclovir)
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received her first dose about 2 years ago has not received her second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 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 did not know the lot number or expiration date of the Shingrix vaccine originally administered. No additional information provided. The reporter did not consent to follow up.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Atrial fibrillation
Clinical narrative: ATRIAL FIBRILLATION; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: stroke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. The patient received rivaroxaban (Xarelto) (film-coated tablet, route of admin not reported, batch number: Unknown) dose, frequency, and therapy dates were not reported for an unspecified indication.  No concomitant medications were reported. After receiving vaccine, On an unspecified date, the patient experienced atrial fibrillation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with rivaroxaban was not reported. The outcome of atrial fibrillation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210833202- covid-19 vaccine ad26.cov2.s-atrial fibrillation. 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). 20210833202-Xarelto -atrial fibrillation. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; GOT COVID; This spontaneous report received from a male patient of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: Unknown, expiry: unknown) 1 total, frequency, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient tested positive to Covid-19 (got Covid and suspected clinical vaccination failure). No further information provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got covid and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210841128-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: M
Vaccine: COVID19
Symptoms: Coma, Gangrene, General physical health deterioration, Pulmonary haemorrhage, SARS-CoV-2 test
Clinical narrative: COMA; GANGRENE ON HANDS AND FEET; YELLOW WELTS AROUND EYES; BODY WAS WILTING OUT; BLEEDING LUNGS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer who reported that he heard of a friend's cousin, a 6 decade old male (52-54 years old) 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date on MAY-2021, after vaccination the patient was diagnosed with Covid-19 (suspected covid-19 infection) and had suspected clinical vaccination failure. He was hospitalized (date unspecified). On an unspecified date on AUG-2021, the patient's lungs were bleeding and had been doing worse. On an unspecified date, the patient was unconscious and in a coma and also had gangrene on hands and feet which needs to be amputated and his body was wilting out. The patient had yellow welts all around eyes. Reporter was not clear on if these afflictions were induced by the vaccine or from being infected with the coronavirus after vaccination. Number of days hospitalized was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and bleeding lungs, and the outcome of coma, gangrene on hands and feet, yellow welts around eyes, suspected clinical vaccination failure, and body was wilting out was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210841428-COVID-19 VACCINE AD26.COV2.S.- Coma, Bleeding lungs, Gangrene on hands and feet, Suspected clinical vaccine failure, Suspected covid-19 infection, Yellow welts around eyes, Body was wilting out. This events is considered unassessable. The events has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure, Xanthelasma
Clinical narrative: COMA; GANGRENE ON HANDS AND FEET; YELLOW WELTS AROUND EYES; BODY WAS WILTING OUT; BLEEDING LUNGS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer who reported that he heard of a friend's cousin, a 6 decade old male (52-54 years old) 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date on MAY-2021, after vaccination the patient was diagnosed with Covid-19 (suspected covid-19 infection) and had suspected clinical vaccination failure. He was hospitalized (date unspecified). On an unspecified date on AUG-2021, the patient's lungs were bleeding and had been doing worse. On an unspecified date, the patient was unconscious and in a coma and also had gangrene on hands and feet which needs to be amputated and his body was wilting out. The patient had yellow welts all around eyes. Reporter was not clear on if these afflictions were induced by the vaccine or from being infected with the coronavirus after vaccination. Number of days hospitalized was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and bleeding lungs, and the outcome of coma, gangrene on hands and feet, yellow welts around eyes, suspected clinical vaccination failure, and body was wilting out was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210841428-COVID-19 VACCINE AD26.COV2.S.- Coma, Bleeding lungs, Gangrene on hands and feet, Suspected clinical vaccine failure, Suspected covid-19 infection, Yellow welts around eyes, Body was wilting out. This events is considered unassessable. The events has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypokinesia, Insomnia, Muscular weakness, Neck pain
Clinical narrative: INSOMNIA; NECK PAIN; HEADACHE; COULD NOT USE ARM; ARM WEAKNESS; PINCHED NERVE; FROZEN SHOULDER; THROBBING AND PULSATING PAIN IN RIGHT ARM; 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 past medical history included: mastectomy, radiation, and surgery, and concurrent conditions included: diabetes, high blood pressure, high cholesterol, high blood sugar, non-smoker, non-alcohol user, lymphedema in left arm, breast cancer, sciatic nerve pain, lumbar disease five discs in back deteriorated, and chemotherapy, and other pre-existing medical conditions included: The patient had no history of illicit drug use/abuse. The patient was also prescribed a muscle relaxer and takes at night and also used a massager for relief. The patient experienced drug allergy when treated with amitriptyline, and atorvastatin. 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 30-JUN-2021 for prophylactic vaccination. Concomitant medications included anastrozole for breast cancer, insulin for diabetes, linagliptin for diabetes, diclofenac for left arm burning sensation, gabapentin, paracetamol, and pravastatin. On 01-JUL-2021, the patient experienced throbbing and pulsating pain in right arm. On 05-JUL-2021, the patient experienced pinched nerve. On 05-JUL-2021, the patient experienced frozen shoulder. On 05-JUL-2021, the patient experienced arm weakness. On 10-JUL-2021, the patient experienced could not use arm. On an unspecified date, the patient experienced insomnia, neck pain, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, had not recovered from pinched nerve, frozen shoulder, insomnia, throbbing and pulsating pain in right arm, arm weakness, and neck pain, and the outcome of could not use arm was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve compression, Pain in extremity, Periarthritis
Clinical narrative: INSOMNIA; NECK PAIN; HEADACHE; COULD NOT USE ARM; ARM WEAKNESS; PINCHED NERVE; FROZEN SHOULDER; THROBBING AND PULSATING PAIN IN RIGHT ARM; 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 past medical history included: mastectomy, radiation, and surgery, and concurrent conditions included: diabetes, high blood pressure, high cholesterol, high blood sugar, non-smoker, non-alcohol user, lymphedema in left arm, breast cancer, sciatic nerve pain, lumbar disease five discs in back deteriorated, and chemotherapy, and other pre-existing medical conditions included: The patient had no history of illicit drug use/abuse. The patient was also prescribed a muscle relaxer and takes at night and also used a massager for relief. The patient experienced drug allergy when treated with amitriptyline, and atorvastatin. 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 30-JUN-2021 for prophylactic vaccination. Concomitant medications included anastrozole for breast cancer, insulin for diabetes, linagliptin for diabetes, diclofenac for left arm burning sensation, gabapentin, paracetamol, and pravastatin. On 01-JUL-2021, the patient experienced throbbing and pulsating pain in right arm. On 05-JUL-2021, the patient experienced pinched nerve. On 05-JUL-2021, the patient experienced frozen shoulder. On 05-JUL-2021, the patient experienced arm weakness. On 10-JUL-2021, the patient experienced could not use arm. On an unspecified date, the patient experienced insomnia, neck pain, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, had not recovered from pinched nerve, frozen shoulder, insomnia, throbbing and pulsating pain in right arm, arm weakness, and neck pain, and the outcome of could not use arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative from social media concerned an 8 decade old of unspecified age, sex, race and ethnicity. 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, and batch number were not reported, expiry: Unknown) 1 total, 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 died from unknown cause of death. It was unspecified 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 20210844359.; Sender's Comments: V0: 20210845181-covid-19 vaccine ad26.cov2.s- Death.This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SEVERE ARM SORENESS THAT CONTINUED AFTER RECEIVING VACCINE; This spontaneous report received from a consumer concerned multiple patients. 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced severe arm soreness that continued after receiving vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe arm soreness that continued after receiving vaccine. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Malaise, Paraesthesia
Clinical narrative: TINGLING PRICKLY FEELING IN HANDS; SHIVERS; DIDN'T FEEL TOO WELL; FEVER OF 39 DEGREES; WEAK; This spontaneous report received from a consumer 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, and batch number were not reported) dose was not reported, administered on 10-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 weak. On 10-AUG-2021, the patient experienced tingling prickly feeling in hands. On 10-AUG-2021, the patient experienced shivers. On 10-AUG-2021, the patient experienced didn't feel too well. On 10-AUG-2021, the patient experienced fever of 39 degrees. Laboratory data included: Body temperature (NR: not provided) 39 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weak, and the outcome of tingling prickly feeling in hands, fever of 39 degrees, shivers and didn't feel too well was not reported. This report was non-serious. This case, from the same reporter is linked to 20210850476.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: TINGLING PRICKLY FEELING IN HANDS; SHIVERS; DIDN'T FEEL TOO WELL; FEVER OF 39 DEGREES; WEAK; This spontaneous report received from a consumer 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, and batch number were not reported) dose was not reported, administered on 10-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 weak. On 10-AUG-2021, the patient experienced tingling prickly feeling in hands. On 10-AUG-2021, the patient experienced shivers. On 10-AUG-2021, the patient experienced didn't feel too well. On 10-AUG-2021, the patient experienced fever of 39 degrees. Laboratory data included: Body temperature (NR: not provided) 39 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weak, and the outcome of tingling prickly feeling in hands, fever of 39 degrees, shivers and didn't feel too well was not reported. This report was non-serious. This case, from the same reporter is linked to 20210850476.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: THIS VACCINE IS THE LEAST LIKELY  TO WORK ON ANYTHING, IT'S THE  WORST OF THE WORST/BLOOD TESTS SHOW THAT I DONT HAVE AN IMMUNITY; This spontaneous report received from a patient concerned a female of unspecified age with unspecified race & ethinicity. The patient's height, and weight were not reported. The patient's concurrent conditions included disabled. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 Total was administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient reported that the vaccine was the least likely to work on anything, it was the worst of the worst, every time patient turns on the computer somebody was dying from a blood clot. Laboratory data (dates unspecified) included: Blood test (NR: not provided) lack of immunity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of this vaccine was the least likely to work on anything, it was the worst of the worst/blood tests show that patient did not have an immunity was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000190591.; Sender's Comments: V0: 20210846262- covid-19 vaccine ad26.cov2.s-this vaccine was the least likely to work on anything, it was the worst of the worst/blood tests show that patient did not have an immunity (Drug ineffective). This event(s) is considered not related. The event(s) has an unknown/unclear 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
Age: 50.0
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 concerned a 50 year old white not Hispanic or Latino female. Initial information was processed along with the additional information received on 24-AUG-2021. 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: 1808980, and expiry: 18-SEP-2021) dose was not reported, 1 total administered to the left arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced symptoms of Covid (headache, congestion, exhausted, things taste funny, runny nose). On 22-AUG-2021, patient received a result of COVID-19 virus test positive. The symptoms started last week but patient did not realize she had been infected (suspected covid-19 infection and suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000190597.; Sender's Comments: V0 20210846287- 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
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a pharmacist concerned a 69 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: 042A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-AUG-2021, SARS-CoV-2 test was done to detect spike protein and result came as negative antibody test on 17-AUG -2021 (Confirmed immunological vaccination failure). On unspecified date in AUG-2021, again covid-19 antibody test was done which came negative on 23-AUG-2021. 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 serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000190644.; Sender's Comments: V0. 20210846353-covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccination 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: SPECIAL SITUATIONS
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Eye irritation, Fatigue, Hyperhidrosis, Injection site pain
Clinical narrative: ACHY; SWEATY; BURNING BEHIND THE EYES; LOW GRADE FEVER; SORE AT INJECTION SITE; FATIGUE; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sinusitis, penicillin allergy, hashimoto's, epstein barr, minor palpitations, non alcohol user, non smoker, and thyroid nodule, and other pre-existing medical conditions included: The patient had no drug abuse or illicit 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 20-AUG-2021 for prophylactic vaccination. Concomitant medications included loratadine. On AUG-2021, the patient experienced achy. On AUG-2021, the patient experienced sweaty. On AUG-2021, the patient experienced burning behind the eyes. On AUG-2021, the patient experienced low grade fever. On AUG-2021, the patient experienced sore at injection site. On AUG-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 99-100 Fahrenheit. Treatment medications (dates unspecified) included: vitamins nos, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore at injection site, and had not recovered from low grade fever, fatigue, burning behind the eyes, sweaty, and achy. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: ACHY; SWEATY; BURNING BEHIND THE EYES; LOW GRADE FEVER; SORE AT INJECTION SITE; FATIGUE; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sinusitis, penicillin allergy, hashimoto's, epstein barr, minor palpitations, non alcohol user, non smoker, and thyroid nodule, and other pre-existing medical conditions included: The patient had no drug abuse or illicit 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 20-AUG-2021 for prophylactic vaccination. Concomitant medications included loratadine. On AUG-2021, the patient experienced achy. On AUG-2021, the patient experienced sweaty. On AUG-2021, the patient experienced burning behind the eyes. On AUG-2021, the patient experienced low grade fever. On AUG-2021, the patient experienced sore at injection site. On AUG-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 99-100 Fahrenheit. Treatment medications (dates unspecified) included: vitamins nos, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore at injection site, and had not recovered from low grade fever, fatigue, burning behind the eyes, sweaty, and achy. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SYMPTOMS OF COVID-19; This spontaneous report received from a consumer concerned a 29 year old female. The patient's weight was 165 pounds, and height was 65 inches. The patient's concurrent conditions included: alcohol non-user, and non smoker, and other pre-existing medical conditions included: The patient did not have any drug abuse/illicit drug use. The patient experienced drug allergy when treated with amoxicillin, and clarithromycin for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A and expiry: unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-AUG-2021, the patient experienced symptoms of covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from symptoms of covid-19. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Chills, Computerised tomogram, Eye pain
Clinical narrative: TINGLING SENSATION/ PINS AND NEEDLES IN THE FINGERS OF LEFT ARM; JOINT ACHES; EYES HURTED; BODY ACHES; ARM SORE; CHILLS; A BASE BALL SIZE LYMPHATIC MASS IN THE LEFT AXILLA; SLIGHT HEADACHE; PAINFUL INJECTION; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's past medical history included: lymph node swelling of both armpits, and concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 0421A21, expiry: UNKNOWN) dose was not reported, administered on 21-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-AUG-2021, the patient experienced painful injection. On 22-AUG-2021, the patient experienced eyes hurted. On 22-AUG-2021, the patient experienced body aches. On 22-AUG-2021, the patient experienced arm sore. On 22-AUG-2021, the patient experienced chills. On 22-AUG-2021, the patient experienced a base ball size lymphatic mass in the left axilla. On 22-AUG-2021, the patient experienced slight headache. Laboratory data included: Blood pressure (NR: not provided) 220/110 mmHg, 168/98 mmHg, CBC (NR: not provided) Normal, CT scan (NR: not provided) Negative for blood clot, and Ultrasound scan (NR: not provided) Lymphatic mass in the left axilla. On 23-AUG-2021, the patient experienced tingling sensation/ pins and needles in the fingers of left arm. On 23-AUG-2021, the patient experienced joint aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 22-AUG-2021, was recovering from painful injection, and arm sore, had not recovered from body aches, slight headache, eyes hurted, a base ball size lymphatic mass in the left axilla, and joint aches, and the outcome of tingling sensation/ pins and needles in the fingers of left arm was not reported. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Headache, Injection site pain, Lymphadenopathy, Pain
Clinical narrative: TINGLING SENSATION/ PINS AND NEEDLES IN THE FINGERS OF LEFT ARM; JOINT ACHES; EYES HURTED; BODY ACHES; ARM SORE; CHILLS; A BASE BALL SIZE LYMPHATIC MASS IN THE LEFT AXILLA; SLIGHT HEADACHE; PAINFUL INJECTION; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's past medical history included: lymph node swelling of both armpits, and concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 0421A21, expiry: UNKNOWN) dose was not reported, administered on 21-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-AUG-2021, the patient experienced painful injection. On 22-AUG-2021, the patient experienced eyes hurted. On 22-AUG-2021, the patient experienced body aches. On 22-AUG-2021, the patient experienced arm sore. On 22-AUG-2021, the patient experienced chills. On 22-AUG-2021, the patient experienced a base ball size lymphatic mass in the left axilla. On 22-AUG-2021, the patient experienced slight headache. Laboratory data included: Blood pressure (NR: not provided) 220/110 mmHg, 168/98 mmHg, CBC (NR: not provided) Normal, CT scan (NR: not provided) Negative for blood clot, and Ultrasound scan (NR: not provided) Lymphatic mass in the left axilla. On 23-AUG-2021, the patient experienced tingling sensation/ pins and needles in the fingers of left arm. On 23-AUG-2021, the patient experienced joint aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 22-AUG-2021, was recovering from painful injection, and arm sore, had not recovered from body aches, slight headache, eyes hurted, a base ball size lymphatic mass in the left axilla, and joint aches, and the outcome of tingling sensation/ pins and needles in the fingers of left arm was not reported. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Ultrasound scan
Clinical narrative: TINGLING SENSATION/ PINS AND NEEDLES IN THE FINGERS OF LEFT ARM; JOINT ACHES; EYES HURTED; BODY ACHES; ARM SORE; CHILLS; A BASE BALL SIZE LYMPHATIC MASS IN THE LEFT AXILLA; SLIGHT HEADACHE; PAINFUL INJECTION; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's past medical history included: lymph node swelling of both armpits, and concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 0421A21, expiry: UNKNOWN) dose was not reported, administered on 21-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-AUG-2021, the patient experienced painful injection. On 22-AUG-2021, the patient experienced eyes hurted. On 22-AUG-2021, the patient experienced body aches. On 22-AUG-2021, the patient experienced arm sore. On 22-AUG-2021, the patient experienced chills. On 22-AUG-2021, the patient experienced a base ball size lymphatic mass in the left axilla. On 22-AUG-2021, the patient experienced slight headache. Laboratory data included: Blood pressure (NR: not provided) 220/110 mmHg, 168/98 mmHg, CBC (NR: not provided) Normal, CT scan (NR: not provided) Negative for blood clot, and Ultrasound scan (NR: not provided) Lymphatic mass in the left axilla. On 23-AUG-2021, the patient experienced tingling sensation/ pins and needles in the fingers of left arm. On 23-AUG-2021, the patient experienced joint aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 22-AUG-2021, was recovering from painful injection, and arm sore, had not recovered from body aches, slight headache, eyes hurted, a base ball size lymphatic mass in the left axilla, and joint aches, and the outcome of tingling sensation/ pins and needles in the fingers of left arm was not reported. This report was non-serious.