chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 3 and half years ago, is yet to receive 2nd dose; 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 female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix vaccine (1st dose received 3 and half 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 reported as follows: This case was reported by the son-in-law for her mother-in-law. The age at vaccination was not applicable for this report. The patient yet to receive the second dose, which led to incomplete course of vaccination. The reporter did not give a consent to follow-up with health care professional. Therefore health care professional contact information was not collected. The reporter provided his email address. The reporter stated that first dose given intramuscularly and did not reported about batch number and expiry date and anatomical location and date of administration. The reporter did not consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 3 years ago, never went back 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 female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix 3 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 information was provided as follows: The age at vaccination was not applicable for this report. The patient received the 1st dose and never went back for the second dose of Shingrix. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix which led to incomplete course of vaccination. No further details were provided at the time of the call. No vaccine information was provided at the time of the call because patient received the first shot at another facility. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Headache; Aches, pain; Tired; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th July 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced headache, pain and tiredness. On an unknown date, the outcome of the headache, pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the headache, pain and tiredness to be related to Shingrix.  Additional details provided were as follows: The case was reported by the patient herself. Age at vaccination was not reported. The patient received a dose of Shingrix and experienced headache, aches, pain, and was tired (symptomatic adverse event). The patient stated that her second dose of the vaccine was scheduled for the upcoming friday. The patient wanted to know if she would have similar side effects as the first dose. The patient provided her personal email address. The reporter consented to follow up. The reporter provided consent to contact health care professional.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had 1st shot 2 years ago no 2nd shot; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (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 reporter was the patient. The age at vaccination was not applicable for this report. The pharmacist submitted afterhours web form on 20th September 2021 which was retrieved by medical information at start of business on 21st September 2021. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No further details provided via form. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Rash pruritic
Clinical narrative: Shingles; rash was painful and itchy was on the face, head, neck, and along their right side; rash was painful and itchy was on the face, head, neck, and along their right side; painful; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced shingles, pain, generalized rash and itchy rash. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles, pain, generalized rash and itchy rash were recovered/resolved.   It was unknown if the reporter considered the shingles, pain, generalized rash and itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received first dose of Shingrix and experienced a confirmed case of Shingles. The patient reported that the rash was painful and itchy and was on the face, head, neck, and along their right side. The pain and itch resolved after approximately 4 or 5 days, with use of antivirals prescribed by the health care professionals. The reporter reported rash resolved a few weeks ago from reporting date. Till the time of reporting, patient did not receive 2nd dose of Shingrix vaccine. No patient demographics was provided. All information provided had been reported. No additional details to provide.  The reporter did not consent to follow-up.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: received the adult dose; received the adult dose; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 11-year-old female patient who received HBV (Engerix B adult) (batch number p4dj5, expiry date 15th December 2022) for prophylaxis.   On 21st September 2021, the patient received the 3rd dose of Engerix B adult (intramuscular). On 21st September 2021, unknown after receiving Engerix B adult, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.  Additional details were reported as follows: The age at vaccination was not reported. A healthcare provider reported that a patient inadvertently received the adult dose of Engerix-B in the left deltoid which led to product administered to child and accidental overdose. The consented to follow up. The case had been linked with US2021199872 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021199872:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: Due to Covid-19 lockdown the patient has not been able to receive the second dose.; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1s dose received on 12th December 2019).   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 age at vaccination was not applicable for this report. The pharmacist reported that, due to Covid-19 lockdown the patient had not been able to receive the second dose of Shingrix, which led to social problem.  The reporter consented to follow up. This case was 1 of 5 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021199882:same reporter US-GLAXOSMITHKLINE-US2019AMR161146:same reporter US-GLAXOSMITHKLINE-US2019AMR157845:same reporter US-GLAXOSMITHKLINE-US2019157535:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: Due to Covid-19 lockdown the patient has not been able to receive the second dose.; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 98-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th December 2019).   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 age at vaccination was not applicable for this report. The pharmacist reported that, due to Covid-19 lockdown the patient had not been able to receive the second dose of Shingrix, which led to social problem.  The reporter consented to follow up. This case was 1 of 5 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021199879:same reporter US-GLAXOSMITHKLINE-US2019AMR161146:same reporter US-GLAXOSMITHKLINE-US2019AMR157845:same reporter US-GLAXOSMITHKLINE-US2019157535:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received first dose of SHINGRIX in January 2021 and has not received her second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 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 was rushing towards the end of the call. Therefore, was unable to collect the following information: lot/exp date and the dosage of first dose of shingrix, route and date of administration, and an email address. The reporter gave a consent to follow-up with himself.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Sleep disorder
Clinical narrative: DISTURBED SLEEP; BAD HEADACHE; CHILLS; MILD FEVER; This spontaneous report received from a consumer 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: Unk) dose was not reported, administered on APR-2021 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 APR-2021, the patient experienced chills. On APR-2021, the patient experienced mild fever. On an unspecified date, the patient experienced disturbed sleep, and bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and mild fever, and the outcome of disturbed sleep and bad headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210925695.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pancreatitis acute
Clinical narrative: ACUTE PANCREATITIS; This spontaneous report received from a consumer (wife of the patient) concerned a male of unspecified age, race and ethnic origin.  The patient's height, and weight were not reported. The patient's concurrent conditions included: idiopathic severe acute pancreatitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, 1 total administered on 11-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unknown date, the patient had acute pancreatitis. It was suspected that the attack was precipitated by the COVID vaccine and was reported to the Vaccine Adverse Event Reporting System (VAERS) per reporter. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from acute pancreatitis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210936117- covid-19 vaccine ad26.cov2.s-Acute pancreatitis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Sex: M
Vaccine: COVID19
Symptoms: Thinking abnormal, Thrombosis
Clinical narrative: SOFTBALL SIZED BLOOD CLOT IN ARM; THOUGHT GOING TO DIE; This spontaneous report received from a consumer via company representative via social media and concerned a male patient of unspecified age of unknown 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) 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 got a "softball sized blood clot in arm and thought was going to die" for four days from vaccine The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the softball sized blood clot in arm and thought going to die was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210936181-Covid-19 vaccine ad26.cov2-Softball sized blood clot in arm . This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Cognitive disorder, Injection site pain, Myalgia, Pyrexia
Clinical narrative: COGNITIVE DYSFUNCTION; LOW-GRADE FEVER/FOREHEAD WAS HOT; SORE ARM AT THE INJECTION SITE; MUSCLE PAIN QUADS, BACK; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight was 200 pounds, and height was 71 inches. The patient's concurrent conditions included: alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient had no any past medications. The patient experienced rash when treated with acetylsalicylic acid, and benzylpenicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 08-SEP-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced muscle pain quads, back. On 08-SEP-2021, the patient experienced low-grade fever/forehead was hot. On 08-SEP-2021, the patient experienced sore arm at the injection site. On 09-SEP-2021, the patient experienced cognitive dysfunction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low-grade fever/forehead was hot, and sore arm at the injection site on 09-SEP-2021, and had not recovered from muscle pain quads, back, and cognitive dysfunction. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Oropharyngeal pain, Pyrexia
Clinical narrative: FELT REALLY TIRED; SORE THROAT; COUGHING; FELT CHILLS; POSSIBLE FEVER; SINUS CONGESTION; This spontaneous report received from a patient concerned a 34 year old male. The patient's weight was 210 pounds, and height was 71 inches. The patient's concurrent conditions included: non smoker, and alcohol user, and other pre-existing medical conditions included: The patient had no known drug or non-drug allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced sinus congestion. On 19-SEP-2021, the patient experienced sore throat. On 19-SEP-2021, the patient experienced coughing. On 19-SEP-2021, the patient experienced felt chills. On 19-SEP-2021, the patient experienced possible fever. On 20-SEP-2021, the patient experienced felt really tired. Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore throat, coughing, possible fever, felt chills, sinus congestion and felt really tired was not reported. This report was non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinus congestion
Clinical narrative: FELT REALLY TIRED; SORE THROAT; COUGHING; FELT CHILLS; POSSIBLE FEVER; SINUS CONGESTION; This spontaneous report received from a patient concerned a 34 year old male. The patient's weight was 210 pounds, and height was 71 inches. The patient's concurrent conditions included: non smoker, and alcohol user, and other pre-existing medical conditions included: The patient had no known drug or non-drug allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced sinus congestion. On 19-SEP-2021, the patient experienced sore throat. On 19-SEP-2021, the patient experienced coughing. On 19-SEP-2021, the patient experienced felt chills. On 19-SEP-2021, the patient experienced possible fever. On 20-SEP-2021, the patient experienced felt really tired. Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore throat, coughing, possible fever, felt chills, sinus congestion and felt really tired was not reported. This report was non-serious.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Muscle strain, Rash, Ultrasound scan, Urticaria
Clinical narrative: UPPER LEFT THIGH FELT LIKE HE HAD PULLED OR STRAINED A MUSCLE; REDDISH RASH ON THE CHEST AND BACK; HORRIBLE HIVES OUTBREAK (MASSIVE PATCHES OF HIVES ON YOUR STOMACH, BACK, ARMS, KNEES, UPPER THIGHS, HEAD, NECK, HANDS, FEET, RING FINGER IS SWOLLEN, PALM OF BOTH HANDS); This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, egg allergies, seasonal allergies, and eczema. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-AUG-2021, the patient experienced reddish rash on the chest and back. On 08-AUG-2021, the patient experienced horrible hives outbreak (massive patches of hives on your stomach, back, arms, knees, upper thighs, head, neck, hands, feet, ring finger is swollen, palm of both hands). On 29-AUG-2021, the patient experienced upper left thigh felt like he had pulled or strained a muscle. On SEP-2021, treatment medications included: methylprednisolone. Laboratory data (dates unspecified) included: Blood test (NR: not provided) normal, and Diagnostic ultrasound (NR: not provided) normal. Additional treatment medications (dates unspecified) included: famotidine, cetirizine hydrochloride, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from horrible hives outbreak (massive patches of hives on your stomach, back, arms, knees, upper thighs, head, neck, hands, feet, ring finger is swollen, palm of both hands), and reddish rash on the chest and back, and the outcome of upper left thigh felt like he had pulled or strained a muscle was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased, Feeling abnormal, Haemoglobin, Haemorrhage
Clinical narrative: VERY HEAVY BLEEDING THAT LASTED FOR A MONTH; FEELING VERY BAD; IRON DEFICIENCY ANEMIA; TSH INCREASE IN 13; PAIN IN THE LEGS; HEADACHE; This spontaneous report received from a patient concerned a female 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, and batch number were not reported) dose was not reported, 1 total administered on 27-JUL-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 reported feeling very bad and patient consulted health care provider for this but they did not provide with any attention. Later, the patient experienced very heavy bleeding (that lasted for a month) while, laboratory data included: Hemoglobin was 9, and TSH (thyroid stimulating hormone) was 13 (NR and units not provided for lab tests) while, currently experiencing iron deficiency anemia, pain in the legs and headache. It was reported that, patient did not have medical consultation for this events.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very heavy bleeding that lasted for a month, and the outcome of feeling very bad, iron deficiency anemia, pain in the legs, headache and TSH increase in 13 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210939719-Covid-19 vaccine ad26.cov2.s-very heavy bleeding that lasted for a month. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Headache, Iron deficiency anaemia, Pain in extremity
Clinical narrative: VERY HEAVY BLEEDING THAT LASTED FOR A MONTH; FEELING VERY BAD; IRON DEFICIENCY ANEMIA; TSH INCREASE IN 13; PAIN IN THE LEGS; HEADACHE; This spontaneous report received from a patient concerned a female 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, and batch number were not reported) dose was not reported, 1 total administered on 27-JUL-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 reported feeling very bad and patient consulted health care provider for this but they did not provide with any attention. Later, the patient experienced very heavy bleeding (that lasted for a month) while, laboratory data included: Hemoglobin was 9, and TSH (thyroid stimulating hormone) was 13 (NR and units not provided for lab tests) while, currently experiencing iron deficiency anemia, pain in the legs and headache. It was reported that, patient did not have medical consultation for this events.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very heavy bleeding that lasted for a month, and the outcome of feeling very bad, iron deficiency anemia, pain in the legs, headache and TSH increase in 13 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210939719-Covid-19 vaccine ad26.cov2.s-very heavy bleeding that lasted for a month. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer via a company representative concerned a multiple female patient who was in their 40's (5 decades) of unknown race and ethnicity. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number were not reported and expiry: Unknown) dose, start therapy date were not reported, 1 total, administered 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 reporter reports of "women in their 40's experienced blood clots after vaccination". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210940304-Covid-19 vaccine ad26.cov2.s-Blood Clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; ENTIRE LEFT ARM FROM SHOULDER TO THE ELBOW ON THE LEFT SIDE HURT; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection in JAN-2020 (recovered on her own). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A or could be GU1A21A or 6U1A21A (the lot number was written messily) expiry: unknown) dose was not reported, frequency time 1 total administered on 31-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On an unspecified date of FEB-2021, patient had COVID-19 antibody test, which was positive. On 01-APR-2021, the patient experienced pain in entire left arm from shoulder to the elbow (entire left arm from shoulder to the elbow on the left side hurt). On 07-SEP-2021, the patient had COVID-19 antibody test, which was negative (confirmed immunological vaccine failure).  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from entire left arm from shoulder to the elbow on the left side hurt on 01-MAY-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority:90000194167; Sender's Comments: V0: 20210940935-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Confirmed immunological vaccine 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Paranasal sinus discomfort, SARS-CoV-2 test, Sinus congestion
Clinical narrative: SINUS CONGESTION; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SINUS PRESSURE; This spontaneous report received from a patient concerned a 52 year old white female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient had no daily medications or medical conditions. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1821287, and expiry: unknown) dose was not reported, 1 total administered on 21-JUN-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 10-SEP-2021, patient developed some symptoms, in the evening patient experienced scratchy throat and sinus pressure (Confirmed covid-19 infection). On 11-SEP-2021, the patient tested positive for Covid-19 (Confirmed clinical vaccination failure), Laboratory data included:COVID-19 PCR test (NR: not provided) positive. On same day, she experienced fever, Laboratory data included: Body temperature (NR: not provided) over 100.4 degrees Fahrenheit and recovered on (Tuesday) 14-SEP-2021. On unspecified date, the patient experienced a little bit of a cough, a bad headache, loss of taste and smell. The patient stated that her overall condition was improving and was feeling okay, but other than feeling tired and a little bit of sinus congestion, also the smell hasn't came back and the taste came back slowly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sinus pressure, had not recovered from confirmed covid-19 infection, and sinus congestion, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000194180.; Sender's Comments: V0: 20210940995-Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: SINUS CONGESTION; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SINUS PRESSURE; This spontaneous report received from a patient concerned a 52 year old white female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient had no daily medications or medical conditions. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1821287, and expiry: unknown) dose was not reported, 1 total administered on 21-JUN-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 10-SEP-2021, patient developed some symptoms, in the evening patient experienced scratchy throat and sinus pressure (Confirmed covid-19 infection). On 11-SEP-2021, the patient tested positive for Covid-19 (Confirmed clinical vaccination failure), Laboratory data included:COVID-19 PCR test (NR: not provided) positive. On same day, she experienced fever, Laboratory data included: Body temperature (NR: not provided) over 100.4 degrees Fahrenheit and recovered on (Tuesday) 14-SEP-2021. On unspecified date, the patient experienced a little bit of a cough, a bad headache, loss of taste and smell. The patient stated that her overall condition was improving and was feeling okay, but other than feeling tired and a little bit of sinus congestion, also the smell hasn't came back and the taste came back slowly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sinus pressure, had not recovered from confirmed covid-19 infection, and sinus congestion, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000194180.; Sender's Comments: V0: 20210940995-Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: MINI STROKE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient had a genetic predisposition and family history that resulted mini-strokes for him, also had several mini strokes in past before covid vaccination. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported with frequency 1 total administered on an unspecified date in MAR-2021 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 in APR-2021,a month of post vaccination, the patient experienced mini stroke and she was unsure if it was related to vaccine or not. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mini stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210941108-Covid-19 vaccine ad26.cov2.s -Mini stroke. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Laboratory test, Pain in extremity
Clinical narrative: BLOOD CLOT; BILATERAL PULMONARY EMBOLISM; THROMBOCYTOPENIA; PAIN IN LEFT THIGH; EXHAUSTION; FEVER; SEVERE HEADACHE; This spontaneous report received from a consumer concerned a 37 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included controlled high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on 24-AUG-2021 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 02-SEP-2021, the patient started having severe headache. On 04-SEP-2021, the patient had pain in left thigh, shortness of breath, 2 episodes of fever and exhaustion. On 09-SEP-2021, the patient was admitted to the Intensive Care Unit (ICU) and according to reporter, patient was diagnosed with blood clot, bilateral pulmonary embolism and thrombocytopenia(low platelets). The reporter stated that according to the doctors the events were related to the vaccine. The patient had done genetic testing and was negative for any clotting disorder. The patient spent two days in inflammatory floor from 11-SEP-2021 to 13-SEP-2021 and was discharged on 13-SEP-2021. The reporter mentioned that the patient almost died and was told at the ICU (intensive care unit) that it was a miracle that the patient was still alive. The reporter also stated that the patient could not receive any COVID-19 vaccine or booster shot anymore. Laboratory data included: Body temperature (NR: not provided) 101.3 F, 100.8 F. Laboratory data included: Lab test (NR: not provided) diagnosed with blood clot, bilateral pulmonary embolism with thrombocytopenia (low platelets) and Platelet count (NR: not provided) Low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bilateral pulmonary embolism, thrombocytopenia, blood clot, fever, severe headache, pain in left thigh and exhaustion was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210941148-covid-19 vaccine ad26.cov2.s-bilateral pulmonary embolism, blood clot, thrombocytopenia. This event(s) is labeled per RA and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Pulmonary embolism, Pyrexia, Thrombocytopenia, Thrombosis
Clinical narrative: BLOOD CLOT; BILATERAL PULMONARY EMBOLISM; THROMBOCYTOPENIA; PAIN IN LEFT THIGH; EXHAUSTION; FEVER; SEVERE HEADACHE; This spontaneous report received from a consumer concerned a 37 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included controlled high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on 24-AUG-2021 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 02-SEP-2021, the patient started having severe headache. On 04-SEP-2021, the patient had pain in left thigh, shortness of breath, 2 episodes of fever and exhaustion. On 09-SEP-2021, the patient was admitted to the Intensive Care Unit (ICU) and according to reporter, patient was diagnosed with blood clot, bilateral pulmonary embolism and thrombocytopenia(low platelets). The reporter stated that according to the doctors the events were related to the vaccine. The patient had done genetic testing and was negative for any clotting disorder. The patient spent two days in inflammatory floor from 11-SEP-2021 to 13-SEP-2021 and was discharged on 13-SEP-2021. The reporter mentioned that the patient almost died and was told at the ICU (intensive care unit) that it was a miracle that the patient was still alive. The reporter also stated that the patient could not receive any COVID-19 vaccine or booster shot anymore. Laboratory data included: Body temperature (NR: not provided) 101.3 F, 100.8 F. Laboratory data included: Lab test (NR: not provided) diagnosed with blood clot, bilateral pulmonary embolism with thrombocytopenia (low platelets) and Platelet count (NR: not provided) Low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bilateral pulmonary embolism, thrombocytopenia, blood clot, fever, severe headache, pain in left thigh and exhaustion was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210941148-covid-19 vaccine ad26.cov2.s-bilateral pulmonary embolism, blood clot, thrombocytopenia. This event(s) is labeled per RA and is therefore considered potentially related.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Extra dose administered, Fatigue, Glycosylated haemoglobin, Malaise
Clinical narrative: FELT LITTLE SICK; SORE ARM; FELT LITTLE TIRED; FEVER; EXTRA DOSE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 155 pounds, and height was 65 inches. The patient's concurrent conditions included: hypertension, vaccine intolerance, diabetes mellitus, hypoglycemia, drug allergy with ace inhibitors and calcium channel blockers and beta blockers and phenergan, and food allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, batch number: 1805031 expiry: 24-AUG-2021, and expiry: 07-AUG-2021) dose was not reported, administered on 17-MAR-2021, and dose was not reported, administered on 22-JUL-2021 for prophylactic vaccination. Concomitant medications included epinephrine for drug used for unknown indication, and metformin for drug used for unknown indication.  On 22-JUL-2021, the patient experienced extra dose of vaccine administered.On an unspecified date, the patient experienced felt little sick, sore arm, felt little tired, and fever. Laboratory data (dates unspecified) included: Fever (NR: not provided) 99.7 F, and HbA1C (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt little sick, sore arm, felt little tired, and fever, and the outcome of extra dose of vaccine administered was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: FELT LITTLE SICK; SORE ARM; FELT LITTLE TIRED; FEVER; EXTRA DOSE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 155 pounds, and height was 65 inches. The patient's concurrent conditions included: hypertension, vaccine intolerance, diabetes mellitus, hypoglycemia, drug allergy with ace inhibitors and calcium channel blockers and beta blockers and phenergan, and food allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, batch number: 1805031 expiry: 24-AUG-2021, and expiry: 07-AUG-2021) dose was not reported, administered on 17-MAR-2021, and dose was not reported, administered on 22-JUL-2021 for prophylactic vaccination. Concomitant medications included epinephrine for drug used for unknown indication, and metformin for drug used for unknown indication.  On 22-JUL-2021, the patient experienced extra dose of vaccine administered.On an unspecified date, the patient experienced felt little sick, sore arm, felt little tired, and fever. Laboratory data (dates unspecified) included: Fever (NR: not provided) 99.7 F, and HbA1C (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt little sick, sore arm, felt little tired, and fever, and the outcome of extra dose of vaccine administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan vagina, Vaginal haemorrhage
Clinical narrative: VAGINAL BLEEDING; This spontaneous report received from a patient concerned an elderly, white, female. The patient's height, and weight were not reported. The patient's concurrent conditions included: lung cancer (2002), breast cancer (2007) and endometriosis, and other pre-existing medical conditions included: patient had history of fertility treatments for 8 years in 1960s. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: Unknown, and expiry: Unknown) dose was not reported, one total administered on 09-APR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Five days after vaccination, on 14-APR-2021, the patient began bleeding vaginally. The patient had bleeding again on an unspecified date, was admitted to the hospital on 20-APR-2021, stayed several days and received a blood transfusion. The patient was discharged from hospital on an unspecified date in APR-2021. The bleeding resolved after the hospital stay and patient had two transvaginal ultrasounds, the second being only a few weeks ago, with appearing normal results. The results of the first transvaginal ultrasound scan was not reported. On an unspecified date the patient visited emergency room/department. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaginal bleeding on APR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210942041- Covid-19 vaccine ad26.cov2.s- Vaginal bleeding. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional 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, and batch number were not reported) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.