chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypokinesia, Pain in extremity, Somnolence
Clinical narrative: SLEEPY AFTER BOOSTER DOSE; SHE CAN NOT MOVE AND DO ANYTHING; PAIN IN SHOULDER, ARMS AND HANDS; TIRED AFTER BOOSTER DOSE; This spontaneous report received from a patient concerned a 74-year-old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy and did not took any medication. She never had any reactions to flu shot and never had a problem. The patient was previously treated with influenza vaccine (Flu shot) for prophylactic vaccination. The patient was previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total administered on 06-APR-2021 for prophylactic vaccination. After receiving primary dose, she felt tremendous electricity going through her body and she was shocked (dose number in series 1). The sensation later disappeared and she did not mention it to the pharmacist at the vaccine facility. On 07-APR-2021, she was so tired and she could hardly get out of bed and slept more than usual (dose number in series 1). On an unspecified date, after few months she felt tired again but decided to get the booster dose (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of administration not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total administered on 26-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, after getting the booster dose patient felt pain that started in shoulders and moved to hands. The patient stated pain was sometimes better but at times and she can not move and do anything (dose number in series 2). Her arm got better slowly but shoulder and hands was painful. On the day of report, her hands was painful and sore and pain seldom gone away. Left hand sometime got better but right hand was struck with pain. She was going to a chiropractor and got a little better. She felt tired and sleepy after the booster dose as well but not as much as the primary dose (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient had not recovered from pain in shoulder, arms and hands, and the outcome of tired after booster dose, sleepy after booster dose and she can not move and do anything was not reported (dose number in series 2). This report was non-serious. This case, involving the same patient is linked to 20220160873.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, alcohol use, and non-smoker, and other pre-existing medical conditions included: Patient has no known drug allergies, patient has no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 12-APR-2021. This report was non-serious. This case, involving the same patient is linked to 20220210630.
Sex: U
Vaccine: COVID19
Symptoms: Nervous system disorder
Clinical narrative: NERVOUS SYSTEM IS UNCONT; This spontaneous report received from a patient via a company representative via a social media 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, and batch number were not reported) 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 experienced nervous system is uncont. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nervous system is uncont was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: BLOOD CLOTS TO LUNGS; This spontaneous report received from a patient via a company representative concerned a 03 decade old female. The patient's height, weight and pre-existing medical conditions were not reported. Patient refused to report if he she had any allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, dose number in series was 01, 01 total was administered on an unspecified date in JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-JAN-2022, the patient experienced blood clots to lungs and trouble breathing (dose number in series was 01)on the same day patient was hospitalized for 5 days and was discharged on 17-JAN-2022. Patient was being treated for blood clots (unspecified treatment) at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clots to lungs. This report was serious (Hospitalization Caused / Prolonged). This case is associated with product quality complaint (PQC): 90000215105. The suspected product quality complaint has been confirmed to be this record indicates a medical adverse event for the patient. There was no product quality issue described in the information reported. It was approved to void this record due to no PQC identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20220200444 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood clots to lungs. 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: Off label use, Poor quality product administered, Product storage error
Clinical narrative: POSSIBLE TEMPERATURE EXCURSION; EXPOSED TO A TEMPERATURE OF 35 DEGREE FAHRENHEIT FOR 4 HOURS; OFF LABEL USE; 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, 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 possible temperature excursion, exposed to a temperature of 35 degree fahrenheit for 4 hours, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use, possible temperature excursion and exposed to a temperature of 35 degree fahrenheit for 4 hours was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, 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 admin were not reported, batch number: 207A21A, expiry: unknown) dose not reported, 01 total, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient felt like flu instead of pneumonia (suspected covid-19 infection). On an unspecified date in DEC-2021, the patient tested positive for Coronavirus disease (covid-19) (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 unknown. This report was serious (Other Medically Important Condition). This case is associated with a product quality complaint: 90000214926. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220200721.; Sender's Comments: V0-20220200531-Covid-19 vaccine ad26.CoV-2.s- Suspected clinical 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
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, 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 admin not reported, and batch number: 207A21A, expiry: unknown) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient felt like flu instead of pneumonia (suspected covid-19 infection). On an unspecified date in DEC-2021, the patient tested positive for coronavirus disease-19 (COVID-19) (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: 90000214935. This case, from the same reporter is linked to 20220200531.; Sender's Comments: V0: 20220200721-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: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. In JAN-2021, the patient was in hospital for seven days for an unspecified reason.  The patient received initial vaccination with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) on an unspecified date in MAR-2021 for prophylactic vaccination.  Following administration of covid-19 vaccine ad26.cov2.s, it was unknown whether patient had any adverse events. The patient received booster vaccination with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) on an unspecified date in NOV-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 JAN-2022, the patient tested positive for COVID-19 and was sick for more than a month (confirmed covid-19 infection and confirmed clinical vaccination failure) (dose number in series 2). The patient was also afraid to go out and be around any close relatives or friends (dose number in series was 2). The patient had never gone out without a mask, was very careful and washed hands more than often. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with a product quality complaint (PQC) number: 90000215107.; Sender's Comments: V0- 20220201023-Covid-19 vaccine ad26.CoV-2.s- Suspected clinical 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
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: TREMORS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 experienced tremors. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tremors was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Feeling abnormal, Inappropriate schedule of product administration, Off label use
Clinical narrative: CONFIRMED COVID-19 INFECTION; BRAIN FOG WHICH WAS REALLY BAD; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTRATION; This spontaneous report received from a patient (Health care Professional) concerned a 67 year old female. Initial information was processed with the additional information received on 02-FEB-2022. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient is HCP. The patient previously received bnt 162 (Pfizer vaccine) (Dose number in series 1) (form of admin, route of admin, and batch number: EN5318, expiry: unknown) dose was not reported, administered on 25-JAN-2021 for prophylactic vaccination. On an unspecified date, following vaccination with Pfizer vaccine, the patient experienced unspecified adverse reaction (Dose number in series 1). The patient had a reaction to the Pfizer vaccine, so the Janssen Covid-19 vaccine was used to complete the primary series. The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 12-APR-2021 on left deltoid for prophylactic vaccination which was off label use, and inappropriate schedule of vaccine administered. No concomitant medications were reported.   On 04-JAN-2022, the patient experienced bad cough, congestion, shortness of breath, muscle aches and pain (coded to confirmed covid-19 infection) and brain fog which was really bad (dose number in series 2).  On 07-JAN-2022, the patient experienced fever which raised to 104 body temperature, for which the patient took Advil (ibuprofen) and Tylenol (paracetamol) around the clock as needed which helped to reduce the temperature and underwent a COVID-19 Binax now test (NR: not provided) Positive (dose number in series 2).  On 09-JAN-2022, the patient performed a COVID-19 PCR (polymerase chain reaction) test which came out to be positive. The patient visited a walk in clinic for her symptoms on 16-JAN-2022 and returned to work on 17-JAN-2022 with diminished symptoms and all symptoms from covid-19 resolved around the 31-Jan-2022. She was asked if she had monoclonal antibody therapy.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and brain fog which was really bad on 31-JAN-2022, and the outcome of off label use, and inappropriate schedule of vaccine administration was not reported. This report was non-serious. This report was associated with product quality complaint: 90000215902.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; BRAIN FOG WHICH WAS REALLY BAD; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTRATION; This spontaneous report received from a patient (Health care Professional) concerned a 67 year old female. Initial information was processed with the additional information received on 02-FEB-2022. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient is HCP. The patient previously received bnt 162 (Pfizer vaccine) (Dose number in series 1) (form of admin, route of admin, and batch number: EN5318, expiry: unknown) dose was not reported, administered on 25-JAN-2021 for prophylactic vaccination. On an unspecified date, following vaccination with Pfizer vaccine, the patient experienced unspecified adverse reaction (Dose number in series 1). The patient had a reaction to the Pfizer vaccine, so the Janssen Covid-19 vaccine was used to complete the primary series. The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 12-APR-2021 on left deltoid for prophylactic vaccination which was off label use, and inappropriate schedule of vaccine administered. No concomitant medications were reported.   On 04-JAN-2022, the patient experienced bad cough, congestion, shortness of breath, muscle aches and pain (coded to confirmed covid-19 infection) and brain fog which was really bad (dose number in series 2).  On 07-JAN-2022, the patient experienced fever which raised to 104 body temperature, for which the patient took Advil (ibuprofen) and Tylenol (paracetamol) around the clock as needed which helped to reduce the temperature and underwent a COVID-19 Binax now test (NR: not provided) Positive (dose number in series 2).  On 09-JAN-2022, the patient performed a COVID-19 PCR (polymerase chain reaction) test which came out to be positive. The patient visited a walk in clinic for her symptoms on 16-JAN-2022 and returned to work on 17-JAN-2022 with diminished symptoms and all symptoms from covid-19 resolved around the 31-Jan-2022. She was asked if she had monoclonal antibody therapy.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and brain fog which was really bad on 31-JAN-2022, and the outcome of off label use, and inappropriate schedule of vaccine administration was not reported. This report was non-serious. This report was associated with product quality complaint: 90000215902.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a male, unspecified age and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808609, expiry: unknown) dose was not reported, 1 total administered on an 25-MAR-2021 to left arm for prophylactic vaccination. It was unknown if the patient experienced any adverse event after vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: unknown) dose was not reported, 1 total administered on 11-NOV-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 20-JAN-2022, the patient took rapid PCR (polymerase chain reaction) test and tested positive. On 22-JAN-2022, the patient took regular PCR (polymerase chain reaction) test and tested positive. (Dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious This report was associated with product quality complaint: 90000215646, 90000215655, 90000215657. The suspected product quality complaint has been confirmed to be voided (did not meet criteria) based on the RA evaluation/investigation performed. This case is a duplicate of 20220204336 and 20220203694.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; BREAKTHROUGH COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative via social media concerned a 74 year old male. Initial information was processed with the additional information received on 02-FEB-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: lung problems. The patient previously received covid-19 vaccine ad26. cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. It was unknown if the patient had any adverse events with series 1 (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported ,1 total, start therapy date was 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 experienced suspected clinical vaccination failure, and breakthrough covid-19 infection (dose number in series 2). The reporter stated that "2 of my family did get the new Covid as a breakthrew. Her older husband about 2 weeks but was at home. He is 74 with lung problems. Doing great now. At the gym working out. That boost he had probably saved his life. He had no problems with the vaccines." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breakthrough covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000215671 This case, from the same reporter is linked to 20220204795.; Sender's Comments: V0-20220203948-Covid-19 vaccine ad26.CoV-2.s- Suspected clinical 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
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous "hearsay" report received from other health care professional concerned an 89 year old female of unknown 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 admin, and batch number were not reported) 1 total, dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that, " a employee called on 01-Feb-2022 to report that a consumer had confirmed covid-19 infection (suspected covid-19 and suspected clinical vaccination failure) that was diagnosed in November of 2021. The employee heard this info through a state representative. The patient in question received the covid-19 vaccine in MAR-2021. The caller did not have any other details about the patient but added that, the patient had a mild infection but made a full recovery".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220204251-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: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Vein collapse
Clinical narrative: TRIPLE BYPASS VEINS COLLAPSED; ATRIOVENTRICULAR NODE IN LOWER HEART CHAMBER DESTROYED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: bypass. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 experienced triple bypass veins collapsed, and atrioventricular node in lower heart chamber destroyed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the atrioventricular node in lower heart chamber destroyed and triple bypass veins collapsed was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure, Vaccine breakthrough infection
Clinical narrative: GOT COVID BREAKTHROUGH; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, start therapy date were not reported, 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, it was reported that "2 of my family did get the new Covid as a breakthrew. My sister felt sick only 3 days." On an unspecified date, the patient experienced got covid breakthrough, and suspected clinical vaccination failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got covid breakthrough and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000215670. This case, from the same reporter is linked to 20220203948.; Sender's Comments: V0 20220204795-COVID-19 VACCINE AD26.COV2.S-got covid breakthrough. 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). V0 20220204795-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: Dysphagia, Migraine, Nervous system disorder, Sinus disorder, Thrombosis
Clinical narrative: CLOT IN THE LEG; MIGRAINE HEADACHE; TROUBLE SWALLOWING FOR 2  WEEKS; TROUBLE TO YOUR NERVOUS SYSTEM; SINUSES PUSHED BACK; This spontaneous report received from a patient concerned a 65 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: degenerative joint disease, sinus, and legally blind, and other pre-existing medical conditions included: Patient had a very very delicate nervous system. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, and batch number: unknown, expiry: unknown)  dose not reported, 1 total administered to right arm on an unspecified date 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 migraine headache, clot in the leg, stated stated vaccine causes trouble to nervous system, trouble swallowing for two weeks, and when asked if he had any allergies, he stated that after the Johnson & Johnson and "sinuses pushed back (all events with dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble swallowing for two weeks, and the outcome of migraine headache, clot in the leg, trouble to your nervous system and sinuses pushed back was not reported. On 03-JAN-2022, the patient received BNT162 Pfizer vaccine (dose number in series 2) (form of admin not reported, route of admin not reported, and batch number: unknown, expiry: unknown) dose was not reported, for prophylactic vaccination. It was unknown if the patient experienced any adverse event after vaccination with BNT162 Pfizer (dose number in series 2). This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220207035-COVID-19 VACCINE AD26.COV2.S- clot in the leg, -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: Adverse event, Neuropathy peripheral
Clinical narrative: NEUROPATHY; SEVERE REACTION; This spontaneous report received from a patient via media 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, 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced neuropathy, and severe reaction. The patient reported as "My first experience with the Johnson and Johnson vaccine was so bad I had a severe reaction with neuropathy".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe reaction and neuropathy was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220207510.; Sender's Comments: V0:20220207073- covid-19 vaccine ad26.cov2.s-Neuropathy. 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: TINGLING IN ARMS AND LEGS AND ALL OVER BODY; This spontaneous report received from a patient concerned a 54 year adult female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 180522, expiry date: unknown) dose was not reported, 1 total, administered on 04-MAR-2021 in right arm for prophylactic vaccination. No adverse events reported post vaccination (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855190 expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-FEB-2022 at 14:15 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 02-FEB-2022, around 15:00, patient started to have tingling in arms and legs and all over body as if arms and legs were falling sleep (dose number in series 2). Patient inquired that patient was nervous and had seek medical advice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in arms and legs and all over body. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin discolouration
Clinical narrative: NECK TURNED BLACK; RASH; This spontaneous report received from a patient via a company representative from social media 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 previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The patient experienced severe reaction with neuropathy following vaccination with first dose of covid-19 vaccine ad26. cov2. s (Dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) 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 patient experienced rash and neck turned black (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash and neck turned black was not reported. This report was non-serious. This case, involving the same patient is linked to 20220207073 (dose number in series 1).
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer via a company representative via social media concerned a six patients of unspecified age sex 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 was not reported, batch number and expiry date were unknown) 1 total administered on unspecified date (therapy start date and therapy end date were not provided) 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 patients had blood clots. The reporter stated that "I know of 6 young healthy and all from blood clots"  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- 20220207869-Covid-19 vaccine ad26.CoV-2.s- Blood clot. 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: Cerebrovascular accident
Clinical narrative: STROKES; This spontaneous report received from a consumer via social media concerned multiple patients (3 patients) with unspecified age, gender, race and ethnicity. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown 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. It was reported that on an unspecified date, the patients experienced strokes. It was stated by the reporter that "I am aware of some horrible jab statistics. In my immediate circle of friends, 2 heart attacks (1 died 5 days after her jab) 3 strokes". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of strokes was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220208979, 20220208988 and 20220208980.; Sender's Comments: V0: 20220208918-COVID-19 VACCINE AD26.COV2.S-strokes. 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: Death, Myocardial infarction
Clinical narrative: DEATH; HEART ATTACK; This spontaneous report received from a consumer via social media concerned a female of unspecified age, 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: unknown, expiry: unknown) dose, 1 total, 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 or lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced heart attack. On an unspecified date, five days after the vaccination, the patient died from unknown cause of death. It was stated by the reporter that "I am aware of some horrible jab statistics. In my immediate circle of friends, 2 heart attacks (1 died 5 days after her jab) 3 strokes". It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of heart attack was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20220208980, 20220208918 and 20220208988.; Sender's Comments: V0:20220208979- COVID-19 VACCINE AD26.COV2.S-Death, Heart attack. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Thrombosis
Clinical narrative: POTENTIAL CLOTS; HIGH BLOOD PRESSURE; This spontaneous report received from a consumer via media via a company representative concerned a female of unspecified age, 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, and batch number were not reported) dose, start therapy date were not reported administered 1 in total 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 experienced high blood pressure, and potential clots "My mother had a dangerously high blood pressure and potential clots for a month after her JnJ jab". Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high blood pressure and potential clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220208979, 20220208988 and 20220208918.; Sender's Comments: V0.20220208980-covid-19 vaccine ad26.cov2.s -Potential 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).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned an adult male. The patient's height and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The patient experienced full blood count decreased when treated with first dose of covid-19 vaccine ad26.cov2.s for prophylactic vaccination (Dose number in series 1) and risankizumab (Skyrizi) for moderate to severe chronic plaque psoriasis.  The patient previously received second dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with second dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination which was an off label use as inappropriate schedule of vaccine administered. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to 20220152014 (Dose number in series 1).
Sex: U
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: CANNOT MOVE; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 number. No concomitant medications were reported. On an unspecified date, the patient experienced cannot move. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cannot move was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: LITTLE SIDE EFFECTS; This spontaneous report received from a consumer via a company representative from social media 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch numbers were 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 experienced little side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little side effects was not reported. This report was non-serious. This case, involving the same patient is linked to 20220216041. This case, from the same reporter is linked to 20220210428 and 20220216024.