chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First / vaccine on October 19, 2020 and never received the second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 19th October 2020).   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 are as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received the 2nd dose of Shingrix, which led to incomplete course of vaccination. The caller refused to provide demographics or answer questions concerning adverse event details. No batch number or expiration date were provided for 1st dose. Did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Pain / at the injection site; Redness / at the injection site; Swelling at the injection site; Muscle pain; Tiredness; Headache; Shivering; Fever; Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 42-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's mother in law. The age at vaccination was not reported. The reporter asked about common side effects and when mentioned the most common side effects were pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever, and upset stomach then mother in law stated that the patient had all those side effects after his Shingrix vaccine. The reporter did not want to provide her address or any additional information. The reporter was referred to HCP (health care professional). The reporter did not consent to follow up. The case was linked with US2021156444 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021156444:Same reporter. Daughter case.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Pain / at the injection site; Redness / at the injection site; Swelling at the injection site; Muscle pain; Tiredness; Headache; Shivering; Fever; Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 42-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's mother in law. The age at vaccination was not reported. The reporter asked about common side effects and when mentioned the most common side effects were pain, redness, and swelling at the injection site, muscle pain, tiredness, headache, shivering, fever, and upset stomach then mother in law stated that the patient had all those side effects after his Shingrix vaccine. The reporter did not want to provide her address or any additional information. The reporter was referred to HCP (health care professional). The reporter did not consent to follow up. The case was linked with US2021156444 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021156444:Same reporter. Daughter case.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: outside recommended schedule; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number abxb2888, expiry date 20th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On 19th July 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 19th July 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient  received a second dose of Bexsero outside recommended schedule the first dose was administrated on 12th July2021 and the second dose administrated on 19th July 2021,which led to shortening of vaccine schedule. The reporter reported that the side effect was not known. The reporter consent to follow up.
Age: 69.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: late Engerix-B third dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device injection syringe for prophylaxis.   Previously administered products included Engerix-B (received 1st dose on 14th August 2019, batch number 54A32 and expiry date 12th November 2021) and Engerix-B (received 2nd dose on 17th September 2019, batch number 53P39).   On 17th June 2021, the patient received the 3rd dose of Engerix B and hepatitis B vaccine pre-filled syringe device. On 17th June 2021, unknown after receiving Engerix B and hepatitis B vaccine pre-filled syringe device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The pharmacist reported that the late Engerix-B third dose was given to the patient, which led to lengthening of vaccinations schedule. The reporter consented to follow up. No information about lot number from Engerix-B third dose at the moment of the call.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Chest X-ray, Chest pain, Dizziness
Clinical narrative: PAIN IN RIGHT ARM; PAIN IN KNEE; CHEST PAIN; TINGLING; NUMBNESS; FEELING LIKE SHE IS GOING TO FAINT; FEVER; FAINTING; This spontaneous report received from a patient concerned a 26 year old White, Non-Hispanic/Latino female. The patient's height, and weight were not reported. The patient's past medical history included birth control stopped 2 months ago, and concurrent conditions included pollen allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with benzoyl peroxide. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-JUL-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 13-JUL-2021, after receiving the vaccine patient reported fainting and fever on the day of injection. On 14-JUL-2021, the day after vaccination patient had chest pain, tingling and numbness and feeling like patient was going to faint. Patient went to the emergency room on the 14-JUL-2021 and patient was told patient was ok. On 16-JUL-2021, patient started feeling pain on the right arm and knee (side of injection). Patient mentioned patient was travelling after few days on a long flight to Germany. Patient mentioned that patient was very healthy. Laboratory data included: Blood test (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, and Urine analysis (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, recovered with sequelae from chest pain, and had not recovered from fainting, tingling, numbness, pain in right arm, pain in knee, and feeling like she is going to faint. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210738815-covid-19 vaccine ad26.cov2.s -fainting. 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia, Pyrexia, Syncope
Clinical narrative: PAIN IN RIGHT ARM; PAIN IN KNEE; CHEST PAIN; TINGLING; NUMBNESS; FEELING LIKE SHE IS GOING TO FAINT; FEVER; FAINTING; This spontaneous report received from a patient concerned a 26 year old White, Non-Hispanic/Latino female. The patient's height, and weight were not reported. The patient's past medical history included birth control stopped 2 months ago, and concurrent conditions included pollen allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with benzoyl peroxide. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-JUL-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 13-JUL-2021, after receiving the vaccine patient reported fainting and fever on the day of injection. On 14-JUL-2021, the day after vaccination patient had chest pain, tingling and numbness and feeling like patient was going to faint. Patient went to the emergency room on the 14-JUL-2021 and patient was told patient was ok. On 16-JUL-2021, patient started feeling pain on the right arm and knee (side of injection). Patient mentioned patient was travelling after few days on a long flight to Germany. Patient mentioned that patient was very healthy. Laboratory data included: Blood test (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, and Urine analysis (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, recovered with sequelae from chest pain, and had not recovered from fainting, tingling, numbness, pain in right arm, pain in knee, and feeling like she is going to faint. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210738815-covid-19 vaccine ad26.cov2.s -fainting. 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: PAIN IN RIGHT ARM; PAIN IN KNEE; CHEST PAIN; TINGLING; NUMBNESS; FEELING LIKE SHE IS GOING TO FAINT; FEVER; FAINTING; This spontaneous report received from a patient concerned a 26 year old White, Non-Hispanic/Latino female. The patient's height, and weight were not reported. The patient's past medical history included birth control stopped 2 months ago, and concurrent conditions included pollen allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with benzoyl peroxide. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-JUL-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 13-JUL-2021, after receiving the vaccine patient reported fainting and fever on the day of injection. On 14-JUL-2021, the day after vaccination patient had chest pain, tingling and numbness and feeling like patient was going to faint. Patient went to the emergency room on the 14-JUL-2021 and patient was told patient was ok. On 16-JUL-2021, patient started feeling pain on the right arm and knee (side of injection). Patient mentioned patient was travelling after few days on a long flight to Germany. Patient mentioned that patient was very healthy. Laboratory data included: Blood test (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, and Urine analysis (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, recovered with sequelae from chest pain, and had not recovered from fainting, tingling, numbness, pain in right arm, pain in knee, and feeling like she is going to faint. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210738815-covid-19 vaccine ad26.cov2.s -fainting. 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: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 50-year-old patient. 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: 1805020, and expiry: unknown) dose was not reported, 1 total, administered on 21-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 11-JUL-2021, the patient developed nasal congestion, coughing and fever. He went and took a Covid-19 polymerase chain reaction (PCR) test on July 15th which came back positive for covid-19 infection on July 16th, hence he experienced confirmed covid-19 infection and confirmed clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, 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: 90000186348.; Sender's Comments: V0-20210739108-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: U
Vaccine: COVID19
Symptoms: Adverse event, Musculoskeletal pain
Clinical narrative: MORE MILD THAN IT WOULD HAVE BEEN HAD I NOT BEEN VACCINATED; A PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 0.5 ml, start therapy date was 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 subject experienced more mild than it would have been had i not been vaccinated, and a pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the more mild than it would have been had i not been vaccinated and a pain was not reported. This report was non-serious. The report was associated with product quality complaint: 90000186436.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Gait disturbance, Impaired work ability, Laboratory test, Malaise
Clinical narrative: DIFFICULTY IN WALKING; VERY STRANGE COUGH; NOT BEEN ABLE TO GO TO WORK; LOT OF CRAMPS; FELT VERY UNWELL; PAIN IN LEG; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced difficulty in walking, very strange cough, not been able to go to work, lot of cramps, felt very unwell, and pain in leg. Laboratory data (dates unspecified) included: Lab test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt very unwell, pain in leg, difficulty in walking, lot of cramps, very strange cough and not been able to go to work was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: DIFFICULTY IN WALKING; VERY STRANGE COUGH; NOT BEEN ABLE TO GO TO WORK; LOT OF CRAMPS; FELT VERY UNWELL; PAIN IN LEG; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced difficulty in walking, very strange cough, not been able to go to work, lot of cramps, felt very unwell, and pain in leg. Laboratory data (dates unspecified) included: Lab test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt very unwell, pain in leg, difficulty in walking, lot of cramps, very strange cough and not been able to go to work was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Mass, Unevaluable event
Clinical narrative: DEVELOPED A GROWTH IN HIS RIB  AREA; INCREASED MEDICAL ISSUE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced developed a growth in his rib area, and increased medical issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the developed a growth in his rib area and increased medical issue was not reported. This report was non-serious. This case, from the same reporter is linked to 20210742055.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: PAIN ON THE ARM; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-JUL-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 16-JUL-2021, the subject experienced pain on the arm. On 16-JUL-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain on the arm, and tiredness on 19-JUL-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; BRAIN FOG; This spontaneous report received from a consumer via a company representative concerned a 32 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included exposure to delta variant covid 19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient got very sick with fever, aches, head congestion, fatigue, general feeling of illness (suspected clinical vaccination failure, suspected covid-19 infection), and brain fog. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, suspected covid-19 infection and brain fog was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint (PQC) number 90000186646.; Sender's Comments: V0: 20210742468-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Diverticulitis, Dizziness, Dyspnoea, Faecaloma
Clinical narrative: HYPERTENSIVE CRISIS (HIGH BLOOD PRESSURE); DIVERTICULITIS; BOWEL IMPACTION; DIZZINESS; FEELING FATIGUE; BLOOD PRESSURE FALLS TOO LOW AT TIMES; SOME HEADACHES; SHORTNESS OF BREATH; SOME LEFT NECK PAIN; This spontaneous report received from a consumer (reported as daughter) concerned a 79 year old White and Not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included that she had no known allergies. 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, frequency time was 1 total administered on right arm on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-APR-2021 (reported as right away after vaccination), the patient started feeling bad which was further elaborated as feeling fatigue, shortness of breath, and had some left neck pain. On an unspecified date in MAY-2021 (reported as on or about 10-MAY-2021), the patient started experiencing some headaches. The patient went to see her doctor on 17- MAY-2021 for routine checkup and got to know that everything was fine, and her blood pressure was fine at this time. On 06-JUNE-2021, the patient was hospitalized with hypertensive crisis, diverticulitis, bowel impaction, dizziness, and fatigue. The patient was discharged from hospital on 11-JUNE-2021. On 28-JUNE-2021, the patient was hospitalized again for second time for high blood pressure, and she was put on 2 different blood pressure medications (unspecified) including a diuretic (reporter was unsure of the medication names/dosages). It was also reported that the patient feels fatigued at times now when her blood pressure falls too low (date unspecified). The results, units and normal ranges for blood pressure was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from some left neck pain, some headaches, and bowel impaction, and had not recovered from hypertensive crisis (high blood pressure), diverticulitis, shortness of breath, blood pressure falls too low at times, dizziness, and feeling fatigue. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210743176 - Covid-19 vaccine ad26.cov2.s - Hypertensive crisis, Diverticulitis, Bowel impaction, Dizziness. 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). 20210743176-Covid-19 vaccine ad26.cov2.s - Fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypertensive crisis, Hypotension, Neck pain
Clinical narrative: HYPERTENSIVE CRISIS (HIGH BLOOD PRESSURE); DIVERTICULITIS; BOWEL IMPACTION; DIZZINESS; FEELING FATIGUE; BLOOD PRESSURE FALLS TOO LOW AT TIMES; SOME HEADACHES; SHORTNESS OF BREATH; SOME LEFT NECK PAIN; This spontaneous report received from a consumer (reported as daughter) concerned a 79 year old White and Not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included that she had no known allergies. 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, frequency time was 1 total administered on right arm on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-APR-2021 (reported as right away after vaccination), the patient started feeling bad which was further elaborated as feeling fatigue, shortness of breath, and had some left neck pain. On an unspecified date in MAY-2021 (reported as on or about 10-MAY-2021), the patient started experiencing some headaches. The patient went to see her doctor on 17- MAY-2021 for routine checkup and got to know that everything was fine, and her blood pressure was fine at this time. On 06-JUNE-2021, the patient was hospitalized with hypertensive crisis, diverticulitis, bowel impaction, dizziness, and fatigue. The patient was discharged from hospital on 11-JUNE-2021. On 28-JUNE-2021, the patient was hospitalized again for second time for high blood pressure, and she was put on 2 different blood pressure medications (unspecified) including a diuretic (reporter was unsure of the medication names/dosages). It was also reported that the patient feels fatigued at times now when her blood pressure falls too low (date unspecified). The results, units and normal ranges for blood pressure was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from some left neck pain, some headaches, and bowel impaction, and had not recovered from hypertensive crisis (high blood pressure), diverticulitis, shortness of breath, blood pressure falls too low at times, dizziness, and feeling fatigue. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210743176 - Covid-19 vaccine ad26.cov2.s - Hypertensive crisis, Diverticulitis, Bowel impaction, Dizziness. 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). 20210743176-Covid-19 vaccine ad26.cov2.s - Fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Blood pressure increased, Blood pressure measurement, Chest pain
Clinical narrative: BLOOD PRESSURE INCREASED; BURNING LIVER; EXACERBATION OF REFLUX; SHARP PAIN IN STOMACH; FELT LIKE KIDNEYS WERE BURNING; SHARP PAIN IN CHEST; FELT THE VACCINE GO TO HEAD 10 MINUTES AFTER GETTING SHOT; RIGHT SHOULDER THROBBING; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy, alcohol use, non-smoker, and hypertension, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 14:10 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, Laboratory data included: Blood pressure (NR: not provided) 144/80 mmHg. On 18-JUN-2021, the subject experienced felt the vaccine go to head 10 minutes after getting shot. On 18-JUN-2021, the subject experienced right shoulder throbbing. On 19-JUN-2021, the subject experienced sharp pain in chest. On 19-JUN-2021, the subject experienced sharp pain in stomach. On 19-JUN-2021, the subject experienced felt like kidneys were burning. On 19-JUN-2021, the subject experienced exacerbation of reflux. On 19-JUL-2021, the subject experienced burning liver. On 20-JUL-2021, the subject experienced blood pressure increased. Laboratory data included: Blood pressure (NR: not provided) 165/105 mmHg. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 100/70 mmHg. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sharp pain in chest, sharp pain in stomach, felt like kidneys were burning, felt the vaccine go to head 10 minutes after getting shot, and right shoulder throbbing on 21-JUN-2021, and burning liver on 21-JUL-2021, was recovering from exacerbation of reflux, and the outcome of blood pressure increased was not reported. This report was non-serious.; Sender's Comments: V0-Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gastrooesophageal reflux disease, Hepatic pain, Renal pain
Clinical narrative: BLOOD PRESSURE INCREASED; BURNING LIVER; EXACERBATION OF REFLUX; SHARP PAIN IN STOMACH; FELT LIKE KIDNEYS WERE BURNING; SHARP PAIN IN CHEST; FELT THE VACCINE GO TO HEAD 10 MINUTES AFTER GETTING SHOT; RIGHT SHOULDER THROBBING; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy, alcohol use, non-smoker, and hypertension, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 14:10 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, Laboratory data included: Blood pressure (NR: not provided) 144/80 mmHg. On 18-JUN-2021, the subject experienced felt the vaccine go to head 10 minutes after getting shot. On 18-JUN-2021, the subject experienced right shoulder throbbing. On 19-JUN-2021, the subject experienced sharp pain in chest. On 19-JUN-2021, the subject experienced sharp pain in stomach. On 19-JUN-2021, the subject experienced felt like kidneys were burning. On 19-JUN-2021, the subject experienced exacerbation of reflux. On 19-JUL-2021, the subject experienced burning liver. On 20-JUL-2021, the subject experienced blood pressure increased. Laboratory data included: Blood pressure (NR: not provided) 165/105 mmHg. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 100/70 mmHg. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sharp pain in chest, sharp pain in stomach, felt like kidneys were burning, felt the vaccine go to head 10 minutes after getting shot, and right shoulder throbbing on 21-JUN-2021, and burning liver on 21-JUL-2021, was recovering from exacerbation of reflux, and the outcome of blood pressure increased was not reported. This report was non-serious.; Sender's Comments: V0-Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Eye swelling, Pruritus, Swelling, Swelling face
Clinical narrative: RIGHT EYE STARTED TO BE SWELLING; FACE STARTED TO BE A LITTLE SWELLING/SEMI-FALLEN FACE; WHOLE BODY STARTED TO BE SWELLING; ITCHY FROM SCALP TO TOES; SEVER STOMACH PAIN; This spontaneous report received from a consumer concerned a 72 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported ,batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 17-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-JUL-2021, the subject experienced sever stomach pain. On 20-JUL-2021, the subject experienced right eye started to be swelling. On 20-JUL-2021, the subject experienced face started to be a little swelling/semi-fallen face. On 20-JUL-2021, the subject experienced whole body started to be swelling. On 20-JUL-2021, the subject experienced itchy from scalp to toes. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sever stomach pain, and itchy from scalp to toes, and was recovering from right eye started to be swelling, face started to be a little swelling/semi-fallen face, and whole body started to be swelling. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per the standard procedure as the case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: PAIN IN THE ARM; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced pain in the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain in the arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Hallucination, Lethargy, Myalgia, Nausea
Clinical narrative: BORDERLINE HALLUCINATIONS; WEIRD DREAMS; LETHARGIC/WEARING OUT; SWEATING ORANGE/RUST; BODY ACHES/HURT TO GET AROUND; MUSCLE PAIN; HIGH FEVER/HOT TO TOUCH/ HOTTEST AS EVER BEEN; NAUSEA; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 18-JUL-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 19-JUL-2021, the patient woke up and felt lethargic and then felt worse as the day went on. Had high fever. He slept ate and drank. He had sweat all discolored, stained orange where he was laying. He felt like he had a feverish day yesterday, just recuperating. He was able to go to work today. Wearing out as the day goes on. Hot to the touch. He had Borderline hallucinations. He was hottest as ever been. He had weird dreams. Muscle and body aches. Hurt to get around yesterday. He was slightly nauseated. On 20-JUL-2021, he was feeling little lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating orange/rust, high fever/hot to touch/ hottest as ever been, and nausea on 20-JUL-2021, was recovering from lethargic/wearing out, weird dreams, muscle pain, and body aches/hurt to get around, and the outcome of borderline hallucinations was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210743423- Covid-19 vaccine ad26.cov2.s-Borderline Hallucinations. 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: Pain, Pyrexia, Sweat discolouration
Clinical narrative: BORDERLINE HALLUCINATIONS; WEIRD DREAMS; LETHARGIC/WEARING OUT; SWEATING ORANGE/RUST; BODY ACHES/HURT TO GET AROUND; MUSCLE PAIN; HIGH FEVER/HOT TO TOUCH/ HOTTEST AS EVER BEEN; NAUSEA; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 18-JUL-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 19-JUL-2021, the patient woke up and felt lethargic and then felt worse as the day went on. Had high fever. He slept ate and drank. He had sweat all discolored, stained orange where he was laying. He felt like he had a feverish day yesterday, just recuperating. He was able to go to work today. Wearing out as the day goes on. Hot to the touch. He had Borderline hallucinations. He was hottest as ever been. He had weird dreams. Muscle and body aches. Hurt to get around yesterday. He was slightly nauseated. On 20-JUL-2021, he was feeling little lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating orange/rust, high fever/hot to touch/ hottest as ever been, and nausea on 20-JUL-2021, was recovering from lethargic/wearing out, weird dreams, muscle pain, and body aches/hurt to get around, and the outcome of borderline hallucinations was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210743423- Covid-19 vaccine ad26.cov2.s-Borderline Hallucinations. 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: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via Pfizer concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included covid on an unspecified date in /DEC/2020.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total administered on 03-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 03-JUL-2021, the patient had an antibody test done for which the results were negative (confirmed immunological vaccine failure). It was reported that the patient did not have any reaction. The patient wanted to know whether a re-vaccination is required. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000186787; Sender's Comments: V0: 20210743623- 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
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure, Vision blurred
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; CLOUDY VISION; FEELING HORRIBLE; This spontaneous report received from a patient concerned a male 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: 1805025 and expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient received the Janssen COVID-19 vaccine on 13-MAY-2021 but that patient had tested positive for COVID-19 recently and has been feeling horrible for 4 to 5 days which included headache, cloudy vision, and body aches. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cloudy vision, feeling horrible, 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: 90000186711; Sender's Comments: V0: 20210743638- 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: Illness, SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: GOT SICK TWICE; SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 TEST POSITIVE; This spontaneous report received from a parent via social media concerned a male of unspecified age, race and ethnic origin. Initial information was processed along with the additional information received on 21-JUL-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date after vaccination, it was reported that the vaccine shot had made the patient sick twice. On 19-JUL-2021, the patient tested for covid-19 and the result was positive (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 test positive, got sick twice and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000186589 The suspected product quality complaint has been confirmed to be not voided (meet PQC criteria) based on the PQC evaluation.; Sender's Comments: V0; 20210743654-COVID-19 VACCINE JANSSEN-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, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned multiple patients. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced covid-19 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. 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 case, from the same reporter is linked to 20210743638. This report was associated with product quality complaint: 90000186715.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case was assessed as non-serious.