chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Administered pediatric dose to adult pt; 22 year old pt received pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 22-year-old female patient who received HBV (Engerix B pediatric) (batch number 77X47, expiry date 22nd December 2023) for prophylaxis.   On 24th October 2021, the patient received the 2nd dose of Engerix B pediatric. On 24th October 2021, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The nurse reported that 22 year old patient who received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The reporter consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on 2020,not received any additional doses; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old male patient who received HAB (Twinrix adult) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix adult (1st dose received on 9th March 2020 with batch number 9355D and expiration date 14 March 2022.).   On an unknown date, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received first dose of Twinrix series and then forgot to come back in for next dosing. Till the time of reporting, the patient had not received any additional dose of Twinrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Cutaneous lupus erythematosus, Drug ineffective, Gene mutation identification test positive
Clinical narrative: discoid lupus; This case was reported by a consumer via call center representative and described the occurrence of discoid lupus erythematosus in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included discoid lupus erythematosus (Family History) (father), pruritus and hair loss. Previously administered products included Shingrix (received 1st dose on 14th January 2021) and Clobetasol cream with an associated reaction of drug ineffective.   On 14th July 2021, the patient received the 1st dose of Shingrix (intramuscular). In July 2021, less than a month after receiving Shingrix, the patient experienced discoid lupus erythematosus (serious criteria GSK medically significant). The patient was treated with fluocinonide cream and steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the discoid lupus erythematosus was unknown.   It was unknown if the reporter considered the discoid lupus erythematosus to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received Shingrix in the left arm.  After receiving Shingrix, the patient was diagnosed with discoid lupus. Prior to 2021, he was told he had a genetic marker for lupus and his father had discoid lupus.  In April 2021, his head was itchy, and he was losing his hair. In July, healthcare professional told him, he had discoid lupus and it was causing bald spots.  The patient reported his healthcare professional initially gave him Clobesterol cream for the itching, in April 2021, and that did not work. Next the healthcare professional gave him Fluocinamide Cream, in July 2021, and that did not work.  Next the healthcare professional injected him with steroids in his head on 14th October 2021 and he went to see the healthcare professional this Thursday on 29th October 2021 to check progress. The reporter did not consent to follow up. The reporter did not give permission to contact healthcare professional.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR224156:Same Patient
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: over 6 months since the 1st dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 4J2SP, expiry date 14th November 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 29th August 2019).   On 25th October 2021, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 25th October 2021, unknown after receiving Shingrix, 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.  Additional details were provided as follows: The reporter was a pharmacy technician. The age at vaccination was not reported. The patient received 2nd dose intramuscularly into her left deltoid later than the recommended interval, which led to drug dose administration interval too long. The reporter inquired if a patient needed to restart the Shingrix series if it had been over 6 months since the 1st dose. The reporter was not asked for consent to contact health care professional because the patient was not available to speak to.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Received 1st dose in May2019, 2nd dose not taken yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in May 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. The patient did not receive 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The patient inquired whether he should receive his 2nd dose now or if he should restart the vaccine Series, also inquired how long after his 2nd dose, he could receive the flu vaccine.  The reporter did not consent to follow-up.
Age: 0.58
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 7-month-old female patient who received Hib (Hiberix) (batch number 937JX, expiry date 26th September 2021) for prophylaxis.   On 25th October 2021, the patient received Hiberix. On 25th October 2021, unknown after receiving Hiberix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received a dose of Hiberix, which was already expired on 26th September 2021. The reporter consented to follow up.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Deltoid tenderness; This case was reported by a nurse and described the occurrence of tenderness muscle in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB29BA, expiry date 1st 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.   On 19th October 2021, the patient received the 1st dose of Bexsero (intramuscular) 1 dosage form(s) and Bexsero Pre-Filled Syringe Device. In October 2021, less than a week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced tenderness muscle. On an unknown date, the outcome of the tenderness muscle was not recovered/not resolved.   It was unknown if the reporter considered the tenderness muscle to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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 dose of Bexsero in the right deltoid. After vaccination with Bexsero, the patient still experienced tenderness in his arm. The reporter was the health care professional therefore did not asked for consent from patient.
Age: 77.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Amnesia, Chills, Depressed level of consciousness, Dizziness, Fatigue
Clinical narrative: Mental Fog; Shivering/ rigors; Exhausted; Memory loss for an hour and a half; Fever; Mild Headache; Dizziness; Felt "out of sorts"; This case was reported by a consumer via call center representative and described the occurrence of consciousness clouding in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 15th October 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml and Influenza vaccine Quadrivalent 2021-2022 season. On 16th October 2021, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced consciousness clouding (serious criteria GSK medically significant), shivering, exhaustion, memory loss, fever, headache, dizziness and feeling abnormal. On 16th October 2021, the outcome of the memory loss was recovered/resolved. On 26th October 2021, the outcome of the consciousness clouding, shivering, exhaustion, fever, headache, dizziness and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the consciousness clouding, shivering, exhaustion, memory loss, fever, headache, dizziness and feeling abnormal to be related to Shingrix and Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: The reporter was the patient.   The patient received Shingrix in an unknown deltoid and also received an unknown brand of Flu vaccine the same day.   The next day after receiving Shingrix and Flu vaccine, the patient began to had shivers, exhaustion, memory loss for an hour and a half, fever, rigors, mild headache, dizziness, mental fog and he felt out of sorts.   The patient reported that, on the date of reporting, the side effects seemed to be resolved as he was feeling better.  No Lot number or expiration date for the vaccine was known. The reporter provided healthcare professional information. The reporter consented to follow up.
Age: 77.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Feeling abnormal, Headache, Pyrexia
Clinical narrative: Mental Fog; Shivering/ rigors; Exhausted; Memory loss for an hour and a half; Fever; Mild Headache; Dizziness; Felt "out of sorts"; This case was reported by a consumer via call center representative and described the occurrence of consciousness clouding in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 15th October 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml and Influenza vaccine Quadrivalent 2021-2022 season. On 16th October 2021, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced consciousness clouding (serious criteria GSK medically significant), shivering, exhaustion, memory loss, fever, headache, dizziness and feeling abnormal. On 16th October 2021, the outcome of the memory loss was recovered/resolved. On 26th October 2021, the outcome of the consciousness clouding, shivering, exhaustion, fever, headache, dizziness and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the consciousness clouding, shivering, exhaustion, memory loss, fever, headache, dizziness and feeling abnormal to be related to Shingrix and Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: The reporter was the patient.   The patient received Shingrix in an unknown deltoid and also received an unknown brand of Flu vaccine the same day.   The next day after receiving Shingrix and Flu vaccine, the patient began to had shivers, exhaustion, memory loss for an hour and a half, fever, rigors, mild headache, dizziness, mental fog and he felt out of sorts.   The patient reported that, on the date of reporting, the side effects seemed to be resolved as he was feeling better.  No Lot number or expiration date for the vaccine was known. The reporter provided healthcare professional information. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes ophthalmic
Clinical narrative: herpes in eye; This case was reported by a consumer via call center representative and described the occurrence of herpes ophthalmic in a 88-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On 7th October 2021, less than 5 months after receiving Shingrix, the patient experienced herpes ophthalmic (serious criteria GSK medically significant). The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the herpes ophthalmic was recovering/resolving.   It was unknown if the reporter considered the herpes ophthalmic to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's wife.  The age at vaccination was not reported, but it could be 87 or 88 years. In June or July 2021, the patient received Shingrix in an unknown arm.  On 7th October 2021, the patient was diagnosed by the eye doctor with early herpes in the eye (unknown eye).  The eye doctor treated the early herpes with Valtrex for 2 weeks which was completed at the time of reporting.  The eye doctor reported that, the patient's eye looked good after treatment with Valtrex. The reporter did not consent to follow up. The reporter did not give permission for GlaxoSmithKline to contact healthcare professional.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: below temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 31-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 3SE27, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 information was provided as follow: The patient was the reporting physician's son in law. The physician reported a below temperature excursion at 26.3 degree F for Fluarix QIV and it was already administered to a patient. The reporter consented to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: administering expired flu vaccine from last year; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in an unspecified number of patients who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number 47G53, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 age at vaccination was not applicable for this report. Fluarix was given to residents age 65 above, both male and female and it was a whole facility. The patient received dose of Flu vaccine from last year that was already got expired on 30th June 2021, which led to expired vaccine used. The reporter had asked about the risks. The reporter consented to follow up via email. No specific patient demographics available as there were numerous patients involved. Health care professional also has the name of the nursing home and director. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Product administered to patient of inappropriate age
Clinical narrative: HEART ISSUES; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; This spontaneous report received via social media from a consumer concerned an adolescent patient of unspecified 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 administration was not reported, batch number: Unknown, Expiry: Unknown) dose, frequency one 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/lot numbers. No concomitant medications were reported.  On an unspecified date, reporter stated that neighbours teen ended up in the hospital (date unspecified) with heart issues after received disease conquering vax and reported inappropriate age at vaccine administration. The number of hospitalized day was unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart issues and inappropriate age at vaccine administration was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211047324- Covid-19 vaccine ad26.cov2.s-heart issues. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 69.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood pressure abnormal, Blood pressure measurement, COVID-19, Hypertension, Hypertonic bladder
Clinical narrative: MIGRAINE; BLOOD PRESSURE ABNORMAL; WEIGHT LOSS; COVID-19; OVERACTIVE BLADDER; BLOOD PRESSURE HIGH; This spontaneous report received from a patient concerned a 68 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date in JAN-2021, the patient experienced covid-19. On an unspecified date, the patient experienced migraine, blood pressure abnormal, weight loss, overactive bladder, and blood pressure high. The patient had issues with blood pressure, high blood pressure and was feeling tired. The patient thought those issues were side effects to having Covid-19 in JAN-2021 (date unspecified), it took several months to recover. The patient stated that she was admitted to the hospital on 10-JUL-2021 due to migraines and blood pressure issues. She thought she was discharged on 12-JUL-2021. The neurologist gave her Botox (botulinum toxin type a) to help with the issues. She had migraines for nine weeks. She had lost 15 pound and was not able to keep food down as of 11-AUG-2021. The patient stated that she had an overactive bladder. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Abnormal, High, and Weight loss (NR: not provided) lost 15 Ibs. Treatment medications (dates unspecified) included: botulinum toxin type a. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient recovered from migraine, and covid-19 on 2021, was recovering from blood pressure abnormal, and blood pressure high, and the outcome of weight loss, and overactive bladder was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211053693- Covid-19 vaccine ad26.cov2.s-migraine and blood pressure abnormal. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 69.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Migraine, Weight, Weight decreased
Clinical narrative: MIGRAINE; BLOOD PRESSURE ABNORMAL; WEIGHT LOSS; COVID-19; OVERACTIVE BLADDER; BLOOD PRESSURE HIGH; This spontaneous report received from a patient concerned a 68 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date in JAN-2021, the patient experienced covid-19. On an unspecified date, the patient experienced migraine, blood pressure abnormal, weight loss, overactive bladder, and blood pressure high. The patient had issues with blood pressure, high blood pressure and was feeling tired. The patient thought those issues were side effects to having Covid-19 in JAN-2021 (date unspecified), it took several months to recover. The patient stated that she was admitted to the hospital on 10-JUL-2021 due to migraines and blood pressure issues. She thought she was discharged on 12-JUL-2021. The neurologist gave her Botox (botulinum toxin type a) to help with the issues. She had migraines for nine weeks. She had lost 15 pound and was not able to keep food down as of 11-AUG-2021. The patient stated that she had an overactive bladder. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Abnormal, High, and Weight loss (NR: not provided) lost 15 Ibs. Treatment medications (dates unspecified) included: botulinum toxin type a. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient recovered from migraine, and covid-19 on 2021, was recovering from blood pressure abnormal, and blood pressure high, and the outcome of weight loss, and overactive bladder was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211053693- Covid-19 vaccine ad26.cov2.s-migraine and blood pressure abnormal. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Autoimmune disorder, Cold agglutinins, Cold agglutinins positive, Fatigue
Clinical narrative: Spike cold agglutinins; AUTOIMMUNE RESPONSE; GI issues; Joint pain; Fatigue; Muscle pain; This spontaneous report received from a patient concerned a 74 year old female of unspecified race and ethnicity. Initial information was processed along with the additional information received on 28-OCT-2021. The patient's height, and weight were not reported. The patient's past medical history included: flu. 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 administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The patient confirmed that she received Covid-19 vaccine on 10-APR-2021.  On APR-2021, for the first few days, she had severe fatigue, muscle pain, joint pain and pretty severe GI issues. This went on for 3 months, not 3 days.  It also caused a spike in cold agglutinins, which is an autoimmune response. The only other time they did appear was when she had the flu 2 years ago.  Laboratory data (dates unspecified) included: Cold agglutinins (NR: not provided) Increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from GI issues, joint pain, fatigue, and muscle pain on JUL-2021, and the outcome of spike cold agglutinins and autoimmune response was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211053826-covid-19 vaccine ad26.cov2.s -Autoimmune response. 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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Myalgia
Clinical narrative: Spike cold agglutinins; AUTOIMMUNE RESPONSE; GI issues; Joint pain; Fatigue; Muscle pain; This spontaneous report received from a patient concerned a 74 year old female of unspecified race and ethnicity. Initial information was processed along with the additional information received on 28-OCT-2021. The patient's height, and weight were not reported. The patient's past medical history included: flu. 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 administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The patient confirmed that she received Covid-19 vaccine on 10-APR-2021.  On APR-2021, for the first few days, she had severe fatigue, muscle pain, joint pain and pretty severe GI issues. This went on for 3 months, not 3 days.  It also caused a spike in cold agglutinins, which is an autoimmune response. The only other time they did appear was when she had the flu 2 years ago.  Laboratory data (dates unspecified) included: Cold agglutinins (NR: not provided) Increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from GI issues, joint pain, fatigue, and muscle pain on JUL-2021, and the outcome of spike cold agglutinins and autoimmune response was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211053826-covid-19 vaccine ad26.cov2.s -Autoimmune response. 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: Fatigue, Pain
Clinical narrative: A LOT OF BODY ACHES; PRETTY TIRED; 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. 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 a lot of body aches, and pretty tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a lot of body aches and pretty tired was not reported. This report was non-serious. This case, from the same reporter is linked to 20211055357.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE REACTION; 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) 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 adverse reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reaction was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Adverse event, Laboratory test, Ultrasound scan, Vasodilatation, Vein disorder
Clinical narrative: VEIN ISSUE; VEIN SWELL; HAD REACTION; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight was 155 pounds, and height was 63 inches. The patient's past medical history included: lack of effect, pain, and hallucination, and concurrent conditions included: shrimp allergy, certain grass allergy, dust allergy, dog dander allergy, non alcoholic, non smoker, psoriatic arthritis, and histamine allergy, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient was previously treated with golimumab; and experienced drug allergy when treated with clarithromycin, prochlorperazine edisylate, and risankizumab. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A ZOZA21A or Z0ZA21A, expiry: UNKNOWN) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. Non-company suspect drugs included: tofacitinib citrate ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. Concomitant medications included guselkumab for psoriatic arthritis. On SEP-2021, the patient experienced vein issue. On SEP-2021, the patient experienced vein swell. On SEP-2021, the patient experienced had reaction. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) inconclusive, backwash stuff, and Laboratory test (NR: not provided) inconclusive, backwash stuff. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with tofacitinib citrate was withdrawn. The patient was recovering from vein issue, vein swell, and had reaction. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Sinus headache
Clinical narrative: KNOCKED ME FLAT; ANNOYING SINUS HEADACHE; ANEMIC LOW ENERGY FEELING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: anemic low energy feeling. 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. 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 knocked me flat, annoying sinus headache, and anemic low energy feeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the knocked me flat, annoying sinus headache and anemic low energy feeling was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Hyperhidrosis, Illness
Clinical narrative: SWEATS; COVID SYMPTOMS; ABSOLUTELY WRECKED; MENTAL FOGGINESS; UNABLE TO RESUME NORMAL PHYSICAL ACTIVITY; BARELY ABLE TO STAY AWAKE/GROGGINESS; COULD NOT WORK; COULD NOT DRIVE; FATIGUE/EXHAUSTED/TIREDNESS; NO ENERGY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: UNKNOWN) dose was not reported, administered on 06-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On OCT-2021, the patient experienced mental fogginess. On OCT-2021, the patient experienced unable to resume normal physical activity. On OCT-2021, the patient experienced barely able to stay awake/grogginess. On OCT-2021, the patient experienced could not work. On OCT-2021, the patient experienced could not drive. On OCT-2021, the patient experienced fatigue/exhausted/tiredness. On OCT-2021, the patient experienced no energy. On 06-OCT-2021, the patient experienced absolutely wrecked. On 07-OCT-2021, the patient experienced covid symptoms. On 07-OCT-2021, the patient experienced sweats. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sweats, had not recovered from covid symptoms, mental fogginess, fatigue/exhausted/tiredness, unable to resume normal physical activity, no energy, barely able to stay awake/grogginess, could not work, and could not drive, and the outcome of absolutely wrecked was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Impaired driving ability, Impaired work ability, Loss of personal independence in daily activities, SARS-CoV-2 test, Somnolence
Clinical narrative: SWEATS; COVID SYMPTOMS; ABSOLUTELY WRECKED; MENTAL FOGGINESS; UNABLE TO RESUME NORMAL PHYSICAL ACTIVITY; BARELY ABLE TO STAY AWAKE/GROGGINESS; COULD NOT WORK; COULD NOT DRIVE; FATIGUE/EXHAUSTED/TIREDNESS; NO ENERGY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: UNKNOWN) dose was not reported, administered on 06-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On OCT-2021, the patient experienced mental fogginess. On OCT-2021, the patient experienced unable to resume normal physical activity. On OCT-2021, the patient experienced barely able to stay awake/grogginess. On OCT-2021, the patient experienced could not work. On OCT-2021, the patient experienced could not drive. On OCT-2021, the patient experienced fatigue/exhausted/tiredness. On OCT-2021, the patient experienced no energy. On 06-OCT-2021, the patient experienced absolutely wrecked. On 07-OCT-2021, the patient experienced covid symptoms. On 07-OCT-2021, the patient experienced sweats. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sweats, had not recovered from covid symptoms, mental fogginess, fatigue/exhausted/tiredness, unable to resume normal physical activity, no energy, barely able to stay awake/grogginess, could not work, and could not drive, and the outcome of absolutely wrecked was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SWEATS; COVID SYMPTOMS; ABSOLUTELY WRECKED; MENTAL FOGGINESS; UNABLE TO RESUME NORMAL PHYSICAL ACTIVITY; BARELY ABLE TO STAY AWAKE/GROGGINESS; COULD NOT WORK; COULD NOT DRIVE; FATIGUE/EXHAUSTED/TIREDNESS; NO ENERGY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: UNKNOWN) dose was not reported, administered on 06-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On OCT-2021, the patient experienced mental fogginess. On OCT-2021, the patient experienced unable to resume normal physical activity. On OCT-2021, the patient experienced barely able to stay awake/grogginess. On OCT-2021, the patient experienced could not work. On OCT-2021, the patient experienced could not drive. On OCT-2021, the patient experienced fatigue/exhausted/tiredness. On OCT-2021, the patient experienced no energy. On 06-OCT-2021, the patient experienced absolutely wrecked. On 07-OCT-2021, the patient experienced covid symptoms. On 07-OCT-2021, the patient experienced sweats. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sweats, had not recovered from covid symptoms, mental fogginess, fatigue/exhausted/tiredness, unable to resume normal physical activity, no energy, barely able to stay awake/grogginess, could not work, and could not drive, and the outcome of absolutely wrecked was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypersomnia
Clinical narrative: A ZOMBIE FOR 10 HOUR WORK DAY; SLEPT A LOT THAT WHOLE WEEKEND; 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, 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 a zombie for 10 hour work day, and slept a lot that whole weekend. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a zombie for 10 hour work day and slept a lot that whole weekend was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death, Injury
Clinical narrative: DEATH; SEVERELY INJURED; This spontaneous report received from a consumer concerned multiple patients with unspecified age, gender, 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 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. 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 multiple patients had died and were severely injured as a direct result of vaccine. The cause of death was unknown. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severely injured was not reported. This report was serious (Death).; Sender's Comments: V0: 20211057445-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Antibody test abnormal
Clinical narrative: ANTIBODY LEVEL DETECTED AT LOW LEVEL; 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. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-SEP-2021, the patient experienced antibody level detected at low level. Laboratory data included: Antibody test (NR: not provided) low level. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of antibody level detected at low level was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Illness, Pyrexia
Clinical narrative: SICK TWICE; 102 FEVER; This spontaneous report received from a consumer concerned a 40 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 15-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 27-OCT-2021, the patient experienced 102 fever. Laboratory data included: Body temperature (NR: not provided) 102 F. On an unspecified date, the patient experienced sick twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick twice and 102 fever was not reported. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Erythema, Peripheral swelling, Skin discolouration, Vaccination site pain
Clinical narrative: BRUISE ON HIS RIGHT UPPER ARM; LOOKED LIKE A PATCH OF RED BLOOD VESSELS, WHICH LOOKED LIKE RED THINGS UNDER HIS LEFT ARM; TURNED BLACK AND BLUE AFTER 1 WEEK LIKE  PUNCHED THERE; PAIN AT THE VACCINE SITE FOR A LONG TIME( 2 WEEKS); LEFT ARM WAS SWOLLEN FOR 2 WEEKS WITH AN ABNORMAL SHAPE; This spontaneous report received from a consumer concerned a 40 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: 004A21A expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the patient experienced left arm was swollen for 2 weeks with an abnormal shape. On 27-MAY-2021, the patient experienced pain at the vaccine site for a long time. On OCT-2021, the patient experienced turned black and blue after 1 week like punched there. On 09-OCT-2021, the patient experienced bruise on his right upper arm. On 09-OCT-2021, the patient experienced looked like a patch of red blood vessels, which looked like red things under his left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left arm was swollen for 2 weeks with an abnormal shape, and pain at the vaccine site for a long time on JUN-2021, and was recovering from bruise on his right upper arm, turned black and blue after 1 week like punched there, and looked like a patch of red blood vessels, which looked like red things under his left arm. This report was non-serious. This case, from the same reporter is linked to 20210555169.
Sex: U
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: TINGLING IN THE HANDS AND FEET LIKE A NEUROPATHY; This spontaneous report received from a consumer concerned a patient 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 not reported, batch number: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  The consumer reported that on an unspecified date, the patient experienced tingling in the hands and feet like a neuropathy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tingling in the hands and feet like a neuropathy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211058394- Covid-19 vaccine ad26.cov2.s-tingling in the hands and feet like a neuropathy. 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.