chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vision blurred, Visual impairment
Clinical narrative: being dizzy; problem with seeing, my eyes are blurry and all of sudden when I look up all I see is stars; problem with seeing, my eyes are blurry and all of sudden when I look up all I see is stars; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number, unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "being dizzy"; VISION BLURRED (non-serious), VISUAL IMPAIRMENT (non-serious), outcome "unknown" and all described as "problem with seeing, my eyes are blurry and all of sudden when I look up all I see is stars".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Seasonal allergy
Clinical narrative: seasonal allergies; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for covid-19 immunization. The following information was reported: SEASONAL ALLERGY (non-serious), outcome "unknown", described as "seasonal allergies". Therapeutic measures were taken as a result of seasonal allergy.  Additional information: Caller (name) called in today and said Yesterday morning she received the 2nd dose of Covid-19 Vaccine. But then she was experiencing seasonal allergies and because of that she took Dayquil Medicine that has a tylenol in it. She wanted to know if that was okay or if that medicine will interfere with Covid-19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever at 100.2 degrees F; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0150) via an unspecified route of administration in the arm left on 02Apr2021 at 18:15 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were reported as N/A. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 12:00, the patient had pretty much every symptom except diarrhea (adverse event nos) for 5 days. The patient received approximately 800mg ibuprofen when symptoms occur and would subside. But would continually come back including fever at 100.2 degrees f. After the 5th day, the patient had third episode of fever. Even after 5 days, it seemed that it would not go away. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with ibuprofen 800mg (MANUFACTURER UNKNOWN). The clinical outcome of the event fever was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: deleted event Adverse event NOS and Lab data updated for Body temperature.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: had knee and hip replacement; had knee and hip replacement; This is a spontaneous report received from a contactable Consumer or other non HCP (patient) for a Pfizer sponsored program.  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) "around Feb2021 or Mar2021" as single dose for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing), notes: just had knee and hip replacement for his arthritis. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose, Lot # unknown), for COVID-19 immunization. The following information was reported: ARTHRITIS (medically significant), ARTHRITIS (medically significant), outcome "unknown" and all described as "had knee and hip replacement".  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Chills; Body aches; Sore at site of injection; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04May2021 at 16:45 (at the age of 46-years-old), as DOSE 2, SINGLE for COVID-19 immunisation. Medical history was reported as none (reported as none known). The patient had latex sensitivity. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), taken from an unknown date for an unspecified indication. The patient previously received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Apr2021 at 14:15 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05May2021 at 08:45, the patient experienced fever (100.6), chills, body aches and soreness at the site of injection. Therapeutic measures were not taken as a result of pyrexia, chills, pain, vaccination site pain. The clinical outcome of the events fever (100.6), chills, body aches and soreness at the site of injection was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: amended narrative to reflect the treatment received information for all the events as "No".
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Pyrexia
Clinical narrative: Fever of about 102 degrees for about 24 hours; Pain in the armpit close to the injection site; This is a spontaneous report from a contactable consumer. A 66-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the arm left on an unknown date (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was unknown. It was unknown if the patient had any known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unspecified date. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, it was unknown if the patient had not been tested for COVID-19. On an unknown date in May2021, the patient experienced a fever of about 102 degrees for about 24 hours, and pain in the armpit close to the injection site. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the events fever of about 102 degrees for about 24 hours, and pain in the armpit close to the injection site was recovered on an unknown date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Amendment: This follow-up report is being submitted to amend previous information: Patient's city, state added in patient tab, vaccine Start Date/Time and Stop Date/Time, AE Stop Date/Time removed as not reported, relevant information updated in narrative, final sentence updated from "The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up" to "No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected".
Sex: F
Vaccine: FLUX
Symptoms: Dementia, Nasopharyngitis
Clinical narrative: dementia; cold; Initial information received on 06-Dec-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional via digital media under reference number US-SA-SAC20211210001289.  This case involves adult female patient who experienced dementia and cold (nasopharyngitis), after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious dementia (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  On an unknown date the patient developed a non-serious cold (nasopharyngitis) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the outcome of events was unknown.  There will be no information available on batch number for this case.; Sender's Comments: This case involves adult female patient who experienced dementia and nasopharyngitis after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is not known for all the events. However, patient's medical condition at time of vaccination, Lab data and other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the individual vaccines cannot be assessed.
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: allergy reaction; Initial information was regarding an unsolicited valid non serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00886495) and transmitted to Sanofi on 06-Dec-2021.  This case involves a one-years-old male patient who experienced allergy reaction (hypersensitivity), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7336NA, expiry date unknown) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious allergy reaction (hypersensitivity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.
Sex: M
Vaccine: FLU4
Symptoms: Medication error, Product storage error
Clinical narrative: This case was linked to case 2021SA412569 (CLUSTER). This case involves a 4-year-old male patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] exposed to the negative 7.8 degree Celsius over a period of 40 minutes and given to two patients after the excursion (product storage error). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 06-Dec-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (Frequency: once, lot UT7378KA, expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error due to product storage error (latency: same day). At time of reporting, no adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: This case involves a female pregnant patient of an unknown age who was exposed to vaccines DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and was supposed to get DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (wrong product administered) and (exposure during pregnancy). Data regarding this pregnancy were received prospectively. Patient was exposed to the vaccine at unknown gestation period. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. It was an actual medication error due to wrong vaccine administered and vaccine exposure during pregnancy (same day). At the time of reporting, no adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Adverse reaction, Loss of personal independence in daily activities, Pain in extremity, Sleep disorder
Clinical narrative: difficulty with his usual activities including working out, weight lifting, and chores around the house; pain in his right arm; Initial information regarding an unsolicited valid non-serious case was received from physician and consumer/non-health care professional via Agency (Reference number- 00888436) and transmitted to Sanofi on 07-Dec-2021.  This case involves 65-year-old male patient who experienced difficulty with his usual activities including working out, weightlifting, and chores around the house (loss of personal independence in daily activities) and pain in his right arm (pain in extremity) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 07-Oct-2021, the patient received 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number was not reported and expiry date: 2021/2022) (Frequency = once) via intramuscular route in the right arm for prophylactic vaccination.  On 07-OCT-2021 the patient developed a non-serious difficulty with his usual activities including working out, weightlifting, and chores around the house (loss of personal independence in daily activities) and pain in his right arm (pain in extremity) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "The caller reported adverse reactions since receiving the vaccine in October. The symptoms have improved but have not resolved. The caller would like to know if these reactions are normal and if we have any further information. He denied going to the Emergency Room. The caller reported that he cannot sleep on that side. The caller saw his primary care physician about 3 weeks ago. The physician informed the patient that the vaccine may have been inserted into a tendon or administered too deeply. The physician recommended that the patient wait to see if the symptoms improve over time. The caller noted that he has experienced some improvement in his symptoms, but that the pain is still impeding his daily life activities. No further information provided by the reporter".  No relevant laboratory data was provided.  The patient has used ice, Ibuprofen, and Diclofenac cream without relief.   At time of reporting, the outcome was resolving for the event pain in extremity and was not resolved for the event loss of personal independence in daily activities.  There will be no information available on the batch number for this case.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC13, RVX
Symptoms: Extra dose administered, No adverse event
Clinical narrative: child received PENTACEL as well as ACT-HIB on the same day, with no reproted adverse event; Initial information received on 08-Dec-2021 regarding an unsolicited valid non-serious case from nurse via Agency (under reference 00890410).  This case involves a 4 months old male patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and HIB (PRP/T) VACCINE [ACT-HIB] on the same day (extra dose administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient received PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) [lot number and expiration date were not reported] via unknown route in an unknown administration site for prophylactic vaccination as concomitant vaccines.  On 08-Dec-2021, the patient received 0.5 mL dose of suspect HIB (PRP/T) VACCINE (Oral solution, Lot: UJ425AA and expiration date: 21-May-2022) via intramuscular route in the left thigh and dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiration date: not reported) via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of an actual medication error due to extra dose administered (same day latency).  It was reported "Nurse calling to report that a 4 month old child received PENTACEL as well as ACT-HIB on the same day. Caller is asking what to do."  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for the suspect PENTACEL.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: not feeling well; This spontaneous case from was retrieved on 12-Nov-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1824719-1), reported by other non-health professional and concerned a patient of unreported age and gender.   The patient's medical history and concomitant medications were not reported.   On unspecified date, the patient was vaccinated with Influenza virus vaccine polyvalent (indication, dose, route of administration, anatomical location: not reported). The batch number was not reported.  On unspecified date, unknown amount of time after receiving Influenza virus vaccine patient was not feeling well (malaise).  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  Company comment: the event malaise was considered unassessable for the suspect product.; Sender's Comments: The event malaise was considered unassessable for the suspect product
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional side effects; Inadverently administered Proquad instead of M-M-R-II; This spontaneous report was received from an other health professional (clinical director) referring to a 42 year old patient. The patient's concurrent condition, pertinent medical history, drug reactions, allergies and concomitant medications were not provided.  On 30-NOV-2021, the patient was inadvertently administered with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant Human albumin (rHA) (PROQUAD) for prophylaxis (0.5 mL; strength, vaccination scheme, route of administration and anatomical location were not reported; lot number T032144 has been verified to be a valid lot number, expiration date was 20-MAR-2022) instead of Measles, mumps, and rubella virus vaccine live (M-M-R II) (wrong product administered). No additional side effects or product quality complaints were reported (no adverse event).
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Patient had no experienced any side effects; Vaccine given intramuscularly instead of subcutaneously; This spontaneous report was received from registered nurse referring to a 4 year old male patient of unknown gender. The information about patient's concurrent conditions, medical history, concomitant medications was not reported.   On 30-NOV-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA) or human serum albumin (HAS) (PROQUAD) 0.5 mL, intramuscularly for prophylaxis (incorrect route of product administration) (strength, vaccination scheme, anatomical location were not reported; lot number U002535 has been verified to be a valid lot number, expiration date was 24-JUL-2022). At the time, the patient had not experienced any adverse event (no adverse event). No product quality complaints (PQC) were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient supposed to received VARIVAX and MMR II but instead inadvertently received both VARIVAX and PROQUAD due to human error; No additional adverse events were reported; This spontaneous report was received from a nurse referring to a 12-month-old patient of an unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  The patient supposed to received varicella virus vaccine live (Oka/Merck) (VARIVAX) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis but instead inadvertently received both varicella virus vaccine live (Oka/Merck) (VARIVAX) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis due to human error (reported as today date unspecified) (wrong vaccine administered). No additional adverse events were reported (no adverse event).
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Neuropathy peripheral, Pain, Pain in extremity
Clinical narrative: Feels like neuropathy; Pain in arm that shoots down; Arm feels dead; This case was reported by a physician via call center representative and described the occurrence of neuropathy in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2021, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 12th November 2021, 1 days after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant), pain in arm and numbness of upper extremities. On an unknown date, the outcome of the neuropathy, pain in arm and numbness of upper extremities were not recovered/not resolved.   It was unknown if the reporter considered the neuropathy, pain in arm and numbness of upper extremities to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself, who was a health care professional (physician). The patient received his second dose of Shingrix in his right arm and started experiencing pain in his right arm that shoots down the arm beginning the day after the injection.  The patient stated that that the pain felt like neuropathy and his arm felt dead.  Till the time of reporting, this sensation and pain were still unresolved, four weeks following the injection. Reporter could not provide the lot and expiration date of the Shingrix vaccine. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID WHILE FULLY VACCINATED; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced covid while fully vaccinated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid while fully vaccinated was not reported. This report was non-serious. Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Impaired quality of life, Vertigo
Clinical narrative: HEARING LOSS IN RIGHT EAR; VERTIGO; POOR QUALITY OF LIFE DUE TO THE HEARING LOSS; This spontaneous report received from a patient concerned a young female of unspecified age, race and ethnicity . The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was in good health prior to the vaccine administered. The patient received covid-19 vaccine ad26.cov2.s (Janssen, dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported,1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced hearing loss in right ear, vertigo, and poor quality of life due to the hearing loss. It was reported that the hearing tests/evaluation was ongoing and the outcome was unknown at the time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hearing loss in right ear, vertigo and poor quality of life due to the hearing loss was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211229639-COVID-19 VACCINE AD26.COV2.S-Hearing loss in right ear. 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood glucose increased, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID-19 INFECTION; BLOOD SUGAR HIGH; This spontaneous report received from a patient concerned a 48 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic, hypertension, non alcohol user, and non smoker. The patient had no known drug allergies. and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on JUN-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-DEC-2021, the patient felt sick and went to hospital. The patient visited emergency room. She underwent covid-19 test and was discharged home on the same day and told to quarantine. Her blood sugar level was also high (over 500). On 11-DEC-2021, the patient received phone call from the hospital, that confirming her test result was positive (confirmed covid-19 infection and confirmed clinical vaccination failure). The patient stated she was at home, self-quarantined. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccine failure and blood sugar high was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0:20211231022-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical 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: Death, Thrombosis
Clinical narrative: DIED; BLOOD CLOTS; This spontaneous report received from a consumer via social media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: surgery, and other pre-existing medical conditions included: The patient was very healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown and expiry: unknown) dose, start therapy date were not reported 1 total, dose number series 1, 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 blood clots. The patient died from unknown cause of death one day after he was forced to take the vaccine. According to reporter patient was very anti vaccine and very healthy. He was there in a rehab from a surgery. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0:20211232634- covid-19 vaccine ad26.cov2.s- Died, Blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATHS; This spontaneous report received from a patient concerned 1,539 patients of unspecified age, sex, race and ethnicity. No past medical histories or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch numbers were not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified dates, 1,539 patients died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211233258- JANSSEN COVID-19 VACCINE Ad26.COV2.S. Deaths. 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
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Influenza like illness, Migraine, Pain
Clinical narrative: FLU-LIKE SYMPTOMS; VERTIGO; MIGRAINE HEADACHE; BLURRED VISION; ACHY; JOINT PAIN (COULD NOT MOVE  AROUND, FELT LIKE MAGNIFIED ARTHRITIS THAT AFFECTED EVERY JOINT); HOT AND COLD CHILLS; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was in quarantine at a hotel in December 2020. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 04-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On NOV-2021, the patient experienced flu-like symptoms. On NOV-2021, the patient experienced vertigo. On NOV-2021, the patient experienced migraine headache. On NOV-2021, the patient experienced blurred vision. On NOV-2021, the patient experienced achy. On NOV-2021, the patient experienced joint pain (could not move around, felt like magnified arthritis that affected every joint). On NOV-2021, the patient experienced hot and cold chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, vertigo, and joint pain (could not move around, felt like magnified arthritis that affected every joint), and the outcome of migraine headache, blurred vision, achy and hot and cold chills was not reported. This report was non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo, Vision blurred
Clinical narrative: FLU-LIKE SYMPTOMS; VERTIGO; MIGRAINE HEADACHE; BLURRED VISION; ACHY; JOINT PAIN (COULD NOT MOVE  AROUND, FELT LIKE MAGNIFIED ARTHRITIS THAT AFFECTED EVERY JOINT); HOT AND COLD CHILLS; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was in quarantine at a hotel in December 2020. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 04-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On NOV-2021, the patient experienced flu-like symptoms. On NOV-2021, the patient experienced vertigo. On NOV-2021, the patient experienced migraine headache. On NOV-2021, the patient experienced blurred vision. On NOV-2021, the patient experienced achy. On NOV-2021, the patient experienced joint pain (could not move around, felt like magnified arthritis that affected every joint). On NOV-2021, the patient experienced hot and cold chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, vertigo, and joint pain (could not move around, felt like magnified arthritis that affected every joint), and the outcome of migraine headache, blurred vision, achy and hot and cold chills was not reported. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Maternal exposure during breast feeding, Pyrexia
Clinical narrative: Swollen bottom lip, swelling started the next morning after and lasted all day, went down by the next day. Ever since then I get a swollen lip or eye every time I take Advil. I believe I have developed an Advil allergy, which I took ibuprofen after taking my shot to manage fever. I was menstruating when I took the shot and was also nursing at the time.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Headache
Clinical narrative: I have no way to know if it's from the vaccine, but it seems like it started shortly after receiving the second booster.  My heart constantly feels like it is fluttering. It's probably not 24/7, but for instance, this morning I noticed it before I even got out of bed. I felt like this was worth reporting since I didn't have it following the first two shots. I would really like to know if it is a common side effect and if it should eventually subside. I've had a pretty consistent headache, but I'm pretty sure that is common with the booster.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: shingles; rash; postherpetic neuralgia.; This case was reported by a nurse via sales rep and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles, rash and post herpetic neuralgia. On an unknown date, the outcome of the shingles, rash and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the shingles, rash and post herpetic neuralgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received first dose of Shingrix and experienced shingles, rash followed by post herpetic neuralgia. The reporter did not consent to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: cold sore outbreak; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cold sores (patient had medical condition history of cold sore breakouts).   On 7th December 2021 16:00, the patient received the 1st dose of Shingrix. On 7th December 2021 20:00, 4 hrs after receiving Shingrix, the patient experienced cold sores. The patient was treated with valaciclovir (Valacyclovir Oral Tablet). On an unknown date, the outcome of the cold sores was unknown.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional details were reported as follows: The reporter was the concerned patient. The patient received Shingrix at around 4 pm. The patient did not have the lot number or expiration date as he indicated he did not have paperwork from the pharmacy. The injection was given in his upper arm (unspecified right versus left) but he did not know for sure if it was given intramuscularly. He provided his pharmacy's contact information which should have the lot number expiration date and route on file. About 4 to 5 hours after vaccination, at around 8 pm, he got a cold sore break out. He had a pre-existing medical history of having prior cold sore breakouts for which he normally uses Valacylovir pills. He normally takes 2 pills every 12 hours for a cold sore outbreak. He had taken the first 2 pills and was calling to see if there was a drug interaction between Shingrix and Valacyclovir to make his decision about whether (or not) to take the second two Valacylovir pills. The reporter did not consent to follow-up. The reporter did not want to provide his doctor's contact information.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Feeling abnormal, Visual impairment
Clinical narrative: NEARLY DIED; NEARLY BLIND; HEART ISSUES; This spontaneous report received from a consumer via a company representative concerned a 40 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch numbers were not reported. The Company was unable to perform follow-up to request batch/lot numbers.  On an unspecified date, the patient experienced nearly died, nearly blind, and heart issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nearly died, heart issues and nearly blind was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Autonomic nervous system imbalance, Disability, Dysstasia, Dystonia
Clinical narrative: NEUROPATHY; ENCEPHALOPATHY; DYSTONIA; DISABLED; DYSAUTONOMIA; ANXIETY; UNABLE TO WORK; BLURRED VISION; COULD NOT STAND UP; COULD NOT LIFT HER ARMS; HEADACHE; 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 (Janssen series 1) (suspension for injection, route of admin, and batch number unknown, expiry 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 unknown date, within 24 hours of receiving vaccination, patient experienced numbness and tingling, headache, blurred vision, and could not stand up. The patient went to emergency room and was told that it was a vaccine adverse reaction. The patient could not able to lift arms, had twitches and tremors. Despite all of the severe symptoms, the patient was dismissed and informed that she had anxiety. The patient was advised to have a neurologist, but that examination would take two months. The patient had visited physician's office. Eventually the patient was diagnosed with neuropathy, encephalopathy, dystonia and dysautonomia. It was reported that after two months, the patient was disabled and unable to work.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anxiety, neuropathy, encephalopathy, dystonia, dysautonomia, disabled, unable to work, headache, blurred vision, could not stand up, and could not lift her arms. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211225584-covid-19 vaccine ad26.cov2.s- neuropathy, encephalopathy, dystonia, disabled. 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: Encephalopathy, Headache, Impaired work ability, Muscular weakness, Neuropathy peripheral
Clinical narrative: NEUROPATHY; ENCEPHALOPATHY; DYSTONIA; DISABLED; DYSAUTONOMIA; ANXIETY; UNABLE TO WORK; BLURRED VISION; COULD NOT STAND UP; COULD NOT LIFT HER ARMS; HEADACHE; 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 (Janssen series 1) (suspension for injection, route of admin, and batch number unknown, expiry 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 unknown date, within 24 hours of receiving vaccination, patient experienced numbness and tingling, headache, blurred vision, and could not stand up. The patient went to emergency room and was told that it was a vaccine adverse reaction. The patient could not able to lift arms, had twitches and tremors. Despite all of the severe symptoms, the patient was dismissed and informed that she had anxiety. The patient was advised to have a neurologist, but that examination would take two months. The patient had visited physician's office. Eventually the patient was diagnosed with neuropathy, encephalopathy, dystonia and dysautonomia. It was reported that after two months, the patient was disabled and unable to work.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anxiety, neuropathy, encephalopathy, dystonia, dysautonomia, disabled, unable to work, headache, blurred vision, could not stand up, and could not lift her arms. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211225584-covid-19 vaccine ad26.cov2.s- neuropathy, encephalopathy, dystonia, disabled. 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).