chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; developed shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter personally knew the patient, who received Shingles vaccine and developed shingles. The reporter stated that, it was not a vaccination if it did not prevent, it was only another money-making shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.    This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR265683:Same reporter US-GLAXOSMITHKLINE-US2021AMR265682:Same reporter US-GLAXOSMITHKLINE-US2021AMR265681:Same reporter US-GLAXOSMITHKLINE-US2021AMR265684:Same reporter US-GLAXOSMITHKLINE-US2021AMR265680:Same reporter US-GLAXOSMITHKLINE-US2021AMR265649:Same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Decreased interest, Headache, Herpes zoster, Pain
Clinical narrative: Suspected vaccination failure; have them now; ZERO energy; headaches; bodyaches; no interest in doing absolutely anything; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, loss of energy, headache, general body pain and loss of interest. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, loss of energy, headache, general body pain and loss of interest were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, loss of energy, headache, general body pain and loss of interest to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received 2 doses of Shingles vaccine 2 years ago from the date of reporting. After receiving Shingles vaccine, the patient was diagnosed with shingles 3 weeks ago from the date of reporting. The patient had zero energy, headaches and body aches, and no interest in doing absolutely anything.  It really stinks him/her. Till the time of the reporting, the patient still had all the adverse events. The patient stated that, might be he/she would feel a lot worse if I did not have them. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation was not provided. This case had been linked with case US2019175353, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019175353:Possible same reporter/patient
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected vaccination failure; have them now; ZERO energy; headaches; bodyaches; no interest in doing absolutely anything; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, loss of energy, headache, general body pain and loss of interest. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, loss of energy, headache, general body pain and loss of interest were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, loss of energy, headache, general body pain and loss of interest to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received 2 doses of Shingles vaccine 2 years ago from the date of reporting. After receiving Shingles vaccine, the patient was diagnosed with shingles 3 weeks ago from the date of reporting. The patient had zero energy, headaches and body aches, and no interest in doing absolutely anything.  It really stinks him/her. Till the time of the reporting, the patient still had all the adverse events. The patient stated that, might be he/she would feel a lot worse if I did not have them. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation was not provided. This case had been linked with case US2019175353, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019175353:Possible same reporter/patient
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose of shingrix on april 2020 / 1st dose on 2018; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2018).   In April 2020, the patient received the 2nd dose of Shingrix. In April 2020, 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 age at vaccination was not reported The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 84.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles in his back / under his left arm and on the front of his chest; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   The patient's past medical history included chickenpox (had chickenpox at 12 years of age).   On 6th December 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg and Boostrix (intramuscular). In December 2021, between 1 and 2 weeks after receiving Shingrix and Boostrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix and Boostrix.  Additional details were provided as follows: The patient had chickenpox when he was 12 years old. The patient received a dose of 50 ug of Shingrix and about 1 to 1 and 1/2 weeks after Shingrix vaccine, the patient had developed shingles in the center of his back, along the left side of his back, under his left arm and on the front of his chest which has not resolved yet. The patient reported that he also received a Boostrix vaccine on the same day as the Shingrix.  The patient did not knew in which arm received the Shingrix and in which arm received the Boostrix. The patient could not provide the lot or expiration date of the Shingrix or the Boostrix. The caller gave consent to contact his health care professional. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had SHINGRIX dose one over a year ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over an year ago, from the day of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter wanted additional guidance on whether to administer dose 2 or restart the series.  The patient did not have exact date of first dose but noted it was over a year ago.  Provided Healthcare professionals information per content on Centre for disease control and prevention recommendations to take second dose as soon as possible.  The reporter asked if there was any additional info, warm transferred to Medical Information for further assistance.  The reporter did not consent to follow-up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 1stdose in 2018, 2nd dose this past weekend; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   In December 2021, the patient received the 2nd dose of Shingrix. In December 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 reported as follows: The reporter was the concerned patient. The patient received her second dose this past weekend of reporting day in December 2021, which led to lengthening of vaccination schedule. The patient had nothing else to report.
Age: 52.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in OCT 2019, 2nd dose in 2020, and 3rd dose in 2021; 1st dose in OCT 2019, 2nd dose in 2020, and 3rd dose in 2021; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 52-year-old male patient who received HAB (Twinrix) 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, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose of Twinrix suspension for injection in prefilled syringe was received in October 2019).   In November 2020, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. In December 2021, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. In November 2020, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. In December 2021, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long and drug dose administration interval too long were 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 reporter was the patient.  The patient received his first dose of Twinrix in October 2019, second dose in November 2020 and third dose in December 2021.  The patient received 2nd and 3rd dose which led to lengthening of vaccination schedule. The patient received all 3 doses at the same pharmacy.  The reporter did not consent to followup.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong technique in product usage process
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of wrong technique in product usage process in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number C43KM, expiry date 10th April 2023) for prophylaxis. On 29th December 2021 07:14, the patient received Shingrix. On 29th December 2021, unknown after receiving Shingrix, the patient experienced wrong technique in product usage process. On an unknown date, the outcome of the wrong technique in product usage process was unknown. Additional details were provided as follows: The healthcare professional reported administration of Shingrix to the patient after reconstitution on 28th December 2021, stored in refrigerator overnight and accidentally administered at morning of reporting date, which led to wrong technique in product usage process. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Dizziness, Initial insomnia, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of trouble falling asleep in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 27th December 2021, the patient received the 2nd dose of Shingrix. In December 2021, less than a week after receiving Shingrix, the patient experienced trouble falling asleep, appetite absent, fever, dizziness and nausea. On an unknown date, the outcome of the trouble falling asleep, appetite absent, fever, dizziness and nausea were not recovered/not resolved. It was unknown if the reporter considered the trouble falling asleep, appetite absent, fever, dizziness and nausea to be related to Shingrix. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported that he was experiencing nausea, dizziness, fever, no appetite, and cannot fall asleep. Moreover, the patient reported that his healthcare professional was in the process of calling a prescription for sleep aid. The symptoms were on going and had not resolved. Very limited information was provided. The patient was rushing, and he was being rushed by his family member as well to disconnect the call. Due to the reporter rushing to disconnect the call, could not get details information and a consent to follow-up with healthcare professional. Therefore, healthcare professional contact information was not collected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first in November 2019, second July of 2021; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019).   In July 2021, the patient received the 2nd dose of Shingrix. In July 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 the patient. The patient received 2nd dose of Shingrix later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter stated her healthcare provider told her she should receive a third dose due to the timing between the first two doses.The reporter inquired if there was a third dose recommended and if her insurance would pay for it.  The reporter consented to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles belt; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 7742Z, expiry date 25th March 2023) for prophylaxis.   On 15th October 2021, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of Shingrix, a couple days after that experienced shingles belt for a couple weeks.  The patient completely recovered from the  shingles belt. The reporter consented to follow up.
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 61 years old received bexsero; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 61-year-old male patient who received Men B NVS (Bexsero) 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 an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 reported. The patient received dose of Bexsero at the age of 61 years old, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose two years ago, not yet received 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago, 50 microgram).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient's husband. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received HBV (Engerix B pediatric) (batch number 77B59, expiry date 30th September 2021) for prophylaxis.   On 29th December 2021, the patient received Engerix B pediatric (intramuscular). On 29th December 2021, unknown after receiving Engerix B pediatric, 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 age at vaccination was not reported. The patient received Engerix B pediatric in left arm. The patient inadvertently received expired dose of 10mcg Engerix-B, which led to expired vaccine used.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female. Initial information processed with additional information received from a regulatory authority on 28-DEC-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A and expiry: UNKNOWN), dose was not reported, dose series in number was 1, administered 1 in total on 06-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. The patient also received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: UNKNOWN) dose was not reported, dose number in series was 2, 1 in total, administered to left arm on 10-DEC-2021 for prophylactic vaccination. On 19-DEC-2021, the patient experienced cough, chills and low grade fever. on the same day the patient went to get tested by Polymerase chain reaction (PCR) and found positive which was confirmed clinical vaccination failure and confirmed covid-19 infection (dose number in series was 1). Laboratory data included: Polymerase chain reaction (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000208077. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20211247358-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Cardiac disorder, Cerebrovascular accident, Death, Heart rate irregular
Clinical narrative: DEATH; STROKE; VACCINE WEAKENED THE HEART/HEART INFLAMED; HEARTBEATS IRREGULAR; TINY TUMORS; LOSING MEMORY SLOWLY; This spontaneous report received from a consumer via social media through company representative concerned a female of unspecified age race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown expiry : unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination (Dose number in series 1). 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 had tiny tumors appear, and started losing her memory slowly, and soon after had a stroke. The reporter stated that the vaccine weakened the patient's heart and the heart inflamed which led to an irregular heartbeat. On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and had not recovered from tiny tumors, losing memory slowly, stroke, heartbeats irregular, and vaccine weakened the heart/heart inflamed. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20211258139, 20211263643 and 20211263721.; Sender's Comments: V0: 20211256750-covid-19 vaccine ad26.cov2.s-Death, stroke. 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: F
Vaccine: COVID19
Symptoms: Neoplasm
Clinical narrative: DEATH; STROKE; VACCINE WEAKENED THE HEART/HEART INFLAMED; HEARTBEATS IRREGULAR; TINY TUMORS; LOSING MEMORY SLOWLY; This spontaneous report received from a consumer via social media through company representative concerned a female of unspecified age race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown expiry : unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination (Dose number in series 1). 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 had tiny tumors appear, and started losing her memory slowly, and soon after had a stroke. The reporter stated that the vaccine weakened the patient's heart and the heart inflamed which led to an irregular heartbeat. On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and had not recovered from tiny tumors, losing memory slowly, stroke, heartbeats irregular, and vaccine weakened the heart/heart inflamed. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20211258139, 20211263643 and 20211263721.; Sender's Comments: V0: 20211256750-covid-19 vaccine ad26.cov2.s-Death, stroke. 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
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Inappropriate schedule of product administration, Off label use, Syncope, Urinary incontinence
Clinical narrative: FAINTED; BROKE OUT INTO COLD SWEAT; URINATED MYSELF; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 29 year old male. The patient's height and weight were not reported. The patient's concurrent conditions included: drug allergy (drug type not reported). The patient had no medical history and concurrent conditions. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not on any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 and since the vaccination the patient had not tested for COVID-19. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number not reported, dose number 1) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN, dose number 2) dose was not reported, 1 total, administered on 17-MAR-2021 18:00 on left arm for prophylactic vaccination which was an off label use and the second dose was an inappropriate schedule of vaccine administered (dose number in series 1).  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label use and inappropriate schedule of vaccine administered was not reported. Non-company suspect vaccine included: BNT 162 (Dose number in series 2) (batch number: FH8027,form of admin and route of admin were not reported) dose was not reported, administered on 21-DEC-2021 14:00 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 22-DEC-2021 at 11:30 AM, the patient experienced broke out into cold sweat, fainted and urinated myself in barbers chair while getting a haircut (Dose number in series was 2).  The action taken with BNT 162 was not applicable. The patient was recovering from broke out into cold sweat, fainted, and urinated myself. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20211259337-covid-19 vaccine ad26.cov2.s-Fainted. 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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Body temperature, Chills, Diarrhoea, Headache
Clinical narrative: HARD TIME THINKING; BURNING IN THE ARM; FAST HEART RATE AROUND 120-130  BPM; SENSITIVITY TO LIGHT; BODY ACHES; CHILLS; DIARRHEA; HEADACHE (HEAD KILLING HER); FEVER OF 103F; NAUSEA; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, social drinker, penicillin allergy, iodine allergy, and drug allergy (Erythromycin Zoloft). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, expiry: 09-APR-2022) dose was not reported, 1 total, administered on 27-DEC-2021 at around 12:30 PM on left arm for prophylactic vaccination (Dose number in series 1). Concomitant medications included acetylsalicylic acid.  On 27-DEC-2021, the patient experienced burning in the arm after the shot, patient took Benadryl because she was scared. Around at 19:00-20:00 patient started having symptoms of body aches, chills and fever 103 F (Fahrenheit), nausea, diarrhea, patient's watch recorded heart rate around 120-130 BPM (beats per minute) and her head was killing. The symptoms were getting worse until 02:30 or 03.00 in the morning. Her fever broke 100.9 F after she took Tylenol 500 mg (milligram). But at the time of reporting she was still experiencing headache (head killing her) and sensitivity to light. Tylenol was not helping her headache. Later at the time of reporting she reported that she had a hard time thinking. She called her doctor but haven't heard back from him. The patient had tested positive for ANA (Antinuclear antibodies) antibody. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever of 103f, had not recovered from headache (head killing her), sensitivity to light, and hard time thinking, and the outcome of burning in the arm, body aches, chills, diarrhea, fast heart rate around 120-130 bpm and nausea was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211260926-covid-19 vaccine ad26.cov2.s -Hard time thinking. 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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Mental impairment, Nausea, Pain
Clinical narrative: HARD TIME THINKING; BURNING IN THE ARM; FAST HEART RATE AROUND 120-130  BPM; SENSITIVITY TO LIGHT; BODY ACHES; CHILLS; DIARRHEA; HEADACHE (HEAD KILLING HER); FEVER OF 103F; NAUSEA; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, social drinker, penicillin allergy, iodine allergy, and drug allergy (Erythromycin Zoloft). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, expiry: 09-APR-2022) dose was not reported, 1 total, administered on 27-DEC-2021 at around 12:30 PM on left arm for prophylactic vaccination (Dose number in series 1). Concomitant medications included acetylsalicylic acid.  On 27-DEC-2021, the patient experienced burning in the arm after the shot, patient took Benadryl because she was scared. Around at 19:00-20:00 patient started having symptoms of body aches, chills and fever 103 F (Fahrenheit), nausea, diarrhea, patient's watch recorded heart rate around 120-130 BPM (beats per minute) and her head was killing. The symptoms were getting worse until 02:30 or 03.00 in the morning. Her fever broke 100.9 F after she took Tylenol 500 mg (milligram). But at the time of reporting she was still experiencing headache (head killing her) and sensitivity to light. Tylenol was not helping her headache. Later at the time of reporting she reported that she had a hard time thinking. She called her doctor but haven't heard back from him. The patient had tested positive for ANA (Antinuclear antibodies) antibody. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever of 103f, had not recovered from headache (head killing her), sensitivity to light, and hard time thinking, and the outcome of burning in the arm, body aches, chills, diarrhea, fast heart rate around 120-130 bpm and nausea was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211260926-covid-19 vaccine ad26.cov2.s -Hard time thinking. 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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Photosensitivity reaction, Pyrexia, Skin burning sensation
Clinical narrative: HARD TIME THINKING; BURNING IN THE ARM; FAST HEART RATE AROUND 120-130  BPM; SENSITIVITY TO LIGHT; BODY ACHES; CHILLS; DIARRHEA; HEADACHE (HEAD KILLING HER); FEVER OF 103F; NAUSEA; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, social drinker, penicillin allergy, iodine allergy, and drug allergy (Erythromycin Zoloft). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, expiry: 09-APR-2022) dose was not reported, 1 total, administered on 27-DEC-2021 at around 12:30 PM on left arm for prophylactic vaccination (Dose number in series 1). Concomitant medications included acetylsalicylic acid.  On 27-DEC-2021, the patient experienced burning in the arm after the shot, patient took Benadryl because she was scared. Around at 19:00-20:00 patient started having symptoms of body aches, chills and fever 103 F (Fahrenheit), nausea, diarrhea, patient's watch recorded heart rate around 120-130 BPM (beats per minute) and her head was killing. The symptoms were getting worse until 02:30 or 03.00 in the morning. Her fever broke 100.9 F after she took Tylenol 500 mg (milligram). But at the time of reporting she was still experiencing headache (head killing her) and sensitivity to light. Tylenol was not helping her headache. Later at the time of reporting she reported that she had a hard time thinking. She called her doctor but haven't heard back from him. The patient had tested positive for ANA (Antinuclear antibodies) antibody. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever of 103f, had not recovered from headache (head killing her), sensitivity to light, and hard time thinking, and the outcome of burning in the arm, body aches, chills, diarrhea, fast heart rate around 120-130 bpm and nausea was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211260926-covid-19 vaccine ad26.cov2.s -Hard time thinking. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19; SUSPECTED CLINICAL VACCINATION FAILURE; 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 (dose number in series: 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced death from covid-19 (suspected covid-19 and suspected clinical vaccination failure). On an unspecified date, Laboratory data included: COVID-19 virus test (NR: not provided) positive. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of suspected covid-19 on an unspecified date, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20211262948- Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.  V0: 20211262948- Covid-19 vaccine ad26.cov2.s- Suspected covid 19. 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: COVID-19
Sex: M
Vaccine: COVID19
Symptoms: Ischaemic stroke
Clinical narrative: STROKE; This spontaneous report received from a consumer via a company representative concerned a 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 (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 was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, as per the reporter "a friend is in rehab from a stroke due to a blood clot. He too JJ". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211263238-covid-19 vaccine ad26.cov2.s-stroke. 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).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: GOT COVID; This spontaneous report received from a patient via social media via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced got covid. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious. This report was associated with product quality complaint: 90000209424.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DROPPED DEAD; This spontaneous report received from a consumer via social media via a company representative 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, and batch number and expiry were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). 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 dropped dead from unknown cause. It was unspecified if an autopsy was performed. Reporter stated that, "It was more than my family who dropped dead. You got it wrong, people still dyeing fully vaccinated (contaminated) with the booster as well" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case is a duplicate of 20211263643. This case, from the same reporter is linked to 20211258139 and 20211256750.; Sender's Comments: V0-20211263721-COVID-19 VACCINE AD26.COV2.S-Dropped Dead . 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: DROPPED DEAD
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: DIZZY SPELLS; BAD HEADACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced dizzy spells, and bad headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizzy spells, and bad headaches. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, batch number and expiry were not reported) dose was not reported,1 total, dose number in series was 1, administered on OCT-2021 (The location of vaccination in which arm was unknown) 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. Patient experienced chest pain recently and felt bad. On DEC-2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive. the patient had confirmed covid-19 infection and confirmed clinical vaccination failure (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). his report was associated with a regulatory authority: 90000209387; Sender's Comments: V0: 20211264034-Covid-19 vaccine ad26.cov2.s - confirmed covid-19 infection. 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). 20211264034-covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS