chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On 9th December 2021, the patient received Menveo. On 9th December 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The medical assistant reported that a technician reconstituted Menveo with sterile water, instead of accompanying liquid conjugate and this incorrectly reconstituted vaccine was administered to a patient, which led wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter reported that the patient had reported no adverse reactions at time of reporting. The reporter consented to follow-up.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose given; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 41-year-old male patient who received HBV (Engerix B) (batch number 5397F, expiry date 6th December 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th December 2021, the patient received Engerix B (intramuscular) and Engerix B Pre-Filled Syringe Device. On 9th December 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient inadvertently given an expired dose of Engerix-B, which led to expired vaccine used. It was unknown at the time of this call which dose of the series this was. No further details provided. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose several years ago). 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. Aditional details were provided as follows: The reporter was the patient. 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 declined to provide any additional information. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received vaccine #1 on 12/06/2021 and 2nd on 12/08/2021.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 6th December 2021).   On 8th December 2021, the patient received the 2nd dose of Shingrix. On 8th December 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose early than the recommended time interval, which led to shortening of vaccination schedule. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose 2 years ago, second dose on 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years and 6 months ago).   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 provided as follows: The age at vaccination was not reported. The patient received 2nd dose later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter did not provide other information than name and phone number to follow up. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix 7 months ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, 7 months ago on 22nd May 2021).   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 2nd dose of Shingrix, which led to  incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 14-SEP-2018, second dose had not been given; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14th September 2018).   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 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED A HALF DOSE FOR THEIR  BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 57 year old male of unspecified race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received covid-19 vaccine ad26. cov2. s unspecified manufacturer (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 unspecified date for prophylactic vaccination. The batch number was not reported and has been requested.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2 : suspension for injection, route of admin not reported, batch number: provided was  211A21A, expiry: UNKNOWN) dose of 0.25 milliliters, 1 total, administered on 28-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-NOV-2021, the patient received half dose (0.25 milliliters) for their booster dose (coded as vaccine underdose and off label use) (dose number in series was 2). As described by reporter, HCP (health care provider) (from public health dept) stated that there were 33 patients who received half doses (0.25ml (milliliter)) for their booster or 3rd dose a few days ago. Most of them were patients from state. HCP stated that something was printed and disseminated that said to administer .25ml. HCP was not sure where that information came from. Stated it was over the holidays so people could have thought that info changed and staff was just not made aware. HCP did not think it had been reported yet through VAERS. HCP thought that the vendor will file the report with VAERS, not public health department. HCP stated that they figured it out after the event because they could not figure out how so many doses were given. They were looking for a discrepancy in the number of vials perhaps, but then realized that half doses were given. HCP consented to being contacted, but stated that she may not be the best person to contact. If she had an alternate contact she would provide it to whomever reached out to her. The reporter went on to report that HCP stated that Spartan is the vendor. At the time of the discussion they were both teaming up together to gather information and they may have called to report these events as well, so HCP warned to be mindful of possible duplicate reports. (dose number in series was 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for their booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211201082, 20211201228, 20211201168, 20211200752, 20211201351, 20211202193, 20211200717, 20211200723, 20211200769, 20211201179, 20211201304, 20211201362, 20211201392, 20211201443, 20211201963, 20211202161, 20211202199, 20211202207, 20211202246, 20211202379, 20211201351, 20211201286, 20211201450 and 20211202371.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED HALF DOSE FOR BOOSTER; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 25 year old male of unspecified race and ethnic origin. The patient's weight, height, and medical history were not reported. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s vaccination from an unspecified manufacturer (suspension for injection, route of admin not reported, batch number: unknown expiry: UNKNOWN) dose was not reported, 1 in total, (dose number in series: 1) for prophylactic vaccination and it was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) dose was not reported, 1 in total, (dose number in series: 2), administered on 27-NOV-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 27-NOV-2021, the patient experienced received half dose for the booster (vaccine underdose) and off label use (dose number in series: 2). HCP (from public health department) stated that there were 33 patients who received half doses (0.25ml) for their booster or 3rd dose. Most of them were patients from Texas. HCP stated that something was printed and disseminated that said to administer .25ml. HCP was not sure where that information came from. Stated it was over the holidays so people could have thought that info changed, and staff was just not made aware. HCP stated that they figured it out after the event because they could not figure out how so many doses were given. They were looking for a discrepancy in the number of vials perhaps, but then realized that half doses were given. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for booster and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211202193, 20211201082, 20211200717, 20211200723, 20211200752, 20211200769, 20211200994, 20211201168, 20211201179, 20211201286, 20211201304, 20211201351, 20211201362, 20211201392, 20211201443, 20211201450, 20211201963, 20211202161, 20211202199, 20211202207, 20211202246, 20211202371 and 20211202379.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED A HALF DOSE FOR THEIR BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 27 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received  with covid-19 vaccine ad26. cov2..s (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown expiry: UNKNOWN) dose was not reported, 1 in total, (dose number in series: 1) for prophylactic vaccination The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported batch number: 1822809 ,211A21A expiry: UNKNOWN) 0.25 ml, 1 in total, administered on 28-NOV-2021 for prophylactic vaccination. (dose number in series: 2) No concomitant medications were reported.  On 28-NOV-2021, the patient experienced received a half dose for their booster dose (coded as Vaccine under dose) On 28-NOV-2021, the patient experienced off label use (both events dose number in series: 2). The reporter stated that something was printed and was disseminated which said to administer 0.25ml. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received a half dose for their booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211202193, 20211201082, 20211200752, 20211200994, 20211201450, 20211201351, 20211201046, 20211202469, 20211202515, 20211200675, 20211201168, 20211201179, 20211201228, 20211201304 20211201392, 20211201443, 20211201963, 20211202161, 20211202199, 20211200717, 20211200723, 20211200769 20211201362, 20211202207, 20211202246, 20211202371 and 20211202379.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED HALF DOSE FOR THEIR BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 27 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination (dose number in series )1.  It was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number 211A21A, expiry: unknown) dose was not reported, 1 total, administered on 27-NOV-2021 for prophylactic vaccination (dose number in series 2). No concomitant medications were reported. On 27-NOV-2021, the patient experienced received half dose for the booster (vaccine underdose) and off label use (dose number in series 2). HCP (from public health department) stated that there were 33 patients who received half doses (0.25ml) for their booster or 3rd dose. Most of them were patients from different locations. HCP stated that something was printed and disseminated that said to administer .25ml. HCP was not sure where that information came from. Stated it was over the holidays so people could have thought that info changed, and staff was just not made aware. HCP stated that they figured it out after the event because they could not figure out how so many doses were given. They were looking for a discrepancy in the number of vials perhaps, but then realized that half doses were given. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for their booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211202193, 20211201082, 20211201228, 20211201168, 20211200752, 20211200723, 20211200769, 20211200994, 20211201179, 20211202246, 20211202379, 20211201304, 20211201362, 20211201392, 20211201443, 20211201963, 20211202161, 20211202199, 20211202207, 20211201450, 20211200717, 20211201286, 20211201304 and 20211202371.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED HALF DOSE FOR THEIR BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 60-year-old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 01 total, administered on unspecified date for prophylactic vaccination (dose number in series 1). No adverse events were reported following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number was either 1822809 or 211A21A expiry: unknown) dose was not reported, 01 total, administered on 27-NOV-2021 for prophylactic vaccination (dose number in series 2). No concomitant medications were reported.  On 27-NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient received half dose for her booster dose (vaccine under dose and off label use).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for their booster dose and off label use was unknown. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211202193, 20211201228, 20211201168, 20211200752, 20211201351, 20211200994, 20211201450, 20211202199, 20211202469, 20211204104, 20211202379, 20211201179, 20211201443, 20211220152, 20211220146, 20211220262, 20211220250, 20211220145, 20211219871, 20211219926, 20211220155, 20211201963, 20211220129, 20211220619, 20211202371, 20211202246, 20211202207, 20211201362, 20211201304, 20211200769, 20211200717 and 20211200723.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED HALF DOSE FOR THEIR BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 31 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously vaccinated with covid-19 vaccine ad26. cov2. s unspecified manufacturer (suspension for injection, route of admin, and batch number were not reported) dose was not reported for prophylactic vaccination (dose number in series 1). No adverse events were reported following administration of covid-19 vaccine ad26. cov2. s (dose number in series 1) The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 211A21A, expiry: 28-NOV-2021) 0.25 ml, 01 total administered on 28-NOV-2021 for prophylactic vaccination (dose number in series 2).  On 28-NOV-2021, the patient received a half dose of the Janssen Covid-19 vaccine for their booster dose (Vaccine underdose and off label use) (dose number in series 2). As described by reporter, HCP (health care provider) (from public health dept) stated that there were 33 patients who received half doses (0.25ml (milliliter)) for their booster or 3rd dose a few days ago. Most of them were patients from Texas. HCP stated that something was printed and disseminated that said to administer .25ml. HCP was not sure where that information came from. Stated it was over the holidays so people could have thought that info changed and staff was just not made aware. HCP did not think it had been reported yet through VAERS. HCP thought that the vendor will file the report with VAERS, not public health department. HCP stated that they figured it out after the event because they could not figure out how so many doses were given. They were looking for a discrepancy in the number of vials perhaps, but then realized that half doses were given. HCP consented to being contacted, but stated that she may not be the best person to contact. If she had an alternate contact she would provide it to whomever reached out to her. The reporter went on to report that HCP stated that Spartan is the vendor. At the time of the discussion they were both teaming up together to gather information and they may have called to report these events as well, so HCP warned to be mindful of possible duplicate reports.(dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received half dose for their booster dose and off label use was unknown. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211202193, 20211201082, 20211201228, 20211201168, 20211200752, 20211201351, 20211200994, 20211201450, 20211202469, 20211165041, 20211202379, 20211202371, 20211202246, 20211202207, 20211201443, 20211201392, 20211201362, 20211201304, 20211201179, 20211200769, 20211200723, 20211200717, 20211200675 and 20211165041.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED HALF DOSE FOR THEIR BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned two male patients of 48 years old of unspecified race and ethnic origin. No past medical history or concurrent conditions were reported. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously vaccinated with covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (suspension for injection, route of administration, and batch number were not reported) 0.25 ml for prophylactic vaccination (dose number in series 1). The reporter had not reported any adverse events following vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1822809 or 211A21A, expiry: unknown) dose was not reported, 01 total administered on 28-NOV-2021 for prophylactic vaccination (dose number in series 2). No concomitant medications were reported.  On 28-NOV-2021, the patient received a half dose of the Janssen Covid-19 vaccine for their booster dose (vaccine underdose and off label use) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received half dose for their booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202193, 20211201450, 20211202199, 20211202250, 20211201046, 20211201228, 20211201168, 20211200752, 20211201351, 20211200994, 20211165041, 20211202379, 20211202371, 20211202246, 20211202207, 20211201443, 20211201392, 20211201362, 20211201304, 20211201179, 20211200769, 20211200723, 20211200717, 20211200675, 20211165041 and 20211201286.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hypersomnia, Staphylococcal infection
Clinical narrative: SLEPT FOR 18 HOURS; FELT MISERABLE/TERRIBLE; FATIGUE; STAPHYLOCOCCUS INFECTION; This spontaneous report received from a consumer concerned an adult male of an unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic lymphocytic leukemia since an unspecified date in 2017. There was no other reported medical history. The patient received covid-19 vaccine ad26.cov2.s (dose number  in series 01) (suspension for injection, intramuscular, batch number and expiry were not reported) dose was not reported, 01 total, administered on an unspecified date in 2020 for Covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ibrutinib (Imbruvica) for chronic lymphocytic leukemia. On an unspecified date, the patient slept for 18 hours, and felt miserable for a couple of days due to fatigue, he slept for 18 hours and some days he felt terrible and some days not so bad while he was taking the Imbruvica. He resumed taking the Imbruvica however it was unknown why he was stopped from taking the Imbruvica before and it was not stated also if it was due to fatigue or not. On an unspecified date in 2020, the patient experienced staphylococcus infection and fatigue. Alternative etiology for fatigue was due to chronic lymphocytic leukemia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and the outcome of staphylococcus infection, slept for 18 hours and felt miserable/terrible was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20211203320.; Sender's Comments: V0: 20211210427-covid-19 vaccine ad26.cov2.s-Staphylococcus infection. 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: CONMEDS-OTHER SUSPECT DRUGS, MEDICAL HISTORY
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness, Unevaluable event
Clinical narrative: TATTOO ON INJECTION SITE DISAPPEARED; SORE ARM; TENDERNESS; This spontaneous report received from a patient concerned a 54-year-old adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: the patient was hypersensitive, drug allergy (narcotics), and other pre-existing medical conditions included the patient had Chest pain and was sick with Narcotics. The patient was previously received with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (suspension for injection, route of admin, and batch number: unknown, Expiry: unknown) dose not reported, frequency 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: Unknown) dose was not reported, 1 total, administered at right arm on 03-DEC-2021 for prophylactic vaccination (Dose number in series 2).  No concomitant medications were reported.  On 05-DEC-2021, the patient experienced tenderness.  On 06-DEC-2021, the patient experienced sore arm and tattoo on injection site disappeared. It was reported that, the patient had tattoo of about 2 by 2 inches and noticed tattoo was dissolving. Treatment medications (dates unspecified) included Motrin (Naproxen) for the sore arm and tenderness.(Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tattoo on injection site disappeared, sore arm, and tenderness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Death
Clinical narrative: DEATH; HEART HAD STOPPED ONLY FOR 4 HOURS AFTER SHE HAD GONE TO BED; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: colon cancer surgery. The surgery was performed to remove the cancerous tumor from her colon. The patient received Covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, with frequency time 1 total, administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-JUL-2021, her heart had stopped only for 4 hours after she had gone to bed. On 23-JUL-2021, four months after the vaccination the patient died. The cause of death was unknown. An autopsy was performed on an unspecified date. It is reported that the pathologist who had performed the autopsy was deliberately holding back the toxicology results which could prove the cause of death. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. Patient died due to unknown cause of death. The patient died on 23-JUL-2021, and had recovered from heart had stopped only for 4 hours after she had gone to bed. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20211220645-COVID-19 VACCINE AD26.COV2.S- Death, heart had stopped only for 4 hours. 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: Adverse event
Clinical narrative: This spontaneous report received from a consumer via social media company representative concerned a patient of unspecified age and sex and unknown race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, 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 numbers. No concomitant medications were reported. The reporter stated that "Johnson & Johnson I have photos of what happened to someone I know. Why report it? Are you going to pay for the 7 hospital stays? These vaccines are killing people and damaging people, yet you want people to take another". The action taken with covid-19 vaccine was not applicable. The outcome of what happened to someone I know, and 7 hospital stays was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211222367-Covid-19 vaccine I have photos of what happened to someone I know. 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: Bedridden
Clinical narrative: BEDRIDDEN FOR THREE MONTHS FROM THE JANSSEN VACCINE; This spontaneous report received from a consumer via media through company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: Unknown and expiry: Unknown) dose not reported, frequency 1 total, start therapy date were not reported administered 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 it was reported that the patient was bedridden for 3 months after vaccination. The reporter stated that, "And my neighbor has been bedridden for 3 months from the J & J vaccine. Her Dr (doctor) and the hospital also refuse to admit it's from the vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bedridden for three months from the Janssen vaccine was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211223490.; Sender's Comments: V0:20211223119- JANSSEN COVID-19 VACCINE Ad26.COV2.S -bedridden for three months from the Janssen vaccine.This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Feeling abnormal, Nervousness
Clinical narrative: ANXIETY; FEELING SPACY/FELT BLAH; LIGHT HEADEDNESS; NERVOUS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height and weight were not reported. The patient's concurrent conditions included slight anxiety and worrying when he had to have a medical procedure (for example, an upcoming colonoscopy).  The patient previously 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, administered on 07-JUN-2021 for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s (dose in series 1), the patient felt okay and just experienced some achiness and little tiredness. The patient received covid-19 vaccine ad26.cov2.s (Janssen dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 02-DEC-2021 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.  Following vaccination with covid-19 vaccine ad26.cov2.s (dose in series 2), the patient had the same experience initially (similar to dose in series 1) and felt good on Sunday, 05-DEC-2021. On an unspecified date in DEC-2021, the patient experienced feeling spacy/felt blah, anxiety and light headedness for the past 2-3 days. The patient had been experiencing the same post coffee, but these symptoms felt different which last all day. The patient was able to drive. On an unspecified date in DEC-2021, the patient felt nervous due to the feeling spacy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anxiety, feeling spacy/felt blah, light headedness, and nervous. This report was non-serious. This case, involving the same patient is linked to 20211222743. This case, from the same reporter is linked to 20211223201.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Injection site pain, Radiculitis brachial
Clinical narrative: BRACHIAL NEURITIS; INJECTION SIDE FOREARM  AND HAND DELTOIDS  WILL BE PRETTY PAINFUL AT THE INJECTION SITE; GRIP STRENGTH IN INJECTION SIDE HAND; This spontaneous report received from a patient via media concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 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 numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced brachial neuritis, injection side forearm and hand deltoids will be pretty painful at the injection site, and grip strength in injection side hand. "injection side forearm and hand, lost about 80 percent of strength in grip. "Tell patient to get ready for the brachial neuritis. Hope patient doesn't need any grip strength at the injection side hand for a couple months. The deltoids will be pretty painful at the injection site as well. Now 2 months post not much improvement." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from brachial neuritis, injection side forearm and hand deltoids will be pretty painful at the injection site, and grip strength in injection side hand. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a patient via media concerned a female of unspecified age, race and ethnicity who experienced brachial radiculitis and loss of grip strength after an unspecified duration of vaccination. Medical history and concomitant medications were not provided. The patient experienced loss of 80% grip strength and brachial radiculitis after an unspecified duration of vaccination and did not see much improvement after 2 months of onset of symptoms. No imaging or electromyography details were provided. Outcome is reported as not recovered. Information (medical history, chronology and clinical course of events) is limited in this case. Therefore, the relationship of events to vaccination is considered unclassifiable due to insufficient information
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Death
Clinical narrative: DIED; REACTION NOS; This spontaneous report received from a consumer via a company representative via social media  concerned multiple patients of unknown age, sex, race and ethnicity.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported, 1 total (dose number in series: 1) administered 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 died from unknown cause of death and reaction nos. The reporter stated that "others who did have a reaction to and died" . "You may have later in life from the vaccine it's your choice to get it .Don't criticize others who didn't .We have neighbors who were healthy get it and died the next day after receiving the vaccine". It was unknown 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: 20211225095 -COVID-19 VACCINE AD26.COV2.S- Died 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: Pain in extremity
Clinical narrative: SORE ARM; 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 Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: TERRIBLE TREMORS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced terrible tremors. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of terrible tremors was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID; This spontaneous report received from a patient concerned a 77 year old female. 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 was not reported, administered on OCT-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 got covid. 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 is associated with Product quality complaint: 90000206642.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: GOT COVID; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via media  with unknown age, gender, race and ethnicity. Initial information was processed along with the additional information received on 11-Dec-2021. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN, Frequency: 1 total) dose, therapy start and end dates 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.  Dose number series was 1. No concomitant medications were reported.  On an unspecified date, the patient reported of taking the covid shots and got covid (suspected clinical vaccination failure, suspected covid-19 infection) It was so bad that the patient was afraid, but wasn't going to die. The patient also dehydrated so bad and had to go to emergency room for fluids in the vains. Then had to go to a trailer two days after that to get an infusion.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the events got covid and suspected clinical vaccination failure was not reported.  This report was serious (Other Medically Important Condition).  This report was associated with regulatory authority: 90000206656; Sender's Comments: V0; 20211227706-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: 20211227706-covid-19 vaccine ad26.cov2.s- got covid. 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: Cough, Rhinorrhoea
Clinical narrative: COUGH; RUNNY NOSE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's pre-existing medical conditions included: The patient did not have any known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-DEC-2021, the patient experienced cough. On 08-DEC-2021, the patient experienced runny nose. The action taken with covid-19 vaccine was not applicable. The patient recovered from runny nose, and had not recovered from cough. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, COVID-19
Clinical narrative: GOT THE COVID 6 WEEKS LATER; STILL HAVING ISSUES; This spontaneous report received from a patient via a company representative concerned an 82 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. 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 got the covid 6 weeks later, and still having issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from still having issues, and the outcome of got the covid 6 weeks later was not reported. This report was non-serious. This report was associated with product quality complaint: 90000206755.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via media 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 were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The dose number in series was 1. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers.  On an unspecified date, the patient experienced mild covid (suspected clinical vaccination failure, and suspected covid-19 infection), and lost the taste and smell, 4 months post vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a regulatory authority: 90000206781.; Sender's Comments: V0:20211229718 -Covid-19 vaccine ad26.cov2.s- suspected clinical  vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS