chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5ML (APPROXIMATELY AROUND 0.3ML) OF VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 33-year-old female with unspecified ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported (dose number in series  1), 1 in total administered for prophylactic vaccination. 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 administration not reported, batch number: 213D21A, and expiry: 11-APR-2022) dose was not reported, 1 total administered (dose number in series 2) on left arm on 01-DEC-2021 for prophylactic vaccination which was an off label use as patient received less than 0.5 ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose). No concomitant medications were reported.  "As per the report, the health care professional (HCP) withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5 mL but the caller mentioned that the math (she arrived at that by dividing 2.5 mL by 5 doses) did prove that they received approximately around 0.3 mL."(dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml (approximately around 0.3ml) of vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210684, 20211210197, 20211210409, 20211210067, 20211209551, 20211210160, 20211210058, 20211209843, 20211210549, 20211209775, 20211210159, 20211210610, 20211210555, 20211210408, 20211209880, 20211210133, 20211209816, 20211209782, 20211212088, 20211212082, 20211209679, 20211209740, 20211210588, 20211210670, 20211210824, 20211209912, 20211210350, 20211210141, 20211210585, 20211210107, 20211210112, 20211210385, 20211210590, 20211210662, 20211210334, 20211210180, 20211210143, 20211210106, 20211210019, 20211209706, 20211209884,20211209874, 20211209798, 20211210733 and 20211210165.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5ML OF VACCINE AS A BOOSTER DOSE (0.3ML); OFF LABEL USE; This spontaneous report received from a health care professional concerned an 18 year old  female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, and batch number were not reported), 1 in total, dose was not reported (dose number in series was 1), for prophylactic vaccination. The reporter does not reported any adverse events following vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: 11-APR-2022) dose was not reported, (dose number in series was 2), 1 total administered on 01-DEC-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the reporter mentioned that patient received less than 0.5 Milliliter (mL) of the vaccine as a booster dose approximately around 0.3mL of dose (vaccine under dose and off label use) (both events dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of vaccine as a booster dose (0.3ml) and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210684, 20211209912, 20211210067, 20211209775, 20211209874, 20211209874, 20211209880, 20211209884, 20211210107, 20211210112, 20211210112, 20211210141, 20211210143, 20211210159, 20211210165, 20211210180, 20211210197, 20211210334, 20211210350, 20211210385, 20211210408, 20211210409, 20211210585, 20211210590, 20211210662, 20211210733, 20211210824, 20211212082, 20211212088, 20211209551, 20211210160, 20211210549, 20211210610, 20211210555, 20211210133, 20211209816, 20211209782, 20211209551, 20211209775, 20211209782, 20211209798, 20211209798, 20211209816, 20211209874, 20211209884, 20211210107 and 20211210588.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5 ML OF VACCINE AS A BOOSTER DOSE (0.3 ML); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 53 year old 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 covid-19 vaccine ad26. cov2. s from unspecified manufacturer (form of admin, route of admin, and batch number were not reported), 1 total, dose was not reported 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: 213D21A, expiry: 11-APR-2022) with dose less than 0.5 ml (approximately around 0.3ml) (Dose number in series 2) 1 total, administered on 01-DEC-2021 to left arm for prophylactic vaccination which was an off label use as patient received less than 0.5ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine under dose). No concomitant medications were reported. As per the report, the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL (both events dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5 ml of vaccine as a booster dose (0.3 ml) and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210684, 20211210197, 20211210409, 20211210067, 20211209551, 20211210058, 20211210160, 20211209843, 20211210549, 20211209775, 20211210159, 20211210610, 20211210555, 20211210733, 20211210408, 20211209880, 20211210133, 20211209816, 20211209782, 20211212088, 20211212082, 20211209679, 20211209740, 20211210588, 20211210670, 20211210824, 20211209912, 20211210350, 20211210141, 20211210585 and 20211210107.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 42 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 in total, administered (dose number in series was 1) for prophylactic vaccination. 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: 213D21A, expiry: 11-APR-2022) dose was not reported, 1 total, (dose number in series was 2), administered on 01-DEC-2021 into left arm for prophylactic vaccination which was an off label use as patient received less than 0.5 ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose) (dose number in series 2). No concomitant medications were reported. As per the report, the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that, on 01-DEC-2021 they received approximately around 0.3 milliliter. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the individual received less than 0.5ml of the Janssen covid-19 vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210684, 20211210197, 20211210409, 20211210350, 20211210160, 20211209551, 20211209976, 20211209679, 20211209706, 20211209775, 20211209782, 20211209798, 20211209874, 20211209912, 20211210019, 20211210106, 20211210107, 20211210112, 20211210133, 20211210141, 20211210143, 20211210159, 20211210165, 20211210165, 20211210180, 20211210197, 20211210165, 20211210334, 20211210350, 20211210385, 20211210408, 20211210409, 20211210555, 20211210585, 20211210588, 20211210590, 20211210610, 20211210662, 20211210670, 20211210684, 20211209843, 20211209921, 20211209740, 20211209884, 20211210067, 20211210824 and 20211210733.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5ML OF VACCINE AS A BOOSTER DOSE (0.3ML); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 74 year old  female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, and batch number were not reported), 1 in total, dose was not reported (dose number in series was 1), for prophylactic vaccination. The batch number was not reported and has been requested. The reporter had not reported any adverse events following vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: 11-APR-2022) dose was not reported, (dose number in series was 2), 1 total administered on 01-DEC-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the reporter mentioned that patient received less than 0.5 Milliliter (mL) of the vaccine as a booster dose approximately around 0.3mL of dose (vaccine under dose and off label use) (both events dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of vaccine as a booster dose (0.3ml) and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209679, 20211209706, 20211209740, 20211209843, 20211209880, 20211209912, 20211209921, 20211209976, 20211210019, 20211210106, 20211210670, 20211210662, 20211210610, 20211210590, 20211210585, 20211210555, 20211210409, 20211210408, 20211210385, 20211210350, 20211210334, 20211210197, 20211210180, 20211210165, 20211210160, 20211210159, 20211210143, 20211210141, 20211210112, 20211210112, 20211209551, 20211210058, 20211209775, 20211210733, 20211210133, 20211209816, 20211209782, 20211212088, 20211212082, 20211210588, 20211209775, 20211209874, 20211209880, 20211210824 and 20211209884.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: THE INDIVIDUAL RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 29 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported (dose number in series 1), 1 in total administered for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. The patient received additional dose with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 11-APR-2022) dose was not reported (approximately around 0.3 mL) (dose number in series 2), 1 total, administered on 01-DEC-2021 on left arm for prophylactic vaccination which was an off label use as patient received less than 0.5ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose). No concomitant medications were reported.  As per the report, "the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL."(dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of the vaccine as a booster dose (0.3ml) and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211209976, 20211210058, 20211210160, 20211210588, 20211209775, 20211210159, 20211210610, 20211210409, 20211210733, 20211210408, 20211210555, 20211209880, 20211210133, 20211209816, 20211209782, 20211212082, 20211209679, 20211209740, 20211210670, 20211210824, 20211210350, 20211209912, 20211210141, 20211210585, 20211210067, 20211212088, 20211210662, 20211209706, 20211210019, 20211210112, 20211209798, 20211209874, 20211209884, 20211210549, 20211210106, 20211210143, 20211210180, 20211210334, 20211210590, 20211210590, 20211210684, 20211210385, 20211210165, 20211209843 and 20211209921.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 46 year old. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, and batch number were not reported), 1 in total, dose was not reported (dose number in series was 1), for prophylactic vaccination. The batch number was not reported and has been requested. The reporter had not reported any adverse events following vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: 11-APR-2022) dose was not reported, (dose number in series was 2), 1 total administered on 01-DEC-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the reporter mentioned that patient received less than 0.5 Milliliter (mL) of the Janssen COVID-19 vaccine as a booster dose approximately around 0.3mL of dose (captured as: vaccine underdose) and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of the Janssen COVID-19 vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211210067, 20211209976, 20211210058, 20211210160, 20211210588, 20211209874, 20211209884, 20211210159, 20211210334, 20211210385, 20211210408, 20211210409, 20211210549, 20211210555, 20211210585, 20211210590, 20211210610, 20211210662, 20211210670, 20211210824, 20211212082 and 20211212088.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: THE INDIVIDUAL RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 62 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported (dose number in series 1), 1 in total administered for prophylactic vaccination. 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: 213D21A and expiry: 11-APR-2022) dose was not reported (dose number in series 2), 1 total, administered on right arm, on 01-DEC-2021 for prophylactic vaccination which was an off label use as patient received less than 0.5ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose). No concomitant medications were reported.  As per the report, "the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL."(dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5 ml (approximately around 0.3 ml) of vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to  20211210197, 20211210067, 20211209551, 20211209976, 20211210058, 20211210160, 20211210588, 20211210610, 20211209775, 20211210159, 20211210409, 20211210733, 20211210408, 20211209880, 20211210133, 20211209816, 20211209782, 20211212088, 20211212082, 20211209679, 20211209740, 20211210670, 20211210824, 20211210350, 20211209912, 20211209706, 20211209843, 20211209921, 20211210019, 20211210112, 20211209798, 20211209874, 20211209884, 20211210549, 20211210106, 20211210107, 20211210143, 20211210165, 20211210180, 20211210334, 20211210385, 20211210585, 20211210590, 20211210662, 20211210684 and 20211210555.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 71-year-old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, 1 in total, administered (dose number in series was 1) for prophylactic vaccination. 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: 213D21A expiry: 11-APR-2022), 0.3 ml, 1 in total, administered (dose number in series was 2) to right arm on 01-DEC-2021 for prophylactic vaccination which was an off label use as patient received less than 0.5ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose) (dose number in series 1). No concomitant medications were reported. As per the report, the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of the Janssen covid-19 vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211210067, 20211209976, 20211210058, 20211210160, 20211210588, 20211210610, 20211209775, 20211210159, 20211210409, 20211210733, 20211210408, 20211210555, 20211209880, 20211210133, 20211209816, 20211209782, 20211212088, 20211212082, 20211210662, 20211209679, 20211209740, 20211210670, 20211210824, 20211210350, 20211209912, 20211210141, 20211210585 and 20211210107.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5ML OF VACCINE AS A BOOSTER DOSE (0.3ML); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 70 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, 1 in total, administered (dose number in series was 1) for prophylactic vaccination. 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: 213D21A expiry: 11-APR-2022), 0.3 ml, 1 in total, administered (dose number in series was 2) to left arm on 01-DEC-2021 for prophylactic vaccination which was an off label use as patient received less than 0.5ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose). No concomitant medications were reported. As per the report, the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL (both events dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of vaccine as a booster dose (0.3 ml) and off label use was not reported. This report was non-serious.  This case, from the same reporter is linked to 20211210197, 20211209551, 20211210067, 20211209976, 20211210058, 20211210160, 20211210112, 20211209679, 20211209706, 20211209740, 20211209782, 20211209816, 20211209843, 20211209880, 20211209912, 20211209921, 20211210019, 20211210106, 20211210107, 20211210141, 20211210143, 20211210165, 20211210180, 20211210350, 20211210385, 20211210585, 20211210588, 20211210590, 20211210610, 20211210662 and 20211210824.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN  0.5 ML BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 59 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported (dose number in series was 1), 1 in total administered for prophylactic vaccination. 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, intramuscular, batch number: 213D21A, expiry: 11-APR-2022) dose was not reported, 1 in total, administered (dose number in series was 2) on 01-DEC-2021 on left arm for prophylactic vaccination which was an off label use as patient received less than 0.5ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose). No concomitant medications were reported. As per the report, "the health care professional (HCP) withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL"  (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event received less than 0.5 ml booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210067, 20211209551, 20211210058, 20211209679, 20211209706, 20211209775, 20211209782, 20211209798, 20211209874, 20211209880, 20211209912, 20211209921, 20211209976, 20211210019, 20211210106, 20211210107, 20211210112, 20211210133, 20211210141, 20211210143, 20211210159, 20211210165, 20211210180, 20211210334, 20211210350, 20211210385, 20211210408, 20211210409, 20211210555, 20211210585, 20211210590, 20211210610, 20211210662, 20211210670, 20211210684, 20211210197, 20211210733, 20211209816, 20211212088, 20211212082, 20211210588, 20211209740, 20211209843, 20211209976, 20211209884, 20211210549 and 20211210733.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5ML (APPROXIMATELY AROUND 0.3ML) OF VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 35 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported (dose number in series was 1), 1 in total administered for prophylactic vaccination. 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: 213D21A, expiry: 11-APR-2022) dose was not reported, 1 total, administered (dose number in series was 2) at left arm on 01-DEC-2021 for prophylactic vaccination which was an off label use as patient received less than 0.5 ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine under dose) (both events dose number in series was 2). No concomitant medications were reported.  "As per the report, the health care professional (HCP) withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5 mL but the caller mentioned that the math (she arrived at that by dividing 2.5 mL by 5 doses) did prove that they received approximately around 0.3 mL." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml (approximately around 0.3ml) of vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211210067, 20211209976, 20211210160, 20211210588, 20211210159, 20211210610, 20211210409, 20211210733, 20211210408, 20211209880, 20211210133, 20211209816, 20211209782, 20211209775, 20211212088, 20211212082, 20211210662, 20211209679, 20211209740, 20211210670, 20211210824, 20211210350, 20211209912, 20211210141, 20211210585, 20211210107, 20211210684, 20211210590, 20211210385, 20211210334, 20211210143, 20211210106, 20211210058, 20211210019, 20211209843, 20211209706, 20211209884, 20211209874, 20211209798, 20211210555, 20211210112, 20211210549 and 20211209921.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5 ML OF THE VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 45 year old white, not Hispanic or Latino male. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose was not reported (dose number in series was 1), 1 in total administered for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. The patient received additional dose with covid-19 vaccine ad26.cov2.s (dose in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 11-APR-2022) dose was not reported (approximately around 0.3 mL), 1 total, administered on 01-DEC-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the reporter mentioned that the patient received less than 0.5 ml of the vaccine as a booster dose approximately around 0.3 mL of dose (vaccine underdose and off label use). As per the report, "the health care professional (HCP) withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL"  (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5 ml of the vaccine as a booster dose  and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211210067, 20211210058, 20211209976, 20211210160, 20211210588, 20211210610, 20211209775, 20211210159, 20211210409, 20211210555, 20211210733, 20211210408, 20211209880, 20211210133, 20211209816, 20211209782, 20211212088, 20211212082, 20211210662, 20211209679, 20211209740, 20211210670, 20211210824, 20211209706, 20211209912, 20211209921, 20211210019, 20211210112, 20211209798, 20211209874, 20211209884, 20211210549, 20211210106, 20211210107, 20211210141, 20211210143, 20211210180, 20211210334, 20211210585, 20211210590, 20211210590, 20211210684, 20211210385, 20211210165 and 20211209843.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5ML (APPROXIMATELY AROUND 0.3ML) OF VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 60 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported (dose number in series was 1), 1 in total administered for prophylactic vaccination. 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 (dose number in series was 2) (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: 11-APR-2022) with dose less than 0.5 ml (approximately around 0.3ml), 1 total, administered on 01-DEC-2021 to right arm for prophylactic vaccination which was an off label use as patient received less than 0.5 ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose)(both events dose number in series was 2). No concomitant medications were reported.  "As per the report, the health care professional (HCP) withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5 mL but the caller mentioned that the math (she arrived at that by dividing 2.5 mL by 5 doses) did prove that they received approximately around 0.3 mL." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml (approximately around 0.3ml) of vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211210067, 20211209976, 20211210058, 20211210160, 20211210588, 20211210112, 20211209775, 20211210610, 20211210159, 20211210409, 20211210555, 20211210733, 20211210408, 20211209880, 20211210133, 20211209816, 20211209782, 20211212088, 20211212082, 20211210662, 20211209679, 20211209740, 20211210670, 20211210824, 20211210350, 20211209912, 20211210141, 20211210585, 20211210107, 20211209921, 20211210684, 20211210590, 20211210334, 20211210165, 20211210143, 20211210106, 20211210019, 20211209843, 20211209706, 20211209884, 20211209874, 20211209798, 20211210549 and 20211210180.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5ML (APPROXIMATELY AROUND 0.3ML) OF VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 43 year old   female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported (dose number in series  1), 1 in total administered for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. The patient received additional dose of covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: 11-APR-2022)  approximately around 0.3mL (dose number in series  2), 1 in total, administered on 01-DEC-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 01-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the reporter mentioned that patient received less than 0.5ml of the vaccine as a booster dose approximately around 0.3mL of dose (vaccine underdose and off label use). The health care professional who administered the vaccine mentioned that the patient was injected 0.5mL but the reporter mentioned that the calculation (she arrived at that by dividing 2.5mL by 5 doses) did prove that the patient received approximately around 0.3mL only.(dose number in series  2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml (approximately around 0.3ml) of vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211209679, 20211209706, 20211209740, 20211209782, 20211209816, 20211209843, 20211209880, 20211209912, 20211209921, 20211210019, 20211210058, 20211209551, 20211210067, 20211209976, 20211210160, 20211210588, 20211210197, 20211210112, 20211209775, 20211210610, 20211209798, 20211209874, 20211209884, 20211210133, 20211210549, 20211210106, 20211210107, 20211210141, 20211210143, 20211210159, 20211210165, 20211210180, 20211210334, 20211210350, 20211210385, 20211210408, 20211210585, 20211210590, 20211210662, 20211210670, 20211210684, 20211210733, 20211210824, 20211212082, 20211212088 and 20211210555.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5ML OF VACCINE AS A BOOSTER DOSE (0.3ML); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 76 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, 1 in total, administered (dose number in series was 1) for prophylactic vaccination. 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: 213D21A expiry: 11-APR-2022), 0.3 ml, 1 in total, administered (dose number in series was 2) to right arm on 01-DEC-2021 for prophylactic vaccination which was an off label use as patient received less than 0.5ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose). No concomitant medications were reported. As per the report, the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL (both events dose number in series was 2. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of vaccine as a booster dose (0.3 ml) and off label use was not reported. This report was non-serious.  This case, from the same reporter is linked to 20211210197, 20211209551, 20211210067, 20211210058, 20211210160, 20211210588, 20211210112, 20211210610, 20211210733, 20211209679, 20211209740, 20211209775, 20211209782, 20211209798, 20211209816, 20211209843, 20211209874, 20211209880, 20211209884, 20211209912, 20211209921, 20211209976, 20211210019, 20211210019, 20211210197, 20211210385, 20211210408, 20211210409, 20211210549, 20211210585, 20211210590, 20211210662, 20211210670, 20211210824, 20211212082 and 20211212088.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5ML OF VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 49-year-old white, not Hispanic or Latino male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, 1 in total, administered (dose number in series was 1) for prophylactic vaccination. 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: 213D21A expiry: 11-APR-2022), 0.3 ml, 1 in total, administered (dose number in series was 2) to left arm on 01-DEC-2021 for prophylactic vaccination which was an off label use as patient received less than 0.5ml of the Janssen covid-19 vaccine as a booster dose( vaccine uderdose). No concomitant medications were reported. As per the report, the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the individual received less than 0.5ml of the Janssen covid-19 vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211210058, 20211209740, 20211209775, 20211209782, 20211209798, 20211209816, 20211209843, 20211209874, 20211209880, 20211210067, 20211210106, 20211210107, 20211210112, 20211210141, 20211210143, 20211210165, 20211210180, 20211210350, 20211210385, 20211210408, 20211210409, 20211210549, 20211210555, 20211210585, 20211210590, 20211210662, 20211210662, 20211210670, 20211210733, 20211210824, 20211212082, 20211212088, 20211210610, 20211210159, 20211210133, 20211209976, 20211209679, 20211209706, 20211209884, 20211209912, 20211209921, 20211210019, 20211210160 and 20211210334.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: THE INDIVIDUAL RECEIVED LESS THAN 0.5ML VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 67 year old white and non Hispanic or Latino female. 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 unspecified manufacturer (suspension for injection, route of admin not reported, batch number: unknown, and expiry: unknown) dose and therapy start date was not reported, 1 total administered on unspecified date for prophylactic vaccination (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: 11-APR-2022) with dose less than 0.5 ml ( approximately around 0.3ml), 1 total administered on 01-DEC-2021 at right arm for prophylactic vaccination (Dose number in series 2). No concomitant medications were reported.  The HCP (health care provider) reported that they had a pod on 01-DEC-2021 and a HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL (vaccine underdose) and had off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.(Dose number in series 2) The outcome of the individual received less than 0.5ml vaccine as a booster dose and off label use was not reported.  This report was non-serious. This case, from the same reporter is linked to 20211209551, 20211210067, 20211209976, 20211210058, 20211210160, 20211210588, 20211210112, 20211210197, 20211210159, 20211210610, 20211210409, 20211210555, 20211210733, 20211210408, 20211209880, 20211209816, 20211209782, 20211212088, 20211212082, 20211210662, 20211209679, 20211209740, 20211210670 and 20211210824.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5ML (APPROXIMATELY AROUND 0.3ML) OF VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 25 year old. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported (dose number in series 1), 1 in total administered for prophylactic vaccination. 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: 213D21A, expiry: 11-APR-2022) dose was not reported, 1 in total, administered (dose number in series 2) on 01-DEC-2021 for prophylactic vaccination which was an off label use as patient received less than 0.5 ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose). No concomitant medications were reported.  As per the report, the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5 mL but the caller mentioned that the math (she arrived at that by dividing 2.5 mL by 5 doses) did prove that they received approximately around 0.3 mL."(dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received less than 0.5 ml of the Janssen covid-19 vaccine as a booster dose (approximately around 0.3 ml) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211210067, 20211210058, 20211210160, 20211209679, 20211209706, 20211209740, 20211209782, 20211209816, 20211209843, 20211210106, 20211210141, 20211210143, 20211210160, 20211210165, 20211210350, 20211209843, 20211209816, 20211209782, 20211209740, 20211209706, 20211209679, 20211210112, 20211209775, 20211209874, 20211210385, 20211210408, 20211210409, 20211210549, 20211210555, 20211210585, 20211210588, 20211210662, 20211210662, 20211210684, 20211210733, 20211210824, 20211212082, 20211212088, 20211210159, 20211210670, 20211210590, 20211210334, 20211210180, 20211210133, 20211210112, 20211210107, 20211210019, 20211209921, 20211209912, 20211209880, 20211209551, 20211209798, 20211209884 and 20211209976.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse drug reaction, Chills, Pyrexia
Clinical narrative: FULL-BLOWN FEVER; TEETH CHATTERING; MILD UNSPECIFIED ADVERSE EVENTS; This spontaneous report received from a patient via a company representative via media article 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 administration not reported, batch number: Unk) dose was not reported, 1 total administered on FEB-2021 for prophylactic vaccination (Dose number in series 1). The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced full-blown fever, and teeth chattering (both events dose number in series 1). The patient reported, J and J knocked her out.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unk) dose was not reported, 1 total administered on unspecified date for prophylactic vaccination (Dose number in series 2).  on unspecified date subject experienced mild adverse reaction (Dose number in series 2). Patient also reported that, she felt much milder. "This was like nothing,"  and  within 48 hours she felt completely normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the full-blown fever and teeth chattering was not reported. The outcome of mild adverse reaction was recovered. This report was non-serious.