chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 35 year old male 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 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 (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) (lot number also reported at 211A21A) 0.25 ml (milliliter), frequency 1 total, administered on 27-NOV-2021 for prophylactic vaccination (Dose series number 2, Booster dose). No concomitant medications were reported.  On 27-NOV-2021, the patient received half dose of their Booster dose vaccine (captured as: Vaccine underdose) and off Label use (dose number in series 2). The reporter stated that something was printed and was disseminated which said to administer 0.25ml. It was reported that HCP (from public health dept) stated that there were 33 patients who received half doses (0.25mL) for their booster or 3rd dose a few days ago. Most of them were patients from (town). HCP stated that something was printed and disseminated that said to administered .25ml. HCP is 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. At the time of conversation with HCP, they did not think it has been reported through VAERS. HCP thought that vendor will file the report with VAERS, not the 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 preferred contact be on alternative contact. Specific report was in regards to male patient aged 35 received half dose of the Janssen COVID-19 vaccine for their BOOSTER dose. They were given at a pop up clinic at a renaissance festival by Medical clinic. 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 20211201046, 20211202193, 20211201228, 20211201168, 20211200752, 20211201351, 20211200994, 20211201450, 20211201286, 20211204104, 20211201179, 20211201443, 20211220152, 20211220146, 20211220262, 20211220250, 20211220145, 20211219871, 20211219926 and 20211202250.
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 a 52 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 previously received covid-19 vaccine ad26.cov2.s (un specified manufacturer) (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). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number was either 1822809 or 211A21A and expiry: UNKNOWN) 0.25 ml, 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 received half dose for their booster dose (coded as vaccine under dose and 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 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, 20211202469, 20211202515, 20211200675, 20211201168, 20211201179, 20211201228, 20211201286, 20211201304, 20211201351, 20211201362, 20211201392, 20211201443, 20211201450, 20211201963, 20211202161, 20211202199, 20211201046, 20211200752, 20211200994, 20211204104, 20211202379, 20211220146, 20211220262, 20211220250, 20211220145, 20211220619, 20211220129, 20211219871 and 20211219926.
Age: 28.0
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 a 28 year old male 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 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). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number was 211A21A expiry: unknown) 0.25 ml, 1 total, administered on 27-NOV-2021 for prophylactic vaccination (Dose number in series is 2). No concomitant medications were reported.  On 27-NOV-2021, the patient received half dose for their booster dose (coded as vaccine under dose and off label use). 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 is 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, 20211200717, 20211201351, 20211200994, 20211201450, 20211202199, 20211202469, 20211201286, 20211204104, 20211202379, 20211201179, 20211201443, 20211220146, 20211220262, 20211220250, 20211220145, 20211220619, 20211220129, 20211219871 and 20211220152.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Off label use
Clinical narrative: RECEIVED HALF DOSE FOR THEIR  BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 59 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. 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 administered, (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 booster dose (suspension for injection, route of admin not reported, batch number: 1822809 OR 211A21A expiry: UNKNOWN) dose was not reported, 1 total administered (dose number in series: 2) on 28-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-NOV-2021, following vaccination with booster dose of covid-19 vaccine ad26.cov2.s, the patient received half dose for their booster dose 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 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, 20211200994, 20211201450, 20211202199, 20211202469, 20211201286, 20211204104, 20211202379, 20211201179, 20211201443, 20211220146, 20211220262, 20211220250, 20211220145, 20211220619, 20211220129, 20211219871 and 20211220152.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Off label use
Clinical narrative: RECEIVED HALF DOSE FOR THEIR  BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned an 18 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. 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 administered, (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 booster dose (suspension for injection, route of admin not reported, batch number: 1822809 OR 211A21A expiry: UNKNOWN) dose was not reported, 1 total administered (dose number in series: 2) on 27-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-NOV-2021, following vaccination with booster dose of covid-19 vaccine ad26.cov2.s, the patient received half dose for their booster dose 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 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 20211202193, 20211201450, 20211201286, 20211204104, 20211201179 and 20211201443.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5 ML  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. The patient was previously treated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (suspension for injection, route of administration, and batch number were not reported) 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 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, 1 total administered on left arm on 01-DEC-2021 for prophylactic vaccination (dose number in series 2).  No concomitant medications were reported.  On 01-DEC-2021, the patient experienced received less than 0.5 ml of the vaccine as a booster dose (vaccine underdose) and off label use (dose number in series 2). 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 0.5 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, 20211209551, 20211210067, 20211209976, 20211210058, 20211210160, 20211210588, 20211210610, 20211209775, 20211210159, 20211210409, 20211210733, 20211210408, 20211209880, 20211210133, 20211209816, 20211209782, 20211212088, 20211212082, 20211210662, 20211209679, 20211209740, 20211210670, 20211210824, 20211210350, 20211209912, 20211210141, 20211210585, 20211210107, 20211209921, 20211210180 and 20211210385.
Age: 60.0
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 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 previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin, batch number and expiry were not reported), 01 in total, dose was not reported for prophylactic vaccination. No adverse event was reported following covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received booster 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, 01 in total, administered (dose number in series was 2) on 01-DEC-2021 to left arm for prophylactic vaccination which was an off label as the patient received less than 0.5ml (milliliter) 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. It was reported that she would filed VAERS report for all of these individuals tomorrow after she informed each of them. She also communicated these incidences with New York Department of Health who suggested to contact the Janssen. She provided all available information. 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 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, 20211210408, 20211210733, 20211209880, 20211209816, 20211209782, 20211212088, 20211212082, 20211210662, 20211209679, 20211209740, 2021121067, 20211210824, 20211210350, 20211210141, 20211210684, 20211209706, 20211209874, 20211209843, 20211209798, 20211209884, 20211209912, 20211209921, 20211210019, 20211210106, 20211210107, 20211210143, 20211210165, 20211210180, 20211210334, 20211210385, 20211210549, 20211210590, 20211212082 and 20211210684.
Age: 70.0
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 70 year old white male of an unspecified ethnic origin. 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  (manufacturer not specified) (suspension for injection, route of admin not reported, batch number and expiry were unknown), 1 in total, dose was not reported, 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: 213D21A and expiry: 11-APR-2022) dose was not reported, 1 total administered on 01-DEC-2021 for prophylactic vaccination (dose number in series 2). No concomitant medications were reported. On 01-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s booster dose, the patient experienced received less than 0.5 ml of the vaccine as a booster dose and off label use (dose number in series 2).   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 0.5ml 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, 20211210733, 20211210588, 20211210112, 20211210610, 20211210159, 20211210409, 20211210555, 20211210408, 20211209880, 20211209816, 20211209782, 20211212088, 20211212082, 20211209775, 20211210334, 20211210385, 20211210590, 20211210350, 20211210180, 20211210165, 20211210143, 20211210585, 20211210058, 20211210549, 20211210684, 20211209798, 20211210670, 20211210824, 20211210107, 20211209679, 20211209706, 20211209740, 20211210019, 20211210106, 20211210141, 20211209740, 20211209679, 20211210133 and 20211210141.
Age: 30.0
Sex: F
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 30 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. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (manufacturer not specified) (suspension for injection, route of admin not reported, batch number and expiry were unknown), 1 in total, dose was not reported, for prophylactic vaccination. 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 (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A and expiry: 11-APR-2022) dose not reported, 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, (dose number in series 2) booster dose, the healthcare professional injected the individual received less than 0.5 milliliter (mL) of the Janssen COVID-19 vaccine as a booster dose (captured as: vaccine underdose) and off label use (dose number in series 2). It was reported to be confirmed that the reporter "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, 20211209976, 20211210058, 20211210549, 20211210662, 20211210588, 20211210610, 20211210684, 20211209775, 20211212088, 20211212082, 20211210555, 20211210408, 20211210334, 20211210112, 20211210067, 20211210160, 20211209798, 20211210409, 20211209782, 20211209816, 20211210670, 20211210824, 20211210590, 20211210385, 20211210350, 20211210180, 20211210165, 20211210159, 20211210143, 20211210107, 20211209679, 20211209706, 20211209740, 20211209816, 20211210019, 20211210106, 20211210141, 20211209740, 20211209679, 20211210141, 20211210058, 20211210585, 20211209880 and 20211210133.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 LESS THAN ONE WEEK AFTER THE BOOSTER; This spontaneous report received from a consumer (wife) via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported for prophylactic vaccination. No adverse events associated with covid-19 vaccine ad26.cov2.s (dose number in series 1) were reported. On an unspecified date, the patient was vaccinated with covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s , the patient experienced got Coronavirus-19 (COVID-19) less than a week after the booster (dose number in series 2). The case of Covid-19 was reported as mild/moderate and the patient was high risk. On 02-DEC-2021, he received an infusion of Monoclonal antibodies and felt better after the infusion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from covid-19.  This report was non-serious. This case, from the same reporter is linked to 20211212660.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5ML AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 74 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated 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, 1 total administered on unspecified day 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) less than 0.5ml dose (approximately around 0.3m), 1 total administered on 01-DEC-2021 on left arm for prophylactic vaccination (Dose number in series 2).  No concomitant medications were reported.  On 01-DEC-2021, the patient experienced administered less than 0.5ml as a booster dose (Vaccine under dose and off label use). The health care reporter (HCP) 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 the math (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 administered less than 0.5ml 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, 20211210662, 20211209679, 20211209740, 20211210670, 20211210824, 20211210350, 20211209921, 20211210585, 20211210141 and 20211209912.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; This spontaneous report received from a patient via social media (Facebook) via a 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 unspecified manufacturer (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on unspecified date 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 fatigue. "Didn't get the fatigue like I did with the first one".(Dose number in series 1) The patient received additional covid-19 vaccine ad26. cov2. s unspecified manufacturer (suspension for injection, route of administration, and batch number were not reported) dose was not reported, 1 total administered on unspecified date for prophylactic vaccination (Dose number in series 2). It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: hypoglycemia, and concurrent conditions included: penicillin allergy, idiopathic thrombocytopenic purpura, and hashimoto. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced low grade aching, low grade chills, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade aching, low grade chills, and fatigue. This report was non-serious. This case, involving the same patient is linked to 20211214362.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE (VACCINE WAS HELD FOR MORE THAN 2 HOURS OUTSIDE OF THE FRIDGE AND ADMINISTERED 25 MINUTES AFTER 2 HOURS OF ROOM TEMPERATURE WINDOW); OUT OF SPECIFICATION PRODUCT USE/ADMINISTRATION ERROR; This spontaneous report received from a pharmacist concerned a 72 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) .5 ml, administered on 22-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 22-OCT-2021, the patient experienced incorrect product storage (vaccine was held for more than 2 hours outside of the fridge and administered 25 minutes after 2 hours of room temperature window). On 22-OCT-2021, the patient experienced out of specification product use/administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage (vaccine was held for more than 2 hours outside of the fridge and administered 25 minutes after 2 hours of room temperature window) and out of specification product use/administration error was not reported. This report was non-serious. This case, from the same reporter is linked to 20211047306.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: HEADACHE; CHILLS; FEVER; This spontaneous report received from a consumer concerned a 41 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (series 1 from unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination . The patient received covid-19 vaccine ad26.cov2.s (Janssen series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 08-DEC-2021 into left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-DEC-2021, around 11 PM, the patient experienced chills and fever. On 09-DEC-2021, in morning hours, the patient experienced headache (series 2 adverse events). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and headache was not reported.  This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia, Rash
Clinical narrative: FOUR LITTLE RED DOTS ON ABDOMINAL; CHILLS; SEVERE DIARRHOEA; FEVER; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy to mango, alcoholic, and non smoker, and other pre-existing medical conditions included: The patient has been healthy and vegetarian. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient experienced severe diarrhoea. On APR-2021, the patient experienced four little red dots on abdominal. On APR-2021, the patient experienced chills. On APR-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe diarrhoea on APR-2021, and chills, and fever, and had not recovered from four little red dots on abdominal. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: ITCHING; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: various allergies, chronic migraines, restless leg syndrome, hypothyroidism, asthma, non alcoholic, and non smoker, and other pre-existing medical conditions included: Patient had allergy to steroids increase pressure in the eyes. Patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with tramadol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: unknown) dose was not reported, administered on 08-DEC-2021 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for allergic symptoms, thyroid for hypothyroidism, rimegepant sulfate for migraines, and topiramate for migraines.  On 08-DEC-2021, the patient experienced itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cerebral palsy, Guillain-Barre syndrome
Clinical narrative: CEREBRAL PALSY; GUILLAIN-BARRE SYNDROME; This spontaneous report received from a consumer via media through a company representative concerned a male 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) 1 total, dose and start therapy date were not reported administered for prophylactic vaccination. The dose number in series was 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 cerebral palsy and Guillain-Barre Syndrome (GBS). The consumer stated that " I met a man who is now got GBS, another sudden cerebral palsy, after the Janssen. I want Sinovac even more now". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cerebral palsy and Guillain-Barre Syndrome syndrome was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20211222475.  It was determined that Manufacturer Case Number 20211222475 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20211223649.; Sender's Comments: V0: 20211223649-covid-19 vaccine ad26.cov2.s-cerebral palsy. 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). 20211223649-covid-19 vaccine ad26.cov2.s-Guillain-Barre Syndrome. This event(s) is labeled per Agency and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced 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: COVID-19
Clinical narrative: COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned multiple patients.  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 numbers were not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint: 90000206601.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event was not reported. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS/FEVER/CHILLS/ACHINESS; This spontaneous report received from a patient concerned a 42 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 not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced flu like symptoms/fever/chills/achiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like symptoms/fever/chills/achiness was not reported. This report was non-serious. This case, involving the same patient is linked to 20211229198.
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance, Tremor
Clinical narrative: HAND TREMORS; FEELING OF ELECTRICITY GOING DOWN HER ARMS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced hand tremors, and feeling of electricity going down her arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling of electricity going down her arms and hand tremors was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced got covid. 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.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Laboratory test
Clinical narrative: HAD PROBLEMS (UNSPECIFIED ADVERSE EVENT); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced had problems (unspecified adverse event). Laboratory data (dates unspecified) included: Laboratory test (NR: not provided) Unknown (Not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from had problems (unspecified adverse event). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: POSITIVE FOR COVID-19; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic, high blood pressure, and high cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, the patient experienced positive for covid-19. Laboratory data included: SARS-CoV-2 test (NR: not provided) false negative, positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from positive for covid-19. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Colonoscopy, Contusion, Gait inability, Hot flush
Clinical narrative: SMALL BRUISES ON LEGS WHICH CONSTANTLY APPEAR; POLYPS IN UTERUS; FIBROIDS; TILTED UTERUS; BACK PAIN/BACK ISSUES; UMBILICAL HERNIA; SLUGGISH AND SLOW; LETHARGIC; UNABLE TO WALK AND SWIM; 2 POLYPS FOUND DURING COLONOSCOPY; A BIG HOT FLASH RIGHT AFTER GETTING THE VACCINE; This spontaneous pregnancy report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient had no relevant medical history and had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the patient experienced a big hot flash right after getting the vaccine. On OCT-2021, the patient experienced 2 polyps found during colonoscopy. Laboratory data included: Colonoscopy (NR: not provided) 2 polyps were found. On an unspecified date, the patient experienced small bruises on legs which constantly appear, polyps in uterus, fibroids, tilted uterus, back pain/back issues, umbilical hernia, sluggish and slow, lethargic, and unable to walk and swim. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a big hot flash right after getting the vaccine, small bruises on legs which constantly appear, polyps in uterus, fibroids, tilted uterus, back pain/back issues, 2 polyps found during colonoscopy, umbilical hernia, sluggish and slow, lethargic and unable to walk and swim was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Polyp, Sluggishness, Umbilical hernia, Uterine leiomyoma
Clinical narrative: SMALL BRUISES ON LEGS WHICH CONSTANTLY APPEAR; POLYPS IN UTERUS; FIBROIDS; TILTED UTERUS; BACK PAIN/BACK ISSUES; UMBILICAL HERNIA; SLUGGISH AND SLOW; LETHARGIC; UNABLE TO WALK AND SWIM; 2 POLYPS FOUND DURING COLONOSCOPY; A BIG HOT FLASH RIGHT AFTER GETTING THE VACCINE; This spontaneous pregnancy report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient had no relevant medical history and had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the patient experienced a big hot flash right after getting the vaccine. On OCT-2021, the patient experienced 2 polyps found during colonoscopy. Laboratory data included: Colonoscopy (NR: not provided) 2 polyps were found. On an unspecified date, the patient experienced small bruises on legs which constantly appear, polyps in uterus, fibroids, tilted uterus, back pain/back issues, umbilical hernia, sluggish and slow, lethargic, and unable to walk and swim. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a big hot flash right after getting the vaccine, small bruises on legs which constantly appear, polyps in uterus, fibroids, tilted uterus, back pain/back issues, 2 polyps found during colonoscopy, umbilical hernia, sluggish and slow, lethargic and unable to walk and swim was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Uterine malposition, Uterine polyp
Clinical narrative: SMALL BRUISES ON LEGS WHICH CONSTANTLY APPEAR; POLYPS IN UTERUS; FIBROIDS; TILTED UTERUS; BACK PAIN/BACK ISSUES; UMBILICAL HERNIA; SLUGGISH AND SLOW; LETHARGIC; UNABLE TO WALK AND SWIM; 2 POLYPS FOUND DURING COLONOSCOPY; A BIG HOT FLASH RIGHT AFTER GETTING THE VACCINE; This spontaneous pregnancy report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient had no relevant medical history and had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the patient experienced a big hot flash right after getting the vaccine. On OCT-2021, the patient experienced 2 polyps found during colonoscopy. Laboratory data included: Colonoscopy (NR: not provided) 2 polyps were found. On an unspecified date, the patient experienced small bruises on legs which constantly appear, polyps in uterus, fibroids, tilted uterus, back pain/back issues, umbilical hernia, sluggish and slow, lethargic, and unable to walk and swim. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a big hot flash right after getting the vaccine, small bruises on legs which constantly appear, polyps in uterus, fibroids, tilted uterus, back pain/back issues, 2 polyps found during colonoscopy, umbilical hernia, sluggish and slow, lethargic and unable to walk and swim was not reported. This report was non-serious.