chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Monoplegia, Pyrexia
Clinical narrative: Fever; Chills; Temporary paralysis of upper arm; This case was reported by a nurse via sales rep and described the occurrence of arm paralysis in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced arm paralysis (serious criteria GSK medically significant), fever and chills. On an unknown date, the outcome of the arm paralysis was recovered/resolved and the outcome of the fever and chills were unknown.   It was unknown if the reporter considered the arm paralysis, fever and chills to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported but patient was in 70s. The patient received a dose of Shingrix and experienced temporary paralysis of upper arm for approximately 24 hours, fever and chills. The reporter did not agreed for follow up. Note: There is discrepancy regarding patient's date of birth as it was approx. 1950 was reported therefore conservatively age group and age decades was capture in the case.
Sex: F
Vaccine: UNK, UNK, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 2nd case of shingles. Pt has received Shingrix vaccines/ suspected vaccination failure; shingles; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a 91-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, mepolizumab (Nucala) solution for injection for product used for unknown indication and prednisone for product used for unknown indication.   The patient's past medical history included shingles (had 1st outbreak of shingles, refer case US2021252020).   On an unknown date, the patient received Shingrix, the 1st dose of Shingrix, Nucala 100 mg at an unknown frequency and prednisone at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix and Shingrix and not applicable after starting Nucala, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The action taken with Nucala was unknown. The action taken with prednisone was unknown. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles to be related to Nucala.  Additional details were provided as follows: The age at vaccination was unknown. The patient received Shingrix vaccines (timeline of Shingrix vaccine was unknown) and developed 2nd case of shingles while on Nucala 100 mg and Prednisone. No updated status and date of onset was available for the patient at the time of reporting. The patient's history part and demographics were unknown. It was unknown if the reporter considered the shingles to be related to Prednisone. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding the laboratory test confirming shingles and time to onset for shingles were unknown at the time of reporting.  Note: In source document there was discrepancy for outcome details but as per description patient's status was unknown, hence conservative outcome was considered as unknown. Clarification had been raised.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021252020:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine, it gave shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's siblings for his brother. The age at vaccination was not reported. The patient got the Shingle vaccine and it gave them shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case is linked with US2021AMR252710, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR252710:same reporter, other patient
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Cough, Feeling abnormal, Headache, Pain
Clinical narrative: This case was reported by a consumer via Regulatory Authority and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 7th December 2021, the patient received the 2nd dose of Shingles vaccine. In December 2021, less than a week after receiving Shingles vaccine, the patient experienced feeling bad, pain, cough, chills, and headache. On an unknown date, the outcome of the feeling bad, pain, cough, chills, and headache were unknown. It was unknown if the reporter considered the feeling bad, pain, cough, chills, and headache to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient just took the second dose day before reporting date and he/she feel really bad, aching, coughing, chills and headache. The patient mentioned that it would worth it to keep from getting shingles. The follow up would not possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (received 1st dose on 24th April 2019). On 6th December 2021, the patient received the 2nd dose of Shingles vaccine. On 6th December 2021, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The patient received the 2nd dose of Shingles vaccine later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter asked if he/she needed to get another dose. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: vaccinated with both of the vaccines/ shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and COVID-19 VACCINE for prophylaxis.   The patient's past medical history included shingles (had shingles several times).   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The reporter was vaccinated with both of the vaccines and stated that, his/her shingles were not very painful and went away a few days after taking Valtrex. The patient stated that, he/she kept a prescription of Valtrex with him/her everywhere to start it immediately.  The patient had his/her latest episode a few hours after the Covid vaccination. It was unknown if the reporter considered the shingles to be related to Covid-19 vaccine. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding the laboratory test confirming shingles and time to onset for shingles were unknown at the time of reporting.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: leakage from syringe of Fluarix; received only 2/3 to 3/4 of dose; due to leakage from the top of the syringe of Fluarix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 38-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 4L97X, expiry date 30th June 2022) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th November 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 26th November 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered and syringe issue. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the incomplete dose administered, syringe issue and pharmaceutical product complaint were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age  at vaccination was not reported. The reporter stated that, the patient received only two third to three fourth of the Fluarix Quadrivalent dose due to leakage from the top of the syringe of Fluarix, which led to incomplete dose administered, syringe issue and product complaint. A technician reported to her that the needle was on very tight.  There was no option for this vaccine in AE form drop-down menu.  The pharmacy was very busy during the call, so the caller was not able to be transferred to determine whether there was a product quality issue. The reporter consented to follow up via email.
Age: 16.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: already received an unspecified hepatitis A vaccine in 2013 (dose 1) /again in 2016 (dose 2); already received an unspecified hepatitis A vaccine in 2013 (dose 1) /again in 2016 (dose 2); This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 16-year-old female patient who received HAV (Havrix 720) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hepatitis A vaccine for prophylaxis.   Previously administered products included Hepatitis A vaccine (received 1st dose in 2013).   On 5th December 2021, the patient received the 3rd dose of Havrix 720 (intramuscular) .5 ml and Havrix Pre-Filled Syringe Device. On an unknown date, the patient received the 2nd dose of Hepatitis A vaccine. On 5th December 2021, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device and not applicable after receiving Hepatitis A vaccine, the patient experienced extra dose administered. On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that the patient got an injection with Havrix yesterday (from the day of reporting) at a local pharmacy. The reason the dose was given was because the patient got a job at and the vaccine was recommended/suggested/mandated to her as an employee. Reporter did not have the lot number of the product given yesterday (from the day of reporting) but did provide the phone number for the pharmacy where it was administered.  The reporter did not know for sure if the injection was given intramuscularly but he assumes that it was injected into the muscle. The NDC of the product administered was 58160-0825-52 = Havrix. It was the pediatric dose: 720 ELU/0.5 ml given via (pre-filled) syringe. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: exacerbated pulsatile tinnitus; This case was reported by a consumer via call center representative and described the occurrence of pulsatile tinnitus in a 72-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th December 2021, the patient received the 1st dose of Fluarix Tetra 2021-2022 season (intramuscular) .5 ml and Fluarix Tetra Pre-Filled Syringe Device. On 5th December 2021, 1 days after receiving Fluarix Tetra 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced pulsatile tinnitus. On an unknown date, the outcome of the pulsatile tinnitus was recovered/resolved.   It was unknown if the reporter considered the pulsatile tinnitus to be related to Fluarix Tetra 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The case was reported by the patient. The patient stated that she woke up the morning following her flu shot with exacerbated pulsatile tinnitus in her right ear.  She also asked about getting a booster and what strains the vaccines covered.  The reporter was given medical disclaimer and referred to health care professional. The reporter was provided a copy of the product information (PI). The reporter consented to follow up.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received an only dluent part of Menveo Dose; received an only dluent part of Menveo Dose; This case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA586A, expiry date 31st August 2022) for prophylaxis.   On 19th November 2021, the patient received Menveo. On 19th November 2021, unknown after receiving Menveo, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details were reported as follows: The patient received only diluent part of Menveo dose, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received the powder vial reconstituted with a non approved diluent; received the powder vial reconstituted with a non approved diluent; This case was reported by a physician via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient received a dose of Menveo where powder vial was reconstituted with a non approved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose more than two years from the first; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 28th August 2018).   On 2nd November 2020, the patient received the 2nd dose of Shingrix. On 2nd November 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient self reported the case. The patient called to ask if there was any information on the efficacy of taking Shingrix later than the recommended dosing schedule. She stated that, she took the second dose about a year and a half later, later than the recommended interval, which led to lengthening of vaccination schedule, after she spoke with her healthcare professional who recommended her took the second dose as soon as possible.  Call center representative provided information per content on Food drug administration and CDC recommendations and referred to healthcare professional.  She asked if there was a possibility of getting a booster, call center representative told her per content there was no approved booster for Shingrix available.  The patient verbalized understanding. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 20th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced headache, fatigue, myalgia, pain and joint pain. On an unknown date, the outcome of the headache, fatigue, myalgia, pain and joint pain were unknown. It was unknown if the reporter considered the headache, fatigue, myalgia, pain and joint pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that a patient received a Shingrix dose. The patient developed myalgia, fatigue and headache (adverse event, unknown if recovered). The myalgia, fatigue and headache continued for weeks or months. The reporter reported that a patient, age unknown, received a dose of Shingrix. In 2020, after receiving Shingrix, she experienced pain all over and joint pain. It was unknown if the adverse events occurred after the first dose of Shingrix or the second dose of Shingrix. The pain all over and joint pain have lasted for months after the Shingrix was administered. The physician had ruled out rheumatoid arthritis and other auto-immune diseases. As of 8th December 2021, the patient continued to experience pain all over and joint pain. The reporter consented to follow up. Very limited information available. For tolerance to the 2nd dose refer case US2021AMR253393, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR253393:Same reporter.
Age: 0.83
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis. Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: A 10 month old patient received Kinrix instead of Pediarix which led to inappropriate age at vaccine administration and wrong vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: pediatric patient received adult dose; pediatric patient received adult Engerix-B; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 2-month-old female patient who received HBV (Engerix B adult) (batch number 39TZ2, expiry date 7th September 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th December 2021, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 6th December 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: Age at vaccination was not reported. Nurse reported that the pediatric patient received an adult Engerix-B dose, which led to overdose and adult product administered to child. The reporter consented to follow up.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: After the second dose she complained for several months of swollen lymph, so bad and it still continues but it improved; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (After the second dose she complained for several months of swollen lymph, so bad and it still continues but it improved) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer surgery.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (After the second dose she complained for several months of swollen lymph, so bad and it still continues but it improved). At the time of the report, LYMPHADENOPATHY (After the second dose she complained for several months of swollen lymph, so bad and it still continues but it improved) had resolved.            No concomitant medication was reported.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: RECEIVED HALF DOSE FOR BOOSTER; This spontaneous report received from a health care professional concerned multiple patients of unspecified age, race and ethnic origin. The patient's weight and height were not reported. No past medical history or concurrent conditions were reported. The patient was previously vaccinated with covid-19 vaccine ad26. cov2. S (series 1 - manufacturer unknown) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 01 total, start therapy date were not reported, for prophylactic vaccination. No adverse event were reported associated with previous with (series 1) covid-19 vaccine ad26. cov2. S. The patient received booster dose with covid-19 vaccine ad26.cov2.s (series 2) (suspension for injection, route of admin, and batch number were not reported) 0.25 ml dose, 01 total, start therapy date were not reported, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient  received half the dose for booster. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received half dose for booster was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211202199, 20211202193 and 20211202469. This report was associated with a product quality complaint: 90000204554.  The suspected product quality complaint has been confirmed to be voided (There is no product quality issue reported. Approval to void due to no identified.) based on the evaluation/investigation performed.
Age: 32.0
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 32 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination (Dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 or 211A21A expiry: unknown) dose was not reported, 1 total, administered on 27-NOV-2021 for prophylactic vaccination (Dose number in series 2). No concomitant medications were reported. HCP (health care provider) called to advise a patient that received a half dose of the Janssen COVID-19 vaccine for their booster dose On 27-NOV-2021 (vaccine underdose) and had off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for their booster dose and off label use was not reported This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211202193, 20211201228, 20211201168, 20211200752, 20211201351, 20211200994, 20211201450, 20211202199, 20211202469, 20211204104, 20211202379, 20211201082, 20211202515, 20211200675, 20211201304, 20211201392, 20211201443, 20211201963, 20211202161, 20211200717, 20211200723, 20211200769, 20211201362, 20211202207, 20211202246, 20211202371, 20211220152, 20211220146, 20211220262, 20211220250, 20211220145, 20211220619, 20211219926 and 20211220155.
Age: 74.0
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 74 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 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 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 and 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 underdose 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 (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, 20211209775, 20211209782, 20211209816, 20211212088, 20211212082, 20211210824, 20211210670, 20211210662, 20211210610, 20211210590, 20211210585, 20211210555, 20211210549, 20211210409, 20211210408, 20211210385, 20211210350, 20211210334, 20211210197, 20211210180, 20211210165, 20211210159, 20211210143, 20211210112, 20211210112, 20211210107, 20211209679, 20211209706, 20211209740, 20211209816, 20211210019, 20211210067, 20211210106, 20211210141, 20211210160, 20211210588, 20211209921, 20211209740, 20211209679, 20211210141, 20211210733, 20211210058, 20211209976, 20211209782, 20211209798 and 20211210058.
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 64 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, batch number and expiry were not reported) dose was not reported, 1 in total, administered (dose number in series 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 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."(dose number in series 2)  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 20211210684, 20211210197, 20211210409, 20211210067, 20211209551, 20211210160, 20211210058, 20211209843, 20211209775, 20211210549, 20211210610, 20211210159, 20211210555, 20211210733, 20211210408, 20211209880, 20211210133, 20211209816, 20211209782, 20211212088, 20211212082, 20211209740, 20211209706, 20211209798, 20211209874, 20211209884, 20211209921, 20211209976, 20211210019, 20211210106, 20211210107, 20211210141, 20211210112, 20211210143, 20211210165, 20211210180, 20211210334, 20211210350, 20211210385, 20211210585, 20211210588, 20211210590, 20211210670, 20211210824, 20211210662 and 20211209912.
Age: 42.0
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 42 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received covid-19 vaccine ad26. cov2. s from unspecified manufacturer (form of admin, route of admin, and batch number were not reported), 1 in total, dose was not reported 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, expiry: 11-APR-2022) with dose less than 0.5 ml (approximately around 0.3ml) 1 total, administered (Dose number in series 2) 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 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 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, 20211210160, 20211210058, 20211209843, 20211209775, 20211210549, 20211210610, 20211210159, 20211210733, 20211210408, 20211210555, 20211209880, 20211210133, 20211209816, 20211209782, 20211212088, 20211212082, 20211209679, 20211209740, 20211210588, 20211210670, 20211210824, 20211209912, 20211210350, 20211210141, 20211210585 and 20211210107.
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 65 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 ad26.cov2.s unspecified manufacturer (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, administered, (dose number in series:1) for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 11-APR-2022) dose was not reported, administered (dose number in series:2) on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-DEC-2021, the patient experienced the individual received less than 0.5ml of the janssen covid-19 vaccine as a booster dose. On 01-DEC-2021, the patient experienced 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 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, 20211210067, 20211209551, 20211209843, 20211210058, 20211210588, 20211210610, 20211210159, 20211210555, 20211210733, 20211210408, 20211209880, 20211210133, 20211209816, 20211209782, 20211209775, 20211212088, 20211212082, 20211209679, 20211210549, 20211210610, 20211210159, 20211209706, 20211209798, 20211209874, 20211209884, 20211209921, 20211209976, 20211210019, 20211210106, 20211210107, 20211210141, 20211210112, 20211210143, 20211210165, 20211210180, 20211210334, 20211210350, 20211210385, 20211210585, 20211210590, 20211210670, 20211210824 and 20211210662.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5ML OF VACCINE AS A BOOSTER DOSE (0.3 ML); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 45 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 under dose) (both events 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 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 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, 20211209551, 20211209976, 20211210160, 20211210058, 20211209679, 20211209706, 20211209816, 20211209874, 20211210588, 20211209880, 20211209912, 20211209921, 20211210019, 20211210019, 20211210107, 20211210107, 20211210067, 20211210141, 20211210143, 20211210165, 20211210350, 20211210385, 20211210409, 20211210549, 20211210585, 20211210588, 20211210610, 20211210670, 20211210733, 20211210555, 20211210408, 20211210133, 20211209782, 20211209740, 20211209843, 20211209884, 20211210067, 20211210112, 20211210112, 20211210159, 20211210180, 20211210408, 20211210197, 20211210334, 20211210555, 20211210585, 20211212088, 20211212082, 20211210662 and 20211210824.
Age: 44.0
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 44 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, 1 in total administered for prophylactic vaccination (dose number in series 1). It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: 11-APR-2022) dose was not reported, 1 in total, administered on left arm on 01-DEC-2021 for prophylactic vaccination (dose number in series 2) 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, 20211210058, 20211209551, 20211209679, 20211209706, 20211209740, 20211209782, 20211209798, 20211209816, 20211209874, 20211209884, 20211209912, 20211210019, 20211210058, 20211209921, 20211210588, 20211210610, 20211210159, 20211210555, 20211210408, 20211209880, 20211210133, 20211209775, 20211212088, 20211212082, 20211210670, 20211210824, 20211210160, 20211210350, 20211210141, 20211210585, 20211210107, 20211210180 and 20211210385.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5 ML OF THE JANSSEN COVID-19 VACCINE AS A BOOSTER DOSE (0.3 ML); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 49 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 received covid-19 vaccine ad26. cov2. s for prophylactic vaccination from unspecified manufacturer (form of admin, route of admin, and batch number were not reported), 1 in total, dose was not reported 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, expiry: 11-APR-2022) dose less than 0.5 ml (approximately around 0.3ml), administered on 01-DEC-2021 to left arm 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, the reporter mentioned that patient received less than 0.5 Milliliter (mL) of the vaccine as a booster dose approximately around 0.3 mL of dose (vaccine under dose and off label use) (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 the janssen covid-19 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, 20211209976, 20211210160, 20211210058, 20211209843, 20211209775, 20211210588, 20211210112, 20211210610, 20211210670, 20211210409, 20211210555, 20211210408, 20211209880, 20211210133, 20211209816, 20211209782, 20211212088, 20211212082, 20211209679, 20211209740, 20211210067, 20211210824 and 20211209912.
Age: 64.0
Sex: M
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 64-year-old male, 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 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) (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 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 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, 20211209976, 20211210197, 20211210409, 20211210067, 20211210160, 20211210058, 20211209843, 20211210549, 20211209775, 20211210159, 20211210610, 20211210555, 20211210408, 20211209880, 20211210133, 20211209816, 20211209782, 20211212088, 20211212082, 20211210824, 20211210588, 20211210670, 20211209551, 20211209679, 20211209740, 20211209798, 20211209874, 20211209884, 20211209706, 20211209843, 20211209921, 20211210019, 20211210350, 20211210106, 20211210107, 20211210112, 20211210141, 20211210143, 20211210165, 20211210180, 20211210334, 20211210385, 20211210590, 20211210662, 20211210733 and 20211209874.