chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Inappropriate schedule of product administration, Nausea, Pyrexia
Clinical narrative: got her first shingrix shot Novemember 2019 and due to the pandemic got her second shot yesterday; fever; headache; nausea; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in november 2019).   On 1st June 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In June 2021, 1 day after receiving Shingrix, the patient experienced fever, headache and nausea. On an unknown date, the patient experienced social problem. On an unknown date, the outcome of the fever, headache and nausea were not recovered/not resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the fever, headache and nausea to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received the 2nd dose of Shingrix on unknown arm , due to pandemic it was received late. It was stated that one day after the vaccination the patient experienced fever, headache and nausea. The reporter did not consent to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: reconstituted Shingrix Lyophilized powder with Normal Saline and administered to a patient; reconstituted Shingrix Lyophilized powder with Normal Saline and administered to a patient; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 59LK9, expiry date 18th December 2022) for prophylaxis.   On 2nd June 2021, the patient received Shingrix. On 2nd June 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The pharmacist reported that they reconstituted Shingrix lyophilized powder with normal saline and administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not consent to follow-up.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administration of the second dose after 2 weeks of receiving the first dose / first dose / on 5/13/2021 /second dose on  5/29/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 89-year-old female patient who received Herpes zoster (Shingrix) (batch number F5XN2, expiry date 8th October 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 29th May 2021, the patient received the 2nd dose of Shingrix. On 29th May 2021, unknown after receiving Shingrix and 16 days after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were reported as follows: The patient received 2nd dose less than 2 month apart from the 1st dose, which led to shortening of vaccination schedule. No further event was reported. The health care professional consented to follow-up
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: developed a headache about 15 hours after receiving / vaccine / has not resolved yet but is fading some; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2021, the patient received the 2nd dose of Shingrix (intramuscular). In June 2021, 15 hrs after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was recovering/resolving.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The patient developed a headache about 15 hours after receiving her second Shingrix vaccine.  The headache has not resolved yet but was fading some. The reporter did not consented to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: received Havrix that had been exposed to a freezing excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) (batch number 5575N, expiry date 19th June 2020) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. A medical assistant reported that the patient received Havrix that had been exposed to a freezing excursion, which led to Incorrect storage of drug The reporter consented to follow up. This is 1 of 11 cases reported by same reporter.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received the first three doses in 2018, but hasn't gotten the booster; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix with an associated reaction of no adverse event (received the first three doses in 2018).   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received booster dose of Twinrix, which led to incomplete course of vaccination. The reporter asked if the patient need to repeat the entire series. The health care professional declined to leave any patient details and declined follow up. The reporter did not consent to follow-up.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix was given to two patients 4 months of age; Kinrix was given to two patients 4 months of age instead of Pediarix.; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th May 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th May 2021, 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:  The licensed vocational nurse reported that Kinrix was given to a 4 months old patient instead of Pediarix, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter did not consent to follow-up. This case has been linked with US2021120511, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021120511:Same reporter
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix was given to two patients 4 months of age instead of Pediarix.; Kinrix was given to two patients 4 months of age instead of Pediarix.; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 13th 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 28th May 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th May 2021, 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:  The licensed vocational nurse reported that Kinrix was given to a 4 months old patient instead of Pediarix, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter did not consent to follow-up. This case has been linked with US2021120509, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021120509:Same reporter
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: a child was given the adult dose of Havrix.; a child was given the adult dose of Havrix.; This case was reported by a physician via call center representative and described the occurrence of overdose in a 1-year-old patient who received HAV (Havrix 1440 adult) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 28th May 2021, the patient received Havrix 1440 adult. On 28th May 2021, unknown after receiving Havrix 1440 adult, 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.  Additional details were provided as follows: The patient was given an adult dose of Havrix adult, which led to overdose and adult product administered to child. The reporter consented to follow up. This case is 1 of 9 linked reports which were reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021120532:same reporter US-GLAXOSMITHKLINE-US2021120523:same reporter US-GLAXOSMITHKLINE-US2021AMR121314:same reporter US-GLAXOSMITHKLINE-US2021120525:same reporter US-GLAXOSMITHKLINE-US2021120526:same reporter US-GLAXOSMITHKLINE-US2021120528:same reporter US-GLAXOSMITHKLINE-US2021120519:same reporter US-GLAXOSMITHKLINE-US2021120521:same reporter
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: a child was given Havrix adult.; a child was given Havrix adult.; This case was reported by a physician via call center representative and described the occurrence of overdose in a 1-year-old patient who received HAV (Havrix 1440 adult) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 25th May 2021, the patient received Havrix 1440 adult. On 25th May 2021, unknown after receiving Havrix 1440 adult, 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.  Additional details were provided as follows: The patient was given an adult dose of Havrix, which led to overdose and adult product administered to child. The reporter consented to follow up. This case is 1 of the 9 linked case which reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021120523:same reporter US-GLAXOSMITHKLINE-US2021120526:same reporter US-GLAXOSMITHKLINE-US2021120528:same reporter US-GLAXOSMITHKLINE-US2021120516:same reporter US-GLAXOSMITHKLINE-US2021AMR121314:same reporter US-GLAXOSMITHKLINE-US2021120521:same reporter US-GLAXOSMITHKLINE-US2021120525:same reporter US-GLAXOSMITHKLINE-US2021120532:same reporter
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: child was accidentally given the adult (1440 EL.U.ml) of Havrix; child was accidentally given the adult (1440 EL.U.ml) of Havrix; This case was reported by a physician via call center representative and described the occurrence of accidental overdose in a 2-year-old patient who received HAV (Havrix 1440 adult) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 26th May 2021, the patient received Havrix 1440 adult. On 26th May 2021, unknown after receiving Havrix 1440 adult, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.  Additional details were provided as follows: The patient was accidentally administered adult(1440 EL.U.ml) of Havrix, which led to accidental overdose and adult administered to child. The reporter consented to follow up. This case is 1 of the 7 link cases.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021120528:same reporter US-GLAXOSMITHKLINE-US2021120525:same reporter US-GLAXOSMITHKLINE-US2021120526:same reporter US-GLAXOSMITHKLINE-US2021AMR121314:same reporter US-GLAXOSMITHKLINE-US2021120523:same reporter US-GLAXOSMITHKLINE-US2021120519:same reporter US-GLAXOSMITHKLINE-US2021120516:same reporter US-GLAXOSMITHKLINE-US2021120532:same reporter
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: a child was / given the adult (1440 EL.U.ml) of Havrix.; a child was accidentally given the adult (1440 EL.U.ml) of Havrix.; This case was reported by a physician via call center representative and described the occurrence of adult product administered to child in a 19-month-old patient who received HAV (Havrix 1440 adult) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On an unknown date, the patient received Havrix 1440 adult. On an unknown date, unknown after receiving Havrix 1440 adult, the patient experienced adult product administered to child and accidental overdose. On an unknown date, the outcome of the adult product administered to child and accidental overdose were unknown.  Additional details were provided as follows:  This case was reported by a medical doctor (pediatrician). The age at vaccination was not reported. The patient was accidentally given the adult (1440 EL.U.ml) of Havrix, which led to adult product administered to child and accidental overdose. The reporter consented to follow-up. This was 1 of the 9 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021120532:same reporter US-GLAXOSMITHKLINE-US2021120528:same reporter US-GLAXOSMITHKLINE-US2021120526:same reporter US-GLAXOSMITHKLINE-US2021120525:same reporter US-GLAXOSMITHKLINE-US2021120521:same reporter US-GLAXOSMITHKLINE-US2021120516:same reporter US-GLAXOSMITHKLINE-US2021AMR121314:same reporter
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: child was given the adult Havrix; child was given the adult Havrix; This case was reported by a physician via call center representative and described the occurrence of overdose in a 1-year-old patient who received HAV (Havrix adult) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 27th May 2021, the patient received Havrix adult. On 27th May 2021, unknown after receiving Havrix adult, 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.  Additional details were provided as follows: The patient were given an adult dose of Havrix, which led to overdose and adult product administered to child. The reporter consented to follow up. This case was one of 9 linked reports which were reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021120523:same reporter US-GLAXOSMITHKLINE-US2021120525:same reporter US-GLAXOSMITHKLINE-US2021AMR121314:same reporter US-GLAXOSMITHKLINE-US2021120532:same reporter US-GLAXOSMITHKLINE-US2021120526:same reporter US-GLAXOSMITHKLINE-US2021120516:same reporter US-GLAXOSMITHKLINE-US2021120519:same reporter US-GLAXOSMITHKLINE-US2021120521:same reporter
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: a child was given the adult dose of Havrix.; a child was given the adult dose of Havrix.; This case was reported by a physician via call center representative and described the occurrence of adult product administered to child in a 1-year-old patient who received HAV (Havrix 1440 adult) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 28th May 2021, the patient received Havrix 1440 adult. On 28th May 2021, unknown after receiving Havrix 1440 adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional details were provided as follows:  This case was reported by a medical doctor (pediatrician). The patient was given the adult dose of Havrix, which led to adult product administered to child and overdose. The reporter consented to follow-up. This was 1 of the 9 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021120523:same reporter US-GLAXOSMITHKLINE-US2021120532:same reporter US-GLAXOSMITHKLINE-US2021120528:same reporter US-GLAXOSMITHKLINE-US2021120526:same reporter US-GLAXOSMITHKLINE-US2021120521:same reporter US-GLAXOSMITHKLINE-US2021120519:same reporter US-GLAXOSMITHKLINE-US2021120516:same reporter US-GLAXOSMITHKLINE-US2021AMR121314:same reporter
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: child was given the adult dose of Havrix.; child was given the adult dose of Havrix.; This case was reported by a physician via call center representative and described the occurrence of adult product administered to child in a 12-month-old patient who received HAV (Havrix 1440 adult) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 28th May 2021, the patient received Havrix 1440 adult. On 28th May 2021, unknown after receiving Havrix 1440 adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional details were provided as follows:  This case was reported by a medical doctor (pediatrician). The patient was given the adult dose of Havrix, which led to adult product administered to child and overdose. The reporter consented to follow-up. This was 1 of the 9 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021120523:same reporter US-GLAXOSMITHKLINE-US2021AMR121314:same reporter US-GLAXOSMITHKLINE-US2021120532:same reporter US-GLAXOSMITHKLINE-US2021120525:same reporter US-GLAXOSMITHKLINE-US2021120528:same reporter US-GLAXOSMITHKLINE-US2021120521:same reporter US-GLAXOSMITHKLINE-US2021120519:same reporter US-GLAXOSMITHKLINE-US2021120516:same reporter
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: pediatric patients (children) were given the adult dose of Havrix.; pediatric patients (children) were given the adult dose of Havrix.; This case was reported by a physician via call center representative and described the occurrence of overdose in a patient who received HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, 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.  Additional details were provided as follows: The age at vaccination was not reported. The patient was given an adult dose of Havrix, which led to overdose and adult product administered to child. The pediatrician´s office was still trying to identify the patient. The patient identifiers were not available at the moment. The reporter consented to follow up. This case was one of 9 linked reports which were reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021120523:same reporter US-GLAXOSMITHKLINE-US2021120516:same reporter US-GLAXOSMITHKLINE-US2021120521:same reporter US-GLAXOSMITHKLINE-US2021120525:same reporter US-GLAXOSMITHKLINE-US2021120526:same reporter US-GLAXOSMITHKLINE-US2021120528:same reporter US-GLAXOSMITHKLINE-US2021AMR121314:same reporter US-GLAXOSMITHKLINE-US2021120519:same reporter
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 month old / patient received a Boostrix injection; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 3rd June 2021, the patient received Boostrix (intramuscular). On 3rd June 2021, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The reporter informed that 15 month old patient received a Boostrix injection, which led to inappropriate age at vaccine administration. No patient initials or DOB (date of birth) was known or provided. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient has received 1st dose / 10 months ago / did not come back to receive dose 2; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2020, 10 months ago from the day of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not come back and receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. Details were reported for 1st dose. The batch number and expiration date was not provided. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Headache, Muscle spasms, Neck pain
Clinical narrative: join pain/ Pain in knees and ankles; cramping in hands and legs; neck pain; bad headaches; chills; This case was reported by a nurse via call center representative and described the occurrence of joint pain in a 65-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3E52S, expiry date 21st June 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th May 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. In May 2021, 1 week after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced joint pain, cramp of limb, neck pain, headache and chills. The patient was treated with ibuprofen. On an unknown date, the outcome of the joint pain, cramp of limb, neck pain, headache and chills were not recovered/not resolved.   It was unknown if the reporter considered the joint pain, cramp of limb, neck pain, headache and chills to be related to Boostrix and Boostrix 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 provided as follows: The patient received a dose of Boostrix and experienced several adverse reactions included cramping on hands and legs, join pain, chills, pain in knees and ankles, bad headaches, neck pain. The reporter mentioned that the patient was not recovered yet and had been taking ibuprofen as a treatment, that seemed to be helping with the symptoms. The reporter also stated that the patient had been needing braces for her knees and ankles. The reporter consented to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: adult patient received a pediatric dose of Havrix; adult patient received a pediatric dose of Havrix; This case was reported by a physician via call center representative and described the occurrence of adult use of a child product in a adult patient who received HAV (Havrix pediatric) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd June 2021, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 3rd June 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose 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 adult patient received a pediatric dose of Havrix which led to adult use of a child product and underdose. The reporter declined to provide patient information and did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix in December of 2018 / second dose of Shingrix in December of 2020; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2018).   In December 2020, the patient received the 2nd dose of Shingrix. In December 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 reported as follows: The reporter was patient's wife.  The age at vaccination was not reported. The patient received 2nd dose later then the recommended interval, which led to lengthening of vaccination schedule The reporter did not consent to follow-up and did not give permission to contact the healthcare professional.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Night sweats, Pain
Clinical narrative: Shingrix vaccine on Tuesday morning, on Wednesday he felt tired; Shingrix vaccine on Tuesday morning, on Wednesday he felt / achey the next day; sweating in sleep last night; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2021, the patient received the 1st dose of Shingrix. On 2nd June 2021, 1 days after receiving Shingrix, the patient experienced tiredness, pain and night sweat. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the tiredness, pain and night sweat were recovered/resolved.   It was unknown if the reporter considered the tiredness, pain and night sweat to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The age at vaccination was not reported. On the morning of 1st June 2021, the patient got the first Shingrix vaccine.  The patient felt tired and achey the next day of vaccination and had sweating in sleep on the night before the reporting date.  The patient took some advil and felt better.  The reporter did not consent to follow-up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No reaction on previous exposure to drug
Clinical narrative: first dose of Shingrix on September 20th 2020 and the second dose on June 3rd 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 44DX9, expiry date 8th October 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on 20th September 2020).   On 3rd June 2021, the patient received the 2nd dose of Shingrix. On 3rd June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 2nd dose, more than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Illness, Pyrexia
Clinical narrative: SICK FOR DAYS; FELT LIKE BRAIN WAS ON FIRE; CHILLS; FEVER; 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 not reported, batch number: Unknown) 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 subject experienced sick for days, felt like brain was on fire, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick for days, fever, chills and felt like brain was on fire was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness, Lymphadenopathy
Clinical narrative: SWOLLEN LYMPH NODES IN THE BACK OF NECK; STIFF KNEES; JOINT PAIN/KNEE WAS SORE; This spontaneous report received from a patient via (other manufacturer- Abbvie ) concerned a 64 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, intramuscular, batch number was not reported) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 1 week, therapy dates were not reported for moderate to severe chronic plaque psoriasis, and moderate to severe rheumatoid arthritis. Concomitant medications included methotrexate for drug used for unknown indication.  On 2021, the subject experienced stiff knees. On 2021, the subject experienced joint pain/knee was sore. On 16-MAR-2021, the subject experienced swollen lymph nodes in the back of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen lymph nodes in the back of neck on 2021, was recovering from joint pain/knee was sore, and the outcome of stiff knees was not reported. This report was non-serious.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Pain in extremity
Clinical narrative: SORENESS OF BOTH ARM; This spontaneous report received from a consumer concerned an 83-year-old female. The patient's weight was 180 pounds, and height was 148 centimeters. The patient's concurrent conditions included high-blood pressure- 142/69, non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known allergies. There was no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21L, and batch number: 206A21L expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAY-2021, the subject experienced soreness of both arm. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 142/69 mmHg.  Treatment medications (dates unspecified) included: Paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness of both arm. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test, Chills, Malaise, Pain in extremity
Clinical narrative: ALMOST PASSED OUT; SKIN LOOKED WHITE AND PALE; MILD PAIN IN  STOMACH; LEG HURTS; CHILLS (FEELING COLD AND SHIVERING); FEELING UNWELL; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's past medical history included nose bleed, and other pre-existing medical conditions included patient had no other health condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-JUN-2021, the subject experienced almost passed out. On 02-JUN-2021, the subject experienced skin looked  and pale. On 02-JUN-2021, the subject experienced mild pain in stomach. On 02-JUN-2021, the subject experienced leg hurts. On 02-JUN-2021, the subject experienced chills (feeling cold and shivering). On 02-JUN-2021, the subject experienced feeling unwell. Laboratory data (dates unspecified) included: Blood test (NR: not provided) low platelet count. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from almost passed out, had not recovered from skin looked white and pale, leg hurts, and chills (feeling cold and shivering), and the outcome of mild pain in stomach and feeling unwell was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Presyncope
Clinical narrative: ALMOST PASSED OUT; SKIN LOOKED WHITE AND PALE; MILD PAIN IN  STOMACH; LEG HURTS; CHILLS (FEELING COLD AND SHIVERING); FEELING UNWELL; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's past medical history included nose bleed, and other pre-existing medical conditions included patient had no other health condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-JUN-2021, the subject experienced almost passed out. On 02-JUN-2021, the subject experienced skin looked  and pale. On 02-JUN-2021, the subject experienced mild pain in stomach. On 02-JUN-2021, the subject experienced leg hurts. On 02-JUN-2021, the subject experienced chills (feeling cold and shivering). On 02-JUN-2021, the subject experienced feeling unwell. Laboratory data (dates unspecified) included: Blood test (NR: not provided) low platelet count. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from almost passed out, had not recovered from skin looked white and pale, leg hurts, and chills (feeling cold and shivering), and the outcome of mild pain in stomach and feeling unwell was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: DRUG EXPOSURE VIA BREAST MILK; This spontaneous report received from a patient concerned a 3 day old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported .The patient's parent (mother) received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 31-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 31-MAY-2021, the subject experienced drug exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from drug exposure via breast milk. This report was non-serious. This parent/child case is linked to another report.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Thrombosis
Clinical narrative: SEVERE BLOOD CLOTTING; OTHER ISSUES; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age and unknown 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 not reported, batch number: not reported) dose, 1 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 experienced severe blood clotting and other issues (coded to unspecified adverse event) after receiving the one-dose COVID-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe blood clotting and other issues was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210604196-covid-19 vaccine ad26.cov2.s-Severe blood clotting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Speech disorder
Clinical narrative: PROBLEM SPEAKING; COMPLAINT NOT CONFIRMED; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) 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 subject experienced problem speaking, and complaint not confirmed. The action taken with covid-19 vaccine was not applicable. The outcome of the problem speaking and complaint not confirmed was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: WRONG VACCINE ADMINISTERED; This spontaneous report received from a health care professional 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 was previously treated with mrna 1273 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the subject experienced wrong vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of wrong vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210603388.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: LOW-GRADE FEVER; This spontaneous report received from a patient 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 not reported, batch number: UNKNOWN) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced low-grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low-grade fever on 2021. This report was non-serious. This case, from the same reporter is linked to 20210604983.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: FAST HEART RATE; SHORTNESS OF BREATH; This spontaneous report received from a parent concerned a 20 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: Unknown) dose was not reported, administered on 02-JUN-2021 09:15 am for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 02-JUN-2021, the subject experienced fast heart rate. On 02-JUN-2021, the subject experienced shortness of breath. Laboratory data included: Heart rate (NR: not provided) 99. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fast heart rate, and shortness of breath. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Injection site cellulitis, Pain in extremity
Clinical narrative: LOOKS LIKE CELLULITIS AT THE INJECTION SITE DOWN TO HER ELBOW; EXTREME BACK PAIN; BURNING AND SHARP PAIN TO WRIST, HAND, KNUCKLES THEN IT WENT UP ARM/ TIGHTNESS AND TENDERNESS IN ARM; HEADACHE; This spontaneous report received from a patient concerned a 55 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: 207A21A,, expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced looks like cellulitis at the injection site down to her elbow. On MAY-2021, the subject experienced extreme back pain. On MAY-2021, the subject experienced burning and sharp pain to wrist, hand, knuckles then it went up arm/ tightness and tenderness in arm. On MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, burning and sharp pain to wrist, hand, knuckles then it went up arm/ tightness and tenderness in arm, extreme back pain and looks like cellulitis at the injection site down to her elbow was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.