chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 3 years ago, never had the 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-JUL-2022 Reporter's Comments: The case was reported via interactive digital media. The patient had a Shingrix shot 3 years ago but he/she never had the 2nd shot.  The patient asked if get the second shot now then he/she need a 3rd dose. Additional Supportive Information:  Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: Tired; Achy; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced tiredness and pain. On an unknown date, the outcome of the tiredness and pain were unknown.   The reporter considered the tiredness and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-Jul-2022 Reporters comment: This case was reported via interactive digital media. The reporter wanted to know that was it normal to get the side effects from the Shingle shot (tired, achy) to start a couple days after received first dose. Additional Supportive Information: Follow up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Influenza like illness, Pain
Clinical narrative: painful shot, will hurt; sick; flu like symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a 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 pain, sickness and influenza-like symptoms. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the sickness and influenza-like symptoms were not recovered/not resolved.   It was unknown if the reporter considered the pain, sickness and influenza-like symptoms to be related to Shingles vaccine.     Additional Information: GSK receipt date: 20-Jul-202 Reporter's comment: The case was reported by the consumer via interactive digital media. The patient reported that he/she had most painful shot ever and would hurt for 3 to 4 days. The patient had been sick since with flu like symptoms. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: I have enough nerve pain as it is; This case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the nerve pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 21-Jul-2022 Reporter's comment: The case was reported by the consumer via interactive digital media. The patient reported that he/she had first shot with no sore arm at all.  The patient did not want shingles. The patient had enough nerve pain as it was. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Pain in extremity
Clinical narrative: Arm is really sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient had the shingles in 2008 after having breast cancer), breast cancer, stress and nerve pain. Previously administered products included Shingles vaccine (The patient took the shingles shot in 2009).   In July 2022, the patient received the 1st dose of Shingles vaccine. In July 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date:21-JUL-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The shingles was worse than going through breast cancer.  The patient was told he/she needed the new shot but put it off because he/she would have to pay dollar 120.00 per shot. The patient stated that, which had to have two shots 2-6 months apart.  The patient broke his/her back in January and had been going through a lot of stress, he/she was sure that, he/she had the shingles again.  The same place on his/her back as before but he/she did not get the blisters this time but the nerve pain was horrible.  The patient stated that, it was terrible even without the blisters.  The patient further stated that, it seemed like his/her shingles were lasted about 5-6 weeks.  The patient just went a got the new shot 3 days ago.  The patient hoped the second shot would not make his/her arm as sore as this one did. The patient stated that his/her arm was really sore from the shot but he/she hope to never have shingles again. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: got sicker than hell; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 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 sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingles vaccine.  Additional Information: GSK Receipt Date:22-JUL-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got sicker than hell from it, but he/she was told that was better than getting shingles. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Induration, Pain in extremity, Skin warm
Clinical narrative: Arm is sore; arm is red; arm is hard; arm is hard as a rock; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In July 2022, the patient received the 2nd dose of Shingles vaccine. In July 2022, less than a month after receiving Shingles vaccine, the patient experienced pain in arm, erythema of extremities, feeling of warmth and induration. On an unknown date, the outcome of the pain in arm, erythema of extremities, feeling of warmth and induration were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, erythema of extremities, feeling of warmth and induration to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-July-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient just had second shot and experienced arm was sore, red, hot, hard as a rock.  The patient stated that this would pass in a couple days, but the patient had her/his friends who had shingles. Additional supportive information: As it was reported that just had my second shot conservatively the vaccination date and event onset date was captured as partial and the time to onset was captured accordingly. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first shot December 2020, second shot March 2022; This case was reported by a consumer via interactive digital media 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 shot in December 2020).   In March 2022, the patient received the 2nd dose of Shingles vaccine. In March 2022, 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 Information: GSK receipt date: 22-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient asked question that if his/her 1st shot was in December 2020 and 2nd shot in March 2022, how strong was the effectiveness. The patient also asked that two years was too long in between shots. Additional supportive information: The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccine schedule. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Feeling cold, Headache, Myalgia, Pyrexia
Clinical narrative: Severe shaking/shriving; Severe Coldness; Severe Muscle aches; Severe Increased temperature/fever; Severe Headache; severe weakness; This case was reported by a consumer and described the occurrence of tremor in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 9 hrs after receiving Shingrix, the patient experienced tremor, coldness, muscle pain, fever, headache and weakness. On an unknown date, the outcome of the tremor, coldness, muscle pain, fever, headache and weakness were not recovered/not resolved.   It was unknown if the reporter considered the tremor, coldness, muscle pain, fever, headache and weakness to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-JUL-2022 Reporter's Comment: This case was self-reported by patient. The patient received second dose of Shingrix and experienced the side effects that were severe as per reporter that included shaking or shriving, coldness, muscle aches, increased temperature or fever, headache, and weakness. These symptoms began after nine hours of receiving the shot.  The patient talked to PCP (primary care physician) on the day of reporting (24 hours) after the shot and she said that these were common, and the patient would feel better in a couple of days.
Sex: U
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Severe shaking/shriving; Severe Coldness; Severe Muscle aches; Severe Increased temperature/fever; Severe Headache; severe weakness; This case was reported by a consumer and described the occurrence of tremor in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 9 hrs after receiving Shingrix, the patient experienced tremor, coldness, muscle pain, fever, headache and weakness. On an unknown date, the outcome of the tremor, coldness, muscle pain, fever, headache and weakness were not recovered/not resolved.   It was unknown if the reporter considered the tremor, coldness, muscle pain, fever, headache and weakness to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-JUL-2022 Reporter's Comment: This case was self-reported by patient. The patient received second dose of Shingrix and experienced the side effects that were severe as per reporter that included shaking or shriving, coldness, muscle aches, increased temperature or fever, headache, and weakness. These symptoms began after nine hours of receiving the shot.  The patient talked to PCP (primary care physician) on the day of reporting (24 hours) after the shot and she said that these were common, and the patient would feel better in a couple of days.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Rash
Clinical narrative: Fatigue; rash on my stomach; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 22nd July 2022, the patient received the 1st dose of Shingles vaccine. In July 2022, less than a week after receiving Shingles vaccine, the patient experienced fatigue and rash. On an unknown date, the outcome of the fatigue and rash were not recovered/not resolved.   It was unknown if the reporter considered the fatigue and rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-JUL-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient had first vaccination the day before reporting. The patient was fatigued but that was common but the patient was concerned about a rash that came up on his/her stomach. The follow up not possible since contact details not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st dose 7 months ago.; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine  (received 1st dose 7 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 23-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient received his/her 1st dose 7 months ago and asked that the series did need to be reset. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling cold
Clinical narrative: Felt so cold; This case was reported by a consumer via interactive digital media and described the occurrence of feeling cold in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 22nd July 2022, the patient received Shingles vaccine. On 22nd July 2022, less than a day after receiving Shingles vaccine, the patient experienced feeling cold. On an unknown date, the outcome of the feeling cold was unknown.   It was unknown if the reporter considered the feeling cold to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-JUL-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received shingles vaccine on Friday (from the day of reporting). On Friday night, the patient felt so cold. The reporter wanted to know was it normal. Additional Supportive Information: The follow up would not possible, as no contact detail were available.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Malaise, Pyrexia
Clinical narrative: Chills; Fever; Exhaustion, fatigue; Malaise; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced chills, fever, exhaustion and malaise. On an unknown date, the outcome of the chills, fever, exhaustion and malaise were unknown.   It was unknown if the reporter considered the chills, fever, exhaustion and malaise to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-JUL-2022 Reporter's Comments:  This case was received from  consumer via interactive digital media. The patient was scheduled for a second dose. The patient had quite severe symptoms initially, chills, fever and fatigue. It then went on for several weeks of exhaustion, fatigue and malaise.  The reporter wanted to know was the patient likely to experience the same if she gets a second vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 18 months since first vaccine shot; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose 18 months ago ).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 25-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated that it had been 18 months since 1st vaccine shot. The patient asked that the patient should take 1st one again. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.  The follow-up could not be possible as no contact details were available.
Age: 8.0
Sex: U
Vaccine: MENB
Symptoms: Off label use
Clinical narrative: administered to 8 year old; This case was reported by a other health professional via sales rep and described the occurrence of off label use in a 8-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included asplenia (complex medical and family medical history).   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced off label use. On an unknown date, the outcome of the off label use 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 Information: GSK Receipt Date: 25-JUL-2022 Reporter's Comments:  The Bexsero vaccine was administered to 8 years old patient.  Health care professional was aware the use was off-label and stated risk vs benefit was assessed prior to vaccine administration. The patient was vaccinated with Bexsero without incident.  The reporter stated that if pharmacovigilance department needs additional patient-specific details, the patients care providers doctor details were given. No additional details available. The reporter did not consent to follow up. Additional Supportive Information: The patient received Bexsero vaccine at 8 years old, which led to Off label use.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received dose that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received HBV (Engerix B) (batch number D423N, expiry date 1st June 2022) for prophylaxis.   On 14th July 2022, the patient received Engerix B. On 14th July 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     Additional Information: GSK receipt date: 15-Jul-2022 Reporters comment: The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Engerix B, which led to expired vaccine used. This case was linked with case US2022107251, reported by the same reporter.; Sender's Comments:  US-GSK-US2022107251:Same reporter
Age: 0.5
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Younger than indicated age received Kinrix; Kinrix given to patient instead of Pediarix.; Pediarix 1st and 2nd, Kinrix 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received DTPa-IPV (Kinrix) (batch number PX27D, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (On unknown date patient received 1st dose of Pediarix) and Pediarix (On unknown date patient received 2nd dose of Pediarix).   On 13th October 2021, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 13th October 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of 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 Information: GSK Receipt Date: 15-JUL-2022 Reporter's Comments: The reporter was a pharmacist. The reporter stated that, the patient received Kinirix who was younger than the indicated age. The patient received Kinrix for third dose of DTaP. The patient was done with two doses of Pediarix. The reporter did the consent o follow up. Additional supportive information: The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The patient received Kinrix as a third dose in DTap and IPV series which was Pediarix should be the third dose which led to Inappropriate schedule of vaccine administered, and Wrong vaccine administered.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Urticaria
Clinical narrative: breaking out in Hives/ hivescontinued to return/outbreaks in new locations; Sleeping difficulty; This case was reported by a consumer via call center representative and described the occurrence of hives in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th July 2022, the patient received the 2nd dose of Shingrix. On 8th July 2022, 3 days after receiving Shingrix, the patient experienced hives. In July 2022, the patient experienced difficulty sleeping. The patient was treated with azithromycin (Z-Pak), prednisone, benadryl (nos) (Benadryl) and steroids nos (Steroids). On an unknown date, the outcome of the hives and difficulty sleeping were not recovered/not resolved.   It was unknown if the reporter considered the hives and difficulty sleeping to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-JUL-2022 Reporter's Comment: The case was reported by the patient and a nurse. The patient reported breaking out in hives shortly after receiving Shingrix.  The patient reported that, hives had continued to return, despite two shots of steroids and a Z-pack.  The reporter reported less than 2 weeks after vaccination, continuous outbreaks of hives had caused sleeping difficulty.  The had been treated with steroids, Benadryl, and Prednisone given.  However, he had new outbreaks in new locations, the hives were concentrated on trunk and groin but were all over his body.  The reporter nurse stated the vaccine was not given at their office, so they did not have the lot/expiry date. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: an adult patient received as a first dose a pediatric dose instead of an adult one; an adult patient received as a first dose a pediatric dose instead of an adult one; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 15-Jul-2022 Reporter's comment: Clinical pharmacist reported that an adult patient received pediatric dose instead of an adult one. Registered pharmacist had no information regarding patients' demographics and/or vaccination date. The consent to follow up was given. Additional Supportive Information: An adult patient received pediatric dose instead of an adult one, which led to underdose and adult use of a child product.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never got 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th October 2019).   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 Information: GSK Receipt Date: 18-JUL-2022 Reporter's Comment: Pharmacist reported that a patient never got a 2nd dose of Shingrix. The vaccine administration facility was the same as primary reporter. The reporter's consent to follow-up did not asked but contact info above. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. VAERS details was reported for 1st dose.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, IPV
Symptoms: Accidental overdose
Clinical narrative: administered concomitantly a Pediarix and Ipol; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 3-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number BY247, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and POLIOMYELITIS VACCINE (IPOL) for prophylaxis.   On 24th June 2022, the patient received Pediarix, Pediarix Pre-Filled Syringe Device and IPOL. On 24th June 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose 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 Information: GSK Receipt Date: 18-JUL-2022 Reporter's Comment: The other healthcare professional inadvertently administered concomitantly a Pediarix and Ipol non GSK polio to the patient. The nurse stated the other healthcare professional who administered the doses did not know that the Pediarix contains the Polio. The reporter consented to follow up. Additional supportive information: The patient received Ipol and Pediarix on same day, which led to overdose. This case was linked with case US2022107757, reported by same reporter. As it is not clear we are considering reported batch number belongs to Pediarix, Please provide confirmation in further follow up.; Sender's Comments:  US-GSK-US2022107757:same report, other patient
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, IPV
Symptoms: Overdose
Clinical narrative: administered concomitantly Pediarix and Ipol; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 5-year-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and POLIOMYELITIS VACCINE (IPOL) (batch number BY247, expiry date unknown) for prophylaxis.   On 24th June 2022, the patient received Pediarix, Pediarix Pre-Filled Syringe Device and IPOL. On 24th June 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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 Information: GSK Receipt Date: 18-Jul-2022 Reporters comment: Licensed Practical Nurse called into inquire what to look for and how to proceed. LPN reported they inadvertently administered concomitantly a Pediarix and Ipol (non-GSK polio) to 5 year old patient. Licensed Practical Nurse stated the other health care professional who administered the doses did not know that the Pediarix contains the Polio. The reporter consented to follow up. No other details provided from Licensed Practical Nurse. Additional supportive information: This case was linked to case US2022107758, reported by same reporter.; Sender's Comments:  US-GSK-US2022107758:same report, other patient
Sex: U
Vaccine: VARZOS
Symptoms: Renal disorder
Clinical narrative: possible renal complications after Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of renal disorder in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 18th July 2022, unknown after receiving Shingrix, the patient experienced renal disorder. On an unknown date, the outcome of the renal disorder was unknown.   It was unknown if the reporter considered the renal disorder to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-Jul-2022 Reporter's Comments: The reporter stated that there were possible renal complications after Shingrix vaccination. The other healthcare professional ended chat before agent able to confirm if a patient was involved or if this was a general enquiry. No consent for follow up obtained as other healthcare professional ended chat before agent could obtain.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: that an expired dose of Pediarix had been administered on 21Jun2022 to a 2 month old female patient.; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number TN7S9, expiry date 29th May 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st June 2022, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 21st June 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK receipt date: 18-JUL-2022 Reporter's comment: The nurse administrator reported that upon performing inventory and review, she discovered that the patient was administered a dose of Infanrix, which had an expiration date of 29th May 2022 to a 2 month old patient. This was the patient's first dose in the series. At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: The patient had received an expired dose of Infanrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Second dose not administered; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in April 2021, batch number: 9T355 expiry date: 11-SEP-2022).   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 Information: GSK Receipt Date: 19-Jul-2022 Reporter's Comments: Pharmacy intern reported that female patient received the first dose of Shingrix and second dose was not administered. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter. The VAERS details provided for 1st dose. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 40-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 229AN, expiry date 5th July 2022) for prophylaxis.   On 12th July 2022, the patient received the 1st dose of Boostrix. On 12th July 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 19-Jul-2022 Reporter comment: Certified medical assistant reported that expired dose was administered to a male patient. The reporter consented to follow up. Additional Supportive Information:  The patient was administered an expired dose of Boostrix, which led to expired vaccine used.
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: received expired dose of ROTARIX; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 3T77H, expiry date 11th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 14th July 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 14th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 19-JUL-2022. Reporter's Comments: No other symptoms reported. The reporter did not consent to follow-up. The reporter was transferred to medical information for further guidance and provided adverse event reference number to medical information agent. Additional Supportive Information: The patient received vaccine which was already expired on 11th July 2022, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: first dose in 2019, has not received second; Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In September 2021, more than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional Information: GSK Receipt Date: 19-JUL-2022 Reporter's Comment: The case was reported by the patient. The reporter who called in to report that, she received her Shingrix some time in 2019 (exact date unknown) and had not received second dose.  The patient also stated that, she developed a case of shingles in September 2021 (exact date unknown). The provided medical advice disclaimer. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pruritus, Rash, Tenderness
Clinical narrative: Pain over her nerves; Tenderness; Itching; total body rash (chest, back, extremities); This case was reported by a physician via call center representative and described the occurrence of nerve pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2022, the patient received the 1st dose of Shingrix. In July 2022, less than a week after receiving Shingrix, the patient experienced nerve pain, tenderness, itching and generalized rash. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the nerve pain, tenderness, itching and generalized rash were not recovered/not resolved.   It was unknown if the reporter considered the nerve pain, tenderness, itching and generalized rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-JUL-2022 Reporter's comments: The reporter who was a retired dermatologist had reported that a patient who was reporter's friend also in her fifties, had received her first dose of Shingrix about 1 week ago. The patient had developed pain over a linear area over her nerves, and total body rash (chest, back, extremities). The patient had subsequently received steroids even which did not help her. She was also experiencing itching and tenderness.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo reconstituted with wrong diluent; Wrong reconstituted Menveo administered; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva6564a, expiry date 1st January 2023) for prophylaxis.   On 18th July 2022, the patient received Menveo. On 18th July 2022, 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 Information: GSK Receipt Date: 19-JUL-2022 Reporter's Comment: The reporter was medical assistant. The reporter reported that, a patient received a Menveo vaccine that was reconstituted with the wrong diluent inadvertently. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, a patient received a Menveo vaccine that was reconstituted with the wrong diluent inadvertently, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2019 and not received 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   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 Information: GSK receipt date: 19-Jul-2022 Reporter's comment: The pharmacist reported that the patient received his first dose of SHINGRIX in 2019 the exact date was unknown and did not receive his second dose. Provided information per content on agency recommendations for alternative dosing regimens. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 1/22/2020,2nd dose 4/7/2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 86-year-old female patient who received Herpes zoster (Shingrix) (batch number L9F99, expiry date 10th May 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 22nd January 2020).   On 7th April 2022, the patient received the 2nd dose of Shingrix. On 7th April 2022, 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 Information: GSK receipt date: 19-JUL-2022 Reporter comment: The pharmacy intern called regarding dosing regimen for Shingrix. The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 month old got Kinrix; 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 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 6th August 2021, the patient received the 1st dose of Kinrix (intramuscular) .5 ml and Kinrix Pre-Filled Syringe Device. On 6th August 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 Information: GSK Receipt Date: 19-Jul-2022 Reporter's Comments: The nurse reported from a medical office that a 4 months old patient received a Kinrix vaccine. The vaccine was recommended for 4-6 years. The patient did not experienced any side effect. The reporter consented to follow up. Additional Supportive Information: The four months old patient was given Kinrix which led to inappropriate age at vaccine administration.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Feeling hot, Gait disturbance, Vomiting
Clinical narrative: threw up a little bit of orange stuff; needed help getting out of truck and into house,/could barely walk; Patient was weak. Heat, may have been warm; Heat, may have been warm; This case was reported by a pharmacist via sales rep and described the occurrence of vomiting in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number 2g2x7, expiry date 29th July 2023) for prophylaxis.   Previously administered products included Shingrix (received first dose on 28th April 2022).   On 19th July 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 19th July 2022, 30 min after receiving Shingrix, the patient experienced vomiting, unable to walk, weakness and feeling hot. On an unknown date, the outcome of the vomiting, unable to walk, weakness and feeling hot were unknown.   It was unknown if the reporter considered the vomiting, unable to walk, weakness and feeling hot to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-JUL-2022 Reporter's comment: The patient received a dose of Shingrix and was weak when he got home and needed help getting out of truck into the house. He could barely walk and threw up a little bit of orange stuff. He had been warm since there was no AC in car nor at home and he did not wanted to go to doctor as he suffered from heat and his truck had no AC. The reporter consented to follow up.
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Interchange of vaccine products, Pain, Paraesthesia
Clinical narrative: Adacel June 9th 2022, boostrix July 15th 2022; intermittent and sharp pain; pin and needles all over body; This case was reported by a physician via call center representative and described the occurrence of pain in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS TOXOID + TETANUS VACCINE TOXOID (ADACEL) for prophylaxis.   The patient's past medical history included tetanus.   On 15th July 2022, the patient received the 1st dose of Boostrix. On 9th June 2022, the patient received ADACEL. In July 2022, 3 days after receiving Boostrix, the patient experienced pain and pins and needles. On 15th July 2022, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the pain, pins and needles and interchange of vaccine products were unknown.   It was unknown if the reporter considered the pain and pins and needles to be related to Boostrix.     Additional Information: GSK Receipt Date: 19-JUL-2022 Reporter's Comments: The physician reported that she received Boostrix five weeks after receiving the initial dose as patient developed tetanus and it was advised as she needed to complete the primary series. Three days after receiving Boostrix patient developed pin and needles all over body (feet or hands or front or back except face). It was intermittent and sharp pain. The physician also reported that the patient received Adacel.   The reporter consented to follow up. Additional Supportive Information: The patient received a dose of Boostrix and Adacel, which led to interchange of vaccine products.