chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis
Clinical narrative: sweat; mild headache; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (sweat) and HEADACHE (mild headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweat) and HEADACHE (mild headache). At the time of the report, HYPERHIDROSIS (sweat) and HEADACHE (mild headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 32.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: This spontaneous report was received from Licensed Practical Nurse and refers to a 32-year-old female patient. The patient's medical history and concurrent conditions, as well as concomitant therapies, were not reported. On 21-DEC-2021, the patient was vaccinated in error with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, (lot #T032150, expiration date: 20-MAR-2022), administered for prophylaxis (strength and route of administration were not provided); the vaccines that were intended to be administered to the patient were measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and  varicella virus vaccine live (oka/merck) (manufacturer unknown). No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE; Temperature excursion involving administered PROQUAD; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 16-DEC-2021, the patient was vaccinated with temperature excursion involving Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) Lot# U022726 and expiration date 16-JAN-2023 (exact dose, route of administration and frequency were not reported) as prophylaxis.  No additional adverse event (AE) reported (No adverse event).  No PQC reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 20-DEC-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U015679, expiration date 18-MAY-2023 (anatomical location and route of administration were not reported) for prophylaxis (product storage error). No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Other-zoster related conditions; Shingles; Information has been received from a lawyer, regarding a case in litigation, concerning a patient (pt) of unknown age and gender. There was no information provided regarding the pt's concurrent conditions, medical history or concomitant medications. In or around 2012, the pt was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, anatomical location, and route of administration were not reported) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date, reported as subsequent to the zoster vaccine live (ZOSTAVAX) inoculation the pt was treated by physician for shingles and other zoster-related conditions. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX), the pt has and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Temperature 8.2F/ Time frame: 1 hours and 30 minutes; This spontaneous report has been received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not reported.   On 21-DEC-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route of administration, anatomical site of vaccination and vaccine scheme were not reported; lot number U020238 has been verified to be valid, expiration date reported and established as 28-JUN-2023) as prophylaxis.   The vaccine was exposed to a temperature excursion of 8.2 degrees Fahrenheit, during a time frame of 1 hour and 30 minutes (product storage error). There was no previous temperature excursion.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report has been received from medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided. On an unknown date, patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin)(PROQUAD), 0.5 milliliters (lot # U017138 has been verified to be a valid lot number, the expiration date was reported and established as 28-NOV-2022; strength, vaccination scheme, frequency, route of administration and anatomical site of vaccination were not reported)) for prophylaxis after a previously reported temperature excursion (product storage error) that was evaluated with a supported outcome. The vaccine was exposed to a temperature of 140F to 460F (16F), for a time frame of 15 minutes. There were previous temperature excursions of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) at temperature of 60F to 140F (9F) for 40 minutes and 60F to 140F (7F) for 30 minutes. No additional adverse event was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: body aches; arm pain; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th November 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced general body pain and pain in arm. On an unknown date, the outcome of the general body pain and pain in arm were recovered/resolved.   It was unknown if the reporter considered the general body pain and pain in arm to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient himself. Age at vaccination was not reported. The patient received first dose of Shingrix on 15th November 2021 and experienced arm pain and body aches which were later recovered. The patient later received second dose on 31st December 2021 within 46 days interval and experienced same symptoms and they were also later recovered on 3rd January 2022. The reporter wanted to know about efficacy when taken early. The reporter was requested to consent for follow up. This case is linked to US2022002058 and for tolerance of 2nd dose refer case US2022002058.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022002058:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: shingles/ unbelievable painful; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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 shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported.  The patient reported that he/she got one shingles vaccine shot then got the shingles for 6 month and it was unbelievable painful. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: FLU4
Symptoms: Injected limb mobility decreased
Clinical narrative: can't even move my both arms; This case was reported by a consumer via interactive digital media and described the occurrence of injected limb mobility decreased in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concurrent medical conditions included pain in arm.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injected limb mobility decreased was unknown.   It was unknown if the reporter considered the injected limb mobility decreased to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient stated that arm was very painful and then at the other arm he/she had the flu shot.  The patient could not even move his/her both arms. The follow-up could not be possible as no contact details were available.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Pain in extremity
Clinical narrative: feeling dizzy; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in September 2021).   On 4th January 2022, the patient received the 2nd dose of Shingrix. On 4th January 2022, less than a day after receiving Shingrix, the patient experienced pain in arm. On 6th January 2022, the patient experienced dizziness. On an unknown date, the outcome of the pain in arm and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and dizziness to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient experienced a sore arm and was unresolved. He also stated that 2 days after vaccination, he started feeling dizzy this morning (on the day of reporting) which was also unresolved. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022002790:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I received the first dose in May 2021; 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 in May 2021).   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 patient self-reported this case. The age at vaccination was not applicable for this report. The patient missed second Shingrix shot. Till the time of reporting the patient did not receive 2nd dose, which led to incomplete course of vaccination. The follow-up would not be possible as no contact details were available. This case has been linked to US2022AMR003246, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR003246:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Sinus headache
Clinical narrative: occasional sinus headache; This case was reported by a consumer via interactive digital media and described the occurrence of sinus headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (the patient had shingles in eye) and shingles (the patient had shingles on forehead).   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 sinus headache. On an unknown date, the outcome of the sinus headache was unknown.   It was unknown if the reporter considered the sinus headache to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient never wanted to get shingles and was very painful.  The patient received Shingles vaccine and had side effect of occasional sinus headache.  The patient asked that how long the shots last.  The patient asked that it was one and done or had to repeat both shots ever X years. The follow up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2022AMR003424 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR003424:Different dose
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 9th January 2021).   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. The patient received the first dose of Shingrix and had not received 2nd dose till the time of reporting, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: administration of an expired dose of Shingrix; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number c9gm4, expiry date 15th November 2021) for prophylaxis.   On 2nd January 2022, the patient received Shingrix. On 2nd January 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported but it could be 69 or 70 years The patient was given an expired dose of vaccine. No further events were reported . The reporter agreed to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022002051:same reporter US-GLAXOSMITHKLINE-US2022002054:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Administration of an expired dose of Shingrix; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number c9gm4, expiry date 15th November 2021) for prophylaxis.   On 4th January 2022, the patient received Shingrix. On 4th January 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported but it could be 72 or 73 years. The patient was given an expired dose of Shingrix. No further events were reported . The reporter consented to follow-up. This is one of the three cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022002054:same reporter US-GLAXOSMITHKLINE-US2022002050:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: administration of an expired dose of Shingrix; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number c9gm4, expiry date 15th November 2021) for prophylaxis.   On 2nd January 2022, the patient received Shingrix. On 2nd January 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported but it could be 68 or 69 years. The patient was given an expired dose of Shingrix. No further events were reported . The reporter agreed to follow up. This is one of three cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022002050:same reporter US-GLAXOSMITHKLINE-US2022002051:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Inappropriate schedule of product administration, Pain, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: body aches; arm pain/injection site pain; got the second dose early, about 46 days after dose 1; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on 15th November 2021 and experienced arm pain and body aches, refer case US2022AMR002316).   On 31st December 2021, the patient received the 2nd dose of Shingrix. On 31st December 2021, less than a day after receiving Shingrix, the patient experienced general body pain, pain in arm and drug dose administration interval too short. Rechallenge with Shingrix was positive. On 3rd January 2022, the outcome of the general body pain and pain in arm were recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the general body pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter called in to inquire what the timing was of the Shingrix second dose. Patient inadvertently got the second dose early, about 46 days after dose 1, which led to shortening of vaccination schedule. The reporter was provided dose schedule per package insert (PI) and medical advise disclaimer. The reporter wanted to know if there was any information on the efficacy when taken early, advised GlaxoSmithKline do not have any data on other dosing schedules. Patient refused to provide date of birth or mailing address or physician's information. Email was provided for follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR002316:same reporter
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: adult dose to a 19 month old patient; adult dose to a 19 month old patient; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 19-month-old female patient who received HAV (Havrix adult) (batch number g99r4, expiry date 20th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th January 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 4th January 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter reported that the administration of an adult dose of Havrix to an 19 month old patient, which led to overdose and adult product administered to child. No further events were reported. The reporter agreed to be contacted for follow-up.
Age: 0.17
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received HBV (Engerix B pediatric) (batch number 95SN2, expiry date 1st January 2022) for prophylaxis. Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis. On 5th January 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 5th January 2022, unknown after receiving Engerix B pediatric and Engerix B 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 details were provided as follows: Medical assistant reported that a patient received a dose of pediatric Engerix B that had already expired on 1st January 2022, which led to expired vaccine used. The reporter did not consent to follow up. The vaccine administration facility was same as primary reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose given 3-2020; 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 Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2020).   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. The reporter stated the patient missed the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter enquired does the patient need to restart the series, get 2 shingrix vaccines. The reporter declined to provide patient demographics. The reporter consented to follow up via email since mailing address was not asked.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site pain, Pruritus, Scab
Clinical narrative: Pain at the injection site; Itching; Small blisters; Scabbing; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose in September 2021).   In December 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain, pruritus, blister and scab. On an unknown date, the outcome of the injection site pain, pruritus, blister and scab were unknown.   It was unknown if the reporter considered the injection site pain, pruritus, blister and scab to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received Shingrix a week before reporting at the end of December 2021, since then she had noticed pain at the injection site.  The patient had itching, small blisters, and scabbing on her right wrist.  The patient was inquiring how to confirm if that was Shingles.  The reporter consented to follow up. The patient provided permission to contact health care professional.  No additional details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received a dose of adjuvant; received a dose of adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique and incorrect dose administered. On an unknown date, the outcome of the inappropriate reconstitution technique and incorrect dose administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that patient received a dose of Shingrix adjuvant that was not reconstituted with lyophillized powder which led to inappropriate reconstitution technique and incorrect dose administered. The reporter did not consented to follow up.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose on 08/18/2021, dose 2 on 1/5/2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 28-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 18th August 2021, with batch number xa4dd).   On 5th January 2022, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 5th January 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, 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.   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 2nd dose of Engerix-B later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter enquired if revaccination was needed. The reporter consented to follow up.
Age: 0.75
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 9 month old receiving Kinrix; receiving Kinrix instead of Pediarix; 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 9-month-old female patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd December 2020, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 22nd December 2020, 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 reporter was an Health care professionals. The patient had received a shot of Kinrix instead of Pediarix at 9 months of age, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter stated that they realized this mistake on Thursday before reporting date. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact
Clinical narrative: half of the vaccine dose ran down patient's arm; half of the vaccine dose ran down patient's arm; half of the vaccine dose ran down patient's arm; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number G9JA7, expiry date 15th April 2023) for prophylaxis.   On 29th December 2021, the patient received the 2nd dose of Shingrix. On 29th December 2021, unknown after receiving Shingrix, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.  Additional details were provided as follows: The reporter was an office manager. The reporter stated that when a medical assistant was administering a dose of Shingrix to the patient, the patient pulled away and almost half of the vaccine dose ran down the patient's arm, which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. At the time of the report, a repeat dose had not been given. The reporter consented to follow up.
Age: 0.5
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional adverse event; Drug administered to patient of inappropriate age; This spontaneous report was received from an office manager concerning a 6 months old patient. No information about the current condition, medical history or concomitant therapy was reported.   On 29-DEC-2021, pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and lot# were not reported) was administered to this 6-month-old patient for prophylaxis (product administered to patient of inappropriate age). No additional adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Received 3rd dose of Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated the patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter stated the third dose was done two years from the first series and wanted to know what should the patient expect in terms of side effects. The follow-up would not be possible as no contact details were available.
Age: 58.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Chills, Malaise, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: Chicken pox from shingrix vaccine; Red itchy bumps like chicken pox; Red itchy bumps like chicken pox; Red itchy bumps like chicken pox; Chills; Fever; General malaise; This case was reported by a consumer via call center representative and described the occurrence of chickenpox in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included MODERNA (COVID-19 VACCINE MODERNA) for covid-19 prophylaxis.   The patient's past medical history included chickenpox (The patient had the chicken pox when she was a kid).   On 3rd January 2022, the patient received Shingrix and COVID-19 VACCINE MODERNA. In January 2022, less than a week after receiving Shingrix and COVID-19 VACCINE MODERNA, the patient experienced chickenpox, itchy rash, varicella-like rash, red rash, chills, fever and general malaise. On an unknown date, the outcome of the chickenpox, itchy rash, varicella-like rash and red rash were not recovered/not resolved and the outcome of the chills, fever and general malaise were recovered/resolved.   It was unknown if the reporter considered the chickenpox, itchy rash, varicella-like rash, red rash, chills, fever and general malaise to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The patient also got the moderna booster at the same time that she got the Shingrix. The patient had chills, fever, general malaise for two days after vaccination, but now she was noticing red itchy bumps like chicken pox on torso. The patient had chicken pox from Shingrix vaccine. In January 2022, chills, fever and general malaise were resolved. The patient asked if Shingrix could cause chicken pox. The patient asked if she was contagious. It was unknown if the reporter considered the chills, fever, general malaise, itchy rash and chickenpox to be related to Covid-19 Vaccine Moderna.
Age: 58.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Rash vesicular, Varicella
Clinical narrative: Chicken pox from shingrix vaccine; Red itchy bumps like chicken pox; Red itchy bumps like chicken pox; Red itchy bumps like chicken pox; Chills; Fever; General malaise; This case was reported by a consumer via call center representative and described the occurrence of chickenpox in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included MODERNA (COVID-19 VACCINE MODERNA) for covid-19 prophylaxis.   The patient's past medical history included chickenpox (The patient had the chicken pox when she was a kid).   On 3rd January 2022, the patient received Shingrix and COVID-19 VACCINE MODERNA. In January 2022, less than a week after receiving Shingrix and COVID-19 VACCINE MODERNA, the patient experienced chickenpox, itchy rash, varicella-like rash, red rash, chills, fever and general malaise. On an unknown date, the outcome of the chickenpox, itchy rash, varicella-like rash and red rash were not recovered/not resolved and the outcome of the chills, fever and general malaise were recovered/resolved.   It was unknown if the reporter considered the chickenpox, itchy rash, varicella-like rash, red rash, chills, fever and general malaise to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The patient also got the moderna booster at the same time that she got the Shingrix. The patient had chills, fever, general malaise for two days after vaccination, but now she was noticing red itchy bumps like chicken pox on torso. The patient had chicken pox from Shingrix vaccine. In January 2022, chills, fever and general malaise were resolved. The patient asked if Shingrix could cause chicken pox. The patient asked if she was contagious. It was unknown if the reporter considered the chills, fever, general malaise, itchy rash and chickenpox to be related to Covid-19 Vaccine Moderna.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the Engerix B first dose on 5/7/21 / Engerix second dose 8/3/2 / Heplisav B on12/30/21; 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 55-year-old female patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 3rd August 2021, the patient received the 2nd dose of Engerix B. On 3rd August 2021, unknown after receiving Engerix B and an unknown time after receiving ENGERIX B, 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 reporter was a medical assistant. The patient received the Engerix B first dose on 7th May 2021. The patient received 2nd dose of Engerix B later than the recommended interval, which led to lengthening of vaccination schedule. The patient received Heplisav B on 30th December 2021. The reporter inquired that did this count for the complete Hepatitis B series, what to look for in the patient who had the interchange of vaccines. The reporter did not consent to follow-up.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 19-year-old male patient who received HBV (Engerix B adult) (batch number LN9539, expiry date 7th December 2021) for prophylaxis. Previously administered products included Engerix B (received 1st dose on an unknown date).  On 16th August 2021, the patient received the 2nd dose of Engerix B adult 20 ug. On 16th August 2021, unknown after receiving Engerix B adult, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown. Additional details were provided as follows: Pharmacist Manager called to report that a 19 year-old patient received Engerix-B 20 ug on his left arm, which led to overdose and inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2.s (Janssen, Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, 1 total, administered on 14-MAR-2021 for prophylactic vaccination. It was unknown if patient had adverse event following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (Janssen, Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient's son was symptomatic and tested positive on 24-DEC-2021. The patient reported exposure from son who was visiting from college.  On 30-DEC-2021, the patient was tested positive for COVID-19 using the home kit test sent by JnJ. He was feeling "a little bit under the weather" and reported symptoms such as a little bit of chills, difficulty breathing, fatigue, cough, and congestion (suspected covid-19 infection and suspected clinical vaccination failure) (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209617.; Sender's Comments: V0: 20211265893-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACK; This spontaneous report received from a consumer concerned a 49-year-old of an unspecified sex, race and ethnic origin. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, batch number were not reported, expiry: unknown) dose was not reported, (dose number in series 1), 01 in total was administered, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. The reporter had not reported any adverse events following vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient additionally received non-company suspect vaccine MRNA 1273 (form of administration, route of administration, batch number were not reported, expiry: unknown), dose was not reported, (dose number in series 2) start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, following vaccination with MRNA 1273, the patient had heart attack. On the next day (after vaccination) the patient died due to heart attack (dose number in series 2). It was not reported whether autopsy was performed or not. This report was serious (Death).; Sender's Comments: V0: 20220100315-COVID-19 VACCINE AD26.COV2.S-Heart attack. 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).; Reported Cause(s) of Death: HEART ATTACK
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FELT THE NEEDLE WENT CIRCULAR IN ARM; This spontaneous report received from a consumer concerned an male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s from an unspecified manufacturer (Dose number in series 1) (suspension for injection, route of admin not reported, and batch number: unknown, expiry: unknown), dose was not reported, 1 total administered for prophylactic vaccination. It was unknown whether patient had adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, and batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 23-DEC-2021 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 23-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s the patient felt the needle went circular in arm and the patient also mentioned he had never felt that before (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt the needle went circular in arm was unknown. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: MILD FLU; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously vaccinated with Covid-19 vaccine ad26. cov2.s (suspension for injection, route of administration, batch number and expiry date was not reported), (dose number in series 1) 01 in total, administered dose on an unspecified date in MAR-2021 for prophylactic vaccination. No adverse events were reported following vaccination with covid-19 vaccine ad26. cov2. s (dose number in series 1). The patient additionally received Covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of administration was not reported, batch number and expiry: unknown) dose was not reported, (dose number in series 2) 01 total administered on an unspecified date in DEC-2021 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 patient had mild flu (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild flu was unknown (dose number in series 2). This report was non-serious. This report was associated with product quality complaint: 90000210133. This case, from the same reporter is linked to 20220105485 and 20220105064.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: POSITIVE FOR COVID-19; This spontaneous report received from a patient via a company representative concerned a 66 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 03-JAN-2022, the patient experienced positive for covid-19. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of positive for covid-19 was not reported. This report was non-serious.  The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria, due to no PQC identified) based on the PQC evaluation/investigation performed.