chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: SUSPECTED VACCINATION FAILURE/had the shot /HAD THEM TWICE; had them twice; painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain 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 had shot and had shingles twice in 30 years. The patient stated that it was most painful misery ever. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had Shingles twice. Also had the vaccine twice\ suspected vaccination failure; had shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles vaccine twice and had the shingles twice. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling cold, Feeling hot, Pain
Clinical narrative: little achy; Became very cold; feel warm; 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.   Previously administered products included shingles vaccine (1st dose received on an unknown date).   On 8th January 2022, the patient received the 2nd dose of Shingles vaccine. On 8th January 2022, less than a day after receiving Shingles vaccine, the patient experienced feeling cold and feeling of warmth. On an unknown date, the patient experienced pain. On 8th January 2022, the outcome of the feeling cold was recovered/resolved. On an unknown date, the outcome of the feeling of warmth and pain were recovered/resolved.   It was unknown if the reporter considered the feeling cold, feeling of warmth and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient self reported the case. On the reporting day, the patient was given 2nd dose of Shingles vaccine. The patient became very cold for about 4 hours and then felt warm and a little achy. The patient commented that, he/she knew peoples who got shingles. Reporter did not consented to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: I got both vaccine less than one year I got the Shingles\ suspected vaccination failure; Shingles; suffering with nerve pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got both Shingles vaccine less than one year got the Shingles. The patient was still suffering with nerve pain after three years. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; 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.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 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.     Linked case(s) involving the same patient:  US2022AMR004600  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient had a sore arm for a day or two after the shot. The patient commented like, but this pain beats the years of heaving nerve pain. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR004601:same reporter - other patient
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got th shot / got shingles/ suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got Shingles shot and month later got shingles. The patient was glad to have the Shingles shot or they would have been so much worse. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Glaucoma, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Now has glaucoma; Now broken out with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included ankle operation (had major surgery on ankle 13 years ago from reporting date) and shingles (on face).   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), glaucoma (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the glaucoma and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, glaucoma and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's wife. The age at vaccination was not reported. The patient received new Shingles vaccine, last one months ago from the date of reporting and the patient had broken out with shingles on his back at the time of reporting. The patient now also had glaucoma. The patient asked if this Shingles shot did any good or was it just a money maker. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling hot, Illness, Induration, Pain in extremity
Clinical narrative: Sore arm; Hard arm; Hot arm; Felt sick; 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.   Previously administered products included covid 19 vaccine (received covid shots on an unknown date). Concurrent medical conditions included autoimmune disorder.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm, induration, extremities hot feeling of and sickness. On an unknown date, the outcome of the pain in arm, induration and extremities hot feeling of were unknown and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the pain in arm, induration, extremities hot feeling of and sickness to be related to Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that he/she had numerous autoimmune diseases and the Covid shots did the same thing. After receiving Shingles vaccine, the patient experienced hard, hot sore arm and also felt sick for a few days. The patient's doctor said he/she need to keep massaging the area to disperse the medicines. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Malaise
Clinical narrative: sick for 48 hours; 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 recovered/resolved.   It was unknown if the reporter considered the sickness 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 stated that like Covid, his/her Shingles shot made him/her sick for 48 hours. The patient was not sure he/she would get the second dose. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administerd only the Liquid Component; administerd only the Liquid Component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number MAXA587A, expiry date 31st May 2023) for prophylaxis.   On 6th January 2022, the patient received Menveo. On 6th January 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: This case was reported by the medical assistant. The age at vaccination was unknown. The patient was inadvertently administered only the liquid component of (MenCWY) of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow-up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: Shingrix on February 10, 2020 / 2nd dose on the 16th of September 2021; outbreak of shingles; Exhaustion; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th February 2020).   On 16th September 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 16th September 2021, immediately after receiving Shingrix, the patient experienced shingles, exhaustion and drug dose administration interval too long. On an unknown date, the outcome of the shingles and exhaustion were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the shingles and exhaustion to be related to Shingrix.  Additional details were provided as follows: The patient self-reported the case. The patient received 2nd dose of Shingrix later than the recommended schedule which led to lengthening of vaccination schedule. Shortly after receiving the second dose of Shingrix, the patient had an outbreak of shingles and exhaustion that lasted about 5 weeks. No lot number or expiration date was known. The patient declined to provide healthcare professionals information. The reporter did not consent to follow up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Chills, Eye irritation, Eye pain, Eye pruritus
Clinical narrative: headache; shivering; pain all over; one to one and a half inch blister; Itchy spots like mosquito bites; red spots; swollen spots; Itchy eyes; Burning eyes; itchy, burning eyes (AE: itch, pain; recovered); This case was reported by a consumer via call center representative and described the occurrence of headache in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2021, the patient received the 1st dose of Shingrix (intramuscular). In December 2021, less than a day after receiving Shingrix, the patient experienced headache, shivering, general body pain, blister, itchy rash, red spotty rash, papular rash, eye pruritus, burning in eyes and eye pain. On an unknown date, the outcome of the headache, shivering, general body pain, eye pruritus, burning in eyes and eye pain were recovered/resolved and the outcome of the blister, itchy rash, red spotty rash and papular rash were not recovered/not resolved.   It was unknown if the reporter considered the headache, shivering, general body pain, blister, itchy rash, red spotty rash, papular rash, eye pruritus, burning in eyes and eye pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received his first Shingrix dose about 3 weeks prior to the reporting date.  That evening he had headache, shivering and pain all over that he describes as feeling like he had been hit by a truck. The shivering and pain resolved after a few days. The headache continued more than a few days but was now resolved.  Three or four days after vaccination he developed a one to one and a half inch blister on his hip.  At that time, patient developed itchy, red, swollen spots on his back that look like mosquito bites.  The patient had not been anywhere to had been bitten by mosquitoes.  Also, about three to four days after vaccination patient had itchy, burning eyes.  The patient had consulted a dermatologist friend who recommended he had a biopsy done on the hip blister. The patient had nothing else to report. The reporter consented to follow up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain, Rash macular, Rash papular, Rash pruritic
Clinical narrative: headache; shivering; pain all over; one to one and a half inch blister; Itchy spots like mosquito bites; red spots; swollen spots; Itchy eyes; Burning eyes; itchy, burning eyes (AE: itch, pain; recovered); This case was reported by a consumer via call center representative and described the occurrence of headache in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2021, the patient received the 1st dose of Shingrix (intramuscular). In December 2021, less than a day after receiving Shingrix, the patient experienced headache, shivering, general body pain, blister, itchy rash, red spotty rash, papular rash, eye pruritus, burning in eyes and eye pain. On an unknown date, the outcome of the headache, shivering, general body pain, eye pruritus, burning in eyes and eye pain were recovered/resolved and the outcome of the blister, itchy rash, red spotty rash and papular rash were not recovered/not resolved.   It was unknown if the reporter considered the headache, shivering, general body pain, blister, itchy rash, red spotty rash, papular rash, eye pruritus, burning in eyes and eye pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received his first Shingrix dose about 3 weeks prior to the reporting date.  That evening he had headache, shivering and pain all over that he describes as feeling like he had been hit by a truck. The shivering and pain resolved after a few days. The headache continued more than a few days but was now resolved.  Three or four days after vaccination he developed a one to one and a half inch blister on his hip.  At that time, patient developed itchy, red, swollen spots on his back that look like mosquito bites.  The patient had not been anywhere to had been bitten by mosquitoes.  Also, about three to four days after vaccination patient had itchy, burning eyes.  The patient had consulted a dermatologist friend who recommended he had a biopsy done on the hip blister. The patient had nothing else to report. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2022, the patient received the 1st dose of Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not reported. The patient had received his first dose of Shingrix a day before reporting.  He stated that he experienced a sore arm after his dose which had not resolved till the time of reporting. The reporter did not consent to follow-up. Reporter did not wish to provide an address or date of birth.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Menveo expired and was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA431A, expiry date 20th October 2021) for prophylaxis.   On 3rd January 2022, the patient received Menveo. On 3rd January 2022, unknown after receiving Menveo, 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. The patient received expired dose of menveo, which led to expired vaccine used. No reactions reported. The reporter consented to follow up.
Age: 0.67
Sex: U
Vaccine: RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received Rotarix, patient is eight months old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-month-old patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   Concomitant products included ROTAVIRUS VACCINE (ROTATEQ) and ROTAVIRUS VACCINE (ROTATEQ).   On an unknown date, the patient received Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator 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 details were provided as follows: The nurse reported that, the patient might have received a dose of Rotarix after starting the series with two doses of Rotateq. The patient received dose of Rotarix at the age of 8 months old, which led to inappropriate age at vaccine administration. It was unknown whether this occurred a few months ago. The reporter did not consent to follow up.
Age: 38.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 38-year-old female patient who received HAV (Havrix) (batch number E9G4E, expiry date 29th December 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th January 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 10th January 2022, unknown after receiving Havrix and Havrix 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: The office coordinator reported that, patient received an expired dose of Havrix, which led to expired vaccine used. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling at the injection site; Redness at the injection site; Pain at the injection site; area is oval in shape and tender to the touch; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2022, the patient received the 2nd dose of Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site pain and tenderness. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site pain and tenderness were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain and tenderness to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced pain, redness, and swelling at the injection site. The patient also stated that the area was oval in shape and tender to the touch, it was not resolving. The patient was inquiring about treatment recommendations. The reporter was provided medical advice disclaimer. Spoke from Shingrix frequent asked questions (FAQs). The reporter was referred to HCP.  No additional details were provided. The patient provided permission to contact HCP. The reporter consented to follow-up.
Age: 40.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Interchange of vaccine products, Product administered to patient of inappropriate age
Clinical narrative: already had 1 dose of Bexsero; already had 1 dose of Bexsero and Menactra; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 40-year-old female 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 and MENACTRA for prophylaxis.   Concurrent medical conditions included infusion (had infusion called Solaris).   In October 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, the patient received the 1st dose of MENACTRA. In October 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and interchange of vaccine products. On an unknown date, the outcome of the inappropriate age at vaccine administration and interchange of vaccine products 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 patient was on an infusion called solaris and received dose of Bexsero and Menactra, which led to inappropriate age at vaccine administration and interchange of vaccine products. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Vaccinated about 5 years ago, Aug2021 had Shingles; Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 71-year-old male 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 August 2021, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with Shingrix about 5 years ago and in August 2021, he had a case of shingles. The patient did not had information on the dates of 1st and 2nd dose. On an unknown date, symptoms resolved. The patient wanted to know if there was any information on patients taking antivirals or anti-leukemia drugs and the effect of that on vaccination. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation were unknown at the time of reporting. The reporter consented to follow-up.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: Pediarix instead of Kinrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number J7X44, expiry date 11th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th January 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 10th January 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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 was administered a dose of Pediarix instead of Kinrix, which led to wrong vaccine administered. The reporter consented to follow up.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypersensitivity, Lethargy
Clinical narrative: This spontaneous report received from a patient concerned a 35 year old male. The patient's weight, height and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series was 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on an unspecified date in MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. On an unspecified date in MAY-2021 following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series was 1), the patient experienced lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lethargic was not reported. Non-company suspect vaccine included: BNT 162 (Dose number in series was 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 19-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-DEC-2021, following vaccination with BNT 162 (Dose number in series was 2), the patient had allergic reaction (vaccine made his left eye swell up, eye inflamed and his upper eye lid was inflamed). On 21-DEC-2021 patient went to the emergency room and diagnosed with an allergic reaction and prescribed him Zyrtec which failed to work and it has gotten worse in the last two days. According to caller he needs to go to another doctor for this adverse reaction and the patient barely see out of left eye and symptoms got worse and whole left eye was a lot more lower sitting than right eye. The patient was about to lose his mind.  The action taken with bnt 162 was not reported. The patient had not recovered from allergic reaction. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blepharitis, Condition aggravated, Eye disorder, Eye inflammation, Eye swelling
Clinical narrative: This spontaneous report received from a patient concerned a 35 year old male. The patient's weight, height and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series was 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on an unspecified date in MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. On an unspecified date in MAY-2021 following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series was 1), the patient experienced lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lethargic was not reported. Non-company suspect vaccine included: BNT 162 (Dose number in series was 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 19-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-DEC-2021, following vaccination with BNT 162 (Dose number in series was 2), the patient had allergic reaction (vaccine made his left eye swell up, eye inflamed and his upper eye lid was inflamed). On 21-DEC-2021 patient went to the emergency room and diagnosed with an allergic reaction and prescribed him Zyrtec which failed to work and it has gotten worse in the last two days. According to caller he needs to go to another doctor for this adverse reaction and the patient barely see out of left eye and symptoms got worse and whole left eye was a lot more lower sitting than right eye. The patient was about to lose his mind.  The action taken with bnt 162 was not reported. The patient had not recovered from allergic reaction. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypersensitivity, Immunisation, Interchange of vaccine products, Investigation, Off label use
Clinical narrative: This spontaneous report received from a patient concerned a 35 year old male. The patient's weight, height and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series was 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on an unspecified date in MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. On an unspecified date in MAY-2021 following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series was 1), the patient experienced lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lethargic was not reported. Non-company suspect vaccine included: BNT 162 (Dose number in series was 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 19-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-DEC-2021, following vaccination with BNT 162 (Dose number in series was 2), the patient had allergic reaction (vaccine made his left eye swell up, eye inflamed and his upper eye lid was inflamed). On 21-DEC-2021 patient went to the emergency room and diagnosed with an allergic reaction and prescribed him Zyrtec which failed to work and it has gotten worse in the last two days. According to caller he needs to go to another doctor for this adverse reaction and the patient barely see out of left eye and symptoms got worse and whole left eye was a lot more lower sitting than right eye. The patient was about to lose his mind.  The action taken with bnt 162 was not reported. The patient had not recovered from allergic reaction. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: This spontaneous report received from a patient concerned a 35 year old male. The patient's weight, height and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series was 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on an unspecified date in MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. On an unspecified date in MAY-2021 following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series was 1), the patient experienced lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lethargic was not reported. Non-company suspect vaccine included: BNT 162 (Dose number in series was 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 19-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-DEC-2021, following vaccination with BNT 162 (Dose number in series was 2), the patient had allergic reaction (vaccine made his left eye swell up, eye inflamed and his upper eye lid was inflamed). On 21-DEC-2021 patient went to the emergency room and diagnosed with an allergic reaction and prescribed him Zyrtec which failed to work and it has gotten worse in the last two days. According to caller he needs to go to another doctor for this adverse reaction and the patient barely see out of left eye and symptoms got worse and whole left eye was a lot more lower sitting than right eye. The patient was about to lose his mind.  The action taken with bnt 162 was not reported. The patient had not recovered from allergic reaction. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: NO OUT BREAK OF FEVER BLISTER; This spontaneous report received from a patient concerned a 68 year old male of an unspecified race and ethnic origin. The patient's height and weight were not reported. The patient's concurrent conditions included: cold sores. The patient previously 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 was 1), 01 in total was administered on 31-MAR-2021 for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient did not have a fever blister (unexpected therapeutic benefit) (dose number in series was 1). 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 was 2), 01 in total was administered on 03-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. The patient's concomitant medications included lysine as product use for an unknown indication. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient did not have out break of fever blister. He had cold sores for about 45 years. The only thing that helped was L-Lysine (lysine), diet and avoiding L-Arginine. This was the longest he had gone without an episode (unexpected therapeutic benefit) (dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of no out break of fever blister was not reported (dose number in series was 2). This report was non-serious. This case, involving the same patient is linked to 20220104581.; Sender's Comments: V0- Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID 19 INFECTION; This spontaneous report received from a patient concerned a 41 year old female. Initial information processed along with the follow up information received on 07-JAN-2022. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1, unspecified manufacturer)  (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on unspecified date in APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: unknown) dose was not reported, 1 total administered on the left arm on 10-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-DEC-2021, the patient experienced symptoms tired, body aches and headaches (subsumed under confirmed covid-19 infection and confirmed clinical vaccination failure) (dose number in series 2). On 01-JAN-2022, patient tested positive for Covid-19. Laboratory data included: COVID-19 virus test (NR: not provided) positive. On 02-JAN-2022, Covid-19 symptoms of tiredness, body aches and headache resolved. She was not aware of being in contact of anyone who was Covid-19 positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid 19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report is associated with product quality complaint number 90000210071. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the Regulatory Authority evaluation/investigation performed.   .; Sender's Comments: V0- 20220104848- covid-19 vaccine ad26.cov2.s -Confirmed 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
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest discomfort, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; CHEST IS HEAVY; This spontaneous report received from a patient concerned a 55 year old female. Initial information was processed along with the additional information received on 05-JAN-2022 and 10-JAN-2022. 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 (dose number in series 1) (suspension for injection, route of admin, and batch number:1808982, expiry: Unknown) dose was not reported,1 total, administered on 09-APR-2021 on left arm for prophylactic vaccination.  The patient received non-company suspect vaccine included: MRNA 1273 (dose number in series 2) (form of admin, route of admin, and batch number were not reported), dose not reported, administered on an unspecified date for prophylactic vaccination. No concomitant medications were reported.  On 26-DEC-2021, the patient experienced itchy throat, shortness of breath (subsumed under confirmed covid-19 infection) and felt like chest was heavy. On 27-DEC-2021, she did Covid-19 test by going to a testing center (unsure of PCR/antigen test). On 29-DEC-2021, the result received as Covid-19 positive, hence confirmed clinical vaccination failure (dose number in series 1 and 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and, MRNA 1273 was not reported. The patient was recovering from confirmed covid-19 infection, and chest is heavy, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220104857. This report was associated with product quality complaint: 90000210194. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20220104898-covid-19 vaccine ad26.cov2.s-confirmed 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
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Vaccination site pain
Clinical narrative: This spontaneous report received from a patient concerned a 66 year old White not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known drug allergy. The patient previously received with covid-19 vaccine ad26. cov2. s (Dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administrated, therapy start date was not reported for prophylactic vaccination. No adverse events reported after 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 not reported, batch number: 1855194, expiry: UNKNOWN) dose was not reported, 1 total, administered on 23-DEC-2021 in right arm for prophylactic vaccination. No concomitant medications were reported.  On 23-DEC-2021, the patient took booster dose and thought it was improperly administered to her, that it was given on right arm but on the upper back part in the fatty area and not on the muscle (improper administration). The patient stated that she felt the needle seemed shorter and thicker than the first time she received it and that the syringe seemed bigger with more fluid. Patient felt that fatty part of her arm was sore after the injection but that it did go away in a few days. (Dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of soreness in fatty part of arm after the injection (also reported by patient that it went away in a few unspecified number of days) and received vaccine at upper right arm in fatty area and not on the muscle was not reported. This report was non-serious.