chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/I had the shingles vaccine / got shingles; 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and still got shingles. Follow-up would not be possible as no contact details available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix over 2 years ago; This case was reported by a consumer 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 over 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided are as follows: The case was reported by patient for himself/herself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked that he/she could get the 2nd dose now or did have to repeat the 1st dose. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: it didn't work. I got the shingles/suspected vaccination failure; I got the shingles worse than I ever; 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 COVID-19 VACCINE (COVID-19 VACCINE UNKNOWN) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID-19 VACCINE UNKNOWN. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the shingles vaccine before Covid and it did not work.  The patient got the shingles worse than ever had them. The patient stated that it did not work for everyone. It was unknown if the reporter considered the shingles to be related to Covid vaccine. 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 confirmation for shingles were unknown at the time of reporting. Note: It was not clear from the description that if the patient had received shingles vaccine before Covid pandemic or Covid vaccine, hence it was conservatively captured as Covid vaccine.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: arm started to get red at the injection site; arm swollen, at the injection site; arm, itchy at the injection site; Tiredness; Dizziness; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 VACCINE.   On 5th November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 5th November 2021, several hours after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site itching, tiredness and dizziness. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site itching were not recovered/not resolved and the outcome of the tiredness and dizziness were recovered/resolved.   The reporter considered the injection site erythema, injection site swelling, injection site itching, tiredness and dizziness to be related to Shingrix.  Additional details were reported as follows: The patient had reported that he was administered with first dose of Shingrix on 11-May-2021 and few hours later his arm started to get red, swollen, and itchy at the injection site (left arm).  He also stated that about 10 hours later, he started with tiredness and dizziness. The patient reported that the events dizziness and tiredness had resolved but rest events persisted. The patient had reported that he also received Johnson and Johnson Covid vaccine 3 weeks prior reporting the event in the right arm. The reporter was asking if this was expected, why this was happening, and what he could do to get it to resolved. The reporter had not consented to follow up. No health care information was provided.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult received a dose of Pediatric Engerix B; adult received a dose of Pediatric Engerix B; This case was reported by a consumer via call center representative and described the occurrence of underdose in a 27-year-old female patient who received HBV (Engerix B pediatric) (batch number P7294, expiry date 3rd 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 November 2021, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 5th November 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported but it could be 26 or 27 years. The Manager reported that, an adult patient received a dose of Pediatric Engerix B, which led to underdose and adult use of a child product. The reporter did not consented to follow-up
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered
Clinical narrative: a couple drops leaked out onto the patient's arm; a couple drops leaked out onto the patient's arm; a couple drops leaked out onto the patient's arm; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 53-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number T93SR, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th November 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 9th November 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact 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 reported as follows: The Nurse reported that, while she was administering a dose of Fluarix and a couple drops leaked out onto the patient's arm which led to incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. The consent to follow up was not asked.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: how to proceed with 2nd dose, 1st dose given October 11, 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 11th October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient had received first dose of Shingrix and never received second dose, which led to incomplete course of vaccination. The patient consented to follow up via email.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted with a unapproved diluent; administrated a dose of Menveo reconstituted with a unaproved diluent.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 10th November 2021, the patient received Menveo. On 10th November 2021, unknown after receiving Menveo, the patient experienced inappropriate dose of vaccine administered and wrong solution used in drug reconstitution. On an unknown date, the outcome of the inappropriate dose of vaccine administered and wrong solution used in drug reconstitution were unknown.  Additional details were reported as follows: Health care professional (HCP) report that on the same day of the reporting a patient was administrated a dose of Menveo reconstituted with a unaproved diluent, which led to inappropriate dose of vaccine administered and wrong solution used in drug reconstitution.  No further events were reported.  The reporter agreed to be contacted for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on Feb2019, has not received 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in February 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: Age at vaccination was not applicable for this report. Pharmacist reported a patient had not yet received 2nd dose till the time of reporting which led to incomplete course of vaccination. Vaccine was administered at a different facility and pharmacist does not have exact date of administration nor lot number and expiration date. The reporter consented to follow up. HCP gave permission to follow-up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cough, Gastrooesophageal reflux disease, Headache, Incomplete course of vaccination, Pain
Clinical narrative: first dose on 21-NOV-2019, not received the 2nd dose; cough; GERD; Body aches; Headache; Swelling of the throat; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles).   On 21st November 2019, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On an unknown date, the patient received the 2nd dose of Shingrix. On 21st November 2019, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced general body pain, headache and throat swelling. In November 2021, the patient experienced cough and gastroesophageal reflux disease. On an unknown date, the patient experienced incomplete course of vaccination. On 22nd November 2019, the outcome of the general body pain, headache and throat swelling were recovered/resolved. On an unknown date, the outcome of the cough, gastroesophageal reflux disease and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the general body pain, headache and throat swelling to be related to Shingrix. The reporter considered the cough and gastroesophageal reflux disease to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose of Shingrix. The patient received 1st dose of Shingrix in left deltoid at 9 am in Physician's office. The evening after receiving her 1st dose of Shingrix, the patient experienced body aches, headache and swelling of the throat. All symptoms were resolved by the following morning. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pharyngeal swelling
Clinical narrative: first dose on 21-NOV-2019, not received the 2nd dose; cough; GERD; Body aches; Headache; Swelling of the throat; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles).   On 21st November 2019, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On an unknown date, the patient received the 2nd dose of Shingrix. On 21st November 2019, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced general body pain, headache and throat swelling. In November 2021, the patient experienced cough and gastroesophageal reflux disease. On an unknown date, the patient experienced incomplete course of vaccination. On 22nd November 2019, the outcome of the general body pain, headache and throat swelling were recovered/resolved. On an unknown date, the outcome of the cough, gastroesophageal reflux disease and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the general body pain, headache and throat swelling to be related to Shingrix. The reporter considered the cough and gastroesophageal reflux disease to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose of Shingrix. The patient received 1st dose of Shingrix in left deltoid at 9 am in Physician's office. The evening after receiving her 1st dose of Shingrix, the patient experienced body aches, headache and swelling of the throat. All symptoms were resolved by the following morning. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 6.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Pyrexia, Sleep terror, Vomiting
Clinical narrative: hallucination-like symptoms; confusion; dilated eyes; felt like he was "going to die", worried parents might hurt him,; vomiting; head pain, booboo inside his head; fever; night terrors; This case was reported by a other health professional via call center representative and described the occurrence of hallucination in a 6-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and ondansetron (Zofran) for product used for unknown indication.   On 8th November 2021, the patient received FluLaval Quadrivalent 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device and Zofran at an unknown dose and frequency. On 8th November 2021, 3 hrs after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced vomiting, headache, fever and night terrors. On 10th November 2021, the patient experienced hallucination (serious criteria GSK medically significant), confusion, pupils dilated and impending doom. The patient was treated with paracetamol (Tylenol) and ibuprofen. The action taken with Zofran was unknown. On 8th November 2021, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the hallucination, night terrors, confusion, pupils dilated and impending doom were unknown and the outcome of the vomiting was recovered/resolved and the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the hallucination, vomiting, headache, fever, night terrors, confusion, pupils dilated and impending doom to be related to FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: On 8th November 2021, the patient received Flulaval and experienced vomiting, head pain, fever 3 hours after the vaccination.  The patient went to the emergency room on same night and received Zofran. On 8th November 2021, less than a day after receiving Flulaval and Zofran, the patient experienced night terrors. On 10th November 2021, 2 days after receiving Flulaval and Zofran, the patient experienced confusion, hallucination like symptoms, and dilated eyes. The patient stated that he felt like he was going to die, and was worried that his parents might hurt him and there was a booboo inside his head. On 11th November 2021, the patient experienced another fever (100.6 degree F). The patient was altering between Tylenol and Ibuprofen as a treatment for fever. The reporter stated that, emergency room visit was required. No additional information was provided. It was unknown if the reporter considered the hallucination, fever, night terrors, confusion, pupils dilated and impending doom to be related to Zofran. The reporter consented to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: received Fluarix that was inappropriately stored; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 35E27, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th November 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional case details were provided as follows: The age at vaccination was not reported. A nurse reported that, an employee might had received a dose of Fluarix that was inappropriately stored and should have been discarded.  No symptoms reported.  The nurse had not yet confirmed with site if an employee actually received the Fluarix.  The Health care professional (HCP) was unable to provide initials, DOB, gender, etc at the time of report. The reporter stated, she believed it was from 2021-2022 season and provided the NDC 58160-0887-52 LOT number 35E27, expiry date 30th June 2022.  She also reiterated that the employee may had not even received the vaccine, she was still investigating. The reporter consented to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Immediate post-injection reaction, Neuralgia, Rash macular
Clinical narrative: nerve pain on his body, eyes, and buttock area; blotches on his skin, looking as there is bleeding under; Shingles; blisters going down his back; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2021, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 27th September 2021, immediately after receiving Shingrix, the patient experienced shingles and blister. On an unknown date, the patient experienced nerve pain and skin blotches. On an unknown date, the outcome of the shingles and blister were recovered/resolved and the outcome of the nerve pain was not recovered/not resolved and the outcome of the skin blotches was resolved with sequelae.   It was unknown if the reporter considered the shingles, blister, nerve pain and skin blotches to be related to Shingrix.  Additional details were provided as follows: The patient's wife reported this case for the patient. The patient received his 2nd dose of Shingrix at his pharmacy in his left arm, he developed Shingles right after or around the same time as his second dose was given (exact time unknown). He had blisters going down his back that lasted about 6 weeks (AE-Shingles, resolved). The blisters were then gone, but he continued to experience nerve pain shooting throughout his body, in his eyes, and on his buttock area (AE-Nerve pain, unresolved). He had blotches on his skin that come and go that his wife describes as looking as if there is bleeding under his skin. The consent to follow up was granted. Consent given to contact HCP but contact information unknown.
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 47-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2021-2022 season) (batch number D7AE5, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv quebec ; (Flulaval Tetra) injection syringe for prophylaxis. Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE (FLU SHOT)). On 11th November 2021, the patient received FluLaval Tetra 2021-2022 season and Flulaval Tetra. On 11th November 2021, unknown after receiving FluLaval Tetra 2021-2022 season and Flulaval Tetra, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The patient received Fluzone and Flulaval during the same season, which led to extra dose administered. The reporter consented to follow up.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEPA, HIBV, MENB, MNQ, RV1, TDAP
Symptoms: Product storage error
Clinical narrative: frozen vaccinations after having been at a temperature of -11C; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, HAV (Havrix) for prophylaxis, Hib (Hiberix) for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Rota (Rotarix lyophilized formulation) for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 12th November 2021, the patient received Infanrix, Infanrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix, Havrix, Hiberix, Bexsero, Bexsero Pre-Filled Syringe Device, Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Boostrix and Menveo. On an unknown date, unknown after receiving Infanrix, Infanrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix, Havrix, Hiberix, Bexsero, Bexsero Pre-Filled Syringe Device, Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Boostrix and Menveo, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The nurse potentially administer frozen vaccinations after having been at a temperature of minus 11 celcius, which led to incorrect storage of drug. The reporter did not consent to follow up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in arm and pain in thumb; This case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in extremity. On an unknown date, the outcome of the pain in extremity was not recovered/not resolved.   It was unknown if the reporter considered the pain in extremity to be related to Shingrix.  Additional details were reported as follows: The patient reported that he had received second dose of Shingrix about one month ago and immediately experienced pain in the injected arm. Also a month later he also experienced pain in thumb of same hand. Both events still exist. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Intercepted product administration error
Clinical narrative: Near miss- cancelled the vaccine since already received 2 doses; This case was reported by a other health professional via call center representative and described the occurrence of intercepted drug administration error in a female 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 intercepted drug administration error. On an unknown date, the outcome of the intercepted drug administration error was unknown.  Additional details were provided as follows: The reporter pulled a shingrix and corresponding diluent vial out of the refrigerator to begin mixing to give to a patient, as punctured the diluent, the patient cancelled the vaccine since she had already received 2 doses and was mistaken on needing it, which led to intercepted drug administration error. No further details provided on web form. The reporter asked if it was ok to still use the dose. It immediately went back into the refrigerator and had only been out of it for a minute or 2. The reporter consented to follow up.
Age: 41.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Shingrix administered to 41 year-old patient; Shingrix instead of an influenza shot; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 41-year-old male patient who received Herpes zoster (Shingrix) (batch number 7Z29K, expiry date 15th April 2022) for prophylaxis.   On 14th November 2021, the patient received the 1st dose of Shingrix. On 14th November 2021, unknown after receiving Shingrix, 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.  Additional details were provided as follows: The pharmacist gave by error a Shingrix first dose instead of an Influenza shot to a 41 year old patient, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on  16 july 2018, never received the 2nd dose.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16th July 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient never received the 2nd dose, which led to incomplete course of vaccination. No other vaccine details were available. The reporter consented to follow up.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: severe Anaphylactic reaction, was hospitalized; This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a 37-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th November 2020, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 15th November 2020, less than a day after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced anaphylactic reaction (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was recovered/resolved.   The reporter considered the anaphylactic reaction to be related to Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by nurse for herself. The patient received the Fluarix vaccine last year and experienced a severe anaphylactic reaction to the vaccine. The patient was hospitalized for a week.   The patient stated that her doctor suspected Gentamycin as the ingredient in the Fluarix last year that might had caused the reaction, which was why she was inquiring whether gentamycin was an ingredient in the Fluarix this year. The reporter inquired if GlaxoSmithKline vaccines were egg free.  The reporter declined to permission to contact her healthcare professional. The reporter did not consent to follow-up. No additional details were provided by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema
Clinical narrative: Redness at injection site; Chills; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th November 2021, the patient received the 1st dose of Shingrix. In November 2021, less than a week after receiving Shingrix, the patient experienced injection site erythema and chills. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the chills was unknown.   It was unknown if the reporter considered the injection site erythema and chills to be related to Shingrix.  Additional details were provided as follows: The caller was patient. The age at vaccination was not reported. The patient received her first dose of the Shingrix vaccine and experiencing redness at the injection site and chills.   The reporter asked how long do these symptoms last after receiving the vaccine.   The reporter declined to provide demographic information. The reporter did not consent to follow-up. No additional details provided by reporter.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Injection site pain, Product preparation issue
Clinical narrative: soreness at the injection point; did not mix the 2 vials  before administering the vaccine; did not mix the 2 vials before administering the vaccine; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the injection site pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter did not mix the 2 vials for the shingrix vaccine before administering the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient had soreness at the injection point. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Mobility decreased
Clinical narrative: Redness at injection site; Chills; Headache; Decreased arm mobility / only being able to lift arm halfway; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th November 2021, the patient received the 1st dose of Shingrix. In November 2021, less than a week after receiving Shingrix, the patient experienced injection site erythema, chills, headache and mobility decreased. On an unknown date, the outcome of the injection site erythema, chills, headache and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, chills, headache and mobility decreased to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient herself. The patient received the 1st dose of Shingrix and experienced redness at the injections site, chills, headache and decreased arm mobility. The patient reported that she only being able to lift arm halfway.  The patient reported that all the symptoms were ongoing. Limited information were provided and no patient demographic details provided, as caller did not want to document anything. All  the information provided was reported. The reporter did not consent to follow-up. GSK note- it was not clearly mentioned, if patient had mobility issue with injected arm only. Therefore injected limb mobility decreased is not considered as adverse event.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 13 months ago and not getting a second; This case was reported by a consumer 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 13 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was nopt applicbale for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not decline or agree to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site mass
Clinical narrative: INJECTION SITE BRUISE; INJECTION SITE LUMP; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine (Unspecified) for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-Nov-2021 (Wednesday), the patient had the Janssen Covid-19 vaccine booster shot administered. On a unspecified date in NOV-2021, the patient stated that she had a bruise and a lump at the injection site. She had not taken any medication or done anything to treat the area. No information was gathered from the consumer regarding this event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site bruise and injection site lump was not reported. This report was non-serious.
Sex: M
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 an 82 year old male. Initial information was processed along with additional information on 15-NOV-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: Unknown) dose was not reported, 1 total, administered on 06-MAY-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.   The patient had no side effects after vaccination. On 10-SEP-2021, the patient was tested positive for COVID-19 (confirmed clinical vaccination failure and confirmed covid-19 infection). The patient did not have a severe case and thought it was because he received the jnj vaccine was reported. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000201562. 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 PQC evaluation/investigation performed.; Sender's Comments: V0: 20211125378- 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
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Muscle spasms, Muscle tightness
Clinical narrative: CRAMPING MUSCLE PAIN AT THE UPPER ABDOMINAL PART OF THE BODY; UPPER ABDOMINAL MUSCLES TIGHTENING UP; UNUSUAL SENSATION; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was healthy and had no heart related issues or medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: unknown) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAR-2021, the patient experienced cramping muscle pain at the upper abdominal part of the body. On 27-MAR-2021, the patient experienced upper abdominal muscles tightening up. On 27-MAR-2021, the patient experienced unusual sensation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cramping muscle pain at the upper abdominal part of the body, upper abdominal muscles tightening up, and unusual sensation on 03-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on 26-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported at the time of reporting. On NOV-2021, after about 6.5 months after vaccination, the patient did the antibody test for protective antibody. The result was zero (confirmed immunological vaccine failure). The patient spoke to primary care physician (PCP) and the PCP did not believe it and said that might be a mistake. He suggested to repeat the test. The patient did the antibody test again and the result came out to be zero. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000202301.; Sender's Comments: V0: 20211133438-COVID-19 VACCINE AD26.COV2.S- confirmed immunological vaccine 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: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date in Aug-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On Tuesday, 09-Nov-2021, the patient experienced headache and did COVID-19 rapid POC test (NR: not provided) which came negative. The Patient lost her sense of taste and smell and had chills, headache, nasal congestion and cough. On 12-Nov-2021, the Patient had (Home Rapid test) Laboratory data included: COVID-19 rapid POC test (NR: not provided) which was Positive. On 13-NOV-2021, the patient went to her PCP (Primacy care physician) and had COVID-19 PCR test (NR: not provided), the report of test came positive on 15-Nov-2021 (confirmed clinical vaccination failure and confirmed covid-19 infection). 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 was associated with a product quality complaint: 90000202316.; Sender's Comments: V0: 20211133893- COVID-19 VACCINE AD26.COV2.S- Confirmed clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATION