chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TDAP
Symptoms: Product preparation issue
Clinical narrative: Administration without previous shaking; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate reconstitution technique in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate reconstitution technique (Verbatim: Administration without previous shaking). The outcome of the inappropriate reconstitution technique was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 9-Mar-2023 The health care professional called in to ask for information about the reconstitution of Boostrix prior to administration. The reporter asked if they had information about the safety/efficacy of Boostrix if it was administered without previous shaking as mentioned in the package insert. The adverse event filed as conservative since the reporter was not sure that the vaccine was administered without the proper reconstitution. The follow-up could not be possible as no contact details were available. The patient received a dose of Boostrix without proper reconstitution, which led to inappropriate reconstitution technique.
Age: 28.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 28-year-old female patient who received HAV (Havrix 1440) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 08-MAR-2023, the patient received the 2nd dose of Havrix 1440. On 08-MAR-2023, an unknown time after receiving Havrix 1440, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 9-Mar-2023 The reporter  consented to follow-up via postal. The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This non-serious 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 B NVS (Bexsero) (expiry date 28-FEB-2023) for prophylaxis.   In MAR-2023, the patient received Bexsero. In MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 09-Mar-2023 The healthcare processional called to receive a fax with medical information about maladministration of Bexsero after the Expiration Date, however she mentioned that a patient received a Bexsero 7 days a week later after the expiration date of vaccine. The healthcare processional does not want to provide any DOB information.  The reporter stated that was calling and provided only her first name and fax number (information sent by email to Safety Team).  The reporter did not consent to follow up.  The permission for a follow up was not requested due she said that she was looking for information only and not reporting anything. The patient was administered an expired dose of Bexsero, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Adjuvant only administered.; Adjuvant only administered.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 73PP9) for prophylaxis.   On 08-MAR-2023, the patient received the 2nd dose of Shingrix. On 08-MAR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Adjuvant only administered.) and inappropriate dose of vaccine administered (Verbatim: Adjuvant only administered.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 09-Mar-2023 The pharmacist called to inform that on 8th March 2023 a patient was supposed to receive the 2nd dose of Shingrix but received only the adjuvant portion of it. HCP asked to remain anonymous. The reporter consented to follow up. The patient had received only the adjuvant of shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the liquid component; received only the liquid component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA710A, expiry date 30-APR-2023) for prophylaxis.   On 09-MAR-2023, the patient received Menveo. On 09-MAR-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: received only the liquid component) and inappropriate dose of vaccine administered (Verbatim: received only the liquid component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 9-Mar-2023 The reporter consented to follow-up via email. The patient received only the liquid component of Menveo (without the lyophilized component), which led to inappropriate preparation of medication and inappropriate dose of vaccine administration.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired kinrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 03-MAR-2023) for prophylaxis.   On 09-MAR-2023, the patient received Kinrix. On 09-MAR-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Expired kinrix administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-MAR-2023 The reporter reported that the patient received the Kinrix vaccine which was expired on 3rd March 2023. Adverse event contained all reported information. HCP gave consent for safety team follow up. The reporter did consent to follow up. The patient received a Kinrix which was already expired, which led to expired vaccine used.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: injection site was red, reaction; injection site was sore, reaction; injection site was warm to the touch, reaction; swelling at the injection site, reaction; hives on face; itchy hives; fever; shivers; swelling down her arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-MAR-2023 11:00, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 06-MAR-2023, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: fever) and shivers (Verbatim: shivers). On 07-MAR-2023, the patient experienced injection site erythema (Verbatim: injection site was red, reaction), injection site pain (Verbatim: injection site was sore, reaction), injection site warmth (Verbatim: injection site was warm to the touch, reaction), injection site swelling (Verbatim: swelling at the injection site, reaction), hives (Verbatim: hives on face) and pruritus (Verbatim: itchy hives). In MAR-2023, the patient experienced swelling arm (Verbatim: swelling down her arm). The outcome of the injection site erythema, injection site pain, injection site warmth, injection site swelling, hives and pruritus were not recovered/not resolved and the outcome of the fever and shivers were recovered/resolved and the outcome of the swelling arm was unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site warmth, injection site swelling, fever, shivers, hives, swelling arm and pruritus to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site pain, injection site warmth, injection site swelling, fever, shivers, hives, swelling arm and pruritus to be related to Shingrix.   Additional Information: GSK Receipt date: 09-Mar-2023 The reporter was the patient and states that she got her first Shingrix vaccine. She states that by that evening, she had shivers and a fever that lasted for about 3 days. The day following her vaccine, the injection site was red, sore, and warm to the touch.   She also had swelling at the injection site that traveled down her arm.  In addition, the day following her shot she started with a few itchy hives on both sides of her face.  The hives on the left are more pronounced and itchier than on the right.  Her fever and shivers have gone away, but she still had the hives on her face and the injection site reaction.   The patient did not have a lot or exp for the vaccine. The reporter consented to follow up. As per narrative, it seems that swelling extended and it reached to whole arm therefore both arm swelling and injection site swelling was coded.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Urticaria
Clinical narrative: injection site was red, reaction; injection site was sore, reaction; injection site was warm to the touch, reaction; swelling at the injection site, reaction; hives on face; itchy hives; fever; shivers; swelling down her arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-MAR-2023 11:00, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 06-MAR-2023, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: fever) and shivers (Verbatim: shivers). On 07-MAR-2023, the patient experienced injection site erythema (Verbatim: injection site was red, reaction), injection site pain (Verbatim: injection site was sore, reaction), injection site warmth (Verbatim: injection site was warm to the touch, reaction), injection site swelling (Verbatim: swelling at the injection site, reaction), hives (Verbatim: hives on face) and pruritus (Verbatim: itchy hives). In MAR-2023, the patient experienced swelling arm (Verbatim: swelling down her arm). The outcome of the injection site erythema, injection site pain, injection site warmth, injection site swelling, hives and pruritus were not recovered/not resolved and the outcome of the fever and shivers were recovered/resolved and the outcome of the swelling arm was unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site warmth, injection site swelling, fever, shivers, hives, swelling arm and pruritus to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site pain, injection site warmth, injection site swelling, fever, shivers, hives, swelling arm and pruritus to be related to Shingrix.   Additional Information: GSK Receipt date: 09-Mar-2023 The reporter was the patient and states that she got her first Shingrix vaccine. She states that by that evening, she had shivers and a fever that lasted for about 3 days. The day following her vaccine, the injection site was red, sore, and warm to the touch.   She also had swelling at the injection site that traveled down her arm.  In addition, the day following her shot she started with a few itchy hives on both sides of her face.  The hives on the left are more pronounced and itchier than on the right.  Her fever and shivers have gone away, but she still had the hives on her face and the injection site reaction.   The patient did not have a lot or exp for the vaccine. The reporter consented to follow up. As per narrative, it seems that swelling extended and it reached to whole arm therefore both arm swelling and injection site swelling was coded.
Age: 61.0
Sex: M
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: patient got a dose after temp excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 61-year-old male patient who received HBV (Engerix B) (batch number 29RN7, expiry date 25-FEB-2024) for prophylaxis.   On 24-JAN-2023, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: patient got a dose after temp excursion). 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 Information: GSK receipt date: 9-Mar-2023 Adverse event contains all reported information. The patient received a dose of Engerix-B after a temperature excursion on negative 0.1 Celsius, which led to incorrect storage of drug.
Sex: U
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Given a dose reconstituted with a different diluent; Given a dose reconstituted with a different diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: Given a dose reconstituted with a different diluent) and inappropriate dose of vaccine administered (Verbatim: Given a dose reconstituted with a different diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 09-MAR-2023 The Clinic Manager reported that clinic had discovered they had a box of Rotarix containing 1 extra vial of lyophilized Rotarix powder, so they are unsure if a patient was possibly given a dose that was reconstituted with a different diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Clinic Manager stated that they spoke to all of the staff that administered a dose from that box of vaccines, and all of the staff were able to verbalize the correct method for reconstitution, so they were unsure if any patient received an improperly reconstituted dose or not. The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up and inadvertently did not obtain lot number. Case was conservatively kept valid for the inappropriate preparation of vaccine potentially administered to patient.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given 3 weeks after 1st; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number G3T43, expiry date 07-JUL-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 09-MAR-2023, the patient received the 2nd dose of Shingrix. On 09-MAR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose given 3 weeks after 1st). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 9-Mar-2023 The pharmacist reported that he realized that the patient received first dose had been given 3 weeks ago. The reporter asked that if the second dose was valid or if the patient had to receive an extra dose. Permission for follow-up was not requested during the call. The patient received second dose of Shingrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 23-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 08-MAR-2023, the patient received Havrix. On 08-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: administered an expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 9-Mar-2023 The adverse event contains all reported information. The reporter gave consent for safety team follow-up. The reporter consented to follow-up. The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: administered an extra dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA104A, expiry date 30-NOV-2023) for prophylaxis.   Concomitant products included Men ACWY-CRM NVS (Menveo).   On 02-MAR-2023, the patient received the 2nd dose of Menveo. On 02-MAR-2023, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: administered an extra dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date:10-Mar-2023. Licensed Practical nurse called to inquire what to look for and how to proceed. Patient was administered another Menveo dose inadvertently in error. Reporter stated that it was already reported by someone else but unsure.  LPN does not want to be mixed in with this incident because LPN was not the staff who administered the extra dose but agreed to being anonymous. The reporter did not consent to follow-up. Patient received Menveo inadvertently in error, which led to extra dose administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2019, hasn't got the 2nd; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 1st October 2019 of batch number PR5B2 and expiry date 8th November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose in 2019, hasn't got the 2nd). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 10-Mar-2023 The reporter consented to follow-up via email. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number 59M3M, expiry date 28-FEB-2023) for prophylaxis.   On 10-MAR-2023, the patient received the 1st dose of Bexsero. On 10-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-MAR-2023 The nurse reported that expired dose of Bexsero was administered to a patient. The reporter did not consent to follow-up.  The patient received expired Bexsero, which led to expired vaccine used.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: 3rd dose administered; Shingrix given instead of another vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number 7ff7c, expiry date 28-MAY-2024) for prophylaxis.   Previously administered products included Shingrix (had completed the Shingrix series in 2021).   On 10-MAR-2023, the patient received the 3rd dose of Shingrix. On 10-MAR-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 3rd dose administered) and wrong vaccine administered (Verbatim: Shingrix given instead of another vaccine). The outcome of the extra dose administered and wrong vaccine administered were unknown.   Additional Information: GSK receipt date: 10-Mar-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received 3rd dose of Shingirx instead of another vaccine, which led to extra dose administered and wrong vaccine administered.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Reconstituted with saline water; Reconstituted with saline water; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA712A, expiry date 31-MAY-2023) for prophylaxis.   On 23-FEB-2023, the patient received the 2nd dose of Menveo. On 23-FEB-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Reconstituted with saline water) and inappropriate dose of vaccine administered (Verbatim: Reconstituted with saline water). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 10-MAR-2023 The nurse reported that a Menveo dose was reconstituted with saline water and administered.  The reporter did not consent to follow-up.  Permission to create an HCP´s account declined. The patient received Menveo which was reconstituted with saline water, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Age: 17.0
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old patient who received Men B NVS (Bexsero) (batch number A2X3Y, expiry date 28-FEB-2023) for prophylaxis.   On 03-MAR-2023, the patient received the 1st dose of Bexsero. On 03-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-MAR-2023 The nurse reported that a dose of Bexsero was administered to a patient, but such dose had expired. The vaccine administration facility was the same as primary reporter. The reporter was consented to follow up. HCP asked the follow up by Safety team to be done via phone number. The patient received expired Bexsero, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: At least a year since receiving the 1st dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (it had been at least a year since patient received the first Shingrix vaccine 0.5ml intramuscularly in deltoid).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: At least a year since receiving the 1st dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-Mar-2023 The reporter was the patient and reported it had been more than 6 months since he received his first Shingrix vaccine. The reporter stated it had been at least a year since he received the first Shingrix vaccine. The reporter does not have an exact date of vaccination. The reporter would go get the second vaccine as soon as possible. Did not consent to follow-up. The reporter does not give permission to contact HCP. At the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose more than 6 months ago, 2nd not yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose more than 6 months ago, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-MAR-2023 The patient was the reporter. The reporter reported he received his first dose of Shingrix (no further information available/known) but it had been more than 6 months and he had still not had the second dose of Shingrix administered. Minimal information obtained. The reporter was not asked for consent to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Gait disturbance, Headache, Immediate post-injection reaction, Muscular weakness
Clinical narrative: fever 104 degrees Fahrenheit; headache; lost about 40 pounds; hard to walk; Muscle weakness, whole body; fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   In MAR-2019, the patient received the 2nd dose of Shingrix (intramuscular). In MAR-2019, immediately after receiving Shingrix, the patient experienced headache (Verbatim: headache), weight loss (Verbatim: lost about 40 pounds), walking difficulty (Verbatim: hard to walk), generalized muscle weakness (Verbatim: Muscle weakness, whole body) and fatigue (Verbatim: fatigue). On an unknown date, the patient experienced fever (Verbatim: fever 104 degrees Fahrenheit). The outcome of the fever, headache, weight loss, walking difficulty, generalized muscle weakness and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the fever, headache, weight loss, walking difficulty, generalized muscle weakness and fatigue to be related to Shingrix.     It was unknown if the company considered the fever, headache, weight loss, walking difficulty, generalized muscle weakness and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-MAR-2023 The case was reported by the patient's wife. The patient received both Shingrix vaccinations in 2019, and almost immediately after the 2nd shot of Shingrix, the patient began feeling symptoms such as headache, fatigue, muscle weakness to whole body, hard to walk and fever of 104 degrees Fahrenheit. From that time to present, the patient had lost about 40 pounds, and currently weighs 108 pounds. The reporter believed that it could be a Guillain Barre Syndrome (GBS).  The reporter was contacting the patient's doctor to request testing for GBS. The reporter stated that doctors have administered many tests and scans, with no answers.  The reporter was not specific as to what tests were administered. The reporter mentioned talking with a lawyer about her husband's case, and he told her he did not have enough information to pursue a lawsuit at that time. Referred her back to her husband's physician.  The symptoms had never completely disappeared, and they reported that the symptoms exacerbate every year at about the same time (March). The reporter reported that it was a potential legal case. The reporter consented to follow up.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Weight decreased
Clinical narrative: fever 104 degrees Fahrenheit; headache; lost about 40 pounds; hard to walk; Muscle weakness, whole body; fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   In MAR-2019, the patient received the 2nd dose of Shingrix (intramuscular). In MAR-2019, immediately after receiving Shingrix, the patient experienced headache (Verbatim: headache), weight loss (Verbatim: lost about 40 pounds), walking difficulty (Verbatim: hard to walk), generalized muscle weakness (Verbatim: Muscle weakness, whole body) and fatigue (Verbatim: fatigue). On an unknown date, the patient experienced fever (Verbatim: fever 104 degrees Fahrenheit). The outcome of the fever, headache, weight loss, walking difficulty, generalized muscle weakness and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the fever, headache, weight loss, walking difficulty, generalized muscle weakness and fatigue to be related to Shingrix.     It was unknown if the company considered the fever, headache, weight loss, walking difficulty, generalized muscle weakness and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-MAR-2023 The case was reported by the patient's wife. The patient received both Shingrix vaccinations in 2019, and almost immediately after the 2nd shot of Shingrix, the patient began feeling symptoms such as headache, fatigue, muscle weakness to whole body, hard to walk and fever of 104 degrees Fahrenheit. From that time to present, the patient had lost about 40 pounds, and currently weighs 108 pounds. The reporter believed that it could be a Guillain Barre Syndrome (GBS).  The reporter was contacting the patient's doctor to request testing for GBS. The reporter stated that doctors have administered many tests and scans, with no answers.  The reporter was not specific as to what tests were administered. The reporter mentioned talking with a lawyer about her husband's case, and he told her he did not have enough information to pursue a lawsuit at that time. Referred her back to her husband's physician.  The symptoms had never completely disappeared, and they reported that the symptoms exacerbate every year at about the same time (March). The reporter reported that it was a potential legal case. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome; This serious case was reported by a physician via call center representative and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre Syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     It was unknown if the company considered the guillain barre syndrome to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-MAR-2023 The doctor said that her patient called to medical information and one of the representative agreed signs and symptoms could be related to Shingles vaccine the patient got in 2019 and agent wanted to speak with doctor and stated that the vaccine was Shingrix. The healthcare professional requested medical information for a patient who developed the Guillain barre syndrome after Zostavax vaccination on 2019. The reporter reported that this inquiry came in via voicemail, there was a possibility that the signs and symptoms was relating to Guillain barre syndrome after Shingrix as healthcare professional had spoken with an agent earlier to this case and said she would call back to confirm if it was Shingrix (although it was mentioned in voicemail it was Shingrix no other information was available). The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pulmonary oedema
Clinical narrative: Fluid in lungs; This serious case was reported by a consumer via call center representative and described the occurrence of pulmonary edema in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, immediately after receiving Shingrix, [the patient experienced pulmonary edema (Verbatim: Fluid in lungs) (serious criteria GSK medically significant). The outcome of the pulmonary edema was unknown.   It was unknown if the reporter considered the pulmonary edema to be related to Shingrix.     It was unknown if the company considered the pulmonary edema to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-MAR-2023 The patient was reporter's sister. The patient had fluid in lungs shortly after her Shingrix vaccine. Cause of her adverse event was unknown. The reporter collected only minimal information, as this information was just mentioned in passing, and the reporter did not know all the details.  The reporter did not request consent to contact the patient's doctor, as the reporter did not feel that the sister could provide it.  The reporter did not want to provide information on her sister.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure
Clinical narrative: Shingrix 4- 4 and ½ years ago, breakout a month ago/suspected vaccination failure; Shingles twice a year; Received Shingrix about 4- 4 and ½ years ago; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 53-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 first case of shingles about 10 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, unknown arm) .5 ml and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Shingrix 4- 4 and ½ years ago, breakout a month ago/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles twice a year) and inappropriate age at vaccine administration (Verbatim: Received Shingrix about 4- 4 and ½ years ago). The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). The outcome of the vaccination failure and inappropriate age at vaccine administration were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 15-Mar-2023 The patient reported that she received both the doses of Shingrix vaccine about 4 to 4.5 years ago and experienced a breakout of shingles on her backside every 6 weeks.   The shingles would clear-up after 3 weeks with antiviral medications in most cases.   Since receiving the Shingrix vaccine, 4 years ago, the patient reported she now had the breakout on her backside about twice a year. It was a much lesser breakout, it did not need antivirals and it usually clears up in 4 days.  The last breakout was about a month ago. The patient did not share her health care professional information since she had a new health care professional that had not seen her yet. The reporter did not consent to follow-up. The patient received the Shingrix vaccination at inappropriate age, which led to inappropriate age at vaccine administration. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, UNK
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient (pharmacist) via other manufacturer (Pfizer) concerned a 76-year-old female of an unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, diabetes, asthma, and rosemary allergy. Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: unknown) dose was not reported, 1 total administered at left arm on 03-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 74 years old. It was unknown whether patient had any adverse events following vaccination with first dose covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received second dose of non-company suspect vaccine included: Pfizer Biontech (tozinameran) (Dose number in series 2) (form of admin, route of admin were not reported, batch number: FJ8762, expiry: unknown) dose was not reported, administered at left arm on 01-DEC-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with second dose of non-company suspect vaccine Pfizer Biontech (Dose number in series 2). The patient received third dose of non-company suspect vaccine: Pfizer Biontech (tozinameran) (Dose number in series 3) (form of admin, route of admin were not reported, batch number: GL0446, expiry: unknown) dose was not reported, administered at right arm on 30-NOV-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 3). No concomitant medications were reported.  On unspecified date in FEB-2023, the patient experienced covid-19 infection (suspected covid-19 infection) (Dose number in series 3) for which patient received non-company suspect drug Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose and frequency were not reported from 28-FEB-2023 to 06-MAR-2023 for covid-19 treatment.  On 17-MAR-2023, after paxlovid treatment, the patient experienced covid-19 rebound infection. It was reported that, patient was not taking any other medications within 2 weeks of starting covid-19 treatment. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran (Dose number in series 2), and tozinameran (Dose number in series 3) was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient was recovering from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 3 patients were given monovalent vaccine instead of the bivalent booster around 10:00 CST; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (3 patients were given monovalent vaccine instead of the bivalent booster around 10:00 CST) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 074B22A, 058H21A, 001B21A and 031M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-Feb-2021 at 11:06 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Mar-2021 at 12:29 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 03-Mar-2023, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 03-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (3 patients were given monovalent vaccine instead of the bivalent booster around 10:00 CST). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (3 patients were given monovalent vaccine instead of the bivalent booster around 10:00 CST) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (3 patients were given monovalent vaccine instead of the bivalent booster around 10:00 CST).    No concomitant medications was reported. It was unknown whether patient had Chronic or long-standing health conditions and Acute illnesses at the time of vaccination and up to one month before. They recommend to take bivalent 2 month from 03Mar2023 and patient had no reaction. No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713877, US-MODERNATX, INC.-MOD-2023-713958 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2023: Significant follow up received contains reporter details, patient details added and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713877:Patient 3 case US-MODERNATX, INC.-MOD-2023-713958:Patient 2 case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion with our Moderna COVID-19 vaccine; The dose was administered to the patient post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna COVID-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna COVID-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna COVID-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna COVID-19 vaccine) and POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion).    No concomitant medications details were reported.  It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that there was a temperature excursion with Moderna COVID-19 vaccine, both monovalent & bivalent. 27 total doses were administered post excursion.   No treatment medications details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2023: Follow-up received contains non-significant information. On 16-Mar-2023: Live significant follow-up appended: Patient details, suspect vaccine batch number, event verbatim and coding, case narrative were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715674:Master Case