chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RVX
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: knot in my arm; Suffered over 36 hours of low grade fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pyrexia (on 2009 received and also had knot in arm.).   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced fever (Verbatim: Suffered over 36 hours of low grade fever) and local swelling (Verbatim: knot in my arm).  The outcome of the fever was resolved (duration 36 hrs) and the outcome of the local swelling was resolved.   It was unknown if the reporter considered the fever and local swelling to be related to RSV vaccine.     It was unknown if the company considered the fever and local swelling to be related to RSV vaccine.   Additional Information: GSK Receipt date: 29-SEP-2023 This case was reported by patient via interactive digital media. The patient got the RSV vaccine, suffered over 36 hours of low grade fever and a knot in his/her arm and he/she had to use a shoulder massager to break it up and get my shoulder feeling right again.  The patient states that he/she normally do vaccines well but this one and the Shingles shot back in 2009 gave his/her the same reaction and he/she didn't like it.  Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: RVX
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: reaction at the injection point/3 in red spot thats very warm, very sore and swollen; reaction at the injection point/3 in red spot thats very warm, very sore and swollen; reaction at the injection point/3 in red spot thats very warm, very sore and swollen; reaction at the injection point/3 in red spot thats very warm, very sore and swollen; injection site itchy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced injection site rash (Verbatim: reaction at the injection point/3 in red spot thats very warm, very sore and swollen), injection site warmth (Verbatim: reaction at the injection point/3 in red spot thats very warm, very sore and swollen), injection site pain (Verbatim: reaction at the injection point/3 in red spot thats very warm, very sore and swollen), injection site swelling (Verbatim: reaction at the injection point/3 in red spot thats very warm, very sore and swollen) and injection site itching (Verbatim: injection site itchy).  The outcome of the injection site rash, injection site warmth and injection site itching were not resolved and the outcome of the injection site pain was resolving and the outcome of the injection site swelling was not reported.   It was unknown if the reporter considered the injection site rash, injection site warmth, injection site pain, injection site swelling and injection site itching to be related to RSV vaccine.     It was unknown if the company considered the injection site rash, injection site warmth, injection site pain, injection site swelling and injection site itching to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 29-SEP-2023 The case was received from the patient via interactive digital media. The patient got the vaccine and had reactions at the injection point. The patient had 3 red spots which were warm but very sore. The patient felt warm at the injection point. Second day of vaccination soreness was little less, but he/she still had the redness and warm. It was nowitchy. The patient stated it was very strange. The follow-up would not required per process.
Sex: U
Vaccine: RVX
Symptoms: Injection site warmth
Clinical narrative: reaction at the injection point/3 in red spot thats very warm, very sore and swollen; reaction at the injection point/3 in red spot thats very warm, very sore and swollen; reaction at the injection point/3 in red spot thats very warm, very sore and swollen; reaction at the injection point/3 in red spot thats very warm, very sore and swollen; injection site itchy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced injection site rash (Verbatim: reaction at the injection point/3 in red spot thats very warm, very sore and swollen), injection site warmth (Verbatim: reaction at the injection point/3 in red spot thats very warm, very sore and swollen), injection site pain (Verbatim: reaction at the injection point/3 in red spot thats very warm, very sore and swollen), injection site swelling (Verbatim: reaction at the injection point/3 in red spot thats very warm, very sore and swollen) and injection site itching (Verbatim: injection site itchy).  The outcome of the injection site rash, injection site warmth and injection site itching were not resolved and the outcome of the injection site pain was resolving and the outcome of the injection site swelling was not reported.   It was unknown if the reporter considered the injection site rash, injection site warmth, injection site pain, injection site swelling and injection site itching to be related to RSV vaccine.     It was unknown if the company considered the injection site rash, injection site warmth, injection site pain, injection site swelling and injection site itching to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 29-SEP-2023 The case was received from the patient via interactive digital media. The patient got the vaccine and had reactions at the injection point. The patient had 3 red spots which were warm but very sore. The patient felt warm at the injection point. Second day of vaccination soreness was little less, but he/she still had the redness and warm. It was nowitchy. The patient stated it was very strange. The follow-up would not required per process.
Sex: U
Vaccine: RVX
Symptoms: Pain in extremity
Clinical narrative: left arm a little sore for 2 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)) for prophylaxis and COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   In SEP-2023, the patient received RSV vaccine (right arm), FLU VACCINE (NAME UNKNOWN) (left arm) and COVID VACCINE (left arm). In SEP-2023, an unknown time after receiving RSV vaccine and an unknown time after receiving FLU VACCINE (NAME UNKNOWN), the patient experienced pain in arm (Verbatim: left arm a little sore for 2 days).  The outcome of the pain in arm was resolved (duration 2 days).   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK receipt date: 29-SEP-2023 The case was received from the patient interactive digital media. The got the new Covid, Flu and RSV all on the same day and that was 4 days ago.  The patient had zero issues, left arm a little sore for 2 days, but he/she went to the gym on the second day and had been daily since the shots. The patient know that everyones body reacts differently, but that was his/her input. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RVX
Symptoms: Pain
Clinical narrative: just a bit sore and it is almost gone; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain (Verbatim: just a bit sore and it is almost gone).  The outcome of the pain was resolved.   It was unknown if the reporter considered the pain to be related to RSV vaccine.     It was unknown if the company considered the pain to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 29-SEP-2023 This case was reported by a consumer via interactive digital media. No side effects, it was just a bit sore and it was almost gone.
Sex: U
Vaccine: RVX
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   The patient's past medical history included cardiac failure. Previously administered products included Covid vaccine with an associated reaction of pain in extremity (On an unknown date received 6 doses and only after 1st dose experienced sore arm and tired for 2 days) and Flu vaccine. Concurrent medical conditions included chronic obstructive pulmonary disease, emphysema and blood pressure high. Family history included covid-19 (exposed to Covid in my home 5 times.).   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: Sore arm).  The outcome of the pain in arm was resolved (duration 2 days).   The reporter considered the pain in arm to be possibly related to RSV vaccine.     The company considered the pain in arm to be possibly related to RSV vaccine.   Additional Information: GSK Receipt Date: 29-SEP-2023 This case was reported by a patient via interactive digital media. The reporter reported that he or she received all six Covid vaccine, the Flu vaccine and the RSV vaccine.  The reporter stated that the only reaction was a sore arm and tired after the first Covid vaccine that lasted for two days.  The patient reported that the RSV vaccine gave him or her a sore arm for two days. The patient stated that he or she could do whatever needed to through out it all. The flu shot is something he or she get every year. The patient had been exposed to Covid in his or her home 5 times, so far so good as patient in the extreme vulnerable range, heart failure, COPD, emphysema and high blood pressure. Follow-up would not possible as no contact details were available.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Vomiting
Clinical narrative: severe very swollen arm; Severe very sore arm; coughing; abdominal pain; raising phlegm; fever/high fever; chills; vomiting; nausea; higher than usual blood pressure; eyes running; nose running; sweating at night mostly; lower abdominal pain; some bloating; This non-serious case was reported by a physician via sales rep and described the occurrence of swelling arm in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included diverticulitis. Previously administered products included Antibiotics.   On 20-SEP-2023, the patient received Arexvy (intramuscular) .5 ml. In SEP-2023, less than a month after receiving Arexvy, the patient experienced swelling arm (Verbatim: severe very swollen arm), pain in arm (Verbatim: Severe very sore arm), cough (Verbatim: coughing), abdominal pain (Verbatim: abdominal pain), phlegm (Verbatim: raising phlegm), fever (Verbatim: fever/high fever), chills (Verbatim: chills), vomiting (Verbatim: vomiting), nausea (Verbatim: nausea), blood pressure high (Verbatim: higher than usual blood pressure), eye discharge (Verbatim: eyes running), runny nose (Verbatim: nose running), sweating (Verbatim: sweating at night mostly), lower abdominal pain (Verbatim: lower abdominal pain) and bloating (Verbatim: some bloating).  The patient was treated with antiemetics and antinauseants (Anti Nausea Tablet (Nos)). In SEP-2023, the outcome of the swelling arm, pain in arm, cough, abdominal pain, phlegm, chills, vomiting, nausea, blood pressure high, eye discharge and runny nose were resolved (duration 4 days) and the outcome of the fever, sweating, lower abdominal pain and bloating were resolved (duration 6 days).   The reporter considered the swelling arm, pain in arm, cough, abdominal pain, phlegm, fever, chills, vomiting, nausea, blood pressure high, eye discharge, runny nose, sweating, lower abdominal pain and bloating to be related to Arexvy.     The company considered the swelling arm, pain in arm, cough, abdominal pain, phlegm, fever, chills, vomiting, nausea, blood pressure high, eye discharge, runny nose, sweating, lower abdominal pain and bloating to be related to Arexvy.   Additional Information: GSK Receipt Date: 29-SEP-2023 It was reported that initial 4.5 days of duration after vaccination, patient experienced severe very sore swollen arm, coughing, abdominal pain, raising phlegm, fever, chills, vomiting and was better with anti nausea medication. The patient experienced higher than usual blood pressure, eyes and nose running, high fever, chills, sweating at night mostly, then broke and had mild chills. Additionally, lasting the next 2 days patient reported fever, sweats, no chills, lower abdominal pain, some bloating not as bad. The reporter did believed the event was related to the product The reporter stated that the patient had previously been treated for diverticulitis, including antibiotics. This was during the summer months. The patient was feeling great when she went to be vaccinated. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administration of expired product; This non-serious case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a 58-year-old female patient who received HAB (Twinrix) (batch number 2ke55, expiry date 22-SEP-2023) for prophylaxis.   On 27-SEP-2023, the patient received the 1st dose of Twinrix. On 27-SEP-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: administration of expired product).  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: 29-SEP-2023 It was reported that an expired Twinrix vaccine was administered to a patient which led to expired vaccine used. No adverse reaction noted. This was the first dose of a series of 3 doses given. It was reported that expired medication had been removed from office supply and retraining of 5 rights and medication administration will be given to the medical assistant. No known event occurred from administration of expired product. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: Had 2 shots of Shingrix, however because of Covid they were 2 years apart; This non-serious case was reported by a consumer and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago prior to the receiving 2nd dose).   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 social problem (Verbatim: Had 2 shots of Shingrix, however because of Covid they were 2 years apart).  The outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 29-SEP-2023 The patient reported that he or she received two doses of Shingrix vaccine but due to Covid they were two years apart. The patient wanted to know if he or she need to receive the third dose and if he or she covered.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: expired dose of Boostrix was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 67-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2ZF9N, expiry date 24-SEP-2023) for prophylaxis.   On 29-SEP-2023, the patient received Boostrix. On 29-SEP-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: expired dose of Boostrix was administered to a patient).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 29-SEP-2023 The reporter called to report that an expired dose of Boostrix was administered to a patient, which led to expired vaccine used. The reporter consented to follow up.
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: pregnant woman received  INFANRIX; received INFANRIX instead of BOOSTRIX; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 32-year-old female patient who received DTPa (Infanrix) (batch number 7H399, expiry date 13-SEP-2024) for prophylaxis.   Concurrent medical conditions included pregnancy.   On 27-SEP-2023, the patient received Infanrix (right deltoid). On 27-SEP-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: received INFANRIX instead of BOOSTRIX). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant woman received  INFANRIX).  The outcome of the wrong vaccine administered and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Gestation time at first exposure (Infanrix): 28 Weeks Pregnancy Exposure (Infanrix): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   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: 29-SEP-2023 The medical assistant stated that she gave a pregnant woman Infanrix instead of Boostrix in her right deltoid which led to wrong vaccine administered and exposure during pregnancy. The medical assistant stated that she took the wrong vaccine out of the refrigerator by mistake.  The Pregnant woman is at 28 weeks gestation. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Miliaria, Rash
Clinical narrative: left axillary rash; heat rash; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of rash in a 66-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5BN3T, expiry date 05-NOV-2024) for prophylaxis.   On 19-SEP-2023, the patient received Arexvy (intramuscular, left deltoid). On 21-SEP-2023, 2 days after receiving Arexvy, the patient experienced rash (Verbatim: left axillary rash) and heat rash (Verbatim: heat rash).  The patient was treated with hydrocortisone cream and topical antibiotic (nos) (Antibacterial Soap). The outcome of the rash and heat rash were not resolved.   It was unknown if the reporter considered the rash and heat rash to be related to Arexvy.     It was unknown if the company considered the rash and heat rash to be related to Arexvy.   Additional Information: GSK Receipt Date: 29-SEP-2023 The reporter reported that the patient received Arexvy vaccine and he developed left axillary rash, which remains ongoing at the time of reporting. The patient reported that it looks like a heat rash. Patient had used hydrocortisone cream and washed with antibacterial soap, but the rash remains unchanged. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 45.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: inadvertently administered an expired dose of Menveo; 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 45-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA723Z, expiry date 31-AUG-2023) for prophylaxis.   The patient's past medical history included splenectomy.   On 29-SEP-2023, the patient received Menveo (left deltoid). On 29-SEP-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: inadvertently administered an expired dose of Menveo).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-SEP-2023 The office manager called and inquired that should the patient be revaccinate as was inadvertently administered an expired dose of Menveo which led to expired vaccine used. The reporter did not consent to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expired Menveo administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA710A, expiry date 30-APR-2023) for prophylaxis.   On 03-MAY-2023, the patient received Menveo. On 03-MAY-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: expired Menveo administered).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-SEP-2023 The nurse practitioner requested expiration data for Menveo as expired vaccine was administered to a patient which led to expired vaccine used. The nurse practitioner disconnected chat without providing requested patient demographics or agreeing to safety team follow up, stating that she will reach out again with any additional questions.
Age: 8.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: an 8 year old received Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old female patient who received DTPa (Infanrix) (batch number 9HP9Z, expiry date 21-APR-2024) for prophylaxis.   On 13-SEP-2023, the patient received Infanrix. On 13-SEP-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: an 8 year old received Infanrix).  The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-SEP-2023 A nurse reported that an 8 year old received Infanrix which led to inappropriate age at vaccine administration. No symptoms reported. The reporter consented to follow up via mail.
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: patient received  expired dose of Engerix B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 41-year-old male patient who received HBV (Engerix B) (batch number F73DG, expiry date 03-JUL-2023) for prophylaxis.   On 29-SEP-2023, the patient received Engerix B. On 29-SEP-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: patient received  expired dose of Engerix B).  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: 29-SEP-2023 The pharmacist reported that a patient received an expired dose of Engerix B which led to expired vaccine used. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: inadvertently administered a Flulaval instead of Flaud; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 74-year-old female patient who received Flu Seasonal TIV (Flulaval) for prophylaxis.   On 27-SEP-2023, the patient received Flulaval. On 27-SEP-2023, an unknown time after receiving Flulaval, the patient experienced wrong vaccine administered (Verbatim: inadvertently administered a Flulaval instead of Flaud).  The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-SEP-2023 A practice manager called and inquired regarding any information on Flulaval and Fluad or on administering a high dose flu vaccine after Flulaval. The manager mentioned that the Physician ordered the patient to receive Fluad but the patient was inadvertently administered a Flulaval  instead which led to wrong vaccine administered. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: injected arm that was red; injected arm that was swollen; injected arm that hurt; This non-serious case was reported by a consumer via call center representative and described the occurrence of erythema in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chicken pox twice, once as a child and again at the age of 51). Previously administered products included Zostavax (had Zostavax at the age of 60).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced erythema (Verbatim: injected arm that was red), swelling arm (Verbatim: injected arm that was swollen) and pain in arm (Verbatim: injected arm that hurt). The outcome of the erythema, swelling arm and pain in arm were resolved.   It was unknown if the reporter considered the erythema, swelling arm and pain in arm to be related to Shingrix.     It was unknown if the company considered the erythema, swelling arm and pain in arm to be related to Shingrix.   Linked case(s) involving the same patient:  US2023134482   Additional Information: GSK receipt date: 29-Sept-2023 The patient stated that she had a similar local reaction to the first dose of Shingrix (injected arm that was red, swollen and hurt), but was not as severe as the second dose. The reporter gave consent to follow up with health care professional.  However the patient provided limited contact information for the health care professional.  For the tolerance of second dose, refer case US2023134482.; Sender's Comments:  US-GSK-US2023134482:Same patient, second dose
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: administered a extra dose of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number J44K5, expiry date 30-NOV-2024) for prophylaxis.   Concomitant products included MENVEO.   On 29-SEP-2023, the patient received the 2nd dose of Menveo. On 29-SEP-2023, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: administered a extra dose of Menveo).  The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 29-SEP-2023 The nurse reported that 11 year old male patient was administered a dose of Menveo on and afterwards they realized that he had just received a dose on 31 August 2023 which led to extra administered. The nurse did not have lot number information for the first dose. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: 3rd dose of Bexsero administered; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number X4BK3, expiry date 30-SEP-2026) for prophylaxis.   Previously administered products included Bexsero (1st dose received on unknown date) and Bexsero (2nd dose received on unknown date).   On 29-SEP-2023, the patient received the 3rd dose of Bexsero. On 29-SEP-2023, an unknown time after receiving Bexsero, the patient experienced extra dose administered (Verbatim: 3rd dose of Bexsero administered).  The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-SEP-2023 A physician reported that a female patient already completed the 2 dose series for Bexsero and was given an accidental 3rd dose which led to extra dose administered. No symptoms reported. The reporter consented to follow up via mail.
Age: 0.33
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 19 week old received the Flulaval; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-week-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 9E5KE, expiry date 30-JUN-2024) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2022-2023 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced inappropriate age at vaccine administration (Verbatim: 19 week old received the Flulaval).  The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-SEP-2023 The healthcare professional reported that a 19 week old received the Flulaval which led to inappropriate age at vaccine administration. No reactions reported. No additional information provided. The reporter consented to follow up via mail.
Age: 68.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Feeling abnormal
Clinical narrative: Patient received 2 doses of  Spikevax Moderna 23-24, 09/28/23 and 10/04/23. Pt did not have any  reaction with the first dose of Spikevax.  When pt received Spikevax and Fluzone, she felt a little under the weather for about 1 day.  No other issues, confirmed with pt 10/09/23.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Reported metallic taste in mouth that lasted about 60 minutes. Slightly improved after drinking water. Had been wearing N-95 mask for duration of appointment, approx. 80 minutes with observation time. Denies any signs of anaphylaxis.
Age: 79.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Arthralgia, Back pain, Decreased appetite, Fatigue, Feeling cold
Clinical narrative: I first noticed that I was shaking inside. I felt hot, sweaty, and then cold, and then hot again. My body hurt like I had been beat up. My back hurts up to my right side. It hurts all the way up into my shoulder and neck. I felt nauseated the next morning. I had no appetite. I would sleep, wake, sleep, wake. I was thirsty and I drank water constantly and Pedialyte. I have a hard time going to sleep if  I wake up. I am very tired.
Age: 79.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Feeling of body temperature change, Hyperhidrosis, Initial insomnia, Nausea, Neck pain
Clinical narrative: I first noticed that I was shaking inside. I felt hot, sweaty, and then cold, and then hot again. My body hurt like I had been beat up. My back hurts up to my right side. It hurts all the way up into my shoulder and neck. I felt nauseated the next morning. I had no appetite. I would sleep, wake, sleep, wake. I was thirsty and I drank water constantly and Pedialyte. I have a hard time going to sleep if  I wake up. I am very tired.
Age: 79.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Nervousness, Pain, Sleep disorder, Thirst
Clinical narrative: I first noticed that I was shaking inside. I felt hot, sweaty, and then cold, and then hot again. My body hurt like I had been beat up. My back hurts up to my right side. It hurts all the way up into my shoulder and neck. I felt nauseated the next morning. I had no appetite. I would sleep, wake, sleep, wake. I was thirsty and I drank water constantly and Pedialyte. I have a hard time going to sleep if  I wake up. I am very tired.
Age: 45.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Headache, fever, nausea, chills, tinnitus, lightheaded all within 24 hours of vaccinations. Tinnitus first symptom and only symptom that hasn?t cleared up.
Age: 45.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Tinnitus
Clinical narrative: Headache, fever, nausea, chills, tinnitus, lightheaded all within 24 hours of vaccinations. Tinnitus first symptom and only symptom that hasn?t cleared up.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: felt like fluid was injected in spine
Age: 43.0
Sex: M
Vaccine: VARZOS
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: 43-year-old male patient/Shingrix was prescribed by medical order based on his medical history of Systemic Mastocytosis; 43-year-old male patient was provided the 1st dose of Shingrix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of off label use in a 43-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included systemic mastocytosis.   On an unknown date, the patient received the 1st dose of Shingrix (right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced off label use (Verbatim: 43-year-old male patient/Shingrix was prescribed by medical order based on his medical history of Systemic Mastocytosis) and inappropriate age at vaccine administration (Verbatim: 43-year-old male patient was provided the 1st dose of Shingrix vaccine). The outcome of the off label use and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 29-SEP-2023 The patient reported that he was provided the 1st dose of Shingrix vaccine 4 months ago (from the reporting date). The patient reported that Shingrix was prescribed by medical order based on his medical history of systemic mastocytosis. The patient reported that the vaccine was provided at a local pharmacy. No immunosuppression medications were taken at the time of the vaccine, and patient was not immunodeficient at the time of the Shingrix vaccine. The patient was below 50 years when received the Shingrix vaccine and he was not immunodeficient, which led to off label use and inappropriate age at vaccine administration. The reporter did not consent to follow-up.
Age: 81.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: When billing vaccine to insurance, it says patient already received flu vaccine on 8/29/23.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Pain, Pain of skin
Clinical narrative: on the 3rd day after the vaccine was given I experienced sharp shooting pain in left parietal area of brain and scalp ( thunder clap migraine?) which lasted for 4 days. Intensityvaried from 4out of 10 to 9 out of 10 and frequency varied from a few seconds to minutes. Sporadic releif with tylenol or motrin. Finally had to go to doctor appt and received Torodol 60 mg and Decadron 8 mg and now have relief.
Age: 71.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Cerebrovascular accident, Dizziness, Hyperhidrosis, Laboratory test, Malaise
Clinical narrative: patient describes lightheadedness, sweating and an overall feeling of unwell.  patient laid on table until the ambulance was called.  patient stated that he fell later at home and has weakness in his left hand.  patient states that he has had a stroke but was unconfirmed with tests from hospital.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Rash
Clinical narrative: Starting the evening the patient received the vaccine, she developed redness and swelling at injection site, fever, and rash covering body including legs.  Monitored by mother, patient advised by pharmacist to seek immediate medical care if any swelling of face, lips, or tongue occur, or rapid spike in fever, to take antihistamine for itching, ibuprofen or Tylenol to control fever, swelling, or any pain.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Erythema, Impaired work ability, Malaise, Pain in extremity
Clinical narrative: Pt received her Flu vaccine yesterday, she did state that her arm was feeling sore since received. This morning at approximately 9am she also mentioned that her arm was still sore. At approx 11:30am she came back to the office and asked if she could go home because she wasn't feeling well. I asked her what her symptoms were, and she said that she was feeling numbness and tingling on her left arm where she received the vaccine. Pt said she was feeling very dizzy. Pt looked red and shaky. She said that she has had reactions to the Flu vaccine in the past, but she has never felt them as bad as this time. I asked pt. to not go home yet and go in a patient exam room as she needed to be evaluated first. I called a Dr and Dr came to support. After speaking and being evaluated by Dr., Dr. said that her symptoms are possibly caused by the Flu vaccine received yesterday and suggested that pt went home to get some rest she also gave pt instructions on what symptoms to look out for that indicated she needed to be seen at the hospital.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor, Vaccination site hypoaesthesia, Vaccination site paraesthesia
Clinical narrative: Pt received her Flu vaccine yesterday, she did state that her arm was feeling sore since received. This morning at approximately 9am she also mentioned that her arm was still sore. At approx 11:30am she came back to the office and asked if she could go home because she wasn't feeling well. I asked her what her symptoms were, and she said that she was feeling numbness and tingling on her left arm where she received the vaccine. Pt said she was feeling very dizzy. Pt looked red and shaky. She said that she has had reactions to the Flu vaccine in the past, but she has never felt them as bad as this time. I asked pt. to not go home yet and go in a patient exam room as she needed to be evaluated first. I called a Dr and Dr came to support. After speaking and being evaluated by Dr., Dr. said that her symptoms are possibly caused by the Flu vaccine received yesterday and suggested that pt went home to get some rest she also gave pt instructions on what symptoms to look out for that indicated she needed to be seen at the hospital.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in an unapproved storage unit
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Infanrix: expired dose 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 (Infanrix) (batch number LS444, expiry date 16-SEP-2023) for prophylaxis.   On 02-OCT-2023, the patient received Infanrix. On 02-OCT-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Infanrix: expired dose 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: 03-OCT-2023 Nurse reported an expired Infanrix vaccine was administered to a patient on October 2nd 2023, vaccine was expired on September 16th 2023, which led to expired vaccine used. The reporter consented to follow up.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Patient says that she started having itching a day or two after getting Spikevax immunization. The itching is from her breasts down with no rash or hives. She says that it got worse Sunday night.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Heavy menstrual bleeding, Serum ferritin decreased
Clinical narrative: Ever since May of second vaccine I have had horrible menorrhagia. Horrible. I just read on social media how many women are still complaining. I had no idea and did indeed check that there are lots of publications on this adverse effect. My doctor tested by ferritin level and it was 4!!! This is severe. I wish I never had the vaccine. I was started on a  form of progesterone which is not working and now having to schedule a uterine ablation.
Age: 70.0
Sex: F
Vaccine: HEPAB
Symptoms: Headache, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Patient got 2 vaccines in left arm : 2nd dose of twinrix and First dose of shingrix > As per Patient her left arm swell like a bloon and and her Torso was very painful , she had Headache without Aura , high fever
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 2nd dose at 6 week interval instead of 2 month; This non-serious case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   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 drug dose administration interval too short (Verbatim: received 2nd dose at 6 week interval instead of 2 month).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt date: 02-OCT-2023 The reporter asked that what should office do or the patient need to be revaccinated. The patient received 2nd dose of Shingrix at 6 week interval instead of 2 month, which led to shortening of vaccine schedule. The case was linked with case US2023133827 and US2023135142 reported by the same reporter.; Sender's Comments:  US-GSK-US2023133827:Same reporter US-GSK-US2023135142:Same reporter
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Shingrix first dose reconstituted with sterile water; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 83-year-old male patient who received Herpes zoster (Shingrix) (batch number T5J32, expiry date 20-AUG-2024) for prophylaxis.   On 14-SEP-2023, the patient received the 1st dose of Shingrix. On 14-SEP-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix first dose reconstituted with sterile water).  The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 02-OCT-2023 Pharmacist reported that a nurse administered to a patient Shingrix first dose reconstituted with sterile water, which led to wrong solution used in drug reconstitution. The reporter consented to follow up. Follow up accepted to Long Term Care facility.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a 3rd dose of Shingrix in her left arm, on 18-SEP-2023 from her pharmacy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 3B2YJ, expiry date 16-AUG-2025) for prophylaxis.   Previously administered products included Shingrix (received 2 doses  on an unknown date).   On 18-SEP-2023, the patient received the 3rd dose of Shingrix (intramuscular, left arm). On 18-SEP-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received a 3rd dose of Shingrix in her left arm, on 18-SEP-2023 from her pharmacy).  The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 2-Oct-2023 The pharmacist calling on behalf of a patient that received a 3rd dose of Shingrix from her pharmacy.  Patient received all 3 doses over the course of a year and a half (no information provided about previous doses). Consent to follow up with the reporter that called in the adverse event was obtained. The patient received 3 doses of Shingrix, which led to extra dose administered.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: received first dose of Twinrix on 11Sep2023, and has yet to receive the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 11th September 2023 from batch number 2PG39, expiry date 19th September 2025).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: received first dose of Twinrix on 11Sep2023, and has yet to receive the second dose).  The outcome of the incomplete course of vaccination 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: 03-OCT-2023 Pharmacist reports a patient who was going to receive Twinrix accelerated dosing schedule received first dose of Twinrix on 11th September 2023, and has yet to receive the second dose. The patient needs to be on the accelerated schedule because he was going to travel in December. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. HCP gave permission for follow-up. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.