chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Swelling face, Swollen tongue, Syncope, Tachycardia, Throat tightness
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder  (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Mild, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Mild, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild, Additional Details: 2nd dose reaction... 1st was tolerated with no symptoms, Other Vaccines:  VaccineTypeBrand: Heplisav-B; Manufacturer: Dynavax; LotNumber: N/A; Route: IM; BodySite: N/A; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: Shingrix; Manufacturer: GlaxoSmithKline; LotNumber: N/A; Route: IM; BodySite: N/A; Dose: ; VaxDate: UNKNOWN
Age: 52.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Tinnitus, Tremor, Unresponsive to stimuli, Visual impairment, Vomiting
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Abdominal Pain-Mild, Systemic: Autoimmune Disease (diagnosed by MD)-Mild, Systemic: Bell's Palsy-Mild, Systemic: Blood Disorder  (diagnosed by MD)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Mild, Systemic: Heart Attack-Mild, Systemic: Hypertension-Mild, Systemic: Hyperventilation-Mild, Systemic: Hypotension-Mild, Systemic: Joint Pain-Mild, Systemic: Lymph Node Swelling-Mild, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Mild, Systemic: Nausea-Mild, Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Stroke-Mild, Systemic: Tachycardia-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Unable to Sleep-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild, Additional Details: 2nd dose reaction... 1st was tolerated with no symptoms, Other Vaccines:  VaccineTypeBrand: Heplisav-B; Manufacturer: Dynavax; LotNumber: N/A; Route: IM; BodySite: N/A; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: Shingrix; Manufacturer: GlaxoSmithKline; LotNumber: N/A; Route: IM; BodySite: N/A; Dose: ; VaxDate: UNKNOWN
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test normal, Brain fog, Computerised tomogram normal, Dizziness, Electrocardiogram normal
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: BRAIN FOG
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Feeling abnormal, Hypoaesthesia, Impaired work ability, Magnetic resonance imaging normal, Symptom recurrence
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: BRAIN FOG
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Brain fog, Hypoaesthesia
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: BRAIN FOG
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Rash
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Rash papular, Rash vesicular
Clinical narrative: rash on face; rash blistered; sore arm; soreness at the injection site; Large red mark at the injection site, radiating to around her arm and onto her chest; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-JUN-2024, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 02-JUN-2024, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: soreness at the injection site), erythema of extremities (Verbatim: Large red mark at the injection site, radiating to around her arm and onto her chest) and pain in arm (Verbatim: sore arm). On 04-JUN-2024, the patient experienced exanthema facial (Verbatim: rash on face) and blistery rash (Verbatim: rash blistered). The outcome of the injection site pain, erythema of extremities and pain in arm were resolved and the outcome of the exanthema facial was resolving and the outcome of the blistery rash was not resolved.   It was unknown if the reporter considered the injection site pain, erythema of extremities, exanthema facial, blistery rash and pain in arm to be related to Shingrix.     It was unknown if the company considered the injection site pain, erythema of extremities, exanthema facial, blistery rash and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-JUN-2024 The patient was self-reported this case. The patient reported that she received Shingrix vaccine and began to experiencing soreness and large red mark at the injection site. The redness extended around her arm and onto her chest. The reporter stated that these symptoms had resolved.  On 4th June 2024, She noticed a rash on the left side of her face on her temple and extending a little onto her eyelid.  The rash blistered but the blisters did not break and rash was now started to decrease in size.  The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Eyelid rash, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: rash on face; rash blistered; sore arm; soreness at the injection site; Large red mark at the injection site, radiating to around her arm and onto her chest; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-JUN-2024, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 02-JUN-2024, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: soreness at the injection site), erythema of extremities (Verbatim: Large red mark at the injection site, radiating to around her arm and onto her chest) and pain in arm (Verbatim: sore arm). On 04-JUN-2024, the patient experienced exanthema facial (Verbatim: rash on face) and blistery rash (Verbatim: rash blistered). The outcome of the injection site pain, erythema of extremities and pain in arm were resolved and the outcome of the exanthema facial was resolving and the outcome of the blistery rash was not resolved.   It was unknown if the reporter considered the injection site pain, erythema of extremities, exanthema facial, blistery rash and pain in arm to be related to Shingrix.     It was unknown if the company considered the injection site pain, erythema of extremities, exanthema facial, blistery rash and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-JUN-2024 The patient was self-reported this case. The patient reported that she received Shingrix vaccine and began to experiencing soreness and large red mark at the injection site. The redness extended around her arm and onto her chest. The reporter stated that these symptoms had resolved.  On 4th June 2024, She noticed a rash on the left side of her face on her temple and extending a little onto her eyelid.  The rash blistered but the blisters did not break and rash was now started to decrease in size.  The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: rash on face; rash blistered; sore arm; soreness at the injection site; Large red mark at the injection site, radiating to around her arm and onto her chest; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-JUN-2024, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 02-JUN-2024, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: soreness at the injection site), erythema of extremities (Verbatim: Large red mark at the injection site, radiating to around her arm and onto her chest) and pain in arm (Verbatim: sore arm). On 04-JUN-2024, the patient experienced exanthema facial (Verbatim: rash on face) and blistery rash (Verbatim: rash blistered). The outcome of the injection site pain, erythema of extremities and pain in arm were resolved and the outcome of the exanthema facial was resolving and the outcome of the blistery rash was not resolved.   It was unknown if the reporter considered the injection site pain, erythema of extremities, exanthema facial, blistery rash and pain in arm to be related to Shingrix.     It was unknown if the company considered the injection site pain, erythema of extremities, exanthema facial, blistery rash and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-JUN-2024 The patient was self-reported this case. The patient reported that she received Shingrix vaccine and began to experiencing soreness and large red mark at the injection site. The redness extended around her arm and onto her chest. The reporter stated that these symptoms had resolved.  On 4th June 2024, She noticed a rash on the left side of her face on her temple and extending a little onto her eyelid.  The rash blistered but the blisters did not break and rash was now started to decrease in size.  The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium
Age: 64.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium
Sex: U
Vaccine: RV5, UNK, RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Administered after temperature excursions; This spontaneous report has been received from a medical assistant, regarding to a patient of unknow age and gender. The patient's pertinent medical history, concurrent conditions, drug allergies or concomitant medications were not reported.  05-JUN-2024, the patients was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #X023403, expiration date: 03-APR-2025, administered orally (strength and dose were not provided); and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS), 0.5 milliliter injection, lot #U7801AA, expiration date: 30-JUN-2026 (route of administration, anatomical location and dose were not provided), both administered for prophylaxis. The vaccines had a temperature excursion at a temperature of 48.4 Fahrenheit Celsius (F) for 58 minutes (Product storage error). There was no previous temperature excursion. No additional adverse events were reported (no adverse event).
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Confusional state, Dysstasia, Headache, Muscular weakness
Clinical narrative: Chills; Night Sweats; Confusion; Difficulty standing; Headache; rash; muscle weakness; This non-serious case was reported by a consumer and described the occurrence of chills in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-JUN-2024, the patient received Shingrix (right arm). On 10-JUN-2024, less than a day after receiving Shingrix, the patient experienced chills (Verbatim: Chills), night sweat (Verbatim: Night Sweats), confusion (Verbatim: Confusion), difficulty in standing (Verbatim: Difficulty standing), headache (Verbatim: Headache), rash (Verbatim: rash) and muscle weakness (Verbatim: muscle weakness). The outcome of the chills, night sweat, confusion, difficulty in standing, headache, rash and muscle weakness were not resolved.   It was unknown if the reporter considered the chills, night sweat, confusion, difficulty in standing, headache, rash and muscle weakness to be related to Shingrix.     It was unknown if the company considered the chills, night sweat, confusion, difficulty in standing, headache, rash and muscle weakness to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-JUN-2024 The patient had chills, night Sweats, confusion, difficulty standing, headache, rash, muscle weakness after receiving Shingrix. The patient wished that she had been warned of the side effects as she would not had taken the vaccine.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Night sweats, Rash
Clinical narrative: Chills; Night Sweats; Confusion; Difficulty standing; Headache; rash; muscle weakness; This non-serious case was reported by a consumer and described the occurrence of chills in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-JUN-2024, the patient received Shingrix (right arm). On 10-JUN-2024, less than a day after receiving Shingrix, the patient experienced chills (Verbatim: Chills), night sweat (Verbatim: Night Sweats), confusion (Verbatim: Confusion), difficulty in standing (Verbatim: Difficulty standing), headache (Verbatim: Headache), rash (Verbatim: rash) and muscle weakness (Verbatim: muscle weakness). The outcome of the chills, night sweat, confusion, difficulty in standing, headache, rash and muscle weakness were not resolved.   It was unknown if the reporter considered the chills, night sweat, confusion, difficulty in standing, headache, rash and muscle weakness to be related to Shingrix.     It was unknown if the company considered the chills, night sweat, confusion, difficulty in standing, headache, rash and muscle weakness to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-JUN-2024 The patient had chills, night Sweats, confusion, difficulty standing, headache, rash, muscle weakness after receiving Shingrix. The patient wished that she had been warned of the side effects as she would not had taken the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Product preparation issue
Clinical narrative: Patient did develop systemic/local reaction.; patient may had received only the adjuvant portion; patient may had received only the adjuvant portion; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of local reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced local reaction (Verbatim: Patient did develop systemic/local reaction.), inappropriate preparation of medication (Verbatim: patient may had received only the adjuvant portion) and inappropriate dose of vaccine administered (Verbatim: patient may had received only the adjuvant portion). The outcome of the local reaction was not reported and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the local reaction to be related to Shingrix.     It was unknown if the company considered the local reaction to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-JUN-2024 It was reported that patient may had received only the adjuvant portion of a Shingrix vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Patient did develop systemic/local reaction.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Rash, Rash vesicular
Clinical narrative: rash around her face and neck.; chickenpox-like blisters; Dizzy; Felt tired; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on an unknown date).   On 31-MAY-2024, the patient received the 2nd dose of Shingrix. On 31-MAY-2024, less than a day after receiving Shingrix, the patient experienced tiredness (Verbatim: Felt tired). In JUN-2024, the patient experienced rash (Verbatim: rash around her face and neck.), blister (Verbatim: chickenpox-like blisters) and dizziness (Verbatim: Dizzy). The outcome of the tiredness and dizziness were unknown and the outcome of the rash and blister were not resolved.   It was unknown if the reporter considered the tiredness, rash, blister and dizziness to be related to Shingrix.     It was unknown if the company considered the tiredness, rash, blister and dizziness to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-JUN-2024 The reporter was the patient who received the second dose of Shingrix on May 31, 2024 in the upper left arm. Later that day the patient felt tired. Within a few days (around the 3rd or 4th of June 2024) the patient began to develop a rash around her neck. Subsequently the rash increased around her face and neck. The rash was described as chickenpox-like blisters. The patient also had a spot on Left back near the shoulder blade and on the right side of her back. On Friday June 7, 2024 and Saturday June 8, 2024, the patient was feeling tired and dizzy. The patient stated as of today, she had not noticed any new blisters develop. The patient states she was also gardening before rash was noticed. For tolerance of 1st dose refer case US2024072106.; Sender's Comments:  US-GSK-US2024072106:for Shingrix 2nd dose
Sex: U
Vaccine: RSV
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: sore arm; extreme fatigue; slight headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 76-year-old patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 1 day after receiving Arexvy, the patient experienced pain in arm (Verbatim: sore arm), fatigue (Verbatim: extreme fatigue) and headache (Verbatim: slight headache). The outcome of the pain in arm, fatigue and headache were resolved.   It was unknown if the reporter considered the pain in arm, fatigue and headache to be related to Arexvy.     It was unknown if the company considered the pain in arm, fatigue and headache to be related to Arexvy.   Additional Information: GSK receipt date: 08-JUN-2024 This case was reported the patient via interactive digital media. The patient was administered with RSV vaccination due to the age and the doctor seeing a patients with symptoms.  The patient got the vaccination and had sore arm and extreme fatigue the next day and slight headache.  The patient was ok now (at the time of reporting) but wondering if this was not necessary for the patient.  The patient had none of the health issues listed above. The patient felt that, got bad advice.
Sex: U
Vaccine: HEP
Symptoms: False positive investigation result, Hepatitis B surface antibody positive, Therapy non-responder
Clinical narrative: Hep B vaccine was given and HBsAG was drawn and came out positive. it's a false positive result; This non-serious case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a patient who received HBV (Engerix B) for prophylaxis.   Concurrent medical conditions included hemodialysis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced therapy non-responder (Verbatim: Hep B vaccine was given and HBsAG was drawn and came out positive. it's a false positive result). The outcome of the therapy non-responder was unknown.   Additional Information: GSK Receipt Date: 06-JUN-2024 The medical information department received the following email request by a nurse manager reported that he/she inquired about Hepatitis B vaccine administration for hemodialysis patients. As per guidance on hemodialysis patients , vaccines were given in 4 doses being the first 3 doses given 1 dose of 40 mcg every month and the 4th dose being given after six months from the initial start date. As per guidelines which was the regulating body for hemodialysis, monthly hepatitis B surface antigen (HBsAG) must be drawn to monitor Hepatitis B infection. The reporters question was how many days the vaccine stayed in the system once given in order not to be positive with hepatitis B surface antigen (HBsAG). There was an incident in the past where the Hepatitis B vaccine was given and hepatitis B surface antigen (HBsAG) was drawn and came out positive and the reporter wanted to prevent this from happening since it was a false positive result, which led to therapy non-responder. They take Hepatitis B positive seriously so a lot of reports and testing underwent to make sure it was the right result or just a fall alarm. The reporter hopes this cleared the question and comes up with an answer as soon as possible. The reporter was surprised that no one could answer his/her question. As the manufacturer they should be able to answer this or at least have it in the drug manufacturing information. Since this was a clarification email, follow up was not possible to request.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Pediatric 2nd dose on an adult patient; Adult use of a child product; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 21-year-old female patient who received HBV (Engerix B pediatric) (batch number KR3XD, expiry date 17-FEB-2025) for prophylaxis.   Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b).   On 31-MAY-2024, the patient received the 2nd dose of Engerix B pediatric. On 31-MAY-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Pediatric 2nd dose on an adult patient) and adult use of a child product (Verbatim: Adult use of a child product). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 07-JUN-2024 The patient of 21 years old who received second dose as a pediatric dose, which led to underdose and adult used of child product.  The caller needed to know if this was valid dose.
Age: 25.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: accidentally administered a dose of Infanrix to a 25 year old patient instead of Boostrix; accidentally administered a dose of Infanrix to a 25 year old patient instead of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 25-year-old female patient who received DTPa (Infanrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   On 28-MAY-2024, the patient received Infanrix. On 28-MAY-2024, an unknown time after receiving Infanrix, the patient experienced adult use of a child product (Verbatim: accidentally administered a dose of Infanrix to a 25 year old patient instead of Boostrix) and accidental underdose (Verbatim: accidentally administered a dose of Infanrix to a 25 year old patient instead of Boostrix). The outcome of the adult use of a child product and accidental underdose 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: 07-JUN-2024 It was reported that the administrative staff explained that on May 28th 2024 they accidentally administered a dose of Infanrix to a 25 year old patient instead of Boostrix which led to adult use of a child product and accidental underdose.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Scab, Skin lesion
Clinical narrative: a rash on her face in cluster formation; lesions itch; Crust lesion; lesion; This non-serious case was reported by a consumer via call center representative and described the occurrence of exanthema facial in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included herpes virus infection and obesity. Concomitant products included semaglutide (Ozempic).   On 14-MAY-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced exanthema facial (Verbatim: a rash on her face in cluster formation), itchy rash (Verbatim: lesions itch), crust (Verbatim: Crust lesion) and skin lesion (Verbatim: lesion). The patient was treated with pregabalin (Lyrica). The outcome of the exanthema facial, itchy rash, crust and skin lesion were not resolved.   It was unknown if the reporter considered the exanthema facial, itchy rash, crust and skin lesion to be related to Shingrix.     It was unknown if the company considered the exanthema facial, itchy rash, crust and skin lesion to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-JUN-2024 The patient stated that she received her first dose of Shingrix and a few days later she started breaking out in a rash on her face in cluster formation, present around the mouth, underneath bottom lip, on the chin, and both cheeks up to the nose area.  The consumer did call teledoc and Lyrica 25mg 1 capsule twice daily for 5 days was prescribed.  The consumer reported she was actively using Ozempic and called the manufacturer of Ozempic to find out if this was caused by that medication. Unable to determine causation. The consumer reported that the lesions itch and now are crusty.  As of 07 June 2024 the lesions were still present.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles; Rash coming up up her back from her buttocks on her right side (the same side as right arm); This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 53XH9, expiry date 06-APR-2026) for prophylaxis.   On 04-JUN-2024, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On 07-JUN-2024, 3 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles) and rash (Verbatim: Rash coming up up her back from her buttocks on her right side (the same side as right arm)). The patient was treated with valaciclovir (Valacyclovir). The outcome of the shingles and rash were not resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.     It was unknown if the company considered the shingles and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-JUN-2024 The patient self-reported this case. The patient received second dose of Shingrix on Tuesday and by Friday had a rash coming up her back from her buttocks on her right side (the same side as right arm). The patient noticed more on Saturday and she went to an urgent care and was diagnosed with Shingles. The physician had put the patient on Valacyclovir to take 1 pill three times a day for ten days.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   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 fever (Verbatim: Fever). The outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.     It was unknown if the company considered the fever to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR073455   Additional Information: GSK receipt date: 10-JUN-2024 The reporter was the wife of the patient who stated patient received Shingrix Second dose 9 months ago and first dose 3 months before the second shot (specific time unknown). The patient had fever after the first dose.  Did not consent to follow-up.; Sender's Comments:  US-GSK-US2024AMR073455:Second dose
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: reconstituted with sterile diluent instead of the supplied liquid CYW-135 component; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 13-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA981A, expiry date 31-OCT-2024) for prophylaxis.   On 10-JUN-2024, the patient received Menveo. On 10-JUN-2024, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with sterile diluent instead of the supplied liquid CYW-135 component) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 11-JUN-2024 Office Manager reported a vial of Menveo lyophilized portion from 2 vial formulation was reconstituted with sterile diluent instead of the supplied liquid CYW-135 component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered At the time of reporting, the dose had not been repeated. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Age: 0.5
Sex: M
Vaccine: RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Rotarix-Liquid that was given too late; 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 6-month-old male patient who received Rota (Rotarix liquid formulation) (batch number 5F7L2, expiry date 08-MAY-2026) for prophylaxis.   Concomitant products included Rotavirus vaccine live oral 1v (Rotarix).   On 23-MAY-2024, the patient received the 2nd dose of Rotarix liquid formulation. On 23-MAY-2024, an unknown time after receiving Rotarix liquid formulation, the patient experienced inappropriate age at vaccine administration (Verbatim: Rotarix-Liquid that was given too late). 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: 11-JUN-2024 The nurse reported Rotarix-Liquid that was given too late, just want to see if there was any adverse effect, which led to inappropriate age at vaccine administration. Consented to follow up.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 3 year, female patient received a dose of Boostrix; 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 4-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7C75N, expiry date 06-DEC-2025) for prophylaxis.   On 13-MAY-2024, the patient received Boostrix (intramuscular, left deltoid). On 13-MAY-2024, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 3 year, female patient received a dose of Boostrix). 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: 11-JUN-2024 The reporter was a Medical Assistant calling from a Doctor's office to report that a 3 year, female patient received a dose of Boostrix, which led to inappropriate age at vaccine administration.  The patient has had no side effects from receiving the vaccine.  Consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: no treceived 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 25th March 2023, lot number H3SG9, expiration date 03rd January 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: no treceived 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the incomplete course of vaccination to be related to Twinrix and Twinrix Pre-Filled Syringe Device.     It was unknown if the company considered the incomplete course of vaccination to be related to Twinrix and Twinrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-JUN-2024 Pharmacist reported that 64 year old male patient received first dose of Twinrix and at the time of reporting, no additional doses had yet been administered. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Boostrix administered after below temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 59-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number TD2FD, expiry date 31-MAY-2026) and (batch number 45MH5) for prophylaxis.   Previously administered products included Boostrix (1st dose received on 8th May 2015, batch number 45MH5).   On 11-JUN-2024, the patient received the 2nd dose of Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Boostrix administered after below temperature 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: 11-JUN-2024 The caller reported to have a temperature excursion of several vaccines. She said that the vaccines were between 34.4 to 34.6 degree Fahrenheit, from  07:41 p.m. to 08:41 p.m. of 10th June 2024. At 11th June 2024 they administered a Boostrix vaccine to a patient. Of this temperature excursion, the caller reported to administrated 2 doses of Boostrix to 2 different patients and 1 dose of Shingrix. This patient received one of the Boostrix vaccines which led to incorrect storage of drug. This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024072700:Same reporter,Different patient US-GSK-US2024072705:Same reporter
Age: 43.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administered by error Havrix second dose earlier than recommended; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a 43-year-old male patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received 1st dose on 7th February 2024) and Hepatitis A (unknown brand on 11th September 2022).   On 11-JUN-2024, the patient received the 2nd dose of Havrix. On 11-JUN-2024, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: administered by error Havrix second dose earlier than recommended). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 12-JUN-2024 The doctor administered by error Havrix second dose earlier than recommended to a 43 year-old adult male patient, which led to shortening of vaccination schedule. Doctor was planning to run titer for hep A to check immunity and saw if he could follow CDC recommendations The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Headache, Injection site erythema
Clinical narrative: soreness of injected arm; redness of injected arm; muscle pain; tiredness; headache; shivering; freezing; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-JUN-2024, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 11-JUN-2024, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: soreness of injected arm). In JUN-2024, the patient experienced injection site erythema (Verbatim: redness of injected arm), muscle pain (Verbatim: muscle pain), tiredness (Verbatim: tiredness), headache (Verbatim: headache), shivering (Verbatim: shivering) and feeling cold (Verbatim: freezing). The outcome of the injection site pain, injection site erythema, muscle pain and headache were not resolved and the outcome of the tiredness and shivering were unknown and the outcome of the feeling cold was not reported.   The reporter considered the injection site pain, injection site erythema, muscle pain, tiredness, headache and shivering to be related to Shingrix. It was unknown if the reporter considered the feeling cold to be related to Shingrix.     The company considered the injection site pain, injection site erythema, muscle pain, tiredness, headache and shivering to be related to Shingrix. It was unknown if the company considered the feeling cold to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JUN-2024 The reporter was the patient who had Shingrix shot day before reporting intramuscularly in the left deltoid. The shot was given at the pharmacy which did not provide him with any paperwork therefore he does not have the lot number.  He said the injection itself did not hurt (he did not feel anything during the injection process)  but then later on yesterday the injected arm began hurting and was still sore today. There was a red spot about an inch and a half in size where the injection was given which sort of looks like a mild sunburn. The left deltoid did not appear swollen.  Last night he began experiencing muscle pain, tiredness, and headache.  While he was sleeping he experienced shivering. He said that he was freezing and normally he only slept with a sheet but he needed heavy blankets due to the shivering.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: soreness of injected arm; redness of injected arm; muscle pain; tiredness; headache; shivering; freezing; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-JUN-2024, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 11-JUN-2024, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: soreness of injected arm). In JUN-2024, the patient experienced injection site erythema (Verbatim: redness of injected arm), muscle pain (Verbatim: muscle pain), tiredness (Verbatim: tiredness), headache (Verbatim: headache), shivering (Verbatim: shivering) and feeling cold (Verbatim: freezing). The outcome of the injection site pain, injection site erythema, muscle pain and headache were not resolved and the outcome of the tiredness and shivering were unknown and the outcome of the feeling cold was not reported.   The reporter considered the injection site pain, injection site erythema, muscle pain, tiredness, headache and shivering to be related to Shingrix. It was unknown if the reporter considered the feeling cold to be related to Shingrix.     The company considered the injection site pain, injection site erythema, muscle pain, tiredness, headache and shivering to be related to Shingrix. It was unknown if the company considered the feeling cold to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JUN-2024 The reporter was the patient who had Shingrix shot day before reporting intramuscularly in the left deltoid. The shot was given at the pharmacy which did not provide him with any paperwork therefore he does not have the lot number.  He said the injection itself did not hurt (he did not feel anything during the injection process)  but then later on yesterday the injected arm began hurting and was still sore today. There was a red spot about an inch and a half in size where the injection was given which sort of looks like a mild sunburn. The left deltoid did not appear swollen.  Last night he began experiencing muscle pain, tiredness, and headache.  While he was sleeping he experienced shivering. He said that he was freezing and normally he only slept with a sheet but he needed heavy blankets due to the shivering.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Nausea
Clinical narrative: Feels like the flu; Nausea; pain 5 to 6 cm below injection site; reddened area 5 to 6 cm below injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-JUN-2024, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 11-JUN-2024, 1 days after receiving Shingrix, the patient experienced influenza like illness (Verbatim: Feels like the flu), nausea (Verbatim: Nausea), pain (Verbatim: pain 5 to 6 cm below injection site) and localized erythema (Verbatim: reddened area 5 to 6 cm below injection site). On 12-JUN-2024, the outcome of the influenza like illness was resolved. The outcome of the nausea was resolved and the outcome of the pain and localized erythema were not resolved.   It was unknown if the reporter considered the influenza like illness, nausea, pain and localized erythema to be related to Shingrix.     It was unknown if the company considered the influenza like illness, nausea, pain and localized erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JUN-2024 The reporter was the patient who called stating he received his Shingrix 2nd vaccine on Monday, 10th June 2024 in left arm. Reporter stated that he had a reddened area that was painful 5 to 6 cm below the injection site (left arm) that started 24 hours after the injection. Reporter also complained of nausea and flu-like symptoms ( reporter did not elaborate on those symptoms). Reporter stated he threw the paperwork away and could not give the lot number. Reporter did asked for email to send a picture in. Provided the email for to the reporter.
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Product Used; 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 16-year-old female patient who received Men B NVS (Bexsero) (batch number G7KX2, expiry date 31-MAR-2024) for prophylaxis.   On 11-JUN-2024, the patient received the 1st dose of Bexsero. On 11-JUN-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Product Used). 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: 12-JUN-2024 Practice Manager reported that a Medical Assistant administered a dose of Bexsero on 11 June 2024 to 16 year old female patient from lot G7KX2, which had an expiration date of 31 March 2024 which led to expired vaccine used. This was the patient's first dose of Bexsero. At the time of reporting, no additional doses have been administered.