chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Scan with contrast normal
Clinical narrative: The evening of the vaccine andthe  next day, I had the typical symptom of slight headache, sore arm, tiredness that I have had with all my prior Moderna Covid vaccines. (My prior Moderna vaccine was May 2023).   On Day 3, I started getting a terrible throbbing headache that was debilitating.  I also had pain in my shoulder, neck and upper back.   I took 2 extra strength Tylenols and the severe pain improved,  but I still had a low grade headache.  The body aches improved.  However from this day forward until Day 6, the severe headache came back immedialty after the Tylenol wore off.  I was taking Tylenol 24/7 and not sleeping much, waking up with headache pain.  I tried a heating pad on my shoulder, neck and back but that did not help.  On Day 6 (Saturday 10/28), my PCP told me to go to the ER and get a Head CT Scan to see what was going on. At that point I was still taking 2 Extra strength Tylenol every 6 hours 24/7.  I went to the ER and got a CT Scan with and without contract (results below). I was treated with 10mg of Dexamethasone  (Decadron) and sent home.  I have not had a sever hadache and this is Day 7.  Diagnosis-   Migraine without status migrainosus, not intractable, unspecified migraine type
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Paranasal sinus hypersecretion, Throat irritation
Clinical narrative: Scratchy throat, dry cough, white sinus drainage
Age: 16.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Chills, Gait disturbance, Hot flush, Muscular weakness, Pain
Clinical narrative: Initially just soreness of the right arm and nothing else. On Friday, 3 days after receiving the vaccines, she started having severe body aches. On Saturday and today she can barely walk due to aches and weakness in her left leg. She has had some chills/ hot flashes but no fever. Taking over the counter ibuprofen and Tylenol without much relief.
Age: 16.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Pain in extremity
Clinical narrative: Initially just soreness of the right arm and nothing else. On Friday, 3 days after receiving the vaccines, she started having severe body aches. On Saturday and today she can barely walk due to aches and weakness in her left leg. She has had some chills/ hot flashes but no fever. Taking over the counter ibuprofen and Tylenol without much relief.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eyelid function disorder, IIIrd nerve paralysis, Vision blurred
Clinical narrative: Oct. 20, left eye was tearing. Awoke Oct. 21 7 am.unable to control the left eye. When manually opening the eye lid, vision was double.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Contrast echocardiogram, Diplopia, Echocardiogram
Clinical narrative: Oct. 20, left eye was tearing. Awoke Oct. 21 7 am.unable to control the left eye. When manually opening the eye lid, vision was double.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Eye movement disorder, Lacrimation increased, Magnetic resonance imaging, Scan with contrast
Clinical narrative: Oct. 20, left eye was tearing. Awoke Oct. 21 7 am.unable to control the left eye. When manually opening the eye lid, vision was double.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Apraxia, Computerised tomogram, Contrast echocardiogram, Diplopia, Electrocardiogram
Clinical narrative: Oct. 20, left eye was tearing. Awoke Oct. 21 7 am.unable to control the left eye. When manually opening the eye lid, vision was double.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eyelid function disorder, IIIrd nerve paralysis, Impaired driving ability, Laboratory test, Lacrimation increased
Clinical narrative: Oct. 20, left eye was tearing. Awoke Oct. 21 7 am.unable to control the left eye. When manually opening the eye lid, vision was double.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Vision blurred
Clinical narrative: Oct. 20, left eye was tearing. Awoke Oct. 21 7 am.unable to control the left eye. When manually opening the eye lid, vision was double.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd Shingrix vaccine at a 1 month interval rather than the 2 to 6 month interval.; 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: 2nd Shingrix vaccine at a 1 month interval rather than the 2 to 6 month interval.). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 19-OCT-2023 The reporter stated that they had an immune competent patient who received their 2nd shingrix vaccine at a 1 month interval rather than the 2 to 6 month interval, which led to shortening of vaccine schedule. No other information was provided. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: higher fever; chills; body aches; sweating; feeling cold; This non-serious case was reported by a nurse via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 11 hrs after receiving Shingrix, the patient experienced fever (Verbatim: higher fever), chills (Verbatim: chills), general body pain (Verbatim: body aches), sweating (Verbatim: sweating) and feeling cold (Verbatim: feeling cold). The outcome of the fever, chills, general body pain, sweating and feeling cold were resolved (duration 4 hrs).   It was unknown if the reporter considered the fever, chills, general body pain, sweating and feeling cold to be related to Shingrix.     It was unknown if the company considered the fever, chills, general body pain, sweating and feeling cold to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-OCT-2023 The patient experienced higher fever, chills, body aches, sweating, and feeling cold for 4 hours. The reporter did not agree to follow up.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Exposure during pregnancy
Clinical narrative: Pregnant patient was inadvertently administered an expired Fluarix; Pregnant patient was inadvertently administered an expired Fluarix; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 43-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 424R7, expiry date 30-JUN-2023) for prophylaxis.   On 17-OCT-2023, the patient received Fluarix Quadrivalent 2022-2023 season. On 17-OCT-2023, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: Pregnant patient was inadvertently administered an expired Fluarix). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Pregnant patient was inadvertently administered an expired Fluarix). The outcome of the vaccine exposure during pregnancy and expired vaccine used were unknown.   Pregnancy exposure: Gestation time at first exposure (Fluarix Quadrivalent 2022-2023 season): 39 Weeks Pregnancy Exposure (Fluarix Quadrivalent 2022-2023 season): To mother in third trimester Last Menstrual Period Date: 17-JAN-2023 Estimated Delivery/Due date: 27-NOV-2023 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: 18-OCT-2023 The reporter reported that the patient inadvertently received an expired dose of Fluarix vaccine, which led to vaccine exposure during pregnancy and expired vaccine used. The reporter did not consent to follow up.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Incorrect dose administered, Needle issue, Underdose
Clinical narrative: while vaccinating a patient with Arexvy, a couple drops squirted out at the end onto pharmacist's glove; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4ak57, expiry date 23-MAR-2025) for prophylaxis.   On 13-OCT-2023, the patient received Arexvy. On 13-OCT-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: while vaccinating a patient with Arexvy, a couple drops squirted out at the end onto pharmacist's glove). The outcome of the incomplete dose administered was unknown.  Additional Information: GSK Receipt Date: 18-OCT-2023 The registered pharmacist (RPH) reported that while vaccinating a patient with Arexvy, a couple drops squirted out at the end onto pharmacist's glove (not onto patient) due to needle leakage, which led to incomplete dose administered. Consent tot follow-up granted.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site reaction, Injection site swelling, Wrong technique in product usage process
Clinical narrative: experienced a golf ball size lump at the injection site; the swelling; the wrong needle size was used for the patient (5/8" needle, 25g syringe); medication was essentially given subcutaneous versus intramuscularly; the injection site is red; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-OCT-2023, the patient received Shingrix (subcutaneous, unknown deltoid). In OCT-2023, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: the injection site is red). On 17-OCT-2023, the patient experienced injection site lump (Verbatim: experienced a golf ball size lump at the injection site), injection site swelling (Verbatim: the swelling), wrong technique in product usage process (Verbatim: the wrong needle size was used for the patient (5/8" needle, 25g syringe)) and intramuscular formulation administered by other route (Verbatim: medication was essentially given subcutaneous versus intramuscularly). On 18-OCT-2023, the outcome of the injection site lump and injection site swelling were resolved (duration 1 day). The outcome of the injection site erythema was not resolved and the outcome of the wrong technique in product usage process and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site lump, injection site swelling and injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site lump, injection site swelling and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-OCT-2023 Healthcare professional was the reporter. The reporter stated that a patient was vaccinated with the wrong needle size (5/8" needle, 25g syringe) although the medication was injected into the deltoid muscle due to the length of the needle the Healthcare professional stated that the medication was essentially given subcutaneous versus intramuscularly (Medication Error.)  The patient immediately experienced a golf ball size lump at the injection site. On 18th October 2023, the swelling has resolved however, the injection site was red. The patient administered Shingrix vaccine with the wrong needle via subcutaneous route, which led to wrong technique in product usage process and intramuscular formulation administered by other route. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Less than recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 2LC3P, expiry date 15-NOV-2022) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 08-JUL-2021, the patient received the 2nd dose of Shingrix. On 08-JUL-2021, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Less than recommended interval). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 18-OCT-2023 The reporter asked about Shingrix vaccine as what information was available about the administration of Shingrix at less than the recommended interval.  The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Shingrix, early than the recommended interval, which led to shortening of vaccination schedule. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site swelling, Neck pain, Pain, Pain in extremity
Clinical narrative: Puffy arm/puffiness at the injection site; sore arm/pain in her left arm radiating to her neck; sore arm/pain in her left arm radiating to her neck; red arm/redness at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 79-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 13-OCT-2023, the patient received Arexvy (left deltoid). On 13-OCT-2023, less than a day after receiving Arexvy, the patient experienced injection site erythema (Verbatim: red arm/redness at the injection site), pain in arm (Verbatim: sore arm/pain in her left arm radiating to her neck) and neck pain (Verbatim: sore arm/pain in her left arm radiating to her neck). On 14-OCT-2023, the patient experienced injection site swelling (Verbatim: Puffy arm/puffiness at the injection site). The outcome of the injection site erythema, injection site swelling, pain in arm and neck pain were not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, pain in arm and neck pain to be related to Arexvy.     It was unknown if the company considered the injection site erythema, injection site swelling, pain in arm and neck pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 18-OCT-2023 The patient reported after receiving the Arexvy injection she was experiencing pain in her left arm radiating to her neck. The pain was still there but was milder. The patient was still experiencing puffiness and redness at the injection site. The contact to pharmacy was ok. The reporter did not consented to follow up with physician.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Possible late 2nd dose of Shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Possible late 2nd dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-OCT-2023 The reporter reported that the patient received the first dose of Shingrix vaccine in 2019 at the pharmacy. The reporter cannot confirm if she received it.  The reporter wanted to know if patient should receive the Shingrix series both doses or just the second dose. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: COVID19, FLUX, RSV
Symptoms: Petechiae
Clinical narrative: petechiae and husband wondered if this could be related to the co-administration of Arexvy; This non-serious case was reported by a other health professional via call center representative and described the occurrence of petechia in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis and COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   On an unknown date, the patient received Arexvy, Flu vaccine and COVID VACCINE. On an unknown date, an unknown time after receiving Arexvy and Flu vaccine, the patient experienced petechia (Verbatim: petechiae and husband wondered if this could be related to the co-administration of Arexvy). The outcome of the petechia was not resolved.   It was unknown if the reporter considered the petechia to be related to Arexvy and Flu vaccine.   It was unknown if the company considered the petechia to be related to Arexvy and Flu vaccine.   Additional Information: GSK Receipt Date: 18-OCT-2023 The case was reported by patient's husband. The patient received Covid, Flu and Arexvy vaccine at the same time.  It was unknown if the reporter considered the petechia to be related to covid vaccine. The patient now noting onset of petechiae and husband wondered if this could be related to the co-administration of Arexvy with the other vaccines.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of shingrix was administered 3 years ago; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose was administered 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first dose of shingrix was administered 3 years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date - 19-OCT-2023 It was unaware if the patient received 2nd dose or not, which led to incomplete course of vaccination.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: gave Infanrix instead of Tdap to two 7 year old twin siblings; she inadvertently gave Infanrix instead of Tdap; 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 7-year-old female patient who received DTPa (Infanrix) (batch number 7p9nj, expiry date 02-NOV-2024) for prophylaxis.   Previously administered products included DTPA-IPV-HIB (received 1st dose on 30-JUL-2016), DTPA-IPV-HIB (received 2nd dose on 23-NOV-2016) and DTaP vaccine (received one DTap on 26-SEP-2016).   On 18-OCT-2023, the patient received Infanrix. On 18-OCT-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: gave Infanrix instead of Tdap to two 7 year old twin siblings) and wrong vaccine administered (Verbatim: she inadvertently gave Infanrix instead of Tdap). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-OCT-2023 Registered nurse reported that she inadvertently gave Infanrix instead of Tdap to two 7 year old twin siblings yesterday as part of catch-up. The patients were in the schedule, nurse reported the first patient received 1st dose was DTaP/Hepatitis B/IPV on 30-JUL-2016, the 2nd dose was DTaP, Hib, IPV on 23-NOV-2016, and then one (DTaP but didn't mention if it was in combination with other components) on 26-SEP-2016. The 7 years old patient received Infanrix instead of Tdap, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up. Didn't clarify brand name of previous doses. This case had been linked with US2023145262 , reported by the same reporter for 2nd patient.; Sender's Comments:  US-GSK-US2023145262:Same reporter, 2nd patient
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: she inadvertently gave Infanrix instead of Tdap; 7 year old twin siblings; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 7-year-old female patient who received DTPa (Infanrix) (batch number 7p9nj, expiry date 02-NOV-2024) for prophylaxis.   Previously administered products included DTPA-HBV-IPV (1st dose received on 30-JUL-2016) and DTAP + HIB + IPV (2nd dose received on 23-NOV-2016).   On 18-OCT-2023, the patient received Infanrix. On 18-OCT-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: she inadvertently gave Infanrix instead of Tdap) and inappropriate age at vaccine administration (Verbatim: 7 year old twin siblings). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: 19-OCT-2023 Registered nurse reported that she inadvertently gave Infanrix instead of Tdap to two 7 year old twin siblings yesterday as part of catch-up, which led to wrong vaccine administered and inappropriate age at vaccine administration. Registered nurse states their records only show patient received 2 doses of DTaP but the mother of twins said the patient received a 3rd dose as well as her twin sister The reporter consented to follow up. Did not clarify brand name of previous doses. This case had been linked with US2023145259, reported by the same reporter for 2nd patient.; Sender's Comments:  US-GSK-US2023145259:Same reporter, 2nd patient
Sex: F
Vaccine: FLUX, RSV
Symptoms: Erythema, Feeling hot, Headache, Peripheral swelling, Pruritus
Clinical narrative: received Arexvy and the flu shot in the left arm on same day; injection site arm red; headache; itchy left arm; Injection site arm swollen; Hot arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 66-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 16-OCT-2023, the patient received Arexvy (left arm) and Flu vaccine (left arm). In OCT-2023, several hours after receiving Arexvy and Flu vaccine, the patient experienced erythema of extremities (Verbatim: injection site arm red), headache (Verbatim: headache), itchy upper limbs (Verbatim: itchy left arm), swelling arm (Verbatim: Injection site arm swollen) and extremities hot feeling of (Verbatim: Hot arm). On 16-OCT-2023, the patient experienced wrong technique in drug usage process (Verbatim: received Arexvy and the flu shot in the left arm on same day). The outcome of the erythema of extremities, swelling arm and extremities hot feeling of were resolving and the outcome of the headache was resolved and the outcome of the itchy upper limbs was not resolved and the outcome of the wrong technique in drug usage process was unknown.   It was unknown if the reporter considered the erythema of extremities, headache, itchy upper limbs, swelling arm and extremities hot feeling of to be related to Arexvy and Flu vaccine.   It was unknown if the company considered the erythema of extremities, headache, itchy upper limbs, swelling arm and extremities hot feeling of to be related to Arexvy and Flu vaccine.   Additional Information: GSK Receipt Date: 19-OCT-2023 The reporter stated that she received Arexvy and the flu shot (for ages over 65) in the left arm, which led to wrong technique in drug usage process. She stated hours later, injection site arm got red, hot and swollen.  She stated that it was getting a little better but it was itchy now.  The concomitant medication included as Benadryl and Allergy Medicine. She also stated that getting a headache hours after the vaccines but it had since resolved.  The reporter did not consent to follow-up.
Sex: F
Vaccine: FLUX, RSV
Symptoms: Wrong technique in product usage process
Clinical narrative: received Arexvy and the flu shot in the left arm on same day; injection site arm red; headache; itchy left arm; Injection site arm swollen; Hot arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 66-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 16-OCT-2023, the patient received Arexvy (left arm) and Flu vaccine (left arm). In OCT-2023, several hours after receiving Arexvy and Flu vaccine, the patient experienced erythema of extremities (Verbatim: injection site arm red), headache (Verbatim: headache), itchy upper limbs (Verbatim: itchy left arm), swelling arm (Verbatim: Injection site arm swollen) and extremities hot feeling of (Verbatim: Hot arm). On 16-OCT-2023, the patient experienced wrong technique in drug usage process (Verbatim: received Arexvy and the flu shot in the left arm on same day). The outcome of the erythema of extremities, swelling arm and extremities hot feeling of were resolving and the outcome of the headache was resolved and the outcome of the itchy upper limbs was not resolved and the outcome of the wrong technique in drug usage process was unknown.   It was unknown if the reporter considered the erythema of extremities, headache, itchy upper limbs, swelling arm and extremities hot feeling of to be related to Arexvy and Flu vaccine.   It was unknown if the company considered the erythema of extremities, headache, itchy upper limbs, swelling arm and extremities hot feeling of to be related to Arexvy and Flu vaccine.   Additional Information: GSK Receipt Date: 19-OCT-2023 The reporter stated that she received Arexvy and the flu shot (for ages over 65) in the left arm, which led to wrong technique in drug usage process. She stated hours later, injection site arm got red, hot and swollen.  She stated that it was getting a little better but it was itchy now.  The concomitant medication included as Benadryl and Allergy Medicine. She also stated that getting a headache hours after the vaccines but it had since resolved.  The reporter did not consent to follow-up.
Age: 0.67
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 8 month old was given Kinrix instead of the separate Dtap and IPV vaccines; 8 month old was given Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 8-month-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 09-NOV-2023) for prophylaxis.   On 19-OCT-2023, the patient received Kinrix. On 19-OCT-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: 8 month old was given Kinrix instead of the separate Dtap and IPV vaccines) and inappropriate age at vaccine administration (Verbatim: 8 month old was given Kinrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: 19-Oct-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. The patient received a dose of Kinrix instead of the separate Dtap and IPV vaccines at an inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: received 2 doses of the Fluarix 2023-2024 season vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 11-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2023-2024 season) (batch number C2PH4, expiry date 30-JUN-2024) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLUARIX TETRA).   On 18-OCT-2023, the patient received Fluarix Tetra 2023-2024 season (left deltoid). On 18-OCT-2023, an unknown time after receiving Fluarix Tetra 2023-2024 season, the patient experienced overdose (Verbatim: received 2 doses of the Fluarix 2023-2024 season vaccine). The outcome of the overdose 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: 19-OCT-2023 The registered nurse called to report that a minor child (patient) received 2 doses of the Fluarix 2023-2024 season (injection) vaccine. The vaccine was given in the same location, left deltoid, on the same day, which led to overdose. Guardian had been notified. No harm had been reported as of present time. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Product complaint, Underdose
Clinical narrative: Product Complaint; administered under the recommended volume; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 61-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number M2735, expiry date 21-MAR-2024) for prophylaxis. This case was associated with a product complaint.   On 19-OCT-2023, the patient received the 1st dose of Arexvy. On 19-OCT-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: administered under the recommended volume). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the incomplete dose administered and pharmaceutical product complaint were unknown.   Additional Information: GSK receipt date: 19-Oct-2023 A pharmacy intern called in to request information about the validity of a vaccine dose that had been administered being under the recommended volume.  They provided partial information about the event, patient and vaccine. A product quality complaint was filed. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. The patient received less than recommended volume of Arexvy vaccine, which led to incomplete dose administered.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: The vaccine had expired on 29-SEP-2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number GS57B, expiry date 29-SEP-2023) for prophylaxis.   On 16-OCT-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid). On 16-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: The vaccine had expired on 29-SEP-2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date- 19-OCT-2023 The patient was administered 2nd dose of Shingrix which was expired on 29-September-2023, which led to expired vaccine used. Nothing else was reported.  The reporter consented to follow up.
Age: 16.0
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: the administration of an extra dose of Fluarix QIV to a 16 year old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 16-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number 7Z423, expiry date 30-JUN-2024) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT).   On 19-OCT-2023, the patient received the 2nd dose of Fluarix Quadrivalent 2023-2024 season. On 19-OCT-2023, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced extra dose administered (Verbatim: the administration of an extra dose of Fluarix QIV to a 16 year old patient). 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: 19-OCT-2023 The reporter called to ask for safety information regarding the administration of an extra dose of Fluarix QIV to a patient, which led to extra dose administered. The reporter gave permission to follow up but she did not provide an email address.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-OCT-2023, the patient received the 2nd dose of Shingrix. In OCT-2023, 10 days after receiving Shingrix, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-OCT-2023 The patient reported that he received dose 2 of Shingrix and 10 days later he had shingles. He went to Healthcare professional the next day and was confirmed it was shingles. The reporter did not consent to follow up.
Sex: U
Vaccine: RSV
Symptoms: Intercepted product storage error
Clinical narrative: improper storage error/ no patient involvement.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intercepted product storage error in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient did not receive Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted product storage error (Verbatim: improper storage error/ no patient involvement.). The outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 19-OCT-2023 The HCP (health care professional) requested stability data for Arexvy vials after cap removal, unknown length of time for cap removal or if vials have been punctured.  Arexvy refrigerator and in original box. No patient involvement, which led to intercepted product storage error. Did not get permission from reporter for safety follow-up.
Age: 6.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received Boostrix instead of Daptacel; received Boostrix instead of Daptacel as their 4th dose of DTaP; 6 year old patient received Boostrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 6-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number dd7f7, expiry date 06-DEC-2025) for prophylaxis.   On 13-OCT-2023, the patient received Boostrix. On 13-OCT-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: received Boostrix instead of Daptacel), inappropriate schedule of vaccine administered (Verbatim: received Boostrix instead of Daptacel as their 4th dose of DTaP) and inappropriate age at vaccine administration (Verbatim: 6 year old patient received Boostrix). The outcome of the wrong vaccine administered, inappropriate schedule of vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 19-Oct-2023 The reporter consented to follow-up. The patient received a dose of Boostrix as 4th dose of DTaP instead of Daptacel at an inappropriate age, which led to wrong vaccine administered, inappropriate schedule of vaccine administered and inappropriate age at vaccine administration.
Sex: M
Vaccine: RSV
Symptoms: Diarrhoea, Immediate post-injection reaction
Clinical narrative: had diarrhea immediately after administration; This non-serious case was reported by a physician via sales rep and described the occurrence of diarrhea in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In OCT-2023, the patient received Arexvy. In OCT-2023, immediately after receiving Arexvy, the patient experienced diarrhea (Verbatim: had diarrhea immediately after administration). The outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Arexvy.     It was unknown if the company considered the diarrhea to be related to Arexvy.   Additional Information: GSK Receipt Date: 19-OCT-2023 The reporter sent an email informing that a male patient received Arexvy vaccine 2 weeks ago and had diarrhea immediately after administration. No other information provided. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had not received the 2nd dose yet; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: had not received the 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-OCT-2023 The reporter informed that a patient that received the 1st dose of Shingrix back in 2019 had not received the 2nd dose yet. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Age: 71.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received Twinrix 3rd dose at month five instead of a 6 month interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 71-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 18-APR-2023) and Twinrix (received 2nd dose on 18-MAY-2023).   On 24-SEP-2023, the patient received the 3rd dose of Twinrix. On 24-SEP-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: received Twinrix 3rd dose at month five instead of a 6 month interval). The outcome of the drug dose administration interval too short 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: 19-OCT-2023 The pharmacist had a patient who received Twinrix 3rd dose at month five instead of a 6 month interval. The patient received 3rd dose of Twinrix, earlier than the recommended interval, which led to shortening of vaccination schedule. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: breakouts of Herpes zoster after complete scheme of Shingrix/ Suspected vaccination failure; breakouts of Herpes zoster on the lips and on the lumbar area; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster (recovered in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: breakouts of Herpes zoster after complete scheme of Shingrix/ Suspected vaccination failure) (serious criteria GSK medically significant) and herpes zoster (Verbatim: breakouts of Herpes zoster on the lips and on the lumbar area). The outcome of the vaccination failure was unknown and the outcome of the herpes zoster was not resolved.   It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingrix and Shingrix.   It was unknown if the company considered the vaccination failure and herpes zoster to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 19-OCT-2023 The retired physician called to inform that they recovered from Herpes zoster in 2018. After the recovery, they got the complete scheme of Shingrix. The suspect vaccine start date reported was around 2018. Now in 2023, they had been having breakouts of Herpes zoster on the lips and on the lumbar area. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter consented to follow up.
Age: 24.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: patient was administered a expired dose of Bexsero; 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 24-year-old female patient who received Men B NVS (Bexsero) (batch number A2X3Y, expiry date 28-FEB-2023) for prophylaxis.   On 19-OCT-2023, the patient received the 1st dose of Bexsero. On 19-OCT-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: patient was administered a expired dose of Bexsero). 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: 19-OCT-2023 The pharmacy technician reported that a patient was administered a dose of Bexsero which was expired which led to expired vaccine used. At the time of reporting, the dose had not been repeated. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Not received 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 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).  On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-OCT-2023 The pharmacist reported that she had a patient who appeared to have had their first Shingrix in 2019, and he thought that he had received his 2nd dose however, not sure. The vaccine was not given in the reporter's facility and she did not had the exact date, lot number, or expiration date information. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 37.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: accidently received Arexvy today on October 20th 2023; Inappropriate age at vaccine administration; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 37-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 20-OCT-2023, the patient received Arexvy. On 20-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: accidently received Arexvy today on October 20th 2023). The outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 34 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Estimated Delivery/Due date: 26-NOV-2023 Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 20-OCT-2023 Nurse a patient herself is 34 weeks pregnant and accidently received Arexvy today on October 20th 2023 which led to vaccine exposure during pregnancy and inappropriate age at vaccine administration. She wants to know if there is any clinical studies on patient who received Arexvy while pregnant?.The reporter consented to follow up.