chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: discovered that vaccine fridge was set on coldest setting and the temperature was reading at -4C; 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 76-year-old male patient who received Herpes zoster (Shingrix) (batch number 2YC74, expiry date 17-MAY-2026) for prophylaxis.   On 15-APR-2024, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: discovered that vaccine fridge was set on coldest setting and the temperature was reading at -4C). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 18-APR-2024 The reporter stated that she went to one of their clinical sites on 16th April2024 and discovered that vaccine fridge was set on coldest setting and the temperature was reading at minus 4 degree C. The reporter stated the at that facility had not documented a temperature recording since 05th April 2024, so the reporter was unsure how long the temperature was out of range. There was a dose of Shingrix administered on 15th April 2024 to a 76 year old male patient which led to incorrect storage of drug. At the time of reporting, the dose has not been repeated. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up. This was 1 of the 6 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024050075:same reporter US-GSK-US2024050073:same reporter US-GSK-US2024050077:same reporter US-GSK-US2024050076:same reporter US-GSK-US2024050072:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: discovered that vaccine fridge was set on coldest setting and the temperature was reading at -4C; 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 84-year-old female patient who received Herpes zoster (Shingrix) (batch number 2YC74, expiry date 17-MAY-2026) for prophylaxis.   On 15-APR-2024, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: discovered that vaccine fridge was set on coldest setting and the temperature was reading at -4C). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 18-APR-2024 The reporter stated that she went to one of their clinical sites on 16th April 2024 and discovered that vaccine fridge was set on coldest setting and the temperature was reading at minus 4 degree Celsius and a dose of Shingrix was administered, which led to incorrect storage of drug. She stated that the medical assistant at that facility had not documented a temperature recording since 05th April 2024, so she was unsure how long the temperature was out of range.  At the time of reporting, the dose had not been repeated. The Vaccine Administration Facility was the same as Primary Reporter The reporter consent to follow up. This was 1 of the 6 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024050077:same reporter US-GSK-US2024050076:same reporter US-GSK-US2024050074:same reporter US-GSK-US2024050073:same reporter US-GSK-US2024050072:same reporter
Sex: U
Vaccine: RSV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: a technician injected 2 Arexvy, one shot on each arm, by error instead of a pneumonia vaccine to an adult over 60 years; a technician injected 2 Arexvy, one shot on each arm, by error instead of a pneumonia vaccine to an adult over 60 years; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a patient who received RSVPreF3 adjuvanted (Arexvy) (batch number A9KY9, expiry date 21-AUG-2025) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 18-APR-2024, the patient received the 2nd dose of Arexvy (unknown arm). On 18-APR-2024, an unknown time after receiving Arexvy, the patient experienced accidental overdose (Verbatim: a technician injected 2 Arexvy, one shot on each arm, by error instead of a pneumonia vaccine to an adult over 60 years) and wrong vaccine administered (Verbatim: a technician injected 2 Arexvy, one shot on each arm, by error instead of a pneumonia vaccine to an adult over 60 years). The outcome of the accidental overdose and wrong vaccine administered were unknown.   Additional Information: GSK Receipt date: 19-APR-2024 A pharmacist reported that on 18 April 2024, a technician injected 2 Arexvy, one shot on each arm, by error instead of a pneumonia vaccine to a patient which led to Wrong vaccine administered and accidental overdose. HCP was concern about side effects expected and what to tell the patient.
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: 3rd dose of Rotarix-Liquid was administered yesterday on April 18th 2024 to a 7 month old baby; Rotarix-Liquid was administered yesterday on April 18th 2024 to a 7 month old baby; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number H29H4, expiry date 13-OCT-2025) for prophylaxis.   Previously administered products included Rotarix (received 1st dose on an unknown date) and Rotarix (received 2nd dose on an unknown date).   On 18-APR-2024, the patient received the 3rd dose of Rotarix lyophilized formulation. On 18-APR-2024, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: 3rd dose of Rotarix-Liquid was administered yesterday on April 18th 2024 to a 7 month old baby) and inappropriate age at vaccine administration (Verbatim: Rotarix-Liquid was administered yesterday on April 18th 2024 to a 7 month old baby). The outcome of the extra dose 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-APR-2024 The licensed practical nurse (LPN) reported that a 3rd dose of Rotarix liquid was administered yesterday to a 7 month old baby, which led to extra dose administered and inappropriate age at vaccine administration. The reporter asked what would be the next steps.
Sex: F
Vaccine: HEP, HEPA, HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: three months after (April 2024) she got a Twinrix dose again; patient that got first Twinrix dose then for second dose they used Havrix and Engerix-B since they didn't have Twinrix vaccine available; patient that got first Twinrix dose then for second dose they used Havrix and Engerix-B since they didn't have Twinrix vaccine available; This non-serious case was reported by a other health professional via call center representative and described the occurrence of interchange of vaccine products in a 49-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis and HAB (Twinrix) (batch number H7RF2, expiry date 17-JAN-2026) for prophylaxis.   In APR-2024, the patient received the 3rd dose of Twinrix. On 11-JAN-2024, the patient received Havrix and Engerix B. On 12-JAN-2023, the patient received the 1st dose of Twinrix. On 11-JAN-2024, not applicable after receiving Twinrix and Twinrix, an unknown time after receiving Havrix and Engerix B and not applicable after receiving Twinrix and Twinrix, the patient experienced drug dose administration interval too long (Verbatim: patient that got first Twinrix dose then for second dose they used Havrix and Engerix-B since they didn't have Twinrix vaccine available). In JAN-2024, the patient experienced interchange of vaccine products (Verbatim: patient that got first Twinrix dose then for second dose they used Havrix and Engerix-B since they didn't have Twinrix vaccine available). In APR-2024, the patient experienced drug dose administration interval too short (Verbatim: three months after (April 2024) she got a Twinrix dose again). The outcome of the interchange of vaccine products, drug dose administration interval too long and drug dose administration interval too short 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-APR-2024 The reporter wants to know information available on patient who got first Twinrix dose and then her second dose, but they used Havrix and Engerix-B since they did not had Twinrix vaccine available. The Twinrix vaccine would be available three months after (April 2024) and she got a Twinrix dose again.  The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had not received the second shot 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 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: had not received the second shot yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-APR-2024 The pharmacist reported that, the patient had his Shingrix vaccine just one shot. The pharmacist did not specify which of the two patients (male or female) had received the vaccine 3 years ago, and who received it one year ago. According to the pharmacist, the patient had not received the second shot yet (till the time of reporting), which led to incomplete course of vaccination. The vaccine administration facility was the same as primary reporter This case had been link with US2024050676, reported by the same reporter.; Sender's Comments:  US-GSK-US2024050676:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Late 2nd dose/received first shot 3 years ago; 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 female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first shot of Shingrix vaccine 3 years ago).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Late 2nd dose/received first shot 3 years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-APR-2024 The pharmacist reported that, the patient had his Shingrix vaccine just one shot. The pharmacist didn't specify which of the two patients (Male or Female) had received the vaccine 3 years ago, and who received it one year ago. According to the pharmacist, the patient had not received the second shot yet. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. This case was linked with the case US2024050674, reported by same reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2024050674:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Scab
Clinical narrative: he noticed a spot on his right arm, two days later a spot appeared on his chest and one day ago, one on his right leg; spot now scabbed; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   In NOV-2019, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: he noticed a spot on his right arm, two days later a spot appeared on his chest and one day ago, one on his right leg) and scab (Verbatim: spot now scabbed). The outcome of the rash was resolving and the outcome of the scab was not reported.   It was unknown if the reporter considered the rash and scab to be related to Shingrix.     It was unknown if the company considered the rash and scab to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-APR-2024 The patient received his Shingrix series in 2019, with the 2nd dose taken in November, 2019. He stated that he had both doses as recommended and during the recommended time frame. Last week, he noticed a spot on his right arm, two days later a spot appeared on his chest and one day ago, one on his right leg. He stated that they were not fluid filled blisters, also stated that the first spot was currently scabbed over. He reported that the spots on his chest and arm were approximately 3/16 in diameter. The spot on his leg was larger than 1/4  in diameter and it could be two lesions connected in an oval shape approximately 3/8 long. He reported that all of the spots had started out like mosquito bites, but there were no mosquitoes in his area. There was no consent to contact healthcare professional (HCP), as he has not notified his healthcare professional yet (he/she encouraged him to do so). He states that if further complications develop he will contact them with an update. The reporter did not consent to follow-up.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Eyelid function disorder, Fatigue, Somnolence
Clinical narrative: Explosive diarrhea; Stomach cramps; sleeping all day; Extreme tiredness or fatigue; not able to open eyes for 24 hours; This non-serious case was reported by a consumer via call center representative and described the occurrence of explosive diarrhea in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-APR-2024, the patient received the 1st dose of Shingrix. In APR-2024, an unknown time after receiving Shingrix, the patient experienced fatigue (Verbatim: Extreme tiredness or fatigue) and eyelid function disorder (Verbatim: not able to open eyes for 24 hours). On 18-APR-2024, the patient experienced sleepiness (Verbatim: sleeping all day). On 19-APR-2024, the patient experienced explosive diarrhea (Verbatim: Explosive diarrhea) and stomach cramps (Verbatim: Stomach cramps). On 18-APR-2024, the outcome of the sleepiness was resolved. The outcome of the explosive diarrhea, stomach cramps and fatigue were unknown and the outcome of the eyelid function disorder was resolved (duration 24 hrs).   It was unknown if the reporter considered the explosive diarrhea, stomach cramps, fatigue, eyelid function disorder and sleepiness to be related to Shingrix.     It was unknown if the company considered the explosive diarrhea, stomach cramps, fatigue, eyelid function disorder and sleepiness to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-APR-2024 The patient self-reported this case. The patient mentioned after receiving this shot he was not being able to open his eyes for 24 hours, he was on his back, slept all day yesterday (day before reporting), and today (on the day of reporting) the explosive diarrhea and the stomach cramps. The patient stated that the shot put him basically on his back for 2 days. Time to onset of explosive diarrhea and stomach cramps was 2 days with Shingrix and time to onset of sleepiness was 1 day with Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient has already missed the 6 month for 2nd dose and now it is more than 1 year; This non-serious case was reported by a pharmacist 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 received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient has already missed the 6 month for 2nd dose and now it is more than 1 year). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-APR-2024 The reporter called for Shingrix, he/she basically had a question about the intervals 2 to 6 months, as patient had already missed the 6 month and now it was more than 1 year, so, they need to figure it out to do 2 dose series again or just do another one (2nd one). Reporter asked to give him/her a call. The adverse event left on afterhours voicemailbox, Safety team follow-up not provided on voicemail. Medical information specialist (MIS) called back to healthcare professional (HCP), no answer, left voicemail message. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: severe pain on the shoulder; This non-serious case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shoulder pain (Verbatim: severe pain on the shoulder). The outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the shoulder pain to be related to Shingrix.     It was unknown if the company considered the shoulder pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-APR-2024 The patient self-reported this case. The customer (patient) experienced severe pain on the shoulder after she received the Shingrix vaccine. The reporter did not consent to follow-up.
Age: 1.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix was administered to a 18 month old patient; patient were supposed to get a Dtap vaccine/wrong vaccine administered; 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 18-month-old male patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   On 03-APR-2024, the patient received Kinrix. On 03-APR-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 18 month old patient) and wrong vaccine administered (Verbatim: patient were supposed to get a Dtap vaccine/wrong vaccine administered). 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-APR-2024 The Kinrix was administered to a 18 month old patient, the patient were supposed to get a Dtap vaccine, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter asked, was there anything they need to be looking for or any complications that could arise. The vaccine administration facility was the same as primary reporter.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Catheterisation cardiac, Dyspnoea, Echocardiogram, Extrasystoles, Fatigue
Clinical narrative: diagnosed with PVC; premature heart beats; having muscle aches/muscles bothered; shortness of breath; palpitations; very tired; This serious case was reported by a nurse via call center representative and described the occurrence of muscle pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15-FEB-2024, the patient received the 1st dose of Shingrix (left arm). In MAR-2024, less than 3 weeks after receiving Shingrix, the patient experienced muscle pain (Verbatim: having muscle aches/muscles bothered) (serious criteria hospitalization), shortness of breath (Verbatim: shortness of breath) (serious criteria hospitalization), palpitation (Verbatim: palpitations) (serious criteria hospitalization) and tiredness (Verbatim: very tired) (serious criteria hospitalization). On an unknown date, the patient experienced premature ventricular contractions (Verbatim: diagnosed with PVC) (serious criteria hospitalization) and heartbeats premature (Verbatim: premature heart beats) (serious criteria hospitalization). The outcome of the muscle pain, shortness of breath, tiredness and premature ventricular contractions were unknown and the outcome of the palpitation was not resolved and the outcome of the heartbeats premature was not reported.   It was unknown if the reporter considered the muscle pain, shortness of breath, palpitation, tiredness, premature ventricular contractions and heartbeats premature to be related to Shingrix.     It was unknown if the company considered the muscle pain, shortness of breath, palpitation, tiredness, premature ventricular contractions and heartbeats premature to be related to Shingrix.   Additional Information: GSK receipt date: 23-APR-2024 The reporter reported that a patient received Shingrix vaccine and 2 and a half weeks later she was having muscle aches, and shortness of breath, palpitations and was very tired. She had muscle aches, mainly on the big muscles like the biceps,mainly the left side muscles bothered the most.  She was hospitalized for three days. Patient reports she was diagnosed with premature ventricular contractions, premature heart beats, went back home for two days and returned to the emergency room because she was still having palpitations. The vaccine was administered by a pharmacist at a local pharmacy and she did not have the lot number and expiry date of the administered vaccine. The reporter consented  to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test abnormal, Myalgia, Palpitations, Ultrasound scan, Ventricular extrasystoles
Clinical narrative: diagnosed with PVC; premature heart beats; having muscle aches/muscles bothered; shortness of breath; palpitations; very tired; This serious case was reported by a nurse via call center representative and described the occurrence of muscle pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15-FEB-2024, the patient received the 1st dose of Shingrix (left arm). In MAR-2024, less than 3 weeks after receiving Shingrix, the patient experienced muscle pain (Verbatim: having muscle aches/muscles bothered) (serious criteria hospitalization), shortness of breath (Verbatim: shortness of breath) (serious criteria hospitalization), palpitation (Verbatim: palpitations) (serious criteria hospitalization) and tiredness (Verbatim: very tired) (serious criteria hospitalization). On an unknown date, the patient experienced premature ventricular contractions (Verbatim: diagnosed with PVC) (serious criteria hospitalization) and heartbeats premature (Verbatim: premature heart beats) (serious criteria hospitalization). The outcome of the muscle pain, shortness of breath, tiredness and premature ventricular contractions were unknown and the outcome of the palpitation was not resolved and the outcome of the heartbeats premature was not reported.   It was unknown if the reporter considered the muscle pain, shortness of breath, palpitation, tiredness, premature ventricular contractions and heartbeats premature to be related to Shingrix.     It was unknown if the company considered the muscle pain, shortness of breath, palpitation, tiredness, premature ventricular contractions and heartbeats premature to be related to Shingrix.   Additional Information: GSK receipt date: 23-APR-2024 The reporter reported that a patient received Shingrix vaccine and 2 and a half weeks later she was having muscle aches, and shortness of breath, palpitations and was very tired. She had muscle aches, mainly on the big muscles like the biceps,mainly the left side muscles bothered the most.  She was hospitalized for three days. Patient reports she was diagnosed with premature ventricular contractions, premature heart beats, went back home for two days and returned to the emergency room because she was still having palpitations. The vaccine was administered by a pharmacist at a local pharmacy and she did not have the lot number and expiry date of the administered vaccine. The reporter consented  to follow up.
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Dyspnoea, Guillain-Barre syndrome
Clinical narrative: and diagnosed the patient with Guillain Barre due to receiving the Arexvy vaccine; got weak; Problem breathing; This serious case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: and diagnosed the patient with Guillain Barre due to receiving the Arexvy vaccine) (serious criteria hospitalization and GSK medically significant), weakness (Verbatim: got weak) (serious criteria hospitalization) and difficulty breathing (Verbatim: Problem breathing) (serious criteria hospitalization). The outcome of the guillain barre syndrome, weakness and difficulty breathing were unknown.   The reporter considered the guillain barre syndrome to be related to Arexvy. It was unknown if the reporter considered the weakness and difficulty breathing to be related to Arexvy.     The company considered the guillain barre syndrome to be related to Arexvy. It was unknown if the company considered the weakness and difficulty breathing to be related to Arexvy.   Additional Information: GSK Receipt Date: 23-APR-2024 The reporter reported that a Pulmonologist stated in his office that a patient received the Arexvy vaccine (no date provided), had problems breathing, got weak and ended up in a hospital setting. The Pulmonologist treated the patient while in the hospital and diagnosed the patient with Guillain Barre due to receiving the Arexvy vaccine, as the patient was only taking supplements (no information provided) at the time.  The Pulmonologist did not know if the patient stayed overnight in the hospital.  The Pulmonologist stated that he released the patient back to her Primary Care Physician, did not follow up with the patient and did not know anything further about these adverse events.  The Pulmonologist did not provide the GlaxoSmithKline Field Representative with any information about the Arexvy vaccine, no lot/expiry/NDC/date of administration/route of administration.  The pulmonologist did not provide the GlaxoSmithKline Field Representative with any patient demographics other than female. The reporter reported all that was provided by the GlaxoSmithKline Field Representative. The reporter consented to follow up.
Age: 24.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Infanrix was given to a 35 year old female by mistake; 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 24-year-old female patient who received DTPa (Infanrix) (batch number 7C9NJ, expiry date 02-NOV-2024) for prophylaxis.   On 31-OCT-2023, the patient received Infanrix. On 31-OCT-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Infanrix was given to a 35 year old female by mistake). 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: 23-APR-2024 The nurse reported that, Infanrix was given to a 35 year old patient by mistake, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Had the Moderna vaccinations (Unspecified Vaccine); I have COVID/Trouble swallowing and breathing, I already have shortness of breath and I am on a CPAP machine and it says throat tightness; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Had the Moderna vaccinations (Unspecified Vaccine); I have COVID/Trouble swallowing and breathing, I already have shortness of breath and I am on a CPAP machine and it says throat tightness) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy and Skin rash.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had the Moderna vaccinations (Unspecified Vaccine); I have COVID/Trouble swallowing and breathing, I already have shortness of breath and I am on a CPAP machine and it says throat tightness). At the time of the report, COVID-19 (Had the Moderna vaccinations (Unspecified Vaccine); I have COVID/Trouble swallowing and breathing, I already have shortness of breath and I am on a CPAP machine and it says throat tightness) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant medication was not reported. It was reported that, patient did not to be on ongoing with Pfizer and had the Moderna vaccinations (Unspecified Vaccine) when she had the vaccines in 2020, did not have Pfizer. Patient read the side effects of the Paxlovid, and she already had issues with my skin. Trouble swallowing and breathing, already had shortness of breath and was on a CPAP machine, and it says throat tightness and did not really know if she had that hoarseness. So, she was not too sure that she even really wants to take this since it was going to exaggerate all the problems those already have.  Treatment medication was not reported.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Feeling hot, Headache, Injection site erythema
Clinical narrative: Severe vertigo for 5 days; I have had BPPV episodes in the past, half of them within a week or more of getting vaccines like  COVID19 & first Shingrix, but never such an almost instant reaction as this time. Also, long/wide red welt at injection site, muscle pain, headache , stomachache, nausea, alternate shivering or hot but no fever. I took Dramamine during the day on 4/24 and 4/25 just to be able to walk from bed to chair to bathroom or kitchen, and Tylenol PM to help me sleep. On 4/26 I switched to Aleve (one at 9 am, one at 9 pm) thinking that muscle pain can equal neck stiffness which can trigger BPPV and that seemed to help the most. I was pretty much back to normal by 4/29.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Myalgia, Nausea, Urticaria, Vertigo
Clinical narrative: Severe vertigo for 5 days; I have had BPPV episodes in the past, half of them within a week or more of getting vaccines like  COVID19 & first Shingrix, but never such an almost instant reaction as this time. Also, long/wide red welt at injection site, muscle pain, headache , stomachache, nausea, alternate shivering or hot but no fever. I took Dramamine during the day on 4/24 and 4/25 just to be able to walk from bed to chair to bathroom or kitchen, and Tylenol PM to help me sleep. On 4/26 I switched to Aleve (one at 9 am, one at 9 pm) thinking that muscle pain can equal neck stiffness which can trigger BPPV and that seemed to help the most. I was pretty much back to normal by 4/29.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo positional
Clinical narrative: Severe vertigo for 5 days; I have had BPPV episodes in the past, half of them within a week or more of getting vaccines like  COVID19 & first Shingrix, but never such an almost instant reaction as this time. Also, long/wide red welt at injection site, muscle pain, headache , stomachache, nausea, alternate shivering or hot but no fever. I took Dramamine during the day on 4/24 and 4/25 just to be able to walk from bed to chair to bathroom or kitchen, and Tylenol PM to help me sleep. On 4/26 I switched to Aleve (one at 9 am, one at 9 pm) thinking that muscle pain can equal neck stiffness which can trigger BPPV and that seemed to help the most. I was pretty much back to normal by 4/29.
Age: 92.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given 2 RSV vaccines accidentally.  Received Arexvy 10/11/23 and Abrysvo  04/25/2024.  Issue with pulling system information when second shot was given.  No adverse effects from vaccine per patient.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Vaccine positive rechallenge
Clinical narrative: Severe headache with both doses of Shingrix
Age: 90.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 2 doses of RSV vaccine, received Arexvy 10/11/23 and Abrysvo 4/25/24.  Issue with checking system and 1st vaccine not showing on report.  Patient reports no adverse reactions or problems.
Age: 1.58
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Expired vaccine by 9 days
Age: 0.5
Sex: M
Vaccine: HIBV, PNC20, RV5, SMALL
Symptoms: Decreased appetite, Injection site erythema, Injection site swelling, Listless, Pyrexia
Clinical narrative: Developed fever, decreased appetite, listless and right thigh localized swelling and redness at injection site (Hib and PCV site).   Symptoms started on day of immunization (04/29/24) and continued into following day. Seen at Hospital ED on evening after vaccines due to fever and listlessness. Given ibuprofen and reassurance. Seen back at PCP office following day (today 4/30/24) for follow up. Noted at that time with localized redness and swelling at right thigh injection site. Fever had resolved and baby well appearing. Advised of minor adverse reaction to vaccine and healthy immune system. Advised NOT allergic to vaccine or any component of vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: her brother-in-law died due to the vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "her brother-in-law died due to the vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical Course: The reporter was concerned about the  safety and efficacy of the Pfizer COVID-19 vaccine, alleging that it contains cancer-causing ingredients and has resulted in numerous deaths. Also enquired, why vaccine was distributed despite reports of adverse effects, including deaths allegedly linked to cancer and other serious illnesses. The reporter further stated concerns on individuals who have experienced adverse reactions. Also stated that her brother-in law died due to the vaccine.  Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: her brother-in-law died due to the vaccine
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a Physician.  A 49-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: Jan2000. The patient also took other concomitant therapy. Past drug history included: Pan, reaction(s): "Known allergies: Pan". Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant) with onset Apr2024, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Apr2024, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included paxlovid from 16Apr2024 to 20Apr2024. Clinical course: Concomitant medication included: seasonable, start date: Jan2006.; Sender's Comments: Based on the information available, known safety profile the causal association between the reported events Vaccination failure, COVID-19  and suspect drug cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination Failure; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 49-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Lot number: HD9835) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: dust" (unspecified if ongoing); "Known allergies: cats/dogs" (unspecified if ongoing). Concomitant medication(s) included: PROBIOTICS, start date: 01Sep2012; ALLER ZYR, start date: 01Sep2012; MAGNESIUM GLYCINATE, start date: 01Sep2023. Past drug history included: Spermicide, reaction(s): "Known allergies: Spermicide". The following information was reported: COVID-19 (medically significant) with onset Apr2024, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Apr2024, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 16Apr2024 to 21Apr2024.
Sex: F
Vaccine: COVID19
Symptoms: Body height, Generalised tonic-clonic seizure
Clinical narrative: The adverse event was grand mal seizure. I do not know if it was related but the doctor have no idea.; This is a spontaneous report received from a Consumer or other non HCP.  A 3-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (medically significant), outcome "recovering", described as "The adverse event was grand mal seizure. I do not know if it was related but the doctor have no idea.". The patient underwent the following laboratory tests and procedures: Body height: 40 inches, notes: I believe 40 inches. Therapeutic measures were not taken as a result of generalised tonic-clonic seizure. Clinical course: The reporter stated, "I was just reporting my daughter, few years back with in the clinical trial for the Covid vaccine. She recently had a seizure that did not have any real explanation which happen sometimes, but I also know that ongoing reporting that is something that I think could been monitored. So, I just did not know adverse could be related to the study or not but I figured I may call in." When probed for the vaccine name, reporter stated, "It was a clinical trial, so I have the study protocol." When probed for the adverse event, reporter stated, "The adverse event was grand mal seizure. I do not know if it was related but the doctor has no idea. They sometime state that this happens, I think that something that Pfizer is tracking for the clinical trial is how often seizures happens." Other medical conditions: Reporter stated, "There were no other conditions. The doctor said, they are not seeming to be related to any other underline medical conditions." Start date of event: Reporter stated, "This was about, I think it was like the beginning of the Mar, I just recently, I just saw that there is a new study that is tracking seizure activity, so it was like 01Mar." When paraphrased again regarding the start date of event, reporter stated, "Well that is when it happened, just today I thought there is some collection for a covid vaccine, so I figured I called in. It was, the seizure was one time, and it was 01Mar, that is once in a day."  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: PNC20
Symptoms: Fatigue, Injection site erythema, Injection site pain
Clinical narrative: usual pain at the injection site; fatigue; a red square at the injection site; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 79-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 25Apr2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "usual pain at the injection site"; FATIGUE (non-serious), outcome "unknown"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "a red square at the injection site".  Additional inforation: Caller mentioned he is going back to work. Caller is a patient who has questions on Prevnar 20. Caller got the Prevnar 20 vaccine yesterday(15Apr2024).  He is experiencing the usual pain at the injection site. He is also experiencing some fatigue and has a "red square" at the injection site. He wants to know if these are normal and how long these side effects are expected to last. He wants to know any serious adverse reactions he should look out for. No information found on how long these side effects last. No information found on any serious adverse reactions linked to the Prevnar 20 vaccine.   Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: PNC20
Symptoms: Pruritus
Clinical narrative: itchiness but no rash; This is a spontaneous report received from an Other HCP from a sales representative.  An elderly female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 16Apr2024 as dose 1, single (Lot number: HE6176) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "itchiness but no rash". It was unknown if therapeutic measures were taken as a result of pruritus.
Sex: F
Vaccine: PNC20
Symptoms: Decreased appetite, Fatigue, Injection site swelling, Macule, Pyrexia
Clinical narrative: severe swelling at the injection sight; loss of appetite; fever; fatigue; had spot appear on her skin in clusters of 3; This is a spontaneous report received from an Other HCP.  An adult female patient (unknown if pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Mar2024 as dose 1, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Mar2024, outcome "unknown"; PYREXIA (non-serious) with onset Mar2024, outcome "unknown", described as "fever"; MACULE (non-serious) with onset Mar2024, outcome "unknown", described as "had spot appear on her skin in clusters of 3"; DECREASED APPETITE (non-serious) with onset Mar2024, outcome "unknown", described as "loss of appetite"; VACCINATION SITE SWELLING (non-serious) with onset Mar2024, outcome "unknown", described as "severe swelling at the injection sight". It was unknown if therapeutic measures were taken as a result of vaccination site swelling, decreased appetite, pyrexia, fatigue, macule.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ptsd" (unspecified if ongoing); "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "known allergies"; Norco, reaction(s): "known allergies". The following information was reported: COVID-19 (medically significant) with onset Apr2024, outcome "recovered" (Apr2024); VACCINATION FAILURE (medically significant) with onset Apr2024, outcome "recovered" (Apr2024). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2024) Negative, notes: Covid rebound of symptoms after testing negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 15Apr2024 to 20Apr2024.
Sex: U
Vaccine: RSV
Symptoms: Exposure during pregnancy, Foetal exposure during pregnancy, Premature delivery
Clinical narrative: received Abrysvo at 36 weeks and exactly a week later (37 weeks), experienced a pre-term birth; received Abrysvo at 36 weeks and exactly a week later (37 weeks), experienced a pre-term birth; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A fetus patient was exposed to rsv vaccine prot.subunit pref 2v (ABRYSVO), transplacental, administration details for the mother: not provided as dose number unknown, single (Batch/Lot number: unknown) for maternal exposure timing unspecified. The mother was 37 weeks pregnant at the event onset. The mother's relevant medical history and concomitant medications were not reported.  The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (medically significant), PREMATURE BABY (medically significant), outcome "unknown" and all described as "received Abrysvo at 36 weeks and exactly a week later (37 weeks), experienced a pre-term birth". The baby was delivered premature.  Batch/lot number is not provided, and it cannot be obtained.