chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Headache, Injection site pain, Musculoskeletal stiffness, Sinus pain
Clinical narrative: her neck is stiff; the headache as a pain to the right side of her head/sinus/eye area; pain to the right side of her head/sinus/eye; pain to the right side of her head/sinus/eye; she had injection site pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27-AUG-2024, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). On 27-AUG-2024, immediately after receiving Shingrix, the patient experienced injection site pain (Verbatim: she had injection site pain). On 28-AUG-2024, the patient experienced stiff neck (Verbatim: her neck is stiff), headache (Verbatim: the headache as a pain to the right side of her head/sinus/eye area), eye pain (Verbatim: pain to the right side of her head/sinus/eye) and sinus pain (Verbatim: pain to the right side of her head/sinus/eye). The outcome of the injection site pain, stiff neck, headache, eye pain and sinus pain were not resolved.   It was unknown if the reporter considered the injection site pain, stiff neck, headache, eye pain and sinus pain to be related to Shingrix.     It was unknown if the company considered the injection site pain, stiff neck, headache, eye pain and sinus pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2024 This case was self-reported by patient. The patient received Shingrix. At the time of vaccination, she had injection site pain that continued on the day of reporting. On 28th August 2024, the right side of her neck was stiff which was not resolved. The reporter further described the headache as a pain to the right side of her head sinus and eye area. The reporter did not know the Shingrix lot number. Nothing else was reported.
Sex: F
Vaccine: RSV
Symptoms: Fatigue
Clinical narrative: fever of approx. 99.8 degree F; felt fatigued; This non-serious case was reported by a consumer via sales rep and described the occurrence of fever in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 17-AUG-2024, the patient received the 1st dose of Arexvy. On 17-AUG-2024, less than a day after receiving Arexvy, the patient experienced fever (Verbatim: fever of approx. 99.8 degree F) and fatigue (Verbatim: felt fatigued). The patient was treated with acetylsalicylic acid (Aspirin). The outcome of the fever and fatigue were resolved (duration 24 hrs).   The reporter considered the fever and fatigue to be related to Arexvy.     The company considered the fever and fatigue to be related to Arexvy.   Additional Information: GSK Receipt Date: 30-AUG-2024 The reporter reported that the patient received the first dose of Arexvy vaccine and began running a fever of approximately 99.8 Fahrenheit and felt fatigued. Within 24 hours, the fever resolved, and she felt fine, patient took aspirin to resolve fever.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza
Clinical narrative: flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced influenza (Verbatim: flu). The outcome of the influenza was not resolved.   It was unknown if the reporter considered the influenza to be related to Shingrix.     It was unknown if the company considered the influenza to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2024 This case was reported by patient itself. The patient received first shot of Shingrix and was fine all day, then at midnight felt like had the flu. The patient waited till the last day to get second shot of Shingrix. The patient was so scared.  The 2nd shot had zero issues.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect dose administered, No adverse event, Single component of a two-component product administered
Clinical narrative: patient had given the pentacel but only the dtap-ipv liquid was given, the lyophilized hib was left out with no reported adverse event; Initial information received on 30-Aug-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 months old female patient who had given the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] but only the dtap-ipv liquid was given, the lyophilized hib was left out with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation.  On 27-Aug-2024, the patient had given a standard dose 2 (0.5 ml total) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UK019AA, expiry date- 30-JUN-2025) via intramuscular route in the left thigh for Immunization, but only the DTAP-IPV liquid was given, the lyophilized HIB was left out with no reported adverse event (single component of a two-component product administered) (latency- same day).  Reportedly, No ER (emergency room) visit and no treatment was received.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Heart rate decreased, Palpitations, Reaction to previous exposure to any vaccine
Clinical narrative: Slowed pulse (below 65), feeling like fainting, fuzziness in head. Slowed heart rate with occasional heart palpitation and feeling like it skipping a beat.
Sex: M
Vaccine: DTAP, HIBV, MENB
Symptoms: Wrong product administered
Clinical narrative: NONE AT THE MOMMENT When I went into the patients room, I told mom to help grab him and was when I administered vaccines. I had given the men b vaccine on the Left thigh, and the Dtap, and hib on Right thigh. I had noticed I gave the wrong vaccine when I went into the system to input them. When I had noticed that I administered the wrong vaccine I immediately told my manager. She then advised me to also tell the provider. When I had gone to get the vaccine I saw the PCV20 vaccine I needed to get but I grabbed the men B instead along with the Dtap and Hib
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: No additional AE. No PQC; HBP states 21 year old female received pediatric VAQTA.  Caller is not sure if patient received .5ml or 1.0 ml. as this was found via billing and chart documentation is not clear.  Precautionary AE filed.  No other information provided.  No additiona; This spontaneous report was received from a health business professional and refers to a 21-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 06-AUG-2024 the patient was vaccinated with pediatric dose of hepatitis a vaccine, inactivated (VAQTA) lot # X017317 and expiration date for prophylaxis (exact dose was unknown (reported as "caller was not sure if patient received 0.5ml or 1.0 ml", dose number, route and site of administration were not provided)) (underdose). No other information provided. No additional adverse event and no product Quality complaint (no adverse event).
Sex: U
Vaccine: HEP
Symptoms: Dementia, Fatigue
Clinical narrative: Developing Dementia; Tired; Initial report received on 21-Aug-2024.  A consumer reported that she, a 65-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and was developing dementia and was tired.  No relevant medical history or concomitant medications were reported.    On an unknown date, the patient received dose 1 of HEPLISAV-B (Lot #, expiration date, NDC #, site and route not reported). On an unknown date, the patient received dose 2 of HEPLISAV-B (Lot #, expiration date, NDC #, site and route not reported).  The patient stated that she was in "the 2-dose hepatitis B vaccine trial."   On an unknown date, the patient was "developing dementia."  On 21-Aug-2024, the patient said she was "tired today."  No other side effects were noted.   No additional information was reported.   Company Comment: The company assessed the events as non-serious. Dementia symptoms are progressive and gradually get worse over time leading to dementia. Although dementia is in the list of important medical events (Agency), there is insufficient information regarding the case definition of dementia in this patient. In the absence of signs and symptoms, tests performed, and medical history, the events are considered non-serious.; Sender's Comments: The company assessed the events as non-serious. Dementia symptoms are progressive and gradually get worse over time leading to dementia. Although dementia is in the list of important medical events (Agency), there is insufficient information regarding the case definition of dementia in this patient. In the absence of signs and symptoms, tests performed, and medical history, the events are considered non-serious.
Age: 5.0
Sex: U
Vaccine: DTAPIPV, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Extra dose administered/ following the admnistration of IPV (VERO) and same day; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of overdose in a 5-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included Iodinated glycerol (Ipol) for prophylaxis.   On an unknown date, the patient received Kinrix and Ipol. On an unknown date, an unknown time after receiving Kinrix, the patient experienced overdose (Verbatim: Extra dose administered/ following the admnistration of IPV (VERO) and same day). 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: 27-AUG-2024 The patient received Kinrix and IPOL as well on the same day, with no reported adverse event (extra dose administered) (latency:same day) following administration of IPV (VERO), which led to overdose. This suspected adverse reaction was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the directive and Module VI of good pharmacovigilance practices.  The classification as a medication error was in no way intended nor it should be intercepted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or was to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Pyrexia
Clinical narrative: fever; second shot (a month after the first); This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: fever) and drug dose administration interval too short (Verbatim: second shot (a month after the first)). The outcome of the fever was not resolved and the outcome of the drug dose administration interval too short was not reported.   It was unknown if the reporter considered the fever to be related to Shingrix.     It was unknown if the company considered the fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2024 The patient received first dose of Shingrix and had a slight fever. The patient received 2nd dose in shorter time than recommended, which led to shortening  of vaccination schedule. The patient reported after the second dose, there was no side effects a month after the first.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 60-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included viral infection (got the wicked virus at 60 on patient's fave). Previously administered products included Varicella zoster vaccine with an associated reaction of adverse reaction (received 1st dose of Shingles vaccine on an unknown date and experienced side effects).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick). The outcome of the sickness was resolved (duration 1 day).   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.   It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 29-AUG-2024 This case was reported by the patient via interactive digital media. The patient developed side effects after received both doses of the Shingles vaccines which was ongoing. The patient just (in 2024) completed the second vaccine, and it made him/her sick for a day but a must get to protect.
Sex: U
Vaccine: RVX
Symptoms: Cough, Headache, Malaise, Pyrexia
Clinical narrative: fever; headache; cough; sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced fever (Verbatim: fever), headache (Verbatim: headache), cough (Verbatim: cough) and sickness (Verbatim: sick). The outcome of the fever, headache, cough and sickness were not resolved.   It was unknown if the reporter considered the fever, headache, cough and sickness to be related to RSV vaccine.     It was unknown if the company considered the fever, headache, cough and sickness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 29-AUG-2024 The case was received from the patient via (social media) interactive digital media. The patient was reporter The reporter reported that since patient got the vaccine, they had been constantly sick with cough, flu, fever and headache. It was Coincidence. The reporter did not know.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise
Clinical narrative: flu like; got sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza like illness in a 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 influenza like illness (Verbatim: flu like) and sickness (Verbatim: got sick). The outcome of the influenza like illness and sickness were resolved.   It was unknown if the reporter considered the influenza like illness and sickness to be related to Shingrix.     It was unknown if the company considered the influenza like illness and sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2024 This case was reported by a patient via interactive digital media. The reporter did not like vaccines and opted not to get any Covid shot, however after watching some older loved ones suffered through shingles, he/she did get it.  The patient got really sick (flu like) for a couple days, then he/she was ok.
Sex: F
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick for the first 10 days.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: sick for the first 10 days.). The outcome of the sickness was resolved (duration 10 days).   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-AUG-2024 The case was received from the patient via interactive digital media. The family member the patient reported this case. The reporter reported that reporter mother got a shingles shot and was so sick for the first 10 days, was anyone else??. The reporter heard as if you have chicken pox you don not need a shingles shot?  The reporter really did not hear of the vaccine until last year.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Got the shingles vaccination and was in pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a 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 pain (Verbatim: Got the shingles vaccination and was in pain). The outcome of the pain was not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2024 This case was reported the patient via interactive digital media. The patient mentioned that he/she they already had their shingles vaccine and it was painful but they know women who had gotten shingles and it was obscenely painful and they told to get the vaccine. He/she also said they like older celebrities being advocates for maturing women's health. The patient stated that was for him/her.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Unapproved diluent; Unapproved diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a male patient who received Herpes zoster (Shingrix) (batch number C27N4, expiry date 15-MAY-2026) for prophylaxis.   On 23-AUG-2024, the patient received the 1st dose of Shingrix. On 23-AUG-2024, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Unapproved diluent) and inappropriate dose of vaccine administered (Verbatim: Unapproved diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-AUG-2024 It was reported that one of the staff member, gave a Shingrix vaccine, however they did not use the liquid component that came with the vaccine, they use sterile diluent instead which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. So the reporter wanted to verify the process for the same.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Exposure during pregnancy
Clinical narrative: patient who is the early stage of pregnancy/a dose of Havrix was administered to a 17 years old female patient who is pregnant; This non-serious prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a 17-year-old female patient who received HAV (Havrix) (batch number TF27T, expiry date 05-FEB-2026) for prophylaxis.   On 27-AUG-2024, the patient received Havrix. On 27-AUG-2024, an unknown time after receiving Havrix, the patient experienced vaccine exposure during pregnancy (Verbatim: patient who is the early stage of pregnancy/a dose of Havrix was administered to a 17 years old female patient who is pregnant). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Havrix): To mother in first trimester Pregnancy Outcome: Pregnancy was ongoing   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-AUG-2024 The physician reported that they inadvertently administered a dose of Havrix to a patient at the time of reporting who was the early stage of pregnancy, which led to vaccine exposure during pregnancy. The reporter consented to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Early 2nd dose of vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 10-year-old patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: Early 2nd dose of vaccine). 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: 28-AUG-2024 The reporter reported that if there was any data on Hepatitis A (Havrix) vaccine regarding 2nd dose if it was given like uncertain amount of days early which led to shortening of vaccinations schedule. If it was need to be repeated, he/she could not find nay in the package insert. The Vaccine Administration Facility was the same as Primary Reporter. The HCP confirmed that this was the Havrix vaccine, also this was not an hypothetical case. HCP did not confirm the date of vaccination, nor for the 1st or 2nd dose. Related to the 2nd dose, she said that it was a couple of days ago. HCP said that she found some info on the internet, and they found out that if it was given in 4 days it was okay, that the vaccine should not be repeated, however, HCP said that they already revaccinate the patient.
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: the other one is today, and she is 34 weeks (pregnant); Boostrix was given when the patient was 28 weeks (pregnant); she got one on July, and another one today; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 31-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5YD56, expiry date 09-OCT-2026) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 28-AUG-2024, the patient received the 2nd dose of Boostrix. In JUL-2024, the patient received the 1st dose of Boostrix. On 28-AUG-2024, an unknown time after receiving Boostrix and not applicable after receiving Boostrix, the patient experienced extra dose administered (Verbatim: she got one on July, and another one today). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: the other one is today, and she is 34 weeks (pregnant)) and vaccine exposure during pregnancy (Verbatim: Boostrix was given when the patient was 28 weeks (pregnant)). The outcome of the extra dose administered, vaccine exposure during pregnancy and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Gestation time at first exposure (Boostrix): 34 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Gestation time at first exposure (Boostrix): 28 Weeks Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-AUG-2024 The pharmacist called and informed that a doctor who prescribed the same vaccine twice, Boostrix, to the patient, twice in a month, in between a month and when they tried to enter the second vaccine, they noticed that she got one on July, and another one on the day of reporting which led to extra dose administered. The reporter mentioned that the 1st dose of Boostrix was given when the patient was 28 weeks (pregnant), the other one was on the day of reporting, and she was 34 weeks (pregnant) which led to vaccine exposure during pregnancy. The vaccine administration facility was the same as primary reporter.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: she had 2 Arexvy; 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 77-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number DT9S3, expiry date 20-AUG-2025) for prophylaxis.   On 29-AUG-2024, the patient received the 2nd dose of Arexvy. On 29-AUG-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: she had 2 Arexvy). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 29-AUG-2024 Their residents, a long term care, was inadvertently order a 2nd Arexvy and it was send by the pharmacy and the insurance pay for it, so she had 2 Arexvy, which led to extra dose administered. The reporter could not found anything about a potential problem, they knew you were only supposed to get one, but she had 2 .  The reporter need to know if this was going to be a complication for her. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: patients were administered with expired Boostrix vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 10-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (expiry date 27-OCT-2023) for prophylaxis.   On 22-AUG-2024, the patient received Boostrix. On 22-AUG-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: patients were administered with expired Boostrix vaccine). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2024 The nurse reported that the patient was administered with expired Boostrix vaccine which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. This was 1 of 9 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024107939:Same reporter,Different patient US-GSK-US2024107925:Same reporter/Different patient US-GSK-US2024107929:Same reporter/Different patient US-GSK-US2024107932:Same reporter/Different patient US-GSK-US2024107937:Same reporter/Different patient US-GSK-US2024107923:Same reporter/Different patient US-GSK-US2024107927:Same reporter/Different patient US-GSK-US2024107935:Same reporter/Different patient
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: patient was administered with expired Boostrix vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 10-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (expiry date 27-OCT-2023) for prophylaxis.   On 22-AUG-2024, the patient received Boostrix. On 22-AUG-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: patient was administered with expired Boostrix vaccine). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2024 The nurse reported that the patient was administered with expired Boostrix vaccine which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. This was 1 of 9 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024107925:Same reporter/Different patient US-GSK-US2024107939:Same reporter,Different patient US-GSK-US2024107923:Same reporter/Different patient US-GSK-US2024107929:Same reporter/Different patient US-GSK-US2024107927:Same reporter/Different patient US-GSK-US2024107933:Same reporter/Different patient US-GSK-US2024107937:Same reporter/Different patient US-GSK-US2024107935:Same reporter/Different patient
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered with expired Boostrix vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 13-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (expiry date 27-OCT-2023) for prophylaxis.   On 22-AUG-2024, the patient received Boostrix. On 22-AUG-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administered with expired Boostrix vaccine). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2024 The nurse reported that the patient was administered with expired Boostrix vaccine which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. This was 1 of 9 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024107925:Same reporter/Different patient US-GSK-US2024107935:Same reporter/Different patient US-GSK-US2024107923:Same reporter/Different patient US-GSK-US2024107927:Same reporter/Different patient US-GSK-US2024107932:Same reporter/Different patient US-GSK-US2024107933:Same reporter/Different patient US-GSK-US2024107939:Same reporter/Different patient US-GSK-US2024107937:Same reporter/Different patient
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered with expired Boostrix vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 10-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (expiry date 27-OCT-2023) for prophylaxis.   On 22-AUG-2024, the patient received Boostrix. On 22-AUG-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administered with expired Boostrix vaccine). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2024 The nurse reported that the patient was administered with an expired dose of Boostrix vaccine, which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. The case is 1 of the 9 linked case, by same reporter.; Sender's Comments:  US-GSK-US2024107923:Same reporter,Different patient US-GSK-US2024107927:Same reporter,Different patient US-GSK-US2024107932:Same reporter,Different patient US-GSK-US2024107933:Same reporter,Different patient US-GSK-US2024107937:Same reporter,Different patient US-GSK-US2024107935:Same reporter, different patient US-GSK-US2024107925:Same reporter/Different patient US-GSK-US2024107929:Same reporter/Different patient
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered with expired Boostrix vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (expiry date 27-OCT-2023) for prophylaxis.   On 22-AUG-2024, the patient received Boostrix. On 22-AUG-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administered with expired Boostrix vaccine). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2024 The nurse reported that the patient was administered with an expired dose of Boostrix vaccine, which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. The case is 1 of the 9 linked case, by same reporter.; Sender's Comments:  US-GSK-US2024107939:Same reporter,Different patient US-GSK-US2024107925:Same reporter/Different patient US-GSK-US2024107929:Same reporter/Different patient US-GSK-US2024107935:Same reporter/Different patient US-GSK-US2024107932:Same reporter/Different patient US-GSK-US2024107927:Same reporter/Different patient US-GSK-US2024107923:Same reporter/Different patient US-GSK-US2024107933:Same reporter/Different patient
Sex: F
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: vaccines that were exposed to temperatures below freezing; 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 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   On 29-AUG-2024, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced incorrect storage of drug (Verbatim: vaccines that were exposed to temperatures below freezing). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 29-AUG-2024 The reporter called to verify the stability data of a couple of vaccines that were exposed to temperatures below freezing, the caller said that this was only for 36 minutes, which led to incorrect storage of drug. Latter caller asked if any patient received those vaccines, if they should be revaccinated. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: one of their patients received the Boostrix vaccine that was exposed to temperatures below freezing; 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 12-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number Z7L7H, expiry date 09-AUG-2026) for prophylaxis.   On 29-AUG-2024, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: one of their patients received the Boostrix vaccine that was exposed to temperatures below freezing). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 29-AUG-2024 The reporter called to verify the stability data of a couple of vaccines that were exposed to temperatures below freezing, the caller said that this was only for 36 minutes, which led to incorrect storage of drug. Latter caller asked if any patient received those vaccines, if they should be revaccinated. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: I had tingling in my opposite arm of where I had vaccine and lower leg tingling on the vaccine side
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, COVID-19, Death, Gastric ulcer perforation, SARS-CoV-2 test positive
Clinical narrative: Pt was admitted to the hospital on 8/23 with abdominal pain. Patient had been covid positive since 8/19. Pt died on 9/6. Pt was admitted with gastric ulcer with perforation and septic shock.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Septic shock
Clinical narrative: Pt was admitted to the hospital on 8/23 with abdominal pain. Patient had been covid positive since 8/19. Pt died on 9/6. Pt was admitted with gastric ulcer with perforation and septic shock.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Chest X-ray normal, Chills
Clinical narrative: BRIEF OVERVIEW: Admission Date: 9/1/2024 Discharge Date: Sep 4, 2024 Discharge Disposition:  home or self care   Active Issues Requiring Follow-up:  #acute on chronic hypoxic respiratory failure due to COVID 19 pneumonia  #COPD with exacerbation due to above - RPP positive for COVID - Completed 4 days of Remdesivir, and 4/10 of decadron - c/w mucinex, symbicort - c/w daliresp nightly - follow up with PCP  #Type 2 diabetes mellitus with hyperglycemia, with long-term current use of insulin blood sugars elevated on steroids.   - continue home meds  #Acquired hypothyroidism levothyroxine  #Bipolar affective disorder, current episode depressed: olanzapine, sertraline  #Gastroesophageal reflux disease without esophagitis; on famotidine at home, on hold since admission.    #Insomnia ESZOPICLONE   #OSA on CPAP (RN encouraged patient to bring in home CPAP)  #Class 1 obesity with serious comorbidity and body mass index (BMI) of 33.0 to 33.9 in adult - counseled Pending Labs     DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia [R09.02] Chronic obstructive pulmonary disease with acute lower respiratory infection (HCC) [J44.0] Acute on chronic respiratory failure with hypoxia (HCC) [J96.21] COVID-19 [U07.1] Acute on chronic respiratory failure (HCC) [J96.20]  HOSPITAL COURSE: 59 y.o. female with history of severe COPD with chronic hypoxic respiratory failure on 2L O2, OSA on CPAP, h/o tobacco abuse, diabetes mellitus type 2, anxiety, bipolar, hypothyroidism, obesity, and insomnia who presented to ER again today with complaints of increased shortness of breath, fever, chills, and productive cough that started yesterday.  She presented to the ER yesterday, given a breathing treatment and then discharged home on oral antibiotics.  The patient reports not taking the antibiotics at home prior to return to ER.  She continued to feel fever, chills, and increased shortness of breath.  She was found to be covid positive.  She was given doxycycline and Rocephin in the emergency room.  The CXR in the ER does not show a new consolidation therefore we will not continue antibiotics at this time.  She was given duonebs and steroids in ER.  Remdesevir ordered and will be couriered from pharmacy soon.  The patient is normally on 2L O2 per nasal canula and currently is on 3L with pulse ox 92%.    Vital signs overall stable.  She denies pain but states she does feel short of breath with moving and even talking if more than short answer.  She looks comfortable in the bed, she was eating fast food during my assessment/interview.  She uses a CPAP at night at home, we will have RT place her on CPAP at bedtime with 4L O2.Completed remdesivir and  Decadron daily, continuous pulse ox, and cardiac monitor.  She does not have a new consolidation on the chest x-ray and she has a normal white count therefore we will not continue antibiotics.  Patient completed 4 days of remdesivir and steroids, with significant improvement in symptoms. She was medically optimized and hemodynamically stable at time of discharge.   Discharged to Home
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Treatment noncompliance, White blood cell count normal
Clinical narrative: BRIEF OVERVIEW: Admission Date: 9/1/2024 Discharge Date: Sep 4, 2024 Discharge Disposition:  home or self care   Active Issues Requiring Follow-up:  #acute on chronic hypoxic respiratory failure due to COVID 19 pneumonia  #COPD with exacerbation due to above - RPP positive for COVID - Completed 4 days of Remdesivir, and 4/10 of decadron - c/w mucinex, symbicort - c/w daliresp nightly - follow up with PCP  #Type 2 diabetes mellitus with hyperglycemia, with long-term current use of insulin blood sugars elevated on steroids.   - continue home meds  #Acquired hypothyroidism levothyroxine  #Bipolar affective disorder, current episode depressed: olanzapine, sertraline  #Gastroesophageal reflux disease without esophagitis; on famotidine at home, on hold since admission.    #Insomnia ESZOPICLONE   #OSA on CPAP (RN encouraged patient to bring in home CPAP)  #Class 1 obesity with serious comorbidity and body mass index (BMI) of 33.0 to 33.9 in adult - counseled Pending Labs     DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia [R09.02] Chronic obstructive pulmonary disease with acute lower respiratory infection (HCC) [J44.0] Acute on chronic respiratory failure with hypoxia (HCC) [J96.21] COVID-19 [U07.1] Acute on chronic respiratory failure (HCC) [J96.20]  HOSPITAL COURSE: 59 y.o. female with history of severe COPD with chronic hypoxic respiratory failure on 2L O2, OSA on CPAP, h/o tobacco abuse, diabetes mellitus type 2, anxiety, bipolar, hypothyroidism, obesity, and insomnia who presented to ER again today with complaints of increased shortness of breath, fever, chills, and productive cough that started yesterday.  She presented to the ER yesterday, given a breathing treatment and then discharged home on oral antibiotics.  The patient reports not taking the antibiotics at home prior to return to ER.  She continued to feel fever, chills, and increased shortness of breath.  She was found to be covid positive.  She was given doxycycline and Rocephin in the emergency room.  The CXR in the ER does not show a new consolidation therefore we will not continue antibiotics at this time.  She was given duonebs and steroids in ER.  Remdesevir ordered and will be couriered from pharmacy soon.  The patient is normally on 2L O2 per nasal canula and currently is on 3L with pulse ox 92%.    Vital signs overall stable.  She denies pain but states she does feel short of breath with moving and even talking if more than short answer.  She looks comfortable in the bed, she was eating fast food during my assessment/interview.  She uses a CPAP at night at home, we will have RT place her on CPAP at bedtime with 4L O2.Completed remdesivir and  Decadron daily, continuous pulse ox, and cardiac monitor.  She does not have a new consolidation on the chest x-ray and she has a normal white count therefore we will not continue antibiotics.  Patient completed 4 days of remdesivir and steroids, with significant improvement in symptoms. She was medically optimized and hemodynamically stable at time of discharge.   Discharged to Home
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Dizziness, Muscular weakness, Peripheral swelling
Clinical narrative: dizziness, confusion, extreme swelling in arm and weakness
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Eight-year-old received covid vaccine for 12+. No adverse event taken place.
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient is 17 and vaccine is for >/= 18
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling(3in  x 4in) and redness at injection site; local reaction only, no systemic signs.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Pt has blisters, redness, and swelling to right thigh
Age: 32.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Dyspnoea, Gait disturbance, Hypoaesthesia, Lip discolouration, Paraesthesia
Clinical narrative: Tingling and numbness started at feet and quickly worked it's way up to legs and then lungs/heart/chest, hands, arms, then face. Was hard to breathe, lips turned purple. Severe numbness to legs/feet. Got breathing under control but legs remained numb/tingling. Could hardly walk for 5 days. Brain told legs to walk but legs were only able to do it off of a reflex or muscle memory. At night I would try to go to sleep but body would immediately wake me up gasping for air. After getting proper breathing back I would fall back asleep where I would immediately feel like I stopped breathing again and wake up gasping for air. All night long for 5 nights straight. No fever. Called primary care doctor still hasn't returned my call. I called the pharmacy in which gave me the vaccine day 1 and they told me that they have never heard of a side effect like this with the imovax shot, but to monitor it or go to ER. Then called hospital where lead ER nurse told me to monitor or go to ER. We decided to monitor for financial reasons.
Age: 32.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Sleep disorder
Clinical narrative: Tingling and numbness started at feet and quickly worked it's way up to legs and then lungs/heart/chest, hands, arms, then face. Was hard to breathe, lips turned purple. Severe numbness to legs/feet. Got breathing under control but legs remained numb/tingling. Could hardly walk for 5 days. Brain told legs to walk but legs were only able to do it off of a reflex or muscle memory. At night I would try to go to sleep but body would immediately wake me up gasping for air. After getting proper breathing back I would fall back asleep where I would immediately feel like I stopped breathing again and wake up gasping for air. All night long for 5 nights straight. No fever. Called primary care doctor still hasn't returned my call. I called the pharmacy in which gave me the vaccine day 1 and they told me that they have never heard of a side effect like this with the imovax shot, but to monitor it or go to ER. Then called hospital where lead ER nurse told me to monitor or go to ER. We decided to monitor for financial reasons.
Age: 32.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Back pain, Dyspnoea, Gait disturbance, Muscle fatigue, Muscular weakness
Clinical narrative: Tingling and numbness started at feet and quickly worked it's way up to legs and then lungs/heart/chest, hands, arms, then face. Was hard to breathe, lips turned purple. Severe numbness to legs/feet. Got breathing under control but legs remained numb/tingling. Could hardly walk for 5 days. Brain told legs to walk but legs were only able to do it off of a reflex or muscle memory. At night I would try to go to sleep but body would immediately wake me up gasping for air. After getting proper breathing back I would fall back asleep where I would immediately feel like I stopped breathing again and wake up gasping for air. All night long for 5 nights straight. No fever. Called primary care doctor still hasn't returned my call. I called the pharmacy in which gave me the vaccine day 1 and they told me that they have never heard of a side effect like this with the imovax shot, but to monitor it or go to ER. Then called hospital where lead ER nurse told me to monitor or go to ER. We decided to monitor for financial reasons.