chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: HEP, PPV, TDAP, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered an expired dose of the Pneumovax 23 vaccine.  The vaccine was administered on 08/24/2023 but it expired on 08/18/2023. Pt was monitored post injection with no adverse reaction noted or reported. Patient was ambulating independently when he left the clinic and was alert and orientated to person, place, and time. Upon follow-up, twenty-four and ninety-six hours post vaccination, patient denied symptoms/adverse effects related to the vaccine warranting medical follow-up. Clinic will continue to monitor the client at interval.
Age: 68.0
Sex: M
Vaccine: HEP, PPV, TDAP, PPV
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired dose of the Pneumovax 23 vaccine.  The vaccine was administered on 08/24/2023 but it expired on 08/18/2023. Pt was monitored post injection with no adverse reaction noted or reported. Patient was ambulating independently when he left the clinic and was alert and orientated to person, place, and time. Upon follow-up, twenty-four and ninety-six hours post vaccination, patient denied symptoms/adverse effects related to the vaccine warranting medical follow-up. Clinic will continue to monitor the client at interval.
Age: 1.08
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Incorrect Monovalent vaccine administered.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Wrong product administered
Clinical narrative: Td GIVEN INSTEAD OF Tdap
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: LPN remembers this patient visit.  Patient had a visit at 11am  LPN remembers opening a new vial (same vial)on this day.  Patient aslo got a monkeypox vaccine during this visit. on 7/14/2023, there were 2 doses extra left over in the same lot number, when there should have been 0 per internal inventory, Since it is not possible to pinpoint which doses caused the overage, it appears 1 or more doses given between 6/9/2023 and 7/7/2023 may have been expired- 12 hours after opening and reused, therefore all doses given during that period are considered to potentially be expired.
Age: 6.0
Sex: U
Vaccine: TD
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Td given
Age: 13.0
Sex: F
Vaccine: COVID19-2, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine administered after the BUD. Parent has not reported an adverse reaction.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Condition aggravated, Dizziness, Dyspnoea, Fatigue
Clinical narrative: She got her vaccine, had pain at the injection site.  It was very painful, kept ice on her arm for 3 days.  Her sinuses started to run the first day.  The 4th day she had whelps on her arm, Sunday, Yesterday.  Her arm hurt all the way down to her fingertips, feeling like someone was squeezing her arm, had a general feeling of fatigue.  The sinuses were running down the bakc of her throat making it hurt.  Today, her arm is hurting all the way up her shoulder and into her neck.  She has a feeling of severe fatigue, and felt even worse.  She went to the her doctor today and he told her to keep doing what she was doing, which was ibuprofen for the pain, icing it and taking Allegra and Citrizine during the night. It felt like somebody hit her, like she was swimming in a fog and could not find her way out.  When she got home today she took the Allegra and the sinuses are not running as bad.  She will have to take the Ibuprofen in about an hour, and has been keeping ice on it.  She has a few whelps left, but everything else has gone.  She went to lay down as she could not keep awake anymore and could not sleep because of the pain, so she got up.  She feels like she has a crick in her shoulder and her neck and everytime she moves it hurts.    She had a similar reaction with the last few shots, other than having hives down her arm.  This time the hives are not as noticeable as much anymore and they were itchy as well.  She does not have an itch this time, but just the pain with radiation down her arm into her fingertips.  Today, it is radiating up into her shoulder and into her neck.  The whelps now are very minor as compared to when she had with the last flu shot.  She believes she had trouble breathing with the last one and almost passed out.    She did have reactions to the booster COVID vaccine.  She had pain in the left arm as it was painful and she also had hives with that as well.    Last night her tastebuds changed, and was tested for COVID as she was eating popcorn and she could not taste it.  This morning she was drinking her tea and the cream in her tea did not taste good.  She was tested today and was negative.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Feeling abnormal, Injection site pain, Musculoskeletal discomfort, Neck pain, Oropharyngeal pain
Clinical narrative: She got her vaccine, had pain at the injection site.  It was very painful, kept ice on her arm for 3 days.  Her sinuses started to run the first day.  The 4th day she had whelps on her arm, Sunday, Yesterday.  Her arm hurt all the way down to her fingertips, feeling like someone was squeezing her arm, had a general feeling of fatigue.  The sinuses were running down the bakc of her throat making it hurt.  Today, her arm is hurting all the way up her shoulder and into her neck.  She has a feeling of severe fatigue, and felt even worse.  She went to the her doctor today and he told her to keep doing what she was doing, which was ibuprofen for the pain, icing it and taking Allegra and Citrizine during the night. It felt like somebody hit her, like she was swimming in a fog and could not find her way out.  When she got home today she took the Allegra and the sinuses are not running as bad.  She will have to take the Ibuprofen in about an hour, and has been keeping ice on it.  She has a few whelps left, but everything else has gone.  She went to lay down as she could not keep awake anymore and could not sleep because of the pain, so she got up.  She feels like she has a crick in her shoulder and her neck and everytime she moves it hurts.    She had a similar reaction with the last few shots, other than having hives down her arm.  This time the hives are not as noticeable as much anymore and they were itchy as well.  She does not have an itch this time, but just the pain with radiation down her arm into her fingertips.  Today, it is radiating up into her shoulder and into her neck.  The whelps now are very minor as compared to when she had with the last flu shot.  She believes she had trouble breathing with the last one and almost passed out.    She did have reactions to the booster COVID vaccine.  She had pain in the left arm as it was painful and she also had hives with that as well.    Last night her tastebuds changed, and was tested for COVID as she was eating popcorn and she could not taste it.  This morning she was drinking her tea and the cream in her tea did not taste good.  She was tested today and was negative.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Pain, Pain in extremity, SARS-CoV-2 test negative, Sinus congestion, Sleep disorder
Clinical narrative: She got her vaccine, had pain at the injection site.  It was very painful, kept ice on her arm for 3 days.  Her sinuses started to run the first day.  The 4th day she had whelps on her arm, Sunday, Yesterday.  Her arm hurt all the way down to her fingertips, feeling like someone was squeezing her arm, had a general feeling of fatigue.  The sinuses were running down the bakc of her throat making it hurt.  Today, her arm is hurting all the way up her shoulder and into her neck.  She has a feeling of severe fatigue, and felt even worse.  She went to the her doctor today and he told her to keep doing what she was doing, which was ibuprofen for the pain, icing it and taking Allegra and Citrizine during the night. It felt like somebody hit her, like she was swimming in a fog and could not find her way out.  When she got home today she took the Allegra and the sinuses are not running as bad.  She will have to take the Ibuprofen in about an hour, and has been keeping ice on it.  She has a few whelps left, but everything else has gone.  She went to lay down as she could not keep awake anymore and could not sleep because of the pain, so she got up.  She feels like she has a crick in her shoulder and her neck and everytime she moves it hurts.    She had a similar reaction with the last few shots, other than having hives down her arm.  This time the hives are not as noticeable as much anymore and they were itchy as well.  She does not have an itch this time, but just the pain with radiation down her arm into her fingertips.  Today, it is radiating up into her shoulder and into her neck.  The whelps now are very minor as compared to when she had with the last flu shot.  She believes she had trouble breathing with the last one and almost passed out.    She did have reactions to the booster COVID vaccine.  She had pain in the left arm as it was painful and she also had hives with that as well.    Last night her tastebuds changed, and was tested for COVID as she was eating popcorn and she could not taste it.  This morning she was drinking her tea and the cream in her tea did not taste good.  She was tested today and was negative.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Taste disorder, Urticaria
Clinical narrative: She got her vaccine, had pain at the injection site.  It was very painful, kept ice on her arm for 3 days.  Her sinuses started to run the first day.  The 4th day she had whelps on her arm, Sunday, Yesterday.  Her arm hurt all the way down to her fingertips, feeling like someone was squeezing her arm, had a general feeling of fatigue.  The sinuses were running down the bakc of her throat making it hurt.  Today, her arm is hurting all the way up her shoulder and into her neck.  She has a feeling of severe fatigue, and felt even worse.  She went to the her doctor today and he told her to keep doing what she was doing, which was ibuprofen for the pain, icing it and taking Allegra and Citrizine during the night. It felt like somebody hit her, like she was swimming in a fog and could not find her way out.  When she got home today she took the Allegra and the sinuses are not running as bad.  She will have to take the Ibuprofen in about an hour, and has been keeping ice on it.  She has a few whelps left, but everything else has gone.  She went to lay down as she could not keep awake anymore and could not sleep because of the pain, so she got up.  She feels like she has a crick in her shoulder and her neck and everytime she moves it hurts.    She had a similar reaction with the last few shots, other than having hives down her arm.  This time the hives are not as noticeable as much anymore and they were itchy as well.  She does not have an itch this time, but just the pain with radiation down her arm into her fingertips.  Today, it is radiating up into her shoulder and into her neck.  The whelps now are very minor as compared to when she had with the last flu shot.  She believes she had trouble breathing with the last one and almost passed out.    She did have reactions to the booster COVID vaccine.  She had pain in the left arm as it was painful and she also had hives with that as well.    Last night her tastebuds changed, and was tested for COVID as she was eating popcorn and she could not taste it.  This morning she was drinking her tea and the cream in her tea did not taste good.  She was tested today and was negative.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Hypotonia, Pallor, Syncope
Clinical narrative: Patient received vaccination above, and returned to the waiting room by walking, to wait for UTD vaccination record. A few seconds after entering the waiting room father stated she got really pale and went limp (vasovagal syncope) briefly . Patient's father managed to sit her down in a nearby chair and called out for nurses help. Patient was conscious and talking when nurse entered room but skin was ashen and eyes were shut. Reported to feel lightheaded and dizzy. Offered the patient some water and crackers, plus turned fan to blow on patient.  B/P was 119/ 72.  Patient remained sitting until pallor dissipated and dizziness went awake. Patient ambulated to car and released with father.
Age: 8.0
Sex: U
Vaccine: TD
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Td given
Age: 11.0
Sex: F
Vaccine: HEP, HEPA, MMRV, MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The adverse event was this patient received their second dose of Hep A to soon .  The first dose was given 06/30/2023 and the second the second dose was given 08/21/2023.
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Incorrect Moderna Bivalent vaccine administered
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient was given wrong wrong dose of Hep B vaccine, she received 0.5 ml but should have received 1 ml of this vaccine.
Age: 15.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered after the BUD. Parent has not reported an adverse reaction.
Age: 9.0
Sex: M
Vaccine: HEP, HEPA, MMRV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received second dose of Hep A to soon.  First dose was given 06/30/2023 and the second dose was given 08/21/2023.
Age: 14.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient came in for 2nd dose of MMR & Varivax on 8/24/23.  Realized patient received ProQuad on 7/20 and shouldn't be due to age being 14 yrs old.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Phlebotomy, Polycythaemia vera
Clinical narrative: my husband received 4 covid moderna  vaccines 2/26/21  3/24/21 10/29/21 5/20/22 he had covid in 11/2020 Prior to receiving covid vaccine his hct   in 2017 was 48.4 1/2018 43.5 . 8/2018 43.1  10/2020 6/2021 47.6 5/63.2 He was diagnosed with polycythemia vera and is currently being treated for this with monthly bloddletting
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Incorrect Moderna Bivalent given
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: severe reaction 12 hours after injection included severe sweat, chills, mild headache, nausea, joint and body ache, fatigue, faintness, slightly elevated heart rate; subsided after 8 hours, full recovery after 48 hours
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Heart rate increased, Hyperhidrosis, Nausea, Pain
Clinical narrative: severe reaction 12 hours after injection included severe sweat, chills, mild headache, nausea, joint and body ache, fatigue, faintness, slightly elevated heart rate; subsided after 8 hours, full recovery after 48 hours
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Pt c/o "lump" were vaccine was placed that  never went away and painful to touch.  Pt received 3 Moderna vaccines in the same arm. Vaccines given at a clinic.
Age: 21.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: WARM SORE ARM AT INJECTION SITE AND FEVER ON DAY 4
Age: 2.0
Sex: F
Vaccine: MMR, MMRV
Symptoms: Unevaluable event
Clinical narrative: none
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fall
Clinical narrative: Fire department pick me up, no upper body strength. I can?t pick myself up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Skin warm
Clinical narrative: Got vaccine, went home, around 4 PM started with redness, warm to the touch. Area of redness measures 7" x 7". Came into the office today, redness and temp are better. Told to take Ibuprofen 7.5 ML @ 100 MG/5ML PO.
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: the vaccine was given on the 33 day of thawing.
Age: 57.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Chills, Dizziness, Dyspnoea, Feeling jittery, Hypoaesthesia
Clinical narrative: Patient became dizzy and jittery about 30 minutes after shot, when she got home went to sleep. When she woke up her left side numb. She also experience some shortness of breath and had body aches, fever, chills for 3 days.
Age: 57.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Patient became dizzy and jittery about 30 minutes after shot, when she got home went to sleep. When she woke up her left side numb. She also experience some shortness of breath and had body aches, fever, chills for 3 days.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Urticaria
Clinical narrative: patient developed hives on legs and feet
Age: 39.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: gave wrong dose, had pt come back and gave another pediatric dose to make an adult dose
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Hypersomnia, Myalgia, Pyrexia
Clinical narrative: Fever 100.6, muscle aches and pains, chills, exhaustion - slept all day til 5pm on Sunday Aug 27.  Consulted nurse line of company. Took ibuprofen 2 tabs every 4 hours Sat 8-27. 3 doses of ibuprofen that day.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Fever 100.6, muscle aches and pains, chills, exhaustion - slept all day til 5pm on Sunday Aug 27.  Consulted nurse line of company. Took ibuprofen 2 tabs every 4 hours Sat 8-27. 3 doses of ibuprofen that day.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Papule
Clinical narrative: small vesicle filled papules
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea, Fatigue, Nausea, SARS-CoV-2 test negative, Vomiting
Clinical narrative: Patient reports nausea and vomiting bile, extreme fatigue, diarrhea, and an elevated temperature (99.6) on and off. feeling better today
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: patient had whole body break out in red and itching patches on stomach, back and arms
Age: 9.0
Sex: M
Vaccine: MMR
Symptoms: Dry skin, Erythema, Immunisation reaction, Pustule, Rash
Clinical narrative: Patient was noted to have a red rash starting under his nose that extended down his neck and to his chest and some redness on his back.  5 days later small pustules appeared on his face and neck but, not on his chest or back.
Age: 9.0
Sex: M
Vaccine: MMR
Symptoms: Rash erythematous, Scab
Clinical narrative: Patient was noted to have a red rash starting under his nose that extended down his neck and to his chest and some redness on his back.  5 days later small pustules appeared on his face and neck but, not on his chest or back.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Inbound call from a medical assistant with a physician on the back line reporting AE for VARIVAX.  TE case filed under 02458467. AE details were provided by medical assistant. No symptoms reported. No additional AE/PQC.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.       On 08-AUG-2023 the patient was vaccinated with first dose of improperly stored  varicella virus vaccine live (oka/merck)(VARIVAX) lot # x006983 and expiration date 07-MAR-2025, for prophylaxis (exact dose, route and site of administration were not provided) (product storage error and no adverse event).     ; Sender's Comments:  US-009507513-2308USA009014:
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient has received dose of SHINGRIX outside of vaccination schedule.; This non-serious case was reported by a pharmacist via other manufacturer and described the occurrence of inappropriate schedule of vaccine administered 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 inappropriate schedule of vaccine administered (Verbatim: patient has received dose of SHINGRIX outside of vaccination schedule).  The outcome of the inappropriate schedule of vaccine administered was unknown.   Additional Information: GSK receipt date: 18-Aug-2023 The case was reported the pharmacist. No additional information was provided. No adverse event or product quality complaint was reported. The patient received a dose of Shingrix outside the vaccination schedule, which led to inappropriate schedule of vaccine administered.
Sex: U
Vaccine: MNQ
Symptoms: Intercepted product storage error
Clinical narrative: currently have 38 units to be returned; This non-serious case was reported by a pharmacist and described the occurrence of intercepted product storage error in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) (batch number 52X45) for prophylaxis.   In AUG-2023, the patient received Menveo. On 11-AUG-2023, an unknown time after receiving Menveo, the patient experienced intercepted product storage error (Verbatim: currently have 38 units to be returned).  The outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2023 The reporter stated that we would not be able to send back the 60 units of Menveo and currently had 38 units to be returned. We issued an investigation since the product was received in the system and customers were able to place orders (22 units). The feedback needed from Glaxo for investigation. The 22 units of Menveo vaccine temperature excursion on 11th August 2023. The tag alert alarm 2, 3 with 4 black squares. The Menveo vaccine had temperature excursion, which led to incorrect storage of vaccine.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose on 8/24/2022, 2nd dose on 2/15/2023; 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 1-year-old male patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (On 24th August 2022, received first dose).   On 15-FEB-2023, the patient received the 2nd dose of Havrix. On 15-FEB-2023, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: first dose on 8/24/2022, 2nd dose on 2/15/2023).  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: 18-AUG-2023 The case was reported by the health care professional. The reporter consented to follow up. The patient received 2nd dose of Havrix vaccine, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: itchy rash on both arms/itchy rash chest and left neck area; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and rash (legs/left ankle). Previously administered products included Shingrix (received 1st dose few months ago summer of 2023). Concomitant products included ibuprofen (Advil), paracetamol (Tylenol) and cannabis (Medical Marijuana).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, several months after receiving Shingrix, the patient experienced itchy rash (Verbatim: itchy rash on both arms/itchy rash chest and left neck area).The outcome of the itchy rash was not resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.   It was unknown if the company considered the itchy rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-AUG-2023 The patient was with a history of shingles rash on legs and left ankle.  He states he received Shingrix (2 doses) a few months ago summer of 2023. He stated that a few months later he experienced an itchy rash on both arms, chest and left neck area.  He mentioned that he was taking Advil, Tylenol and medical marijuana.  No other information was provided. The reporter consented to follow up.
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Doctor reports an 8 year old patient is behind on his Td vaccine schedule and she may use Boostrix to catch him up; Circumstance or information capable of leading to medication error; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient did not receive Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Doctor reports an 8 year old patient is behind on his Td vaccine schedule and she may use Boostrix to catch him up) and circumstance or information capable of leading to medication error (Verbatim: Circumstance or information capable of leading to medication error).  The outcome of the inappropriate age at vaccine administration and circumstance or information capable of leading to medication error were unknown.   Additional Information: GSK Receipt Date: 18-AUG-2023 The reporter reported that an 8 years old patient was behind on his Td vaccine schedule. The reporter stated that she may use Boostrix vaccine to catch him, which led to age at vaccine administration and Circumstance or information capable of leading to medication error. The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: her daughter was accidently administered an adult dose of Havrix (1ml) instead of a pediatric dose; her daughter was accidently administered an adult dose of Havrix (1ml) instead of a pediatric dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 12-month-old female patient who received HAV (Havrix 1440 adult) (batch number 3j9g4, expiry date 30-AUG-2025) for prophylaxis.   On 16-AUG-2023, the patient received Havrix 1440 adult 1 ml. On 16-AUG-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced accidental overdose (Verbatim: her daughter was accidently administered an adult dose of Havrix (1ml) instead of a pediatric dose) and adult product administered to child (Verbatim: her daughter was accidently administered an adult dose of Havrix (1ml) instead of a pediatric dose).The outcome of the accidental overdose and adult product administered to child 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: 18-AUG-2023 The reporter who stated that the patient was accidently administered an adult dose of Havrix (1ml) instead of a pediatric dose, which led to accidental overdose and adult product administered to child. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: lyophilized powder of menveo was reconstituted with sterile water and administered to a patient; lyophilized powder of menveo was reconstituted with sterile water and administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 13-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: lyophilized powder of menveo was reconstituted with sterile water and administered to a patient) and inappropriate dose of vaccine administered (Verbatim: lyophilized powder of menveo was reconstituted with sterile water and administered to a patient).The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 18-AUG-2023 The reporter called to report that the lyophilized powder of Menveo was reconstituted with sterile water and administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. More details were asked but reporter declined because event happened at a different facility, so no information was available. The reporter consented to follow up via email.
Age: 1.42
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: Pediarix instead of Dtap; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 17-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number E9Y29, expiry date 26-OCT-2024) for prophylaxis.   On 18-AUG-2023, the patient received Pediarix. On 18-AUG-2023, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: Pediarix instead of Dtap).  The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-AUG-2023 The reporter reported that, they were intending to administered Dtap and inadvertently administered Pediarix instead of Dtap, which led to wrong vaccine administered. The reporter did consent to follow up.
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Dry throat, Insomnia, Malaise, Pain
Clinical narrative: don't feel good; sleeplessness; dry throat; no energy; runny nose; sneezing; she experienced body aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 17-AUG-2023, the patient received the 1st dose of Arexvy. On 18-AUG-2023, 1 days after receiving Arexvy, the patient experienced feeling unwell (Verbatim: don't feel good), sleeplessness (Verbatim: sleeplessness), dry throat (Verbatim: dry throat), loss of energy (Verbatim: no energy), runny nose (Verbatim: runny nose), sneezing (Verbatim: sneezing) and general body pain (Verbatim: she experienced body aches).  The outcome of the feeling unwell, sleeplessness, dry throat, loss of energy, runny nose, sneezing and general body pain were not resolved.   It was unknown if the reporter considered the feeling unwell, sleeplessness, dry throat, loss of energy, runny nose, sneezing and general body pain to be related to Arexvy.     It was unknown if the company considered the feeling unwell, sleeplessness, dry throat, loss of energy, runny nose, sneezing and general body pain to be related to Arexvy.   Additional Information: GSK receipt date: 25-AUG-2023 The patient called to complain of symptoms follow the new flu shot.  After some discussion, the patient was asked if she meant the RSV shot and she said yes.   She stated that she received the vaccine on Thursday.  Beginning about 24 hours later, she experienced body aches, sneezing, runny nose, no energy, dry throat, sleeplessness, and she did not felt good.  The symptoms had not yet dissipated. The patient suggested calling the Clinic and speaking with the nurse. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: don't feel good; sleeplessness; dry throat; no energy; runny nose; sneezing; she experienced body aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 17-AUG-2023, the patient received the 1st dose of Arexvy. On 18-AUG-2023, 1 days after receiving Arexvy, the patient experienced feeling unwell (Verbatim: don't feel good), sleeplessness (Verbatim: sleeplessness), dry throat (Verbatim: dry throat), loss of energy (Verbatim: no energy), runny nose (Verbatim: runny nose), sneezing (Verbatim: sneezing) and general body pain (Verbatim: she experienced body aches).  The outcome of the feeling unwell, sleeplessness, dry throat, loss of energy, runny nose, sneezing and general body pain were not resolved.   It was unknown if the reporter considered the feeling unwell, sleeplessness, dry throat, loss of energy, runny nose, sneezing and general body pain to be related to Arexvy.     It was unknown if the company considered the feeling unwell, sleeplessness, dry throat, loss of energy, runny nose, sneezing and general body pain to be related to Arexvy.   Additional Information: GSK receipt date: 25-AUG-2023 The patient called to complain of symptoms follow the new flu shot.  After some discussion, the patient was asked if she meant the RSV shot and she said yes.   She stated that she received the vaccine on Thursday.  Beginning about 24 hours later, she experienced body aches, sneezing, runny nose, no energy, dry throat, sleeplessness, and she did not felt good.  The symptoms had not yet dissipated. The patient suggested calling the Clinic and speaking with the nurse. The reporter consented to follow up.
Age: 0.75
Sex: M
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted with sterile diluent 0.7ml; reconstituted with sterile diluent 0.7ml; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 9-month-old male patient who received Hib (Hiberix) (batch number 4R924, expiry date 15-MAY-2024) for prophylaxis.   On 18-AUG-2023, the patient received Hiberix. On 18-AUG-2023, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with sterile diluent 0.7ml) and inappropriate dose of vaccine administered (Verbatim: reconstituted with sterile diluent 0.7ml).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date 21 August 2023 The nurse reported that the patient received Hiberix reconstituted with sterile diluent 0.7ml from Merck company which led wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up via email.
Sex: U
Vaccine: TDAP, VARZOS
Symptoms: Arrhythmia, Renal injury
Clinical narrative: renal injury and cardiac arrythmia; renal injury and cardiac arrythmia; This serious case was reported by a physician via call center representative and described the occurrence of renal injury in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Boostrix and Shingrix. On an unknown date, an unknown time after receiving Boostrix and Shingrix, the patient experienced renal injury (Verbatim: renal injury and cardiac arrythmia) (serious criteria GSK medically significant) and cardiac arrhythmia (Verbatim: renal injury and cardiac arrythmia) (serious criteria GSK medically significant).  The outcome of the renal injury and cardiac arrhythmia were unknown.   It was unknown if the reporter considered the renal injury and cardiac arrhythmia to be related to Boostrix and Shingrix.     It was unknown if the company considered the renal injury and cardiac arrhythmia to be related to Boostrix and Shingrix.   Additional Information: GSK Receipt Date: 21-AUG-2023 The physician was trying to find causality between Shingrix and Boostrix for renal injury and cardiac arrhythmia. Physician was not sure what caused the renal injury and cardiac arrhythmia. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix on 2/26/2022 and never came back for the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 26th February 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first dose of Shingrix on 2/26/2022 and never came back for the second dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 21-Aug-2023 The pharmacist called to inquired that the patient should repeat the whole series or could get the second dose. The reporter declined to follow-up from safety. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Boostrix instead of Dtap; Boostrix was administered to a 5-year-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 5-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number DD7F7, expiry date 06-DEC-2025) for prophylaxis.   On 20-AUG-2023, the patient received Boostrix. On 20-AUG-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Boostrix instead of Dtap) and inappropriate age at vaccine administration (Verbatim: Boostrix was administered to a 5-year-old patient).  The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: Receipt Date: 21-AUG-2023 Nurse called to report Boostrix was administered to a 5-year-old patient that was intended to receive Dtap, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter did not consent to follow up.
Sex: M
Vaccine: DTAPIPV
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: Less than recommended dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 25ZH4, expiry date 27-OCT-2024) for prophylaxis.   On 21-AUG-2023, the patient received the 4th dose of Kinrix. On 21-AUG-2023, an unknown time after receiving Kinrix, the patient experienced incomplete dose administered (Verbatim: Less than recommended dose).  The outcome of the incomplete dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 21 August 2023 A healthcare professional reported that a dose of Kinrix was given but as the liquid was being administered, it leaked from the syringe. The provider did not wish to place a product quality complaint. Information about event, vaccine and patient was provided. The vaccine administration Facility was the same as primary reporter. A healthcare professional reported that a dose of Kinrix was given but as the liquid was being administered, it leaked from the syringe which led to incomplete dose administered.  The reporter consented to follow up
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: developed Guillain-Barré syndrome; This serious case was reported by a nurse via sales rep and described the occurrence of guillain barre syndrome 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, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: developed Guillain-Barré syndrome) (serious criteria GSK medically significant).  The outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     It was unknown if the company considered the guillain barre syndrome to be related to Shingrix.   Additional Information: GSK Receipt date: 21-AUG-2023 A nurse practitioner reported that a patient developed Guillain-Barré syndrome after receiving Shingrix.  The patient developed the syndrome after unspecified period after receiving one dose of Shingrix. This case has been linked with the case US2023114891 reported by same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023114891:2nd dose, different patient, same reporter
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Protein total, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: liver transplant (17 years ago. Patient had given birth to a second and it was something to do with the bile ducts of liver, they became exposed. It became known after patient gave birth that had this disease. Within 7 years patient was too toxic in body and had to find a donor. Patient's body rejected the first transplant and had a second transplant), and covid (Patient had COVID in 2019), and other pre-existing medical conditions included: The patient had never been hospitalized. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included sirolimus for liver transplant.  On an unspecified date, the patient experienced suspected covid-19 infection. Laboratory data (dates unspecified) included: Laboratory test not reported, and Protein total high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection. This report was non-serious.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Off label use, Therapeutic response unexpected
Clinical narrative: Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 Patients received bivalent booster with 38 having improvement of symptoms; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Post-acute COVID-19 syndrome.     No Medical History information was reported.    In 2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    No concomitant medication was provided by reporter.  No treatment medication was provided by reporter.  Reporter stated she has been administering the 65 plus bivalent dose to her patients who have symptoms of long-haul COVID and has seen 88-90% success rate in resolving the symptoms of long-haul COVID.  It was reported that, vaccine was given to patients for long COVID between Mar-2023 and 01-Aug-2023. 42 Patients received bivalent booster with 38 having improvement of symptoms and 50s or more. Patient was treated skin lesions, scary brain, body aches. No adverse reactions occurred.  This case contains information about patient 37 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case