chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: get the shots, got shingles/suspected vaccination failure; Shingles; Hurt; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: get the shots, got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Hurt). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that it was horrible to receive the shingles vaccine. The reporter stated that they had a two doses plan and receive it even if you had shingles.  The patient reported that it does not hurt as bad if you receive the vaccine because he/she know he/she experienced shingles after received vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shingles not nearly as bad as the shot/Suspected Vaccination Failure; Had the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the shingles not nearly as bad as the shot/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had the shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-MAR-2023 The case was received from the patient interactive digital media. The patient had the shingles not nearly as bad as the Shingles shot. The patient had every side affect listed. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: shot really hurt; 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: shot really hurt). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.   It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that the shingles shot really hurt but thanked it was better to get shingles shot than worried about it later.  The reporter hoped and prayed that everything would get better for you and thanked for the comment. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased
Clinical narrative: can´t move arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 09-MAR-2023, the patient received Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced mobility decreased (Verbatim: can´t move arm). The outcome of the mobility decreased was not reported.   It was unknown if the reporter considered the mobility decreased to be related to Shingles vaccine.   It was unknown if the company considered the mobility decreased to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via  interactive digital media. The patient just received his/her shingles shot on Thursday.  The patient could not move his/her arm. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: hurt; 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: hurt). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.   It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The patient got his/her shingles shots. The patient stated that it hurt but what he/she heard nothing in comparison to getting shingles.  The reporter further stated that most insurance covered it or went to health unit but got it . The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Hurts; 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Hurts). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that the Shingles vaccine hurts him/her. The patient stated that he/she still have to receive his/her second dose. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain
Clinical narrative: Awful; Very painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feels awful (Verbatim: Awful) and pain (Verbatim: Very painful). The outcome of the feels awful and pain were not reported.   It was unknown if the reporter considered the feels awful and pain to be related to Shingles vaccine.     It was unknown if the company considered the feels awful and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine and it was awful and very painful. The patient stated that wish he/she had never took that vaccine. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received shingles vaccine but the vaccine was administered slowly and his/her was not that bad  The patient experienced very sore arm for a few days. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: They are painful; 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 (Shingles vaccine) for prophylaxis.   Family history included ophthalmic herpes zoster (patient's mother had the shingles and almost went into her right eye and was miserable), shingles (patient's young nephew got shingles at a very young age) and shingles (patient's mother had the shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: They are painful). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.   It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that he/she did not want the Shingles.  The patient got his/her two shingles vaccines several months ago.  They were painful but well worth having them instead of the consequences of not getting them.  The reporter stated that everyone should get their vaccines and their children instead of being made sick from all the viruses going around.  The reporter further stated that love your children enough to not put them in danger. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: painful; 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: painful). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.   It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that he/she was taking the chance on a shingles vaccine.  It was painful but he/she survived. The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Dry skin, Feeling abnormal, Pruritus, Rash
Clinical narrative: Rash; Itches uncontrollably, itchiness; Arm with huge blisters, pop and it heals; dry skin; has only 5 percent vision; miserable; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash in a 93-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced rash (Verbatim: Rash), pruritus (Verbatim: Itches uncontrollably, itchiness), blister (Verbatim: Arm with huge blisters, pop and it heals), dry skin (Verbatim: dry skin), vision decreased (Verbatim: has only 5 percent vision) and feeling miserable (Verbatim: miserable). The patient was treated with dermatologicals nos (Ointment) and dermatologicals nos (Cream (Nos)). The outcome of the rash, blister, dry skin and feeling miserable were not reported and the outcome of the pruritus and vision decreased were not recovered/not resolved.   It was unknown if the reporter considered the rash, pruritus, blister, dry skin, vision decreased and feeling miserable to be related to Shingles vaccine.     It was unknown if the company considered the rash, pruritus, blister, dry skin, vision decreased and feeling miserable to be related to Shingles vaccine.   Additional Information: GSK receipt date: 12-MAR-2023 The case was received from the patient's son/daughter interactive digital media. The reporter stated that everything he/she read here says it was so painful, the reporter's mother had an undiagnosed rash that itches uncontrollably. The reporter stated that it was the worst on her arm with huge blisters and even itches in her sleep.  The reporter stated that they had been to 8 physician who told her it was dry skin.  The blisters pop and it healed and then come back in stressful times.  The reporter stated that she was miserable.  The patient had used every ointment and cream available and to be careful with prescriptions because she had only 5 percent vision and the medicine could hurt whatever vision was left.  The patient got this after a shingles shot and never got her second one because of this continual itchiness. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: Rash; Itches uncontrollably, itchiness; Arm with huge blisters, pop and it heals; dry skin; has only 5 percent vision; miserable; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash in a 93-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced rash (Verbatim: Rash), pruritus (Verbatim: Itches uncontrollably, itchiness), blister (Verbatim: Arm with huge blisters, pop and it heals), dry skin (Verbatim: dry skin), vision decreased (Verbatim: has only 5 percent vision) and feeling miserable (Verbatim: miserable). The patient was treated with dermatologicals nos (Ointment) and dermatologicals nos (Cream (Nos)). The outcome of the rash, blister, dry skin and feeling miserable were not reported and the outcome of the pruritus and vision decreased were not recovered/not resolved.   It was unknown if the reporter considered the rash, pruritus, blister, dry skin, vision decreased and feeling miserable to be related to Shingles vaccine.     It was unknown if the company considered the rash, pruritus, blister, dry skin, vision decreased and feeling miserable to be related to Shingles vaccine.   Additional Information: GSK receipt date: 12-MAR-2023 The case was received from the patient's son/daughter interactive digital media. The reporter stated that everything he/she read here says it was so painful, the reporter's mother had an undiagnosed rash that itches uncontrollably. The reporter stated that it was the worst on her arm with huge blisters and even itches in her sleep.  The reporter stated that they had been to 8 physician who told her it was dry skin.  The blisters pop and it healed and then come back in stressful times.  The reporter stated that she was miserable.  The patient had used every ointment and cream available and to be careful with prescriptions because she had only 5 percent vision and the medicine could hurt whatever vision was left.  The patient got this after a shingles shot and never got her second one because of this continual itchiness. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 09-APR-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient additionally received non-company suspect vaccine included: Pfizer Biontech (tozinameran) (dose number in series 2) (form of admin, route of admin were not reported, batch number: FF8841 expiry: UNKNOWN) dose was not reported, administered at left arm on 04-DEC-2021 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2). Concomitant medications included Excedrin Migraine (acetylsalicylic acid/caffeine/paracetamol), amlodipine, and losartan for unspecified indication. On an unspecified date in FEB-2023, the patient experienced covid-19 infection (suspected covid-19 infection) (dose number in series 2) for which patient received non-company suspect drug Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin, batch number and expiry date were not reported) dose and frequency were not reported from 22-FEB-2023 to 27-FEB-2023 for covid-19 treatment.  On 07-MAR-2023 the patient experienced covid-19 rebound infection (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient had not recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: giving two IPOL doses with no adverse event; Initial information received on 22-Mar-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 years old female patient who received two poliomyelitis vaccine (inactivated) [IPOL] doses with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Mar-2023, the patient received 0.5 ml (dose 4) of suspect poliomyelitis vaccine (inactivated), suspension for injection (lot U1C571M, expiry date: 02-Feb-2024) (With unknown strength) via intramuscular route in the left gluteus medius for immunization.  On 22-Mar-2023, patient was giving two ipol doses with no adverse event (extra dose administered) (latency: same day) following the administration of poliomyelitis vaccine (Inactivated).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for an event.  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 guidelines. 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: 56.0
Sex: F
Vaccine: UNK
Symptoms: Atrial fibrillation, Nausea, Vomiting
Clinical narrative: AFib, vomiting, nausea
Sex: F
Vaccine: PPV
Symptoms: Erythema, Incorrect route of product administration, Vaccination site erythema
Clinical narrative: dose of PNEUMOVAX 23 was administered intradermally by a medical assistant; red raised area "the size of her pinky"; red line running down her arm, to her; This spontaneous report has been received from a nurse referring to a 66-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 21-MAR-2023, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 ml, (lot #U039721 had been verified to be a valid number; expiration date 10-AUG-2023, and upon internal validation established as the same date) administered intradermally for prophylaxis (strength was not provided) (Incorrect route of product administration).  On an unspecified date in March 2023, the patient experienced a red raised area "the size of her pinky" (vaccination site erythema) and a faint red line running down her arm, to her deltoid (erythema). The outcome of the events was not provided.  The causal relationship between the events of vaccination site erythema and erythema, with the vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE reported; extra dose of GARDASIL-9 administered; This spontaneous report was received from a consumer referring the reporter's granddaughter, a female patient of unknown age. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 22-OCT-2022, the patient was vaccinated with extra dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (product circular number: uspi-v503-i-2108r013, product quantity: 1; strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported) for prophylaxis (extra dose administered). No additional adverse events (AE) were reported (no adverse event).
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 14.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; Patient who was previously administered VAQTA via VAQTA Pediatric/Adolescent Formulation on 09/24/2022; 03/15/2023, beforeCorresponding Patient was administered Corresponding Patient's 2nd VAQTA Dose via Intended VAQTA Adult Formulation; This spontaneous report was received from a medical assistant and refers to an 18-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-SEP-2022, the patient vas vaccinated with first dose of hepatitis a vaccine, inactivated (VAQTA) (via VAQTA pediatric/adolescent formulation) while the patient was 18 and 1/2 years old(product administered to patient of inappropriate age). On 15-MAR-2023, the patient left the reporter's facilitybefore being administered patient's second dose of hepatitis a vaccine, inactivated (VAQTA) via intended VAQTA adult formulation adverse event regarding previous dose was spotted. The patient was never administered second dose of hepatitis a vaccine, inactivated (VAQTA) (via intended VAQTA adult formulation prior to or at the time of the report). Caller was unable to further clarify these statement's at the of the report. No additional adverse event was reported and no further information was provided.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; HBP responsible for vaccine storage calling to report temperature excursion for VARIVAX. Product administered after TE.; This spontaneous report was received from a registered nurse (also reported as HBP) and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 16-MAR-2023, the patient was vaccinated with improper stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1x dose, lot #W031811, expiration date: 05-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) after temperature excursion of -14.5 degree Celsius for 19 minutes and 17.2 degree Celsius for 19 minutes (product storage error). There was no previous temperature excursion.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; temperature excursion for VARIVAX. Product administered after TE; This spontaneous report was received from a healthcare business professional (HBP) and referred to a patient of unknown age or gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reaction/allergies were not reported.   On 16-MAR-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dosage form, lot #W031811, expiration date: 05-OCT-2024, administered for prophylaxis (strength and route of administration were not provided) after the vaccine was involved in a temperature excursion (product storage error).  The storage temperature of the varicella virus vaccine live (oka/merck) (VARIVAX) was 14.5 degrees Celsius for a time frame of 19 minutes and 17.2 degrees Celsius for a time frame of 19 minutes. There was no previous temperature excursion. No additional adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm 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 pain in arm (Verbatim: Arm pain). The outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR039031   Additional Information: GSK Receipt Date: 13-MAR-2023 The reporter was patient. The patient experienced arm pain after the 1st dose of Shingrix. The patient got the Shingrix booster after 2 months on the day of reporting at 10:30 am and did not have any side-effects.  The patient asked if it was normal. The follow-up could not be possible as no contact details were available; Sender's Comments:  US-GSK-US2023AMR039031:Same reporter
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose given to adult; Adult use of a child product; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 40-year-old female patient who received HBV (Engerix B pediatric) (batch number f22ez, expiry date 03-JUN-2023) for prophylaxis.   On 10-MAR-2023, the patient received Engerix B pediatric 10 mcg/mg. On 10-MAR-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Pediatric dose given to adult) and adult use of a child product (Verbatim: Adult use of a child product). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-MAR-2023 The registered reported an adult patient received a pediatric dose of Engerix on the day reporting. The reporter consented to follow up. The adult patient received pediatric dose of Engerix B, which led to underdose and adult use of a child product.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Vx given after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   In SEP-2022, the patients received Boostrix. In SEP-2022, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Vx given after temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 13-MAR-2023 The reporter reported that Boostrix vaccines had been out of temperature range since September 2022 and had been administered to various patients since. The reporter did not consent to follow-up. Information about patients and lot number for vaccine requested and declined, health care professional said it was not available. At the time of reporting, Boostrix was given to various patients after temperature excursion, which led to incorrect storage of drug.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Palpitations
Clinical narrative: Heart racing; Head pounding; This non-serious case was reported by a other health professional via call center representative and described the occurrence of heart racing in a female 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 heart racing (Verbatim: Heart racing) and pounding in head (Verbatim: Head pounding). The outcome of the heart racing and pounding in head were unknown.   It was unknown if the reporter considered the heart racing and pounding in head to be related to Shingrix.     It was unknown if the company considered the heart racing and pounding in head to be related to Shingrix.   Additional Information: GSK Receipt date- 13-MAR-2023 The reporter had a patient who had heart racing and head pounding after the 1st dose of Shingrix and was wondering if she should receive the 2nd vaccine or not. No patient demographics provided. The reporter was consented to fallow up
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 1st dose 9Mar2023, 2nd 16Mar2023; 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 29-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7MH39, expiry date 18-NOV-2023) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On 16-MAR-2023, the patient received the 2nd dose of Boostrix (intramuscular) .5 ml. On 16-MAR-2023, an unknown time after receiving Boostrix, the patient experienced drug dose administration interval too short (Verbatim: 1st dose 9Mar2023, 2nd 16Mar2023). 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: 16-MAR-2023 A site manager reported that a patient received their first dose followed by a second dose only 7 days later, earlier than recommended interval, which led to shortening of vaccination schedule.  Information about the patient and vaccine was given.  The vaccine administration facility was the same as primary reporter. The call was escalated to second line. No additional clarifying statements or adverse event (AE)details were provided and no PQC. The reporter agreed to be contacted via e-mail by a second line agent.
Sex: U
Vaccine: COVID19-2
Symptoms: Breakthrough COVID-19
Clinical narrative: She knows of people who have received the Moderna COVID-19 vaccine and have had breakthrough infections; This spontaneous case was reported by a consumer and describes the occurrence of BREAKTHROUGH COVID-19 (She knows of people who have received the Moderna COVID-19 vaccine and have had breakthrough infections) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received 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 BREAKTHROUGH COVID-19 (She knows of people who have received the Moderna COVID-19 vaccine and have had breakthrough infections). At the time of the report, BREAKTHROUGH COVID-19 (She knows of people who have received the Moderna COVID-19 vaccine and have had breakthrough infections) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were reported. No treatment medicine were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2023: Live significant follow up appended: Additional reporter added
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Throat irritation, Urticaria
Clinical narrative: hives in the throat area; itchiness in the throat area; Initial information received on 22-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 years old male patient who experienced hives and itchiness in the throat area after receiving Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Mar-2023, the patient received an unknown dose (Booster) of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (with an unknown strength, route, administration site, expiry date and lot number) for Immunisation.  On an unknown date, the patient developed an event of hives and itchiness in the throat area (urticaria) (throat irritation) (latency: unknown) following the administration of Meningococcal A-C-Y-W135 (T Conj) Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Unknown for the reported events
Age: 56.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 56.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Illness, Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bronchoscopy abnormal, COVID-19, Chronic sinusitis, Computerised tomogram thorax abnormal, Laboratory test normal
Clinical narrative: Discharge summary "Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) the patient presented from home with multiple weeks of fever. CT imaging showed pneumonia. Despite adequate treatment fever failed to resolve. ID was consulted and later Pulmonology. Bronchoscopy was unremarkable however one sample from bronch later showed + COVID, 3 days prior was negative. It is unclear if she had this prior to hospitalization or acquired during. She received treatment with decadron/remdesivir and defervesced within 24 hours of starting this therapy. Early in stay she was on cefepme/vancomycin and changed to levaquin monotherapy on which she completed 14 days total course.    Again, her fever is unclear if from infection that ran its course or perhaps drug fever from vancomycin. Compliment levels were normal so lupus flare seemed less likely.     Referral sent for chronic sinusitis though this was not felt to be playing a role in her hospital stay."
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pneumonia, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Discharge summary "Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) the patient presented from home with multiple weeks of fever. CT imaging showed pneumonia. Despite adequate treatment fever failed to resolve. ID was consulted and later Pulmonology. Bronchoscopy was unremarkable however one sample from bronch later showed + COVID, 3 days prior was negative. It is unclear if she had this prior to hospitalization or acquired during. She received treatment with decadron/remdesivir and defervesced within 24 hours of starting this therapy. Early in stay she was on cefepme/vancomycin and changed to levaquin monotherapy on which she completed 14 days total course.    Again, her fever is unclear if from infection that ran its course or perhaps drug fever from vancomycin. Compliment levels were normal so lupus flare seemed less likely.     Referral sent for chronic sinusitis though this was not felt to be playing a role in her hospital stay."
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Depressed level of consciousness, Dizziness, Heart rate decreased, Pallor, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting-Mild, Additional Details: Patient became pale and fainted shortly after receiving her vaccine. Vitals were obtained. HR dropped to the 40's briefly. Patient became more awake and had two episodes of vomiting. All symptoms resolved after about 2 minutes.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Vomiting-Mild, Additional Details: Patient became pale and fainted shortly after receiving her vaccine. Vitals were obtained. HR dropped to the 40's briefly. Patient became more awake and had two episodes of vomiting. All symptoms resolved after about 2 minutes.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Hypoaesthesia, Injection site bruising, Injection site joint erythema, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Patient called because she is concerned because her left arm is causing her severe pain (starting the night of the vaccine) and has progressively gotten worse with no improvement. I advised patient to contact her physician for a check up (heat/cool compress, tylenol/advil, etc)
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pruritus, Injection site swelling, Limb injury, Pain in extremity, Paraesthesia
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Patient called because she is concerned because her left arm is causing her severe pain (starting the night of the vaccine) and has progressively gotten worse with no improvement. I advised patient to contact her physician for a check up (heat/cool compress, tylenol/advil, etc)
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Fatigue, Malaise, Pyrexia, Respiratory tract congestion
Clinical narrative: I began getting sick on 10/17/2022 and they lasted a week, I decided to do some home COVID-19 test because I was not in my hometown and tested negative for COVID-19. I got to see my doctor the following week and he tested me and I was still negative for COVID-19 but I was still experiencing chest congestion, low grade fever, exhaustion, coughing.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test negative
Clinical narrative: I began getting sick on 10/17/2022 and they lasted a week, I decided to do some home COVID-19 test because I was not in my hometown and tested negative for COVID-19. I got to see my doctor the following week and he tested me and I was still negative for COVID-19 but I was still experiencing chest congestion, low grade fever, exhaustion, coughing.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Cough, Diarrhoea, Fatigue
Clinical narrative: Monday morning, I was feeling tired and had a really bad head cold. I thought I was getting a sinus cold and congestion because I could feel sinus pressure. I rested all of Monday in bed because of my body chills and slight diarrhea. The next day, I developed a fever and cough. I stayed up all night coughing. I took an at-home COVID-19 on 03/21/2023 which came back positive. So I called my doctor, informed him of my status, and was prescribed Paxlovid. I was told to stop taking Atorvastatin when beginning my prescription and take Mucinex with the prescription. I also used a neti pot to help with my congestion. By day 3 of my prescription, I began feeling better. By day 5 of yesterday, I'm up to 85% full recovery and still making improvements.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mobility decreased, Nasopharyngitis, Paranasal sinus discomfort, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Monday morning, I was feeling tired and had a really bad head cold. I thought I was getting a sinus cold and congestion because I could feel sinus pressure. I rested all of Monday in bed because of my body chills and slight diarrhea. The next day, I developed a fever and cough. I stayed up all night coughing. I took an at-home COVID-19 on 03/21/2023 which came back positive. So I called my doctor, informed him of my status, and was prescribed Paxlovid. I was told to stop taking Atorvastatin when beginning my prescription and take Mucinex with the prescription. I also used a neti pot to help with my congestion. By day 3 of my prescription, I began feeling better. By day 5 of yesterday, I'm up to 85% full recovery and still making improvements.
Age: 37.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Colonoscopy normal, Gastric disorder
Clinical narrative: I did not have an adverse reaction to the vaccine. In 02/2023 I began having stomach issues. I had a visit with my provider and was referred to a gastroenterologist. I had a colonoscopy and results are in normal range.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Behaviour disorder, Blood thyroid stimulating hormone decreased, C-reactive protein increased, COVID-19, COVID-19 pneumonia
Clinical narrative: Patient is a 61 y.o. female patient with history of  of COPD. ILD, RA, Anxiety, DDD of L spine, T2DM, HTN, HLD , Chronic pain syndrome presented to Hospital.   Acute delirium from combination of COVID-19 infection and behavioral health issues Suicidal Ideation Extensive psych history, was recently discharged from BH on 2/9 Currently alert and oriented, denies SI/HI CTH No acute findings.  No hemorrhage or mass. Brain atrophy stable.  No hydrocephalus Blood work non revaling, other than positive for COVID19 UA WNL, UDS benzos and opiates positive, TSH 0.28, B-12 742 Consult BH, appreciate assistance Had an episode of attempting to hang herself in her room 2/15 Per BH, palliative care consult recommended and placed. Appreciate assistance BHU OK with discharge once medically cleared and safe discharge plan arranged Palliative and CM helped determine to discharge with return to hospice at home Sister with some concerns prior to discharge, Psych agreed to call her the morning after discharge to discuss her behavioral issues   Nausea/Vomiting Nausea and vomiting still intermittently present, but improved May be secondary to COVID Tolerating PO and ok with discharge Hospice to help manage potential anti-emetics   Chronic hypoxic respiratory failure COVDI19 pneumonia ILD COPD/Asthma CXR Worsening of the mixed interstitial and alveolar opacities in the perihilar regions and lower lungs from the prior study suggesting superimposed edema or pneumonitis on chronic interstitial changes. On chronic 4 L O2 therapy. IV lasix 40 mg one dose, cont po lasix 40mg qd Mucinex, IS/PEP, Check CRP Monitor on continuous pulse ox .  Hold home p.o. prednisone and switch to IV Decadron given elevated CRP Continue breathing treatments and bronchodilator therapy   HTN HLD Resume coreg and lisinopril Resume statin Monitor and adjust BP medication as able   T2DM with hyperglycemia Poorly controled.  A1c 8.8 Lantus and SSI adjusted  Adjust insulin as able.    Chronic leukocytosis Normocytic anemia Likely from steroid, WBC 14, Hg stable at 10.9 monitor