chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling abnormal, Influenza like illness, Nausea, Pain
Clinical narrative: Extreme head ache, body aches, nauseated,  flu feeling for a couple days. felt like I was hit by a truck. I've had all COVID shots, no effects,  and this shot made me sick as a dog. I don't want another if this is what it makes you feel like. Very scary.
Age: 71.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fever, body ache, tiredness.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU4, HEPA
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itchiness, redness, and swelling on left thigh where Dtap and Hepatitis A were administered
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; administration of expired GARDASIL-9 to multiple patients; This is a non-valid case as no patient's identifiers were provided.   This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       Between 28-JUL-2023 and 15-AUG-2023, the patients were vaccinated with expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1691180 with expiration date 15-NOV-2022, 0.5 ml / once, for prophylaxis (strength, route of administration and anatomical location were not reported). No additional adverse event (AE) was reported. It was stated that they had identified 3 patients that had been administered the expired vaccine but they were still in the process of determining if additional patients may have received the expired vaccine. HCP did not have demographics of patients at the time of call. The nurse also confirmed no symptomatic side effects were reported. HCP stated she could call back with additional information when they have it.  Follow up information was received from a vaccine provider. It was stated that this report refers to a 25-year-old female patient, who was seen for her well woman yearly exam. The patient was previously vaccinated with flu vaccine.   On 01-NOV-2023, the patient was vaccinated with first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) on left deltoid. The expiry date of vaccine was 16-NOV-2022, previously reported as 15-NOV-2022.   It was mentioned, that distributor sent a full box of expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The nurse did not notice with documentation that the vaccines were expired.  This case comes from a case previously considered non-valid, but per new information received (patient identifiers) the case was splitted and determined to be valid for a specific patient. ; Sender's Comments:  US-009507513-2312USA010151: US-009507513-2312USA010152: US-009507513-2312USA010153: US-009507513-2312USA010154:
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Liquid product physical issue, No adverse event, Underdose
Clinical narrative: ng administration of ROTATEQ a black particle was noticed; no additional AE/PQC/confirmed no symptomatic adverse events; calling to report AE/PQC on behalf of HCP.  States HCP reports that during administration of ROTATEQ a black particle was noticed and dosing immediately stopped. No adverse effects reported. Patient did not receive full dose or ingest particle. N; calling to report AE/PQC on behalf of HCP.  States HCP reports that during administration of ROTATEQ a black particle was noticed and dosing immediately stopped. No adverse effects reported. Patient did not receive full dose or ingest particle. N; This spontaneous report was received from a registered nurse and refers to a 10-week-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 30-NOV-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1947634, expiration date: 05-MAY-2024, administered orally for immunisation (strength was not provided). During administration of vaccine, when nurse opened a sealed with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vaccine in a patient room in front of a patient's parents and proceeded to administer the vaccine a black particle was noticed (Liquid product physical issue, Poor quality product administered) and dosing was immediately stopped and ordering physician was notified. Patient finally did not received full dose, he received dose of 1 milliliter (Incorrect dose administered ) and did not ingest particle. Foreign matter was black, looked like the size of gnat with line shape, texture was unable to determine. No adverse effect was reported. Patient was fine, but the his mom was upset
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Genital rash, Herpes simplex test positive, Injection site rash, Rash
Clinical narrative: This sample contains HSV-1 DNA by PCR.; within 7 days from the first dose the patient developed a rash/maculopapular,vesicular/ in abdomen,lesgs, genitals; within 7 days from the first dose the patient developed a rash/maculopapular,vesicular/ in abdomen,lesgs, genitals; cough; congestion; This spontaneous report was received from a laboratory technician and referred to a 1-year-old female patient.  The patient's medical history and concomitant medications was not reported. Her concurrent conditions included pineapple and mango allergy.   On 20-NOV-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for disease prevention (.lot number W018828 has been verified to be a valid lot number, expiration date reported and validated as 14-JUN-2024) (strength, dose, frequency, anatomical location and route of administration were not provided); she also received sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion (strength, dose description, lot #, expiry date, route of administration, and indication were not provided).  On 24-NOV-2023 (within 7 days from the first dose [at day 4 or 5]), the patient developed a rash; described as maculopapular and vesicular (rash maculo-papular, rash vesicular) and was accompanied by systemic symptoms as cough and congestion (ill-defined disorder). The rash started inside the left thigh and the diaper area and then was distributed in the abdomen, legs, and genitals. She presented a number of lesions that included more than 50 and less than 100. On an unknown date in 2023, the maximun temperature showed 98.5 (units not provided). On 01-DEC-2023, a sample from vesicle lesion and scab was obtained. On an unspecified day in December 2023, the result of varicella zoster virus (VZV) was negative; however, the sample contained herpes simplex virus (HSV-1) detected in a polymerase chain reaction (PCR) deoxyribonucleic acid (DNA) (herpes simplex test positive). At the reporting time, the outcome of the events was unknown.   The causal relationship between the suspect vaccine and the sterile diluent and the events was not provided.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash maculo-papular, Rash vesicular, Respiratory tract congestion, Varicella virus test negative
Clinical narrative: This sample contains HSV-1 DNA by PCR.; within 7 days from the first dose the patient developed a rash/maculopapular,vesicular/ in abdomen,lesgs, genitals; within 7 days from the first dose the patient developed a rash/maculopapular,vesicular/ in abdomen,lesgs, genitals; cough; congestion; This spontaneous report was received from a laboratory technician and referred to a 1-year-old female patient.  The patient's medical history and concomitant medications was not reported. Her concurrent conditions included pineapple and mango allergy.   On 20-NOV-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for disease prevention (.lot number W018828 has been verified to be a valid lot number, expiration date reported and validated as 14-JUN-2024) (strength, dose, frequency, anatomical location and route of administration were not provided); she also received sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion (strength, dose description, lot #, expiry date, route of administration, and indication were not provided).  On 24-NOV-2023 (within 7 days from the first dose [at day 4 or 5]), the patient developed a rash; described as maculopapular and vesicular (rash maculo-papular, rash vesicular) and was accompanied by systemic symptoms as cough and congestion (ill-defined disorder). The rash started inside the left thigh and the diaper area and then was distributed in the abdomen, legs, and genitals. She presented a number of lesions that included more than 50 and less than 100. On an unknown date in 2023, the maximun temperature showed 98.5 (units not provided). On 01-DEC-2023, a sample from vesicle lesion and scab was obtained. On an unspecified day in December 2023, the result of varicella zoster virus (VZV) was negative; however, the sample contained herpes simplex virus (HSV-1) detected in a polymerase chain reaction (PCR) deoxyribonucleic acid (DNA) (herpes simplex test positive). At the reporting time, the outcome of the events was unknown.   The causal relationship between the suspect vaccine and the sterile diluent and the events was not provided.
Age: 0.5
Sex: M
Vaccine: HPV9
Symptoms: Chills, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Shivering; my son was given hpv9 (GARDASIL9) vaccine in Pediatric hospital instead of his actual medicine supposed to receive for a 6 month baby boy .; my son was given hpv9 (GARDASIL9) vaccine in Pediatric hospital instead of his actual medicine supposed to receive for a 6 month baby boy .; This spontaneous report was received from a consumer via email and refers to a 6-month-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in 2023, 6-month-old patient the patient was vaccinated in a pediatric hospital with a hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (strength, dose, dose#, lot #, expiry date, route of administration, and anatomical site of vaccination were not provided) for prophylaxis, instead of his an actual medicine (wrong product administered) (product administered to patient of inappropriate age). On an unknown date in 2023, he experienced shivering (reported as: sometimes he noticed that his son shivering). The reporter, would like to get better understanding side effects and any precautions to take, and asked for any history, when this vaccine was given to babies and any results we could review for building confidence regarding child and any check ups needed  At the time of reporting, the outcome of shivering was not provided.  The casual relationship between the suspect vaccine and shivering was unknown (reported as: he was unsure if this was related to the suspect vaccine or not).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Nurse confirmed that the patient involved has not reported and medical concerns or symptoms related to the administration of the expired dose of PROQUAD. No additional AE/PQC reported.; Nurse calling to report adverse event regarding an expired administration of a dose of PROQUAD.  Nurse reporting that a patient was administered a dose of PROQUAD on 12/6/2023 with a labeled expiration of 11/29/2023.; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-DEC-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA) injection, 0.5 ml, (two dose series) (lot number W017573 has been verified to be a valid lot number, expiration date reported and validated as 29-NOV-2023) administered as prophylaxis (expired product administered) (vaccination scheme, anatomical location and route of administration were not provided). The nurse confirmed that the patient had not reported medical concerns or symptoms related to the administration of the expired dose.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no additional AE information; TE VARIVAX, and PROQUAD that occurred on three separate occasions since 11/27/2023. The caller stated that the vaccines had possibly been administered to multiple patients/given VARIVAX on 27-NOV-2023; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-NOV-2023, the patient was vaccinated with improperly stored (product storage error) dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # reported and confirmed as: X006982, expiration date reported and confirmed as: 07-MAR-2025, administered for prophylaxis (exact dose, site and route of administration were not provided). The stability evaluation revealed that excursion was supported and the vaccine had not been exposed to any prior excursions. Current excursion details: 5.6 degree Celsius (-10 degree Celsius to 8 degree Celsius ) for 0 hours 1 minute 0 seconds; 5.9 degree Celsius/ (-10 degree Celsius to 8 degree Celsius) for 0 hours 2 minutes 0 seconds; 7.2 degree Celsius/ (-10 degree Celsius to 8 degree Celsius ) for 0 hours 2 minutes 0 seconds. There was no additional adverse event information reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2312USA003876: US-009507513-2312USA003865: US-009507513-2312USA003862: US-009507513-2312USA003863: US-009507513-2312USA003864: US-009507513-2312USA003866: US-009507513-2312USA003867: US-009507513-2312USA003868: US-009507513-2312USA003869: US-009507513-2312USA003870: US-009507513-2312USA003871: US-009507513-2312USA003875: US-009507513-2312USA003874: US-009507513-2312USA003872: US-009507513-2312USA003873:
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: no additional AE information; TE VARIVAX, and PROQUAD that occurred on three separate occasions since 11/27/2023. The caller stated that the vaccines had possibly been administered to multiple patients/given PROQUAD on 28-NOV-2023; This spontaneous report was received from a medical assistant and refers to a 5-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-NOV-2023, the patient was vaccinated with improperly stored (product storage error) dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) injection, lot # reported and confirmed as: X018584, expiration date reported and confirmed as: 05-JAN-2025, administered for prophylaxis (exact dose, site and route of administration were not provided). The stability evaluation revealed that excursion was supported and the vaccine had not been exposed to any prior excursions. Current excursion details: 5.6 degree Celsius (-10 degree Celsius to 8 degree Celsius ) for 0 hours 1 minute 0 seconds; 5.9 degree Celsius/ (-10 degree Celsius to 8 degree Celsius) for 0 hours 2 minutes 0 seconds; 7.2 degree Celsius/ (-10 degree Celsius to 8 degree Celsius ) for 0 hours 2 minutes 0 seconds. There was no additional adverse event information reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2312USA003860:
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; HCP called to report a patient who received their second dose of PROQUAD on 19DEC2023 at the age of 14 years old. Date of first dose of PROQUAD unknown by reporter. No additional AE/PQC.; This spontaneous report was received from a medical assistant refers to a 14-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 19-DEC-2023, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), formulation: injection, 0.5 milliliter (lot#, expiration date, route of administration and anatomical location were not provided) for prophylaxis.      It was reported that the patient received second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) at the age of 14-years-old (product administered to patient of inappropriate age). No additional adverse event reported (no adverse event).
Sex: U
Vaccine: MMRV, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: HCP calling to report she inadvertently administered a third dose of PROQUAD. HCP reports the vaccination history was unknown, and he was due for all of his other shorts, and she assumed he was due for his second PROQUAD vaccination. However, the fam; No additional AE; This spontaneous report was received from a medical assistant and refers to a 5-year-old patient. No information on patient's medical history, concurrent conditions and concomitant medications was provided.  On an unknown date the patient was vaccinated with first and second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided). On unknown date the patient was vaccinated with third dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: rHA) lot number W028558 and expiration date 06-MAR-2024, 0.5 milliliter (route and site of admnistartion were not provided). Other suspect therapies included sterile diluent (STERILE DILUENT) (extra dose administered and no adverse event).
Age: 31.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; administration of expired GARDASIL-9 to multiple patients; This is a non-valid case as no patient's identifiers were provided.   This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       Between 28-JUL-2023 and 15-AUG-2023, the patients were vaccinated with expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1691180 with expiration date 15-NOV-2022, 0.5 ml / once, for prophylaxis (strength, route of administration and anatomical location were not reported). No additional adverse event (AE) was reported. It was stated that they had identified 3 patients that had been administered the expired vaccine but they were still in the process of determining if additional patients may have received the expired vaccine. HCP did not have demographics of patients at the time of call. The nurse also confirmed no symptomatic side effects were reported. HCP stated she could call back with additional information when they have it.  Follow up information was received from a vaccine provider on 29-NOV-2023. It was stated that this report refers to a 31-year-old female patient, the patient's pre-existing medical conditions included cervical dysplasia and polycystic ovarian syndrome (PCOS). On 08-NOV-2023, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) on left deltoid. It was mentioned, that distributor sent a full box of expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The nurse did not notice with documentation that the vaccines were expired.  This case comes from a case previously considered non-valid, but per new information received (patient identifiers) the case was splitted and determined to be valid for a specific patient. ; Sender's Comments:  US-009507513-2312USA010152: US-009507513-2312USA010153: US-009507513-2312USA010154: US-009507513-2308USA006786:
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; administration of expired GARDASIL-9 to multiple patients; This is a non-valid case as no patient's identifiers were provided.   This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       Between 28-JUL-2023 and 15-AUG-2023, the patients were vaccinated with expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1691180 with expiration date 15-NOV-2022, 0.5 ml / once, for prophylaxis (strength, route of administration and anatomical location were not reported). No additional adverse event (AE) was reported. It was stated that they had identified 3 patients that had been administered the expired vaccine but they were still in the process of determining if additional patients may have received the expired vaccine. HCP did not have demographics of patients at the time of call. The nurse also confirmed no symptomatic side effects were reported. HCP stated she could call back with additional information when they have it.  Follow up information was received from a vaccine provider on 29-NOV-2023. It was stated that this report refers to a 20-year-old female patient, who was seen for her well woman yearly exam. The patient's concurrent conditions included asthma and perianal dermatitis for which she was on albuterol sulfate, Advair and triamcinolone.    On 15-AUG-2023, the patient was vaccinated with first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) on left deltoid. It was mentioned, that distributor sent a full box of expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The nurse did not notice with documentation that the vaccines were expired.  This case comes from a case previously considered non-valid, but per new information received (patient identifiers) the case was splitted and determined to be valid for a specific patient.  ; Sender's Comments:  US-009507513-2312USA010151: US-009507513-2312USA010153: US-009507513-2312USA010154: US-009507513-2308USA006786:
Age: 38.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; administration of expired GARDASIL-9 to multiple patients; This is a non-valid case as no patient's identifiers were provided.   This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       Between 28-JUL-2023 and 15-AUG-2023, the patients were vaccinated with expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1691180 with expiration date 15-NOV-2022, 0.5 ml / once, for prophylaxis (strength, route of administration and anatomical location were not reported). No additional adverse event (AE) was reported. It was stated that they had identified 3 patients that had been administered the expired vaccine but they were still in the process of determining if additional patients may have received the expired vaccine. HCP did not have demographics of patients at the time of call. The nurse also confirmed no symptomatic side effects were reported. HCP stated she could call back with additional information when they have it.  Follow up information was received from a vaccine provider on 29-NOV-2023. It was stated that this report refers to a 38-year-old female patient, with herpes zoster, interstitial cystitis and cystocele.   On 08-NOV-2023, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) on right deltoid. It was mentioned, that distributor sent a full box of expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The nurse did not notice with documentation that the vaccines were expired.  This case comes from a case previously considered non-valid, but per new information received (patient identifiers) the case was splitted and determined to be valid for a specific patient.  ; Sender's Comments:  US-009507513-2312USA010151: US-009507513-2312USA010152: US-009507513-2312USA010154: US-009507513-2308USA006786:
Sex: U
Vaccine: PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP called to report T/E. HCP stated ROTATEQ and VAXNEUVANCE were administered on 12/26/2023. No side effects reported. No other information provided. No additional AE reported. No PQC reported.   Names of vaccines involved (including lot/expiration); This spontaneous report was received from medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 26-DEC-2023, the patient was vaccinated with an improperly stored third doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), formulation: oral liquid, lot# X010217, expiration date: 05-NOV-2024, 2 milliliter (route of administration and anatomical location were not provided); and pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE), formulation: injection, lot# X022028, expiration date: 22-OCT-2025, 0.5 milliliter (route of administration and anatomical location were not provided) for prophylaxis.   Administered doses of vaccines were exposed to the temperature excursion of 48.2 degrees Fahrenheit for 1 hour and 32 minutes (product storage error). No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).
Sex: M
Vaccine: RSV
Symptoms: Decreased appetite, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Nausea; Severe fever/ high fever; Anorexia; Poly myalgias; Headache; This serious case was reported by a physician and described the occurrence of fever in a 68-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On 19-DEC-2023, an unknown time after receiving Arexvy, the patient experienced fever (Verbatim: Severe fever/ high fever) (serious criteria clinically significant/intervention required), anorexia (Verbatim: Anorexia) (serious criteria clinically significant/intervention required), polymyalgia (Verbatim: Poly myalgias) (serious criteria clinically significant/intervention required) and headache (Verbatim: Headache) (serious criteria clinically significant/intervention required). On an unknown date, the patient experienced nausea (Verbatim: Nausea) (serious criteria clinically significant/intervention required). The patient was treated with ibuprofen and amoxicillin trihydrate, clavulanate potassium (Augmentin). On 23-DEC-2023, the outcome of the fever, polymyalgia and headache were resolved (duration 4 days) and the outcome of the anorexia was resolved. The outcome of the nausea was not resolved.   It was unknown if the reporter considered the fever, anorexia, polymyalgia, headache and nausea to be related to Arexvy.     It was unknown if the company considered the fever, anorexia, polymyalgia, headache and nausea to be related to Arexvy.   Additional Information: GSK Receipt Date: 23-Dec-2023 The reporter reported that the patient received Arexvy and experienced severe fever every 4 hours that began from Tuesday and  poli myalgias for which intervention was required The reporter reported seriousness for High fever, anorexia, poly myalgias, nauseas and headache as intervention required. The reporter stated that the patient was in excellent health conditions until receiving Arexvy when all the symptoms and signs began. The reporter consented to follow up.
Sex: M
Vaccine: RVX
Symptoms: Arthralgia
Clinical narrative: Joint pain; This serious case was reported by a consumer and described the occurrence of joint pain in a 71-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included gout (occasional gout). Concomitant products included amlodipine besilate, hydrochlorothiazide, valsartan (Exforge Hct).   On 16-DEC-2023, the patient received RSV vaccine. On 22-DEC-2023, 6 days after receiving RSV vaccine, the patient experienced joint pain (Verbatim: Joint pain) (serious criteria clinically significant/intervention required). The outcome of the joint pain was not resolved.   It was unknown if the reporter considered the joint pain to be related to RSV vaccine.     It was unknown if the company considered the joint pain to be related to RSV vaccine.   Additional Information: RA Receipt Date: 26-DEC-2023 The patient was a caregiver.  The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Dehydration, Heart rate increased
Clinical narrative: AFib; Fast pulse rate; Dehydrate; This serious case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation in a 78-year-old 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 atrial fibrillation (Verbatim: AFib) (serious criteria GSK medically significant), pulse rate increased (Verbatim: Fast pulse rate) and dehydration (Verbatim: Dehydrate). The outcome of the atrial fibrillation, pulse rate increased and dehydration were not reported.   It was unknown if the reporter considered the atrial fibrillation, pulse rate increased and dehydration to be related to Shingrix.     It was unknown if the company considered the atrial fibrillation, pulse rate increased and dehydration to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-Dec-2023 The patient reported that he or she received Shingrix vaccine and experienced unique type of AFIB that only causes a fast pulse rate when he or she dehydrated. The reporter wanted to know can a shingles vaccine possible causes an AFIB condition.
Sex: F
Vaccine: RSV
Symptoms: Chills, Local reaction, Malaise, Myalgia, Skin discolouration
Clinical narrative: very ill with muscle aches; Ill; chills; warm to the touch; Local reaction hitch is  in color, raised and warm to the touch; Local reaction hitch is  in color, raised and warm to the touch; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced muscle pain (Verbatim: very ill with muscle aches), unwell (Verbatim: Ill), chills (Verbatim: chills), skin warm (Verbatim: warm to the touch), skin discoloration (Verbatim: Local reaction hitch is  in color, raised and warm to the touch) and local swelling (Verbatim: Local reaction hitch is  in color, raised and warm to the touch). The outcome of the muscle pain, unwell, chills, skin warm, skin discoloration and local swelling were not reported.   It was unknown if the reporter considered the muscle pain, unwell, chills, skin warm, skin discoloration and local swelling to be related to Arexvy.     It was unknown if the company considered the muscle pain, unwell, chills, skin warm, skin discoloration and local swelling to be related to Arexvy.   Additional Information: RA receipt date:20-DEC-2023 This case was reported by a consumer via (Open field AE monitoring) interactive digital media. The reporter was daughter/son of the patient. The reporter reported that the patient was very ill with muscle aches, chills. Local reaction hitch was in color, raised and warm to the touch. The follow up was not possible, as no contact details were available.
Sex: F
Vaccine: RSV
Symptoms: Skin swelling, Skin warm
Clinical narrative: very ill with muscle aches; Ill; chills; warm to the touch; Local reaction hitch is  in color, raised and warm to the touch; Local reaction hitch is  in color, raised and warm to the touch; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced muscle pain (Verbatim: very ill with muscle aches), unwell (Verbatim: Ill), chills (Verbatim: chills), skin warm (Verbatim: warm to the touch), skin discoloration (Verbatim: Local reaction hitch is  in color, raised and warm to the touch) and local swelling (Verbatim: Local reaction hitch is  in color, raised and warm to the touch). The outcome of the muscle pain, unwell, chills, skin warm, skin discoloration and local swelling were not reported.   It was unknown if the reporter considered the muscle pain, unwell, chills, skin warm, skin discoloration and local swelling to be related to Arexvy.     It was unknown if the company considered the muscle pain, unwell, chills, skin warm, skin discoloration and local swelling to be related to Arexvy.   Additional Information: RA receipt date:20-DEC-2023 This case was reported by a consumer via (Open field AE monitoring) interactive digital media. The reporter was daughter/son of the patient. The reporter reported that the patient was very ill with muscle aches, chills. Local reaction hitch was in color, raised and warm to the touch. The follow up was not possible, as no contact details were available.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administered an expired vaccine; This non-serious case was reported by a other health professional via patient support program and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B adult) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced expired vaccine used (Verbatim: administered an expired vaccine). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 19-DEC-2023 The reporter administered an expired vaccine and wanted to know if there was need to be re administered, which led to expired vaccine used. The reporter consented to follow up. This case had been link with US2023177372, reported by the same reporter.; Sender's Comments:  US-GSK-US2023177372:Same reporter
Sex: F
Vaccine: RVX, UNK
Symptoms: Allergy to vaccine
Clinical narrative: she had an allergic reaction to RSV vaccine a few days ago She also stated she has been using Breo Ellipta; This non-serious case was reported by a consumer via patient support programs and described the occurrence of allergic reaction to drug in a 83-year-old female patient who received fluticasone furoate, vilanterol trifenatate (Breo Ellipta) inhalation powder (batch number Unknown) for asthma.   Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Additional patient notes included Other Conditions: Unknown.   In 2016, the patient started Breo Ellipta. On an unknown date, the patient received RSV vaccine. On 14-DEC-2023, an unknown time after starting Breo Ellipta and an unknown time after receiving RSV vaccine, the patient experienced allergic reaction to drug (Verbatim: she had an allergic reaction to RSV vaccine a few days ago She also stated she has been using Breo Ellipta). Breo Ellipta was continued with no change. The outcome of the allergic reaction to drug was unknown.   It was unknown if the reporter considered the allergic reaction to drug to be related to Breo Ellipta, Breo Ellipta Dry Powder Inhaler Device and RSV vaccine.  It was unknown if the company considered the allergic reaction to drug to be related to Breo Ellipta, Breo Ellipta Dry Powder Inhaler Device and RSV vaccine.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   GSK receipt date:18-DEC-2023 This case received via Patient Assistance Program.Patient states she had an allergic reaction to RSV vaccine a few days ago. She also stated she has been using Breo Ellipta for over 5 years.
Sex: F
Vaccine: RVX
Symptoms: Condition aggravated, Salivary hypersecretion
Clinical narrative: Excess salivation around mouth/Excess salivation; Excess salivation around mouth/Excess salivation; This non-serious case was reported by a consumer and described the occurrence of saliva secretion excessive in a 77-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Concurrent medical conditions included saliva secretion excessive (15-DEC-2023 to Ongoing and this symptom was not treated yet), gastroesophageal reflux disease and tremor limb. Concomitant products included famotidine and propanidid.   On 18-DEC-2023, the patient received RSV vaccine. On 18-DEC-2023, less than a day after receiving RSV vaccine, the patient experienced saliva secretion excessive (Verbatim: Excess salivation around mouth/Excess salivation) and condition aggravated (Verbatim: Excess salivation around mouth/Excess salivation). The outcome of the saliva secretion excessive and condition aggravated were not resolved.   It was unknown if the reporter considered the saliva secretion excessive and condition aggravated to be related to RSV vaccine.     It was unknown if the company considered the saliva secretion excessive and condition aggravated to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 26-DEC-2023 The patient self-reported this case. The patient received the RSV vaccine (unspecified manufacturer) and experienced excess saliva and excess salivation around mouth and these symptoms were not treated yet (till the time of reporting). The reporter consented to the follow-up.
Sex: U
Vaccine: RSV
Symptoms: Malaise
Clinical narrative: sick from shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced sickness (Verbatim: sick from shot). The outcome of the sickness was not reported.   The reporter considered the sickness to be related to Arexvy.     The company considered the sickness to be related to Arexvy.   Additional Information: GSK Receipt Date: 19-DEC-2023 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient was sick from shot of Arexvy. The follow-up could not be possible as no contact details were available.
Age: 66.0
Sex: M
Vaccine: COVID19, FLUX, VARZOS
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: given a 3rd Shingrix shot; received a third Shingrix shot instead of the RSV; This non-serious case was reported by a physician via sales rep and described the occurrence of extra dose administered in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis and Influenza vaccine (Flu) for prophylaxis.   Concomitant products included COVID-19 vaccine.   On 12-NOV-2023, the patient received the 3rd dose of Shingrix, COVID-19 vaccine and Flu. On 12-NOV-2023, an unknown time after receiving Shingrix and Flu, the patient experienced extra dose administered (Verbatim: given a 3rd Shingrix shot) and wrong vaccine administered (Verbatim: received a third Shingrix shot instead of the RSV). The outcome of the extra dose administered and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 15-DEC-2023 Patient went to pharmacy to get his RSV, Flu and Covid shot. Patient come in to see physician on 28th November 2023 and reported to doctor that he had received 3 vaccinations at pharmacy. At that time physician looked up on and it showed patient had received a third Shingrix shot instead of RSV along with a Covid and Flu shot. Nurse called the pharmacy immediately during the visit and pharmacist confirmed that patient had received the Shingrix. The patient thought he had received the RSV shot. Now the records on the data bank had been changed and show that patient received two flu shots one on October 23rd and November 2nd. Patient also received a Covid on 1st November 2023. There was now no documentation of the Shingrix shot and it had been deleted. On 12-NOV-2023, an unknown time after receiving Covid vaccine the patient experienced extra dose administered and wrong vaccine administered. The reporter consented to follow-up. The reporter reported that the patient received 3rd dose of Shingrix instead of RSV vaccine, which led to extra dose administered and wrong vaccine administered.
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Product label confusion, Underdose
Clinical narrative: clinic recently had a pediatric dose of Engerix-B given to an adult; clinic recently had a pediatric dose of Engerix-B given to an adult; request a change to the labeling the Engerix-B vaccine syringes; This non-serious case was reported by a nurse and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: clinic recently had a pediatric dose of Engerix-B given to an adult), adult use of a child product (Verbatim: clinic recently had a pediatric dose of Engerix-B given to an adult) and product label confusion (Verbatim: request a change to the labeling the Engerix-B vaccine syringes). The outcome of the underdose, adult use of a child product and product label confusion were unknown.   Additional Information: GSK Receipt Date: 16-Dec-2023 The reporter reported that he or she just wanted to know to reach out to request a change to the labeling the Engerix-B and Havrix vaccine syringes to specify whether they are adult or pediatric dosing.  The reporter stated that his or her clinic recently had a pediatric dose of Engerix-B given to an adult and this was not the first time we have had a situation like this, which led to product label confusion, underdose and adult use of a child product. The reporter reported that without seeing the box, one would had to know the color coding or dosing size of each vaccine as age range was not specified on the syringes.  The reporter stated that even with the appropriate training and having our vaccines boxes labeled and separated in our refrigerator this had happened more than once. The reporter reported that in our most recent error, the vaccine was even checked by a second member of our medical team and was given the okay. It was easy to make mistakes as we are all only human, but he or she  believed it was our duty to do everything we can to prevent future medical errors such as this. The reporter stated that either having different names for pediatric and adult doses or specifying the age range on the syringe itself would greatly reduce the risk of this happening in the future. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: discovered after administering the shot that the product had an expiration date of 11/24/2023; This non-serious case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (expiry date 24-NOV-2023) for prophylaxis.   On 12-DEC-2023, the patient received the 1st dose of Shingrix. On 12-DEC-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: discovered after administering the shot that the product had an expiration date of 11/24/2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 14-DEC-2023 It was reported that they administered an initial dose of the Shingrix vaccine day before reporting and discovered after administering the shot that the product had an expiration date which led to expired vaccine used. The reporter asked for information on how to proceed.
Sex: F
Vaccine: RSV
Symptoms: Exposure via skin contact, Underdose
Clinical narrative: some of the medicine dripped down my arm; some of the medicine dripped down my arm; some of the medicine dripped down my arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete dose administered in a 73-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: some of the medicine dripped down my arm), exposure via skin contact (Verbatim: some of the medicine dripped down my arm) and inadvertent exposure to vaccine (Verbatim: some of the medicine dripped down my arm). The outcome of the incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine were unknown.   Additional Information: GSK Receipt Date: 21-DEC-2023 The patient reported that he/she  received the RSV Arexvy shot, but some of the medicine dripped down on arm which led to incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine. The reporter stated that was he/she vaccinated against RSV. The patient state that it was given certified immunizer and not a pharmacist who claimed that patient's body had enough of the vaccine and pushed it out.
Sex: F
Vaccine: RSV
Symptoms: Dry throat, Feeling hot, Immediate post-injection reaction, Injection site pain
Clinical narrative: feels hot like a fever; dry throat; patient feels vaccine was not given in muscle -Inappropriate technique; immediately felt pain at injection site.; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 18-DEC-2023, the patient received Arexvy (right arm). On 18-DEC-2023, immediately after receiving Arexvy, the patient experienced injection site pain (Verbatim: immediately felt pain at injection site.) and intramuscular formulation administered by other route (Verbatim: patient feels vaccine was not given in muscle -Inappropriate technique). On 19-DEC-2023, the patient experienced feeling hot (Verbatim: feels hot like a fever) and dry throat (Verbatim: dry throat). The outcome of the injection site pain, feeling hot and dry throat were not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site pain, feeling hot and dry throat to be related to Arexvy.     It was unknown if the company considered the injection site pain, feeling hot and dry throat to be related to Arexvy.   Additional Information: GSK receipt date: 19-DEC-2023 The reporter was consumer. The patient was received Arexvy vaccine in right arm and patient was immediately felt pain at injection site. The patient was said at the time of injection the needle was thicker used.. The reporter stated that injection not given in the muscle which led to inappropriate route of vaccination. The patient was woke up feeling hot like a fever ( did not take temperature) and had a dry throat. The reporter consent to follow up.