chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sensory disturbance, Sleep disorder, Spinal X-ray, Ultrasound Doppler, Vestibular function test
Clinical narrative: From 10/30/21:Leg cramps, had to sleep with feet below chest, muscle aces (touch muscle felt like bruses-primarly waste down), Numbness, Felt like legs were wrapped in celefain plastic wrap, couldn't sleep, Arm cramps and muscle pain, Feet pain, etc  Most of the above are still present but in various degrees of intensity.  Three physicians have told me not to take anymore Covid Shots  Below is a list of events thru Sample of Events - Iam still going through this: Date Dr/Sym Time Misc MRA Lower Extremities, Microclotes Heart - Kidneys D-Dimer Test for Microclotes 9/30/21 Prolia shot 10/1-10/14 Cold Calfs At night C Cramps 10/15/21 Cramps Sleep Recliner feet lower chest 10/29/21 Booster Shot Stoped taking Vit and Perscription 10/31/21 Calt ache feeling like from the knee down wrapped a little numb 11/02/21 Dr. VR Persription didn't take Went over the Moderna issue. Cramps, Calfs Wrapped Concerned about Plat, Clots, Blood Flood,etc. Just got a persc no Concern 11/08/21 County Health TXT Q: Sever Leg Cramp? Told me to see a Dr I Let them decide 11/16/21 Dr. VR other Dr not available. Got angry/irritated that I was there, Very little help had to pust to get leg scan and blood work A lot more than Cramps Dr Call to get appt. Legs, other doctor no help ICD Code doesn't support Test. Got the test after they had said I didn't want the test-WHAT 11/17/21 Ultra Scan Initially problem getting the test-ICD 10 issue Blood Work 11/20/21 Stopped taking Vit Perscriptions 11/22/21 Dr. VR Order a Scan A little piting in caft Order a EMG Referal to Vascular Surgeon 11/29/21 Discuss test order by Dr.-She agreed 11/30/21 Imlaging Order by Dr. - Scan Legs Vascular 12/01/21 Around Angle/leg swelling 12/12/21 Dr Just a follow up 12/15/21 Dr VR Appt Visit, 12/22/21 Dr VR Lower 12/23/21 DR VR Upper 12/29/21 Dr Scans Venus & Articular Talk to Dr After Test about results 01/03/22 Dr Review Results Scans Venus & Articular 01/10/22 Note 1 01/13/22 Blood Pressure Arms and Legs Didn't show problems - PAD 01/17/22 Lab Blod 01/20/22 Dr Go over results Wants to do Xray of Back Concern B12 and Colestrol After Xray referal to Dr. Sent Lab results to Dr 01/24/22 Dr Had an appt for a test and FU With Dr They called and told me they had already done the test-Don't have to come in for that but they want me to come in and see Dr. I did He got mad/irritated that I was there. Said he had to many other Patient's to see. UNBELIEVABLE 01/01/22 Stop Linsinpril, all Vit, etc
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vitamin D, X-ray limb abnormal
Clinical narrative: From 10/30/21:Leg cramps, had to sleep with feet below chest, muscle aces (touch muscle felt like bruses-primarly waste down), Numbness, Felt like legs were wrapped in celefain plastic wrap, couldn't sleep, Arm cramps and muscle pain, Feet pain, etc  Most of the above are still present but in various degrees of intensity.  Three physicians have told me not to take anymore Covid Shots  Below is a list of events thru Sample of Events - Iam still going through this: Date Dr/Sym Time Misc MRA Lower Extremities, Microclotes Heart - Kidneys D-Dimer Test for Microclotes 9/30/21 Prolia shot 10/1-10/14 Cold Calfs At night C Cramps 10/15/21 Cramps Sleep Recliner feet lower chest 10/29/21 Booster Shot Stoped taking Vit and Perscription 10/31/21 Calt ache feeling like from the knee down wrapped a little numb 11/02/21 Dr. VR Persription didn't take Went over the Moderna issue. Cramps, Calfs Wrapped Concerned about Plat, Clots, Blood Flood,etc. Just got a persc no Concern 11/08/21 County Health TXT Q: Sever Leg Cramp? Told me to see a Dr I Let them decide 11/16/21 Dr. VR other Dr not available. Got angry/irritated that I was there, Very little help had to pust to get leg scan and blood work A lot more than Cramps Dr Call to get appt. Legs, other doctor no help ICD Code doesn't support Test. Got the test after they had said I didn't want the test-WHAT 11/17/21 Ultra Scan Initially problem getting the test-ICD 10 issue Blood Work 11/20/21 Stopped taking Vit Perscriptions 11/22/21 Dr. VR Order a Scan A little piting in caft Order a EMG Referal to Vascular Surgeon 11/29/21 Discuss test order by Dr.-She agreed 11/30/21 Imlaging Order by Dr. - Scan Legs Vascular 12/01/21 Around Angle/leg swelling 12/12/21 Dr Just a follow up 12/15/21 Dr VR Appt Visit, 12/22/21 Dr VR Lower 12/23/21 DR VR Upper 12/29/21 Dr Scans Venus & Articular Talk to Dr After Test about results 01/03/22 Dr Review Results Scans Venus & Articular 01/10/22 Note 1 01/13/22 Blood Pressure Arms and Legs Didn't show problems - PAD 01/17/22 Lab Blod 01/20/22 Dr Go over results Wants to do Xray of Back Concern B12 and Colestrol After Xray referal to Dr. Sent Lab results to Dr 01/24/22 Dr Had an appt for a test and FU With Dr They called and told me they had already done the test-Don't have to come in for that but they want me to come in and see Dr. I did He got mad/irritated that I was there. Said he had to many other Patient's to see. UNBELIEVABLE 01/01/22 Stop Linsinpril, all Vit, etc
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site urticaria, Injection site warmth, Urticaria
Clinical narrative: Redness, swelling, warmth, hardness, itchiness and discomfort around the site of injection; Redness, swelling, warmth, hardness, itchiness and discomfort around the site of injection; Redness, swelling, warmth, hardness, itchiness and discomfort around the site of injection; Redness, swelling, warmth, hardness, itchiness and discomfort around the site of injection; Redness, swelling, warmth, hardness, itchiness and discomfort around the site of injection; Quickly spread to a welt 4inches by 3 inches and growing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jun2022 at 15:45 as dose 3 (booster), single (Lot number: FN2908) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "Known allergies: Unknown food allergy" (unspecified if ongoing), notes: Known allergies: Unknown food allergy. Concomitant medication(s) included: ANASTROZOLE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: ER8731, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 15Apr2021, when the patient was 60-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: ER2613, Vaccine Administration Time: 01:45 PM), administration date: 23Mar2021, when the patient was 60-year-old, for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious) with onset 14Jun2022 at 08:00, outcome "recovering", described as "Quickly spread to a welt 4inches by 3 inches and growing"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE DISCOMFORT (non-serious) all with onset 14Jun2022 at 08:00, outcome "recovering" and all described as "Redness, swelling, warmth, hardness, itchiness and discomfort around the site of injection". The events "redness, swelling, warmth, hardness, itchiness and discomfort around the site of injection" and "quickly spread to a welt 4inches by 3 inches and growing" required physician office visit. Therapeutic measures were taken as a result of vaccination site swelling, vaccination site erythema, vaccination site warmth, vaccination site pruritus, vaccination site discomfort, urticaria.  Additional information: Serious: No  Seriousness criteria-Results in death: No Seriousness criteria-Life threatening: No Seriousness criteria-Caused/prolonged hospitalization: No Seriousness criteria-Disabling/Incapacitating: No Seriousness criteria-Congenital anomaly/birth defect: No. If other vaccine in four weeks: No. Other medication in 2 weeks: Centrum Silver Multivitamin for Adults 50 Plus. Ae treatment: Cold compresses, Stronger antihistamines. If COVID prior vaccination: No. If COVID tested post vaccination: No
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Redness, swelling, warmth, hardness, itchiness and discomfort around the site of injection; Redness, swelling, warmth, hardness, itchiness and discomfort around the site of injection; Redness, swelling, warmth, hardness, itchiness and discomfort around the site of injection; Redness, swelling, warmth, hardness, itchiness and discomfort around the site of injection; Redness, swelling, warmth, hardness, itchiness and discomfort around the site of injection; Quickly spread to a welt 4inches by 3 inches and growing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jun2022 at 15:45 as dose 3 (booster), single (Lot number: FN2908) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "Known allergies: Unknown food allergy" (unspecified if ongoing), notes: Known allergies: Unknown food allergy. Concomitant medication(s) included: ANASTROZOLE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: ER8731, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 15Apr2021, when the patient was 60-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: ER2613, Vaccine Administration Time: 01:45 PM), administration date: 23Mar2021, when the patient was 60-year-old, for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious) with onset 14Jun2022 at 08:00, outcome "recovering", described as "Quickly spread to a welt 4inches by 3 inches and growing"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE DISCOMFORT (non-serious) all with onset 14Jun2022 at 08:00, outcome "recovering" and all described as "Redness, swelling, warmth, hardness, itchiness and discomfort around the site of injection". The events "redness, swelling, warmth, hardness, itchiness and discomfort around the site of injection" and "quickly spread to a welt 4inches by 3 inches and growing" required physician office visit. Therapeutic measures were taken as a result of vaccination site swelling, vaccination site erythema, vaccination site warmth, vaccination site pruritus, vaccination site discomfort, urticaria.  Additional information: Serious: No  Seriousness criteria-Results in death: No Seriousness criteria-Life threatening: No Seriousness criteria-Caused/prolonged hospitalization: No Seriousness criteria-Disabling/Incapacitating: No Seriousness criteria-Congenital anomaly/birth defect: No. If other vaccine in four weeks: No. Other medication in 2 weeks: Centrum Silver Multivitamin for Adults 50 Plus. Ae treatment: Cold compresses, Stronger antihistamines. If COVID prior vaccination: No. If COVID tested post vaccination: No
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: right knee replacement surgery pain has worsen after booster dose; This spontaneous case was reported by a patient and describes the occurrence of PROCEDURAL PAIN (right knee replacement surgery pain has worsen after booster dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A, 045C21A, 008B21A and 011A21A) for COVID-19 prophylaxis.     The patient's past medical history included Knee replacement on 26-Jan-2022. Previously administered products included for Product used for unknown indication: Shingles vaccine (took 5 weeks after 3rd dose.). Past adverse reactions to the above products included No adverse event with Shingles vaccine. Concurrent medical conditions included Gluten sensitivity, Lactose intolerance, Allergy to antibiotic (Several Antibiotics), Hodgkin's lymphoma, Blood pressure high (Diagnosed in 2016-2017), Cancer and Immunocompromised. Concomitant products included HYDROCHLOROTHIAZIDE, ACETYLSALICYLIC ACID (ASPIRIN 81), FISH OIL, MULTIVITAMIN [VITAMINS NOS], MAGNESIUM OXIDE, CYANOCOBALAMIN (VITAMIN B-12), PYRIDOXINE HYDROCHLORIDE (VITAMIN B-6), VITAMIN D3, IMMUNOGLOBULIN HUMAN NORMAL (GAMUNEX) and SELENIUM for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PROCEDURAL PAIN (right knee replacement surgery pain has worsen after booster dose). At the time of the report, PROCEDURAL PAIN (right knee replacement surgery pain has worsen after booster dose) outcome was unknown.            It was reported that the patient did not experience any COVID or was tested positive.  The patient received 3rd full dose because of cancer and immunocompromised condition.  No treatment medications was reported.   This case was linked to MOD-2022-590647 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Procedural pain
Clinical narrative: right knee replacement surgery pain has worsen after booster dose; This spontaneous case was reported by a patient and describes the occurrence of PROCEDURAL PAIN (right knee replacement surgery pain has worsen after booster dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A, 045C21A, 008B21A and 011A21A) for COVID-19 prophylaxis.     The patient's past medical history included Knee replacement on 26-Jan-2022. Previously administered products included for Product used for unknown indication: Shingles vaccine (took 5 weeks after 3rd dose.). Past adverse reactions to the above products included No adverse event with Shingles vaccine. Concurrent medical conditions included Gluten sensitivity, Lactose intolerance, Allergy to antibiotic (Several Antibiotics), Hodgkin's lymphoma, Blood pressure high (Diagnosed in 2016-2017), Cancer and Immunocompromised. Concomitant products included HYDROCHLOROTHIAZIDE, ACETYLSALICYLIC ACID (ASPIRIN 81), FISH OIL, MULTIVITAMIN [VITAMINS NOS], MAGNESIUM OXIDE, CYANOCOBALAMIN (VITAMIN B-12), PYRIDOXINE HYDROCHLORIDE (VITAMIN B-6), VITAMIN D3, IMMUNOGLOBULIN HUMAN NORMAL (GAMUNEX) and SELENIUM for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PROCEDURAL PAIN (right knee replacement surgery pain has worsen after booster dose). At the time of the report, PROCEDURAL PAIN (right knee replacement surgery pain has worsen after booster dose) outcome was unknown.            It was reported that the patient did not experience any COVID or was tested positive.  The patient received 3rd full dose because of cancer and immunocompromised condition.  No treatment medications was reported.   This case was linked to MOD-2022-590647 (Patient Link).
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient received her first Covid-19 immunization on 1/26/2022 and her second dose on 2/8/2022, only 13 days after her first dose. She tolerated the injection well without adverse effects. Per CDC recommendations, have notified parent, we will re-administer her second dose, and am completing a VAERS report.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Lot number: 30155ba) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 07Jan2021 as dose 1, single (Lot number: 011j20a), in left arm, on 04Feb2021 as dose 2, single (Lot number: 004m20a), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: 048l21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Emphysema" (unspecified if ongoing). Concomitant medication(s) included: ATACAND; BYSTOLIC; CARDURA; CRESTOR. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral treatment included Brand Pfizer started on 24May2022 for Treatment of COVID-19 and stopped on 29May2022. Other medications in 2weeks product included Atacand 32 mg, Bystolic 10 mg, Cardura 4 mg, Crestor 20 mg.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200850354 Same patient, different product and event;
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: HBP reporting AE for improperly stored administered vaccine. Names of vaccines involved (including lot/exp): ROTATEQ Lot U037809 Exp 03/26/2023 Temperature (28.0F) BELOW 36°F Time frame 96Hours Previous temperature excursion? No Additional AE's; This spontaneous report was received from an office manager (also reported as HBP) and refers to 4-month-old patient of unknown gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 16-MAY-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # U037809 with expiration date 26-MAR-2023 (exact dose was not reported) for prophylaxis. The vaccine underwent a temperature excursion of 28 degrees Fahrenheit (F) for 96 hours on an unknown date before administration (product storage error). There was no previous temperature excursion.  On 31-MAY-2022, inbound call received from a healthcare worker. The caller said she received 6 letters from Merck addressed to the office manager, and the office manager no longer worked at the office. The caller wanted to know why those letters were sent. Adverse event process explained to caller. The caller said she would fill out the forms and send back all available information. No further information provided.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2205USA005621: US-009507513-2205USA005673:
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No additional AEs were reported.; Medical assistant reported that a pregnant patient received a dose of GARDASIL 9 on 05/12/2022.; This spontaneous report was received from a medical assistant and refers to a female, pregnant patient of an unknown age. The patient's concomitant medications included insulin lispro (HUMALOG) and insulin glargine (LANTUS). There was no information about the patient's concurrent conditions, drug allergies or reactions and historical conditions provided.   The last menstrual period (LMP) was estimated on 28-OCT-2021. Estimated date of delivery (EDD) was 04-AUG-2022. The pregnancy outcome was lost to follow-up.   On an unknown date, the patient had urine pregnancy test and glycosylated hemoglobin (A1C) tests performed, however no results were reported.   On 12-MAY-2022, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (dose, route and site of administration, lot number and expiration date were not provided) for prophylaxis (exposure during pregnancy). No other adverse events were reported (no adverse event).
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report has been received from a medical assistant, concerning a 4-years-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 31-MAR-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), subcutaneous injection, first dose, administered subcutaneously, for prophylaxis (strength, dose, , vaccination scheme frequency and anatomical location were not provided; lot number U025790 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported and upon internal validation established as 19-AUG-2023) (product storage error).   The administered dose of the varicella virus vaccine live (oka/merck) (VARIVAX) was stored in a temperature between -14 degrees Celsius (C) up to -10 degrees C for 3 hours (h) 0 minutes (min) and 0 seconds (sec) and between -10 degrees C up to 8 degrees C for 1 h 30 min 0 sec, on 23-MAR-2022 as recorded by a data logger. There was no previous temperature excursion reported. It was stated that the event was attributable to a device or device component malfunction, however, there was no device involved. No adverse events were reported.  No additional adverse events (AE) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA009330: US-009507513-2205USA008004: US-009507513-2205USA007861: US-009507513-2205USA007749: US-009507513-2205USA007739: US-009507513-2205USA003614: US-009507513-2205USA008830: US-009507513-2205USA008800: US-009507513-2205USA008795: US-009507513-2205USA008064: US-009507513-2205USA008189: US-009507513-2205USA008100: US-009507513-2205USA008069: US-009507513-2205USA008066: US-009507513-2205USA007957: US-009507513-2205USA008028: US-009507513-2205USA008008: US-009507513-2205USA008002: US-009507513-2205USA008000: US-009507513-2205USA007871: US-009507513-2205USA007860: US-009507513-2205USA007852: US-009507513-2205USA007809: US-009507513-2205USA007723: US-009507513-2205USA007704: US-009507513-2205USA007703: US-009507513-2205USA007978: US-009507513-2205USA008006: US-009507513-2205USA007982: US-009507513-2205USA008106: US-009507513-2205USA008105: US-009507513-2205USA007748: US-009507513-2205USA007821:
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No additional AE information; she had received an 9-valent HPV vaccine while pregnant; This spontaneous prospective pregnancy report was received from a female consumer of unknown age reporting on herself. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     The patient became pregnant on an unknown date. The LMP and EDD were not known.  On 09-MAY-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date not reported) (exposure during pregnancy). No adverse event was reported.  The pregnancy outcome was unknown.
Age: 0.33
Sex: U
Vaccine: HIBV, UNK
Symptoms: Product preparation issue
Clinical narrative: No adverse event; PEDVAX HIB vaccine was administered when mixed with Merck diluent and administered IM; This spontaneous report has been received from a medical assistant concerning a 4-month-old patient of an unknown gender. The patient's concomitant therapies, drug reactions or allergies, medical history, and concurrent conditions were not provided.   On 31-MAY-2022, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PEDVAXHIB) administrated intramuscularly (IM) (formulation, strength, dose, vaccination scheme, and anatomical site of vaccination were not reported, lot number U034518, which has been verified to be valid, expiration date reported and validated as 28-MAR-2024), as prophylaxis. The sterile diluent (MERCK STERILE DILUENT) (lot number T025911, which has been verified to be valid, expiration date reported and validated as 08-MAR-2023) was used to reconstitute the vaccine (medication dilution) (Product preparation issue). No adverse events details were given.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; one dose of VARIVAX was given following a temperature excursion; This spontaneous report has been received from an office vaccine coordinator, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medication was not provided.  On 31-MAY-2022, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # U039948 with expiration date: 16-DEC-2023, single dose, strength and route were unknown) for prophylaxis (product storage error) and sterile diluent (indication, dose, frequency, strength, route, lot number and expiration date were unknown), both following a temperature excursion. No other adverse event/no product quality complaints (PQC).  Administered dose of varicella virus vaccine live (oka/merck)(VARIVAX) experienced the temperature excursion below 18.7 Fahrenheit degrees (F) for 3 hours 15 minutes 0 seconds. No previous temperature excursions reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse event; Nurse reports patient was administered MMR II through a subcutaneous needle in the deltoid intramuscularly; This spontaneous report was received from a nurse referring to an unknown age and gender patient.  The patient's concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 01-JUN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA subcutaneous injection, lot #T028935, expiration date: 26-AUG-2022, administered for prophylaxis through a subcutaneous needle in the deltoid intramuscularly (Incorrect route of product administration) (strength was not provided). No adverse event occurred.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; First dose of GARDASIL 9 was administered on May 20, 2022. Second dose of GARDASIL 9 was administered three weeks later on Jun 3, 2022; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 20-MAY-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis, lot #U035286 and expiration date reported as 21-OCT-2023 (strength, dose, frequency and route of administration was not provided). On 03-JUN-2022 (also reported as three weeks later) the patient was accidentally vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) also for prophylaxis lot #U035286 and expiration date reported as 21-OCT-2023 (inappropriate schedule of product administration). No additional adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported.; Caller reports vaccine administered after temperature excursion.; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medication was not provided.  On 04-JUN-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # U034712 with expiration date: 30-JUL-2023, 0.5 milliliter, strength unknown) intramuscularly for prophylaxis after temperature excursion (product storage error). No additional adverse events (AEs) or product quality complaints (PQC) reported.  Administered dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) experienced the temperature excursion below 34.2 Fahrenheit degrees (F) for 12 hours. No previous temperature excursions reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details are available; Inbound call from HBP who stated PNEUMOVAX 23 was inadvertently administered after a non-supported temp excursion. No additional AE details or PQC. Names of vaccines involved (including lot/exp) PNEUMOVAX 23 U022819 01/14/2023; This spontaneous report was received from a non health professional and refers to a patient of unknown age and gender. The patient's pertinent medical history, previous drug allergies or reactions, concurrent conditions, and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot number U022819, expiration date reported as 14-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided), after a non-supported temperature excursion (product storage error). No additional adverse event was reported.The temperature excursion reported was of 70 degrees Fahrenheit for 90 hours. No previous temperature excursion.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AEs; VARIVAX administered after temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 28-APR-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) after temperature excursion, lot number U022321 and expiration date of 15-JUL-2023 00:00, at a dose of 0.5 milliliter, subcutaneously for prophylaxis (anatomical location was not reported). The vaccine was exposed to a temperature excursion of 6°F with a time frame of 30 minutes. There was no previous temperature excursion. No additional adverse events were reported. There was not product quality complaint involved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; ROTATEQ was administered after a temperature excursion to a patient; This spontaneous report was received from certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 13-APR-2022, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) after temperature excursion, orally, lot number 1742433 and expiration date of 19-SEP-2022 for prophylaxis (dose was not reported).  The vaccine was exposed to a temperature excursion of 9.47°C with a time frame of 15 minutes. There was no previous temperature excursion. No additional adverse events were reported. There was not product quality complaint involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reported VARIVAX administered after temperature excursion.; This spontaneous report was received from an administrator 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 10-MAY-2022, the patient was vaccinated with an inappropriate stored dose of  varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #U022321, expiration date: 15-JUL-2023, administered subcutaneously for prophylaxis (strength was not provided).   Temperature 6F Time frame 30 Minutes Previous temperature excursion? No  No adverse events were reported.
Age: 57.0
Sex: U
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: I'm 57 years old, received an initial dose of Bexsero; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a 57-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient was 57 years old and received an initial dose of Bexsero asked when he/she get a second dose. Additional supportive information: The Bexsero was received at the age of 57, which led to Inappropriate age at vaccine administration. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Crook in my neck, feels different; Can barely turn it; This case was reported by a consumer via interactive digital media and described the occurrence of stiff neck in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In June 2022, the patient received Shingles vaccine. In June 2022, less than 2 weeks after receiving Shingles vaccine, the patient experienced stiff neck and mobility decreased. The patient was treated with diclofenac sodium (Voltaren Cream), non-drug therapy (Ice Pack (No Medication)) and non-drug therapy (Heat (Non-Drug Therapy)). On an unknown date, the outcome of the stiff neck and mobility decreased were unknown.   It was unknown if the reporter considered the stiff neck and mobility decreased to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of shingles vaccine two weeks ago and he/she noticed that he/she now thought he/she had a crook in his/her neck but it felt different. The patient could barely turn it after putting ice and heat on it and valtarin cream. The patient didn't think about it until last night. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain in jaw
Clinical narrative: headache; jaw pain; fatigue; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   In October 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix, the patient experienced headache, jaw pain and fatigue. On an unknown date, the outcome of the headache, jaw pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the headache, jaw pain and fatigue to be related to Shingrix.     Linked case(s) involving the same patient: US2022094110   Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The reporter was the patient's wife.  The patient received his first Shingrix dose in October 2021 and had a headache, jaw pain and fatigue.  The patient was not available to give consent for follow up. Additional Supportive Information: The patient received his 2nd Shingrix dose on 13th Jun 2022, Refer case US2022094110.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022094109:Same reporter US-GLAXOSMITHKLINE-US2022094110:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got shingles right after shingles vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 15-June-2022 Reporter's comment: This case was reported by a consumer via interactive digital media.  The reporter stated that the patient got shingles right after their shingles vaccine. This case has been linked with the case US2022AMR094585 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR094585:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 15-June-2022 Reporter's comment: This case was reported by a consumer via interactive digital media.  The reporter stated that the patient got shingles right after their shingles vaccine. Additional Supportive Information: This case has been linked with the case US2022AMR094584 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR094584:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This 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.   The patient's past medical history included shingles (the patient had shingles on back when he/she was 15 year old and very unusual but the patient vividly remember the pain. Had not had it since).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, 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.     Linked case(s) involving the same patient:  US2022AMR095003   Additional Information: GSK Receipt Date: 16-June-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient had the shingles shots recently, because he/she never want shingles again. The patient received 2 shots. The first one was fine, just a sore arm for a couple of days. Additional supportive information:  For tolerance of 2nd dose of Shingles vaccine, refer case US2022AMR095003 reported by same reporter. The follow-up would not possible, as no contact, details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR095003:same report, 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Pain
Clinical narrative: feel terrible; body hurts; strong headaches; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling bad, general body pain and headache. On an unknown date, the outcome of the feeling bad, general body pain and headache were unknown.   It was unknown if the reporter considered the feeling bad, general body pain and headache to be related to Shingles vaccine.     Additional Information: GSK receipt date: 17-June-2022 Reporter's comment: The patient self-reported the case via interactive digital media. The patient got the shot and felt terrible.  The patient's body hurt and had strong headaches. The patient asked if it was normal. Additional Supportive Information: Consent to follow up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had both shots and I got shingles/ Suspected vaccination failure; Shingles but a light case; This 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 16-June-2022 Reporter's comment: The patient self-reported the case via interactive digital media. The patient had both shots and got a light case of shingles.  Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles was not provided. Additional Supportive Information: Consent to follow up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: I had a fever; Pain on my arm; Fatigue; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's mom got it and it was horrible).   On 17th June 2022, the patient received the 2nd dose of Shingles vaccine. On 17th June 2022, less than a day after receiving Shingles vaccine, the patient experienced fever, pain in arm and fatigue. On an unknown date, the outcome of the fever, pain in arm and fatigue were unknown.   It was unknown if the reporter considered the fever, pain in arm and fatigue to be related to Shingles vaccine.     Additional Information: GSK receipt date: 17-June-2022 Reporter's comment: The patient self-reported the case via interactive digital media. The patient got the shot and had a fever, pain on arm and fatigue.  The patient stated that he/she would rather have this than shingles. Additional Supportive Information: Consent to follow up was not possible as no contact details were available.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Injection site erythema, Injection site pain, Pyrexia, Wrong product administered
Clinical narrative: Had a fever; The injection site became red; The injection site became painful; Got an extra dose (4th) of Pediarix versus just a TDap.; Got an extra dose (4th) of Pediarix versus just a TDap.; This case was reported by a consumer via call center representative and described the occurrence of fever in a 15-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number B4722, expiry date 17th February 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th June 2022, the patient received the 4th dose of Pediarix (intramuscular) .5 ml and Pediarix Pre-Filled Syringe Device. On 10th June 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced extra dose administered and wrong vaccine administered. On 11th June 2022, the patient experienced fever, injection site erythema and injection site pain. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the injection site erythema was not recovered/not resolved and the outcome of the injection site pain, extra dose administered and wrong vaccine administered were unknown.   It was unknown if the reporter considered the fever, injection site erythema and injection site pain to be related to Pediarix and Pediarix Pre-Filled Syringe Device. 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: 13-Jun-2022 Reporter's Comments: The patient was inadvertently administered a dose of Pediarix in Lt. vastus lateralis instead of Infanrix. The patient had not had any doses of Infanrix and now had four doses of Pediarix. The patient had been seen and was fine according to the reporter. The reporter stated that the day following the vaccine, the patient had a fever and the injection site became red and painful. Fever had resolved, but the patient's leg was still painful and red. The vaccine administration facility was the same as primary reporter.  The reporter consented to follow-up. Additional Supportive Information: The patient was inadvertently administered an extra dose of Pediarix on instead of Infanrix, which led to wrong vaccine administered and extra dose administered.