chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Patient was administered vaccine that was found to be over diluted on reconstitution.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 6.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 42.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 21.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chronic spontaneous urticaria, Mechanical urticaria
Clinical narrative: Chronic Spontaneous Urticaria 14 days after vaccination that remains unresolved.  Chronic Spontaneous Dermatographia 14 days after vaccination that remains unresolved.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Patient was administered vaccine that was found to be over diluted on reconstitution.
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Memory impairment, Mental impairment, Thinking abnormal
Clinical narrative: multiple times a day there are decreases in my mental capabilities, such as critical thinking, handling stress, common sense, forming sentences, thinking outside of the box, remembering things that were said a few minutes ago, problem solving, and memory
Age: 5.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 21.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. no symptoms reported. revaccination offered.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac ablation, Cardiac monitoring abnormal, Echocardiogram, Electrocardiogram, Heart rate increased
Clinical narrative: 7/19/2022 - first occurance of rapid heart rate while dancing 9/15/2022 - appointment with cardiologist/heart monitor given 10/3/2022 - registered 18 minute episode of nearly 300 bpm SVT narrow complex.  Diagnosis:  Supraventricular Tachycardia 10/11/2022 - surgery - Catheter Ablation
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Supraventricular tachycardia
Clinical narrative: 7/19/2022 - first occurance of rapid heart rate while dancing 9/15/2022 - appointment with cardiologist/heart monitor given 10/3/2022 - registered 18 minute episode of nearly 300 bpm SVT narrow complex.  Diagnosis:  Supraventricular Tachycardia 10/11/2022 - surgery - Catheter Ablation
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event - vaccine given 23 days too early
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events, however patient received 2 flu vaccines within a month of each other
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Dizziness, Headache, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: The CDC rep. who called me about my V-Safe response said a breakthrough Covid infection in a fully vaxxed and boosted person is an adverse event and should be reported. I had to seek medical care several times while sick. During the first three days of mild symptoms - slight runny nose and sneezing - I continued to test negative on home rapid tests. Day 4 I had a splitting headache on one side of my head. I was encouraged by a representative from the CDC's V-Safe program to report my breakthrough case of COVID to VAERS, since I was fully vaccinated and boosted and had just received the Moderna bivalent booster just a little over two months before contracting COVID earlier this month. I believe that the extreme dizziness I reported on this form was related to Lagevrio, the COVID anti-viral I took, so I am also reporting that to the FDA on Form FDA 3500B. Dizziness is a common side effect for Lagevrio, and I believe that the prescribed dosage of four 200 mg. capsules twice a day was too much for me, since I only weigh 86 lbs. I reduced the dosage to three 200 mg. capsules twice a day, and that helped my dizziness.   Please feel free to contact me if you have any questions about my responses. I was unable to type fast enough to keep from getting kicked off the online form, and I couldn't get the calendar links to work correctly on the downloaded form, so I had to print it, fill it out by hand, and then fax it to you. Oops, the FAX # was busy for three days, so I had to resort to mailing it.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sneezing, Vaccine breakthrough infection
Clinical narrative: The CDC rep. who called me about my V-Safe response said a breakthrough Covid infection in a fully vaxxed and boosted person is an adverse event and should be reported. I had to seek medical care several times while sick. During the first three days of mild symptoms - slight runny nose and sneezing - I continued to test negative on home rapid tests. Day 4 I had a splitting headache on one side of my head. I was encouraged by a representative from the CDC's V-Safe program to report my breakthrough case of COVID to VAERS, since I was fully vaccinated and boosted and had just received the Moderna bivalent booster just a little over two months before contracting COVID earlier this month. I believe that the extreme dizziness I reported on this form was related to Lagevrio, the COVID anti-viral I took, so I am also reporting that to the FDA on Form FDA 3500B. Dizziness is a common side effect for Lagevrio, and I believe that the prescribed dosage of four 200 mg. capsules twice a day was too much for me, since I only weigh 86 lbs. I reduced the dosage to three 200 mg. capsules twice a day, and that helped my dizziness.   Please feel free to contact me if you have any questions about my responses. I was unable to type fast enough to keep from getting kicked off the online form, and I couldn't get the calendar links to work correctly on the downloaded form, so I had to print it, fill it out by hand, and then fax it to you. Oops, the FAX # was busy for three days, so I had to resort to mailing it.
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: vaccine given on time/date w/o fridge temp logs
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: vaccine given on time/date w/o fridge temp logs
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Patient presented to the pharmacy after leaving the hospital stating he was experiencing shoulder pain after receiving a shot on 12/18/22. Patient said he ha seen the doctor and went to the hospital.
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccines given on time/date w/o fridge temp logs
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine given on time/date w/o fridge temp logs
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine given on time/date w/o fridge temp logs
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: vaccine given on time/date w/o fridge temp Loss
Age: 8.0
Sex: F
Vaccine: COVID19, COVID19-2, COVID19-2
Symptoms: Arthralgia, Polyarthritis, Pyrexia, Tachycardia, Urticaria
Clinical narrative: Polyarthritis; Acute arthralgia of knee; Urticaria; Fever; Tachycardia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 8-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 at 12:00 as dose 4 (booster), single (Lot number: GK1657) at the age of 8 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: AMITRIPTYLINE HCL. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FL8095, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 11Jun2022, when the patient was 7-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: Fk5618, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 01Dec2021, when the patient was 7-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 10Nov2021, when the patient was 7-year-old, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (hospitalization) with onset 25Dec2022 at 07:00, outcome "recovering", described as "Acute arthralgia of knee"; PYREXIA (hospitalization) with onset 25Dec2022 at 07:00, outcome "recovering", described as "Fever"; POLYARTHRITIS (hospitalization, medically significant) with onset 25Dec2022 at 07:00, outcome "recovering"; TACHYCARDIA (hospitalization) with onset 25Dec2022 at 07:00, outcome "recovering"; URTICARIA (hospitalization) with onset 25Dec2022 at 07:00, outcome "recovering". The patient was hospitalized for polyarthritis, arthralgia, urticaria, pyrexia, tachycardia (start date: Dec2022, hospitalization duration: 4 day(s)). The events "polyarthritis", "acute arthralgia of knee", "urticaria", "fever" and "tachycardia" required emergency room visit. Therapeutic measures were taken as a result of polyarthritis, arthralgia, urticaria, pyrexia, tachycardia.  Clinical course: It was reported that AE treatment was Acetaminophen, Topical Camphor-Menthol, Cetirizine, Diphenhydramine, Ibuprofen. Patient had COVID prior vaccination and was not COVID tested post vaccination. Patient also had no known allergies.
Age: 8.0
Sex: F
Vaccine: COVID19, COVID19-2, COVID19-2
Symptoms: Arthralgia, Polyarthritis, Tachycardia, Urticaria
Clinical narrative: Polyarthritis; Acute arthralgia of knee; Urticaria; Fever; Tachycardia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 8-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 at 12:00 as dose 4 (booster), single (Lot number: GK1657) at the age of 8 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: AMITRIPTYLINE HCL. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FL8095, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 11Jun2022, when the patient was 7-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: Fk5618, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 01Dec2021, when the patient was 7-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 10Nov2021, when the patient was 7-year-old, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (hospitalization) with onset 25Dec2022 at 07:00, outcome "recovering", described as "Acute arthralgia of knee"; PYREXIA (hospitalization) with onset 25Dec2022 at 07:00, outcome "recovering", described as "Fever"; POLYARTHRITIS (hospitalization, medically significant) with onset 25Dec2022 at 07:00, outcome "recovering"; TACHYCARDIA (hospitalization) with onset 25Dec2022 at 07:00, outcome "recovering"; URTICARIA (hospitalization) with onset 25Dec2022 at 07:00, outcome "recovering". The patient was hospitalized for polyarthritis, arthralgia, urticaria, pyrexia, tachycardia (start date: Dec2022, hospitalization duration: 4 day(s)). The events "polyarthritis", "acute arthralgia of knee", "urticaria", "fever" and "tachycardia" required emergency room visit. Therapeutic measures were taken as a result of polyarthritis, arthralgia, urticaria, pyrexia, tachycardia.  Clinical course: It was reported that AE treatment was Acetaminophen, Topical Camphor-Menthol, Cetirizine, Diphenhydramine, Ibuprofen. Patient had COVID prior vaccination and was not COVID tested post vaccination. Patient also had no known allergies.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Feeling abnormal, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; BRAIN FOG; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via another pharmaceutical company (Pfizer) concerned a 51 year old female of an unspecified ethnicity. The patient's weight was 134.26 kilograms, and height was 168 centimeters. The patient's concurrent conditions included: seizures, asthma (had this condition for probably a year or a little longer), COPD (Chronic obstructive pulmonary disease states that patient was not sure how long she has had this condition, but she knows she has not had it as long as she had the asthma), dust allergy, pollen allergy, allergic to cats, and allergic to dogs. The patient takes unspecified allergy shots at the doctor twice a week. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: Unknown) dose was not reported, 1 total, first dose was administered on 27-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 50 years old. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received non-company suspect vaccine elasomeran (Moderna covid-19 vaccine) (Dose number in series 2) (form of admin, route of admin were not reported, batch number: 0770218 and expiry: Unknown) dose was not reported, booster dose was administered on 10-NOV-2021 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 2). Concomitant medications included azelastine for allergies, fluticasone propionate for allergies, meloxicam for arthritis, benralizumab for asthma, salbutamol sulfate for asthma, budesonide/formoterol fumarate for asthma, and COPD, verapamil for blood pressure, esomeprazole magnesium for heartburn, ropinirole hydrochloride for restless legs, and topiramate for seizures. On 06-NOV-2022, the patient developed covid which was suspected covid-19 infection (Dose number in series 2). On 07-NOV-2022, the patient was dispensed with Paxlovid. On an unspecified date in NOV-2022, the patient took non-company suspect drug Paxlovid (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, for treatment of covid. On an unspecified date in NOV-2022 following treatment with non-company suspect drug Paxlovid, the patient had brain fog (Dose number in series 2) and mentioned that she could not concentrate long enough and was difficult to do anything. On 12-DEC-2022, the patient started on aspirin (acetylsalicylic acid). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran (Moderna covid-19 vaccine) was not applicable, and with Paxlovid was not reported. The outcome of the suspected covid-19 infection, brain fog and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Age: 12.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Meningococcal B vaccine given in place of the intended Meningococal ACWY vaccine
Age: 12.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Wrong product administered
Clinical narrative: Meningococcal B vaccine given in place of the intended Meningococal ACWY vaccine
Age: 14.0
Sex: M
Vaccine: MMRV
Symptoms: Product administration error, Product storage error
Clinical narrative: No A/E; Nurse calling to report temperature excursion. She states PROQUAD was administered. No PQC. No additional information.          ?    Names of vaccines involved (including lot/exp) : PROQUAD W023870 1/24/2024        ?    Temperature : see below; prescribing error; Dispensing error; Preparation for administration error; administration error; This spontaneous report was received from a nurse concerning to a 14-year-old male.The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-DEC-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) subcutaneous injection, 0.5 ml, lot #W023870, expiration date: 24-JAN-2024, administered subcutaneously for prophylaxis (strength was not provided). The temperature excursion was reported by the nurse, the followings results were reported: 14°F up to 46°F (33.4 F) 8 hours 45 minutes; 14°F up to 46°F (28.6 F) for 5 hours 11 minutes; 14°F up to 46°F (20.3 F) for 7 hours 46 minutes; 14°F up to 46°F (19.9 F) for 7 hours 56 minutes ; 14°F up to 46°F (15.6 F) for 0 hours 41 minutes ; 6°F up to 14°F (6.8 F) for 0 hours 12 minutes ; 6°F up to 14°F (7.2 F) for 0 hours 13 minutes; 6°F up to 14°F (9.1 F) for 0 hours 19 minutes. There was previous temperature excursion and the temperature excursion was reading from a digital data logger.   Additionally was reported that no treatment was required, and the point in the processes where the medication occurred was in prescribing (prescribing error), storage in clinical practice (Product storage error), dispensing (Dispensing error), preparation for administration (Preparation for administration error) and administration (administration error). The operator of vaccine was a health care professional who had corrected trained. The reporter was previously reported to the doctor. No additional adverse event reported.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Medication error, No adverse event, Product dispensing issue, Product preparation error, Product prescribing issue
Clinical narrative: No A/E; Nurse calling to report temperature excursion. She states PROQUAD was administered/Which point in the process the medication error ocurred: Administration/Storage in clinical practice; Which point in the process the medication error ocurred: Preescribing; Which point in the proecess the medication error ocurred: Dispensing; Which point in the proecess the medication error ocurred: Preparation for administration; This spontaneous report was received from a nurse concerning a 5-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 06-DEC-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, lot# W023870, expiration date: 24-JAN-2024, 0.5 milliliter administered subcutaneously as prophylaxis (strength, lot #, expiry date, and route of administration were not provided), after the vaccine underwent a temperature excursion (Product storage error). According to the reporter, the medication error occurred at the prescribing (Product prescribing issue), storage in clinical practice, dispensing (Product dispensing issue), preparation for administration (Product preparation issue) and administration of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Additionally, the patient was previously vaccinated with another dose on an unspecified date.   It was reported that the vaccine was stored at the following temperatures: 14 Fahrenheit degrees (F) up to 46 F (33.4 F) for 8 hours and 45 minutes; 14 F up to 46 F (28.6 F) for 5 hours 11 minutes; 14 F up to 46 F (20.3 F) for 7 hours 46 minutes; 14 F up to 46 F (19.9 F) for 7 hours 56 minutes; 14 F up to 46 F (15.6 F) for 41 minutes ; 6 F up to 14 F (6.8 F) for 12 minutes; 6 F up to 14 F (7.2 F) for 13 minutes; and 6 F up to 14 F (9.1 F) for 19 minutes. No additional adverse events were reported.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No A/E; Nurse calling to report temperature excursion. She states PROQUAD was administered/Which point in the process the medication error ocurred: Administration/Storage in clinical practice; Which point in the process the medication error ocurred: Preescribing; Which point in the proecess the medication error ocurred: Dispensing; Which point in the proecess the medication error ocurred: Preparation for administration; This spontaneous report was received from a nurse concerning a 5-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 06-DEC-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, lot# W023870, expiration date: 24-JAN-2024, 0.5 milliliter administered subcutaneously as prophylaxis (strength, lot #, expiry date, and route of administration were not provided), after the vaccine underwent a temperature excursion (Product storage error). According to the reporter, the medication error occurred at the prescribing (Product prescribing issue), storage in clinical practice, dispensing (Product dispensing issue), preparation for administration (Product preparation issue) and administration of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Additionally, the patient was previously vaccinated with another dose on an unspecified date.   It was reported that the vaccine was stored at the following temperatures: 14 Fahrenheit degrees (F) up to 46 F (33.4 F) for 8 hours and 45 minutes; 14 F up to 46 F (28.6 F) for 5 hours 11 minutes; 14 F up to 46 F (20.3 F) for 7 hours 46 minutes; 14 F up to 46 F (19.9 F) for 7 hours 56 minutes; 14 F up to 46 F (15.6 F) for 41 minutes ; 6 F up to 14 F (6.8 F) for 12 minutes; 6 F up to 14 F (7.2 F) for 13 minutes; and 6 F up to 14 F (9.1 F) for 19 minutes. No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE details were provided and no additional AE's were reported; a dose of VARIVAX was administered intramuscularly instead of subcutaneously; This spontaneous report was received from a nurse referring to a patient of unknown gender and age. Information of the patient's pertinent medical history, concomitant therapy, concurrent condition and drug reactions/allergies were not reported.  On 19-DEC-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (0.5 milliliter, lot # U016065, expiration date reported in system, so no need to upon internal review and established as 20-MAY-2023, strength and frequency were not reported) intramuscularly instead of subcutaneously for prophylaxis (incorrect route of product administration). No additional AE details were provided and no additional adverse event (AE) were reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported that PROQUAD that experience a temperature excursion was administered.; This spontaneous report has been received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 14-DEC-2022, the patient was vaccinated with an improper stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot # W024972, has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live [rHA] [PROQUAD], expiration date reported and upon internal validation established as 05-FEB-2024) for prophylaxis (dose, anatomical location and route of administration were not reported). The vaccine suffered a temperature excursion (temperature -14 up to -10 Celsius degrees (-11.11C) for 17 hours and 45 minutes) (Product storage error).  No additional adverse event was reported.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs or PQC reported; Patient is 7 months old and this was her 3rd dose.; This spontaneous report has been received from a physician referring a 7-month-old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 03-JAN-2023, the patient was vaccinated with the 3rd dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, at a dose of 0.5 milliliter, lot number W021181 with expiration date 21-FEB-2025, administered intramuscularly for prophylaxis (specific dosage, vaccination scheme and anatomical site of application were not provided) and with diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) at a dose of 0.5 milliliter administered intramuscularly (strength, specific dosage, vaccination scheme, anatomical site of application, lot number and expiration date were not provided) (product administered to patient of inappropriate age). No additional adverse event reported.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: chills; headache; This case was reported by a consumer via sales rep and described the occurrence of chills in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose was received on unknown date, kindly refer this case - US2022AMR197023).   On 27th December 2022 13:00, the patient received the 2nd dose of Shingrix. On 27th December 2022 21:00, 8 hrs after receiving Shingrix, the patient experienced chills and headache. On 28th December 2022 11:00, the outcome of the chills and headache were recovered/resolved.   It was unknown if the reporter considered the chills and headache to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR197023   Additional Information: GSK Receipt Date: 29-DEC-2022 Reporter's comments: Patient friend had reported to that, her husband received his second dose of Shingrix around 1 pm at the time of reporting and post injection, from around 9pm to 9am he had chills and a headache. By 11am on Wednesday 28 December, all the symptoms had resolved.  She did not know if he took any medication to help with symptoms.  Shingrix was the only vaccine he received that day.  She did not know if he had any issues with first dose but thought he mentioned he was achy then. She was not sure when he received first dose. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2022AMR197023:Same patient- 1st dose
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: no antigen, adjuvant-only used; no antigen, adjuvant-only used; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.    Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's Comment: The HCP (health care professional) reports that administering adjuvant only (no antigen) to the patient.  The reporter consent to follow up. Additional Supportive Information: The patient received Shingrix vaccine without antigen which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case was one of 10 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR194824:Same reporter US-GSK-US2022AMR194823:Same reporter US-GSK-US2022193687:Same reporter US-GSK-US2022193689:Same reporter US-GSK-US2022193680:Same reporter US-GSK-US2022193690:Same reporter US-GSK-US2022193688:Same reporter US-GSK-US2022193685:Same reporter US-GSK-US2022193687:Same reporter
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: double dose was given within a week; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Flu Seasonal QIV Quebec (FluLaval Quadrivalent).   On an unknown date, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:28-DEC-2022. Reporter's Comment: Reporter stated that subject received an accidental double dose of flulaval was given within a week. This was a chat, the chat disappeared after picked it up, this will probably be reported again but this is all  they have, couldn't even confirm if the chatter was an HCP.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only liquid portion was used; Only liquid portion was administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-Dec-2022 Reporter's comment: The pharmacist asked about information of the event, date of vaccination, patient details, vaccine batch number or expiration date but information was declined because health care professional comment the event had occur at a different facility and did not had access to the requested information. The reporter did not consent to follow-up. Additional supportive information: The patient only received the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th December 2022, the patient received the 2nd dose of Shingrix. In December 2022, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Additional Information: GSK receipt date: 29-Dec-2022 Reporter's comment: The reporter was the patient. The patient received a dose of Shingrix and reported pain at injection site. The reporter did not consent to follow-up.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given before the 6 month interval.; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 4-year-old male patient who received HAV (Havrix) (batch number 4KJ79, expiry date 30th October 2021) for prophylaxis.   Previously administered products included Havrix (received first dose on 20th August 2019 of batch number PA99T and expiry date 7th June 2021.).   On 11th February 2020, the patient received the 2nd dose of Havrix. On 11th February 2020, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt date: 03-JAN-2023 Reporter's comment: The nurse called to ask for information about patient who received the first dose of Havrix.  The second dose was administered 9 days before 6 month interval. The reporter asked if the second dose was valid or if the patient had to receive an extra dose of Havrix. The reporter consented to follow up. Additional supportive information: The patient received the dose of Havrix earlier than the recommended interval, which led to shortening of vaccination schedule.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Postmenopausal haemorrhage
Clinical narrative: ALREADY BEEN THROUGH MENOPAUSE AND STARTED BLEEDING AGAIN AFTER COVID VACCINE; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via a company representative concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: relapsing remitting multiple sclerosis, menopause, and allergy to regular painkillers. The patient received two doses of covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, first dose administered on MAR-2021, and second dose administered on an unspecified date in 2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The second dose of vaccine was associated with Off label use (off label dosing frequency). Age at time of vaccination 59 years old. Concomitant medications included amlodipine, botulinum toxin type a, hydromorphone hydrochloride, levothyroxine, methenamine hippurate, and propranolol.  On MAR-2021, Patient reported she got a vaccine and it took her out of menopause. She started bleeding constantly since her first covid vaccine shot. Patient reported she had already been through menopause and started bleeding again after her Covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the already been through menopause and started bleeding again after covid vaccine and off label dosing frequency was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20221262360- already been through menopause and started bleeding again after her Covid vaccine. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS IN LEGS; This spontaneous report received from a patient via social media via a company representative concerned a patient of an unspecified age, sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots in legs. Patient reported as, "...same here blood clots in my legs". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots in legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230103610-blood clots in legs. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: LITTLE TIRED; This spontaneous report received from a patient via a company representative via social media concerned a patient of an unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced little tired (dose number in series 1). It was reported that "I've had all the Coved shots and so for no reactions, no Covid. Only a little tired from the first shot. My family has been the same. I'm NOT suggesting anyone take it. I fully support the right to choice in THIS matter. God bless all. Stay safe and be fair". The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer), (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, start therapy date were not reported for covid-19 prophylaxis. No adverse events were reported following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little tired was not reported. This report was non-serious. This case, from the same reporter is linked to 20230107164.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: VERY SICK WITH COVID; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced very sick with covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very sick with covid was not reported. This report was non-serious. This case was associated with a product quality complaint:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: HIP PAIN; This spontaneous report received from a patient via a company representative through social media  concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis.  It was unknown whether the patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1). The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 01 total, administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced hip pain for two years (Dose number in series 2). It was reported that the doctors could not figure it out. The patient had to use walker at one point.  It was reported as "[Name redacted] I have had hip pain for two years. Doctors can't seem to figure it out. Had to use walker at one point. Had vaccine and one booster. I am done with vaccines. Wouldn't have had any but got tired of husband hounding me". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hip pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative through social media, concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: multiple health problems. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total, dose 1 administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient developed covid (before the booster) and ended up in hospital (hospitalized) for 6 days, but had no complications which was suspected covid-19 infection (Dose number in series: 1). It was reported that "My husband & I had the J and J vaccine plus booster and we had no side effects, My husband has multiple health problems and he developed Covid (before the booster) ended up in hospital 6 days but no complications and I had no sign of it in spite of caring for him for 2 days with no precautions We would take another J and J booster if it were available We will not take the other ones". The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total, dose 2 administered for covid-19 prophylaxis. No adverse events were reported following vaccination with booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000265517.; Sender's Comments: V0: 20230104841- suspected covid-19 infection. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 3 previous Moderna monovalent received a Monovalent booster instead of a Bivalent Booster.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (3 previous Moderna monovalent received a Monovalent booster instead of a Bivalent Booster.) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044C224) for COVID-19 prophylaxis.     Patient never diagnosed with COVID-19 and had no known allergies.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1) on 11-Aug-2021, Moderna COVID-19 Vaccine (Dose 2) on 08-Sep-2021, Moderna COVID-19 Vaccine (Dose 3 and Lot: 033K21-2A) on 05-Apr-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Type 2 diabetes mellitus, Chronic kidney disease, Vitamin D deficiency and Hyperlipidemia.    On 27-Dec-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (3 previous Moderna monovalent received a Monovalent booster instead of a Bivalent Booster.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (3 previous Moderna monovalent received a Monovalent booster instead of a Bivalent Booster.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (3 previous Moderna monovalent received a Monovalent booster instead of a Bivalent Booster.).    No concomitant medications were reported.  It was reported that, patient received a monovalent booster dose instead of a Bivalent Booster.  No treatment medications were reported.