chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aortic dilatation, Bicuspid aortic valve, Chest pain, Ejection fraction, Intensive care
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent. A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: had Covid followed by 2 Pfizer vaccines. The patient's concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis". Clinical course: The reporter stated that the patient has had pericarditis for over 3 months now. The reporter wanted to know any recommendations for medical treatment. The patient had Covid followed by 2 Pfizer vaccines. The reporter stated that they think that everyone assumed it would resolve but it has not. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202200448289 same patient/drug, different dose/event.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging abnormal, Magnetic resonance imaging heart, Myocardial oedema, Myocarditis, Troponin increased
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent. A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: had Covid followed by 2 Pfizer vaccines. The patient's concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis". Clinical course: The reporter stated that the patient has had pericarditis for over 3 months now. The reporter wanted to know any recommendations for medical treatment. The patient had Covid followed by 2 Pfizer vaccines. The reporter stated that they think that everyone assumed it would resolve but it has not. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202200448289 same patient/drug, different dose/event.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pericarditis
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent. A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: had Covid followed by 2 Pfizer vaccines. The patient's concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis". Clinical course: The reporter stated that the patient has had pericarditis for over 3 months now. The reporter wanted to know any recommendations for medical treatment. The patient had Covid followed by 2 Pfizer vaccines. The reporter stated that they think that everyone assumed it would resolve but it has not. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202200448289 same patient/drug, different dose/event.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Angina pectoris, Asthenia, Chest discomfort, Chills, Dizziness
Clinical narrative: 40 hours of side effects: Sore left arm, overall woozy feeling, headache, low grade fever for 24 hours between 99 and 100.6, chills, sweating, fatigue, weakness, shortness of breath, difficulty sleeping, (frequent urination overnight - more than 2 dozen trips to the bathroom with a full bladder on the first night), and moderate pressure/mild pain in heart.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Fatigue, Headache, Hyperhidrosis, Insomnia
Clinical narrative: 40 hours of side effects: Sore left arm, overall woozy feeling, headache, low grade fever for 24 hours between 99 and 100.6, chills, sweating, fatigue, weakness, shortness of breath, difficulty sleeping, (frequent urination overnight - more than 2 dozen trips to the bathroom with a full bladder on the first night), and moderate pressure/mild pain in heart.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: 40 hours of side effects: Sore left arm, overall woozy feeling, headache, low grade fever for 24 hours between 99 and 100.6, chills, sweating, fatigue, weakness, shortness of breath, difficulty sleeping, (frequent urination overnight - more than 2 dozen trips to the bathroom with a full bladder on the first night), and moderate pressure/mild pain in heart.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram abnormal, Deafness neurosensory, Deafness unilateral, Sudden hearing loss, Tinnitus
Clinical narrative: Neurosensory Hearing loss of left ear, sudden onset, Tinnitus, left ear
Age: 1.08
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia, Vomiting projectile
Clinical narrative: Child woke up projectile vomiting with fever
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Shivering and chills lasting over 2 hours
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: I noticed a cold sore this afternoon  and wondered whether it might be related to the vaccine. I am not otherwise sick and am very careful to clean my hands and not touch my face.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old patient received a 1st dose of the Moderna vaccine (Lot#041J21A) on 12/17/2021 at the Community Center.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient failed to inform his first booster prior the 4th dose. The clerk tried to doubled check in the system the vaccine records  via online prior administering the vaccine ; she said "patient is clear and okay to give the 1st BOOSTER shot". The RN clarified to her (clerk) again and said "ok to give the booster shot, he does  not have a booster shot yet". After administering the dose the clerk, checked the online records again and told the RN that he has 1st booster shot already and she admitted that she overlooked it. Monitored the patient for 15-30 minutes for any adverse reaction. No adverse reaction presented after observation.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test negative, Urticaria
Clinical narrative: Have had hives spontaneously (different places on body at random times) since 10 days after dose
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test negative, Antibody test abnormal, Antinuclear antibody, Blood immunoglobulin E, Blood test normal
Clinical narrative: Symptoms: diffuse dermatographic urticaria  Treatments: 40 mg PO prednisone x5 days, 62.5 mg IM solumedrol x2 doses, 50 mg PO diphenhydramine in evenings, 10 mg PO certrizine in mornings (later switched to 60 mg fexofenadine daily)
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone normal, C-reactive protein normal, Complement factor normal, Compression fracture, Full blood count normal
Clinical narrative: Symptoms: diffuse dermatographic urticaria  Treatments: 40 mg PO prednisone x5 days, 62.5 mg IM solumedrol x2 doses, 50 mg PO diphenhydramine in evenings, 10 mg PO certrizine in mornings (later switched to 60 mg fexofenadine daily)
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Red blood cell sedimentation rate normal, Tryptase
Clinical narrative: Symptoms: diffuse dermatographic urticaria  Treatments: 40 mg PO prednisone x5 days, 62.5 mg IM solumedrol x2 doses, 50 mg PO diphenhydramine in evenings, 10 mg PO certrizine in mornings (later switched to 60 mg fexofenadine daily)
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Fever: 101-104 Chills Nausea and vomiting Body aches Headache  Sore throat  Symptoms began at 9/10pm peaking at 11pm
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever: 101-104 Chills Nausea and vomiting Body aches Headache  Sore throat  Symptoms began at 9/10pm peaking at 11pm
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnintus. Increase over usual tinnitus, beginning about 28 hours after injection, continuing. No treatment sought.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Oedema peripheral
Clinical narrative: Arm pit is swollen on the side the shot was administered
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Normal
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Normal
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives. Feels itchy in random places on the body for a couple of minutes. Started taking Antihistamines both Allegra and zyrtec.  From March 28th  I stopped Antihistamines as the doctor suggested the hives started coming back again.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Injection site erythema, Injection site hypoaesthesia, Injection site induration
Clinical narrative: Day after had red sore at injection site size of dime. Also experienced what was like withdrawal symptoms like the shacks and freezing. The next morning (2 days after shot) injection site grew to the size of a 50¢ coin. Within 8 hours grew to the size of my palm. I've taken Tylenol for that along with the headaches and the swollen armpit lymph nodes. Its painful, red, hard to the touch, and when others gently touch it I can't feel it. This is the same reaction i had to the influenza, varicella, and second dose of moderna
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Lymphadenopathy, Tremor
Clinical narrative: Day after had red sore at injection site size of dime. Also experienced what was like withdrawal symptoms like the shacks and freezing. The next morning (2 days after shot) injection site grew to the size of a 50¢ coin. Within 8 hours grew to the size of my palm. I've taken Tylenol for that along with the headaches and the swollen armpit lymph nodes. Its painful, red, hard to the touch, and when others gently touch it I can't feel it. This is the same reaction i had to the influenza, varicella, and second dose of moderna
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Withdrawal syndrome
Clinical narrative: Day after had red sore at injection site size of dime. Also experienced what was like withdrawal symptoms like the shacks and freezing. The next morning (2 days after shot) injection site grew to the size of a 50¢ coin. Within 8 hours grew to the size of my palm. I've taken Tylenol for that along with the headaches and the swollen armpit lymph nodes. Its painful, red, hard to the touch, and when others gently touch it I can't feel it. This is the same reaction i had to the influenza, varicella, and second dose of moderna
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration
Clinical narrative: No additional AEs reported.; a patient was administered PROQUAD intramuscularly instead of subcutaneously.; This spontaneous report was received from a nurse referring to a patient with unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 03-MAR-2022, the patient was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (0.5 milliliter, lot #U030591, expiration date: 29-MAR-2023, strength was not provided) for prophylaxis intramuscularly instead of subcutaneously (inappropriate route of vaccination). No additional adverse event reported.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No further AE reported.; Inadvertently administrated a third dose on 02-MAR-2022; previously received doses of GARDASIL 9 on 07AUG2017 and 21AUG2018. inadvertently administered a third dose on; This spontaneous report was received from a nurse referring to a 15-year-old patient with unknown gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 07-AUG-2017, the patient vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, strength, lot #, expiry date, and route of administration were not provided) for prophylaxis. On 21-AUG-2018, the patient vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, strength, lot #, expiry date, and route of administration were not provided) for prophylaxis (Inappropriate schedule of vaccine administered).   On 02-MAR-2022, the patient was inadvertently administered a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml, lot # reported as U036444, expiry date reported as 09-APR-2023, (Lot number U036444 was not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and does not match any company product as confirmed by Lot Verification team), strength and route of administration were not provided) for prophylaxis (Extra dose administered). No additional adverse event reported.
Sex: M
Vaccine: COVID19, MMR, UNK
Symptoms: Allergy to vaccine
Clinical narrative: Because of the allergies he had and he was not able to take certain vaccination growing up; This spontaneous report as received from a patient's mother via Pfizer Inc. (Manufacturer Report Number: 202200365669) refers to a male patient of unknown age.  Concurrent conditions, medical history and concomitant medications were not reported.  Because of the allergies he had, the patient was not able to take certain vaccination growing up: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (lot number, expiration date, dose and route of administration not provided); diphtheria vaccine toxoid, hib vaccine, pertussis vaccine, tetanus vaccine toxoid (HIB DPT) (lot number, expiration date, dose and route of administration not provided) and COVID-19 vaccine (lot number, expiration date, dose and route of administration not provided). The outcome of allergy to vaccine was unknown.   The reporter considered allergy to vaccine to be related to the vaccines.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other AE; 17-year-old patient received a dose of PROQUAD; This spontaneous report was sent by a registered nurse and refers to a 17-year-old patient of an unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 15-MAR-2022, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human Albumin) (PROQUAD), 0.5 ml subcutaneously, once, lot number: U022726, expiration date 16-JAN-2023 (dose number and anatomical location were not reported) for prophylaxis (product administered to patient of inappropriate age).   No other adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Patient was administered improperly stored ROTATEQ; This spontaneous report has been received from a healthcare professional, concerning a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, drug reactions/allergies or concomitant medications was not reported.   On 18-JAN-2022, the patient was administered improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1742429, expiration date: 11-SEP-2022) administered orally for prophylaxis (strength and dose were not provided).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  was exposed to a temperature excursion of 34°F on 10-OCT-2021, with a time frame of 3 hours 36 minutes. Then, on 08-FEB-2022, the vaccine was exposed below 36°F (34.0°F) for 6 hours 4 minutes, on 10-FEB-2022, (34.3°F) for 23 minutes, on 11-FEB-2022, (34.3°F) for 21 minutes, on 17-FEB-2022, (34.3°F) for 22 minutes, on 18-FEB-2022, (34.5°F) for 18 minutes, on 23-FEB-2022, (34.7°F) for 19 minutes, on 24-FEB-2022, (34.3°F) for 5 minutes, on 25-FEB-2022, (34.3°F) for 18 minutes, on 02-MAR-2022, (34.9°F) for 16 minutes, and on 03-MAR-2022, (34.7°F) for 19 minutes.; Sender's Comments:  US-009507513-2203USA005825:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Patient was administered improperly stored ROTATEQ; This spontaneous report was received from a Healthcare Professional, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 01-FEB-2022, the patient was vaccinated with improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1742429, expiration date 11-SEP-2022, dose, and strength were not provided) or prophylaxis (product storage error).    The vaccine administered experienced temperature excursion of 34.0 Degree Fahrenheit for 3 hours and 36 minutes on 10-OCT-2021. Previous temperature excursion was not applicable. After Event Time, affected product experienced additional temperature excursions as follows: Below 36 Degree Fahrenheit with an average of 34.0 Degree Fahrenheit for 6 hours and 4 minutes on 08-FEB-2022. Below 36 Degree Fahrenheit with an average of 34.3 Degree Fahrenheit for 23 minutes on 10-FEB-2022. Below 36 Degree Fahrenheit with an average of 34.3 Degree Fahrenheit for 21 minutes on 11-FEB-2022. Below 36 Degree Fahrenheit with an average of 34.3 Degree Fahrenheit for 22 minutes on 17-FEB-2022. Below 36 Degree Fahrenheit with an average of 34.5 Degree Fahrenheit for 18 minutes on 18-FEB-2022. Below 36 Degree Fahrenheit with an average of 34.7 Degree Fahrenheit for 19 minutes on 23-FEB-2022. Below 36 Degree Fahrenheit with an average of 34.3 Degree Fahrenheit for 5 minutes on 24-FEB-2022. Below 36 Degree Fahrenheit with an average of 34.3 Degree Fahrenheit for 18 minutes on 25-FEB-2022. Below 36 Degree Fahrenheit with an average of 34.9 Degree Fahrenheit for 16 minutes on 02-MAR-2022. Below 36 Degree Fahrenheit with an average of 34.7 Degree Fahrenheit for 19 minutes on 03-MAR-2022. No additional information provided. No additional adverse event reported.  This is one of two cases from same reporter.   ; Sender's Comments:  US-009507513-2203USA005701:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No further adverse events; patient was administered PROQUAD via IM route; This spontaneous report was received from a registered nurse refers to a 5-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medications was not provided.     On 18-MAR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status: rHA (lot # U028181, expiration date was reported as 08-MAR-2023, dose and strength were not provided) intramuscularly for prophylaxis (incorrect route of product administration). No additional information available. No further adverse events/no product quality complaint.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion / the vaccines were administered after the excursion; No additional AE/PQC reported.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. Concomitant medication included a sterile diluent. There was no information about the patient's concurrent conditions or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) at a dose of 0.5 mL ,lot # U017140, expiration date 28-NOV- 2022 (formulation, dose number, site and route of administration were not reported) for prophylaxis (product storage error). Since 02-NOV-2021, the administered dose of vaccine experienced the temperature excursions of 6 degrees Fahrenheit up to 14 degrees Fahrenheit for 4 hours and of 14 degrees Fahrenheit up to 46 degrees Fahrenheit for 4 hours and 45 minutes. No additional information provided (no adverse event). There were no previous temperature excursions.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: no adverse event; ROTATEQ adminstered after temperature excursion; This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 22-MAR-2022, the patient was vaccinated with a 2 mL dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # 1742431 exp date 31-JAN-2023) orally after temperature excursion. The temperature if excursion was 9.2 C for a time frame of 36 minutes. There was no previous temperature excursion.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; patient received an expired dose of PROQUAD; This spontaneous report as received from a registered nurse refers to a 5 year old patient. On 23-MAR-2022, the patient was vaccinated with a 0.5 mL expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T032146 exp date 30-MAR-2022).
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE; vaccine was administered after expiration; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 23-MAR-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, lot #1707572, expiration date: 11-MAR-2022, route of administration defaulted to oral (strength was not provided) for prophylaxis (expired product administered). No adverse events were reported.
Sex: F
Vaccine: HPV9
Symptoms: Injection site bruising, Injection site rash
Clinical narrative: she experienced bruising and a rash at the injection site that spread down her entire arm.; she experienced bruising and a rash at the injection site that spread down her entire arm.; This spontaneous report was received from a company representative referring to a 11 years old female patient. Information about medical history, concurrent condition and concomitant therapy was not provided.  On 21-MAR-2022, after receiving her 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis, the patient experienced bruising and a rash at the injection site that spread down her entire arm. It was also reported that the patient went to the emergency room for "lab testing" but it was unknown if she was admitted to the hospital. The patient received acetaminophen (TYLENOL) as treatment. The outcome of the events was reported as recovering. The causality of the events was not reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; A physician called to report that an expired dose of ROTATEQ was administered. No additional AE reported, no PQC reported. Vaccine did not experience a temperature excursion.; This spontaneous report was received from a physician referring to a 8-week-old patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 29-MAR-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), oral, lot number 1707467, expiration date 22-MAR-2022 (dose not provided) for prophylaxis (expired product administered). No adverse event was reported. The vaccine did not have any previous temperature excursion.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reporting a patient was administered PROQUAD after a temperature excursion.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history and  concurrent conditions were not reported. Concomitant therapies were not reported.  On 06-JAN-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliter, lot #U019287, expiration date: 15-DEC-2022, administered for prophylaxis (strength, and route of administration were not provided) after a temperature excursion of 12.4F Fahrenheit (°F) during a time frame of 0 hours, 20 minutes and 0 seconds. Previous temperature excursion was of 6°F to 14°F (11.6F) for 0 hours, 25 minutes and 0 seconds.  No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE infomation; expired dose of VARIVAX was inadvertently administered to patient.; This spontaneous report was received from a nurse, regarding an identifiable patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-MAR-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 milliliter, route of administration was unknown; lot #T010313, expiration date: 24-MAR-2022). There was no additional adverse event information.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache
Clinical narrative: HEADACHE; Information was received from a Consumer/other non health professional concerning a 58 Year(s) old Female patient, who received Suspect product APIXABAN for pulmonary embolism, Tablet, Oral (from 01-Feb-2022 2 every 1 Day), lot number:1856965; Suspect product COVID-19 VACCINE for product used for unknown indication (from 20-Mar-2022), lot number:Unknown. On 21-Mar-2022, the patient experienced headache(headache) which was considered not serious. It is unknown if treatment was provided. The outcome of the event is unknown. The status of APIXABAN medication is unknown. The status of COVID-19 VACCINE medication is unknown. Concomitant medications were not reported. The reporter did not provide a causal assessment for event headache to product APIXABAN. The reporter considered event headache related to product COVID-19 VACCINE. Tracking of Changes: 21-Mar-2022: Initial information was received. Eliquis is under agreement with Bristol-Myers Squibb. Causality Assessment for drug Eliquis for event headache as per reporter no Information and as per company (BMS related. And Causality Assessment for COVID-19 VACCINE for headache as per reported related and as per company (BMS) not related.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I forgot to get my second dose and it's been over 6 months.; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date, over 6 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-MAR-2022 Reporter's Comments:  This case was reported by a consumer via interactive digital media. The reporter said that he/she forgot to get second dose of Shingrix and it had been over 6 months.  The reporter wanted to know could he/she still get the second shot now and was the effectiveness compromised. Additional Supportive Information:  Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Impaired work ability, Influenza, Loss of personal independence in daily activities, Nausea
Clinical narrative: massive headache; nausea; achy, really achy; flu achy; actually called out of work; This case was reported by a consumer via interactive digital media and described the occurrence of headache 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 headache, nausea, pain, influenza and activities of daily living impaired. On an unknown date, the outcome of the headache, nausea, pain, influenza and activities of daily living impaired were unknown.   It was unknown if the reporter considered the headache, nausea, pain, influenza and activities of daily living impaired to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 27-Mar-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The case was self reported by the patient. The second dose of Shingrix landed him/her on butt.  The patient actually called out of work due to massive headache, nausea, achy, flu achy. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: massive headache; nausea; achy, really achy; flu achy; actually called out of work; This case was reported by a consumer via interactive digital media and described the occurrence of headache 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 headache, nausea, pain, influenza and activities of daily living impaired. On an unknown date, the outcome of the headache, nausea, pain, influenza and activities of daily living impaired were unknown.   It was unknown if the reporter considered the headache, nausea, pain, influenza and activities of daily living impaired to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 27-Mar-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The case was self reported by the patient. The second dose of Shingrix landed him/her on butt.  The patient actually called out of work due to massive headache, nausea, achy, flu achy. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: MEN
Symptoms: Mobility decreased, Pain
Clinical narrative: pretty intense pain; limited ROM; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   In March 2022, the patient received Meningococcal B vaccine. In March 2022, less than a week after receiving Meningococcal B vaccine, the patient experienced pain and mobility decreased. On an unknown date, the outcome of the pain and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the pain and mobility decreased to be related to Meningococcal B vaccine.     Additional Information: GSK Receipt Date: 28-MAR-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient received meningococcal B 1 week prior to the reporting.  The shot was very painful and had pretty intense pain ever since with limited range of motion. The patient asked what to be done now. Additional Supportive Information:  The follow-up would not possible as no contact details were available.
Age: 0.5
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The vaccine was administered to a 6 month old; This case was reported by a other health professional via other manufacturer and described the occurrence of inappropriate age at vaccine administration in a 6-month-old patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 30-MAR-2022 Reporter's Comment: The physician's assistant stated that the Havrix vaccine was administered to a 6 months old patient, which led to inappropriate age at vaccine administration. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: get a third dose of Shingrix; This case was reported by a other health professional via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st and 2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: Additional Information: GSK Receipt Date: 30-Mar-2022 Reporter's Comments: This case was received from a consumer via interactive digital media. The reporter enquired what to do if a patient accidentally gets a third dose of Shingrix. Additional Supportive Information: The patient accidentally got a third dose of Shingrix, which led to extra dose administered. The follow-up would not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th March 2022, the patient received the 2nd dose of Shingrix. On 29th March 2022, 4 days after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-Mar-2022 Reporter's Comments:  The patient was reporter's husband. The patient received Shingrix on last Friday from day of reporting and on Tuesday tested positive for Covid. The patient wanted to know if Covid would affect the efficacy of the Shingrix vaccine. Additional Supportive Information: This case was linked with US2022AMR057938, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR057938:same reporter - reporter´s case
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Oct2019, has not received 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose intramuscularly on the arm (unknown), in October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-Mar-2022 Reporter's Comments: The case was self reported by the patient. The patient had nothing else to report. The reporter consented to follow up with herself and her physician. Additional Supportive Information: The patient had not received the second dose of Shingrix till time of reporting, which led to incomplete course of vaccination.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Epilepsy, Hypotension, Loss of consciousness
Clinical narrative: passing out; epileptic seizure; hypotension; shivering; This case was reported by a nurse via call center representative and described the occurrence of passed out in a 44-year-old female patient who received HBV (Engerix B) (batch number F73DG, expiry date 3rd July 2023) for prophylaxis.   The patient's past medical history included adverse drug reaction.   On 14th March 2022, the patient received Engerix B. In March 2022, less than 3 weeks after receiving Engerix B, the patient experienced passed out (serious criteria GSK medically significant), epileptic seizure (serious criteria GSK medically significant), hypotension and shivering. On an unknown date, the outcome of the passed out, epileptic seizure, hypotension and shivering were unknown.   It was unknown if the reporter considered the passed out, epileptic seizure, hypotension and shivering to be related to Engerix B.     Additional Information: GSK Receipt Date: 28-Mar-2022 Reporter's Comments: The reporter stated that the patient passed out after being vaccinated with Engerix-B. The patient went to the emergency room, passed out again and was told that she had hypotension. The patient when returned to work, she was shivering, and the reporter stated that it seemed like an epileptic seizure. The patient had some reactions earlier after being injected with any medication, but never as severe as this episode. The reporter consented to follow-up. Additional Supportive Information: This case had been linked with US2022055946, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022055946:same reporter
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Pain
Clinical narrative: Pain described as paralyzing and burning; Whole body began to burn.; This case was reported by a consumer via call center representative and described the occurrence of pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2019 09:30, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd November 2019 10:00, 30 min after receiving Shingrix, the patient experienced pain and burning sensation. On an unknown date, the outcome of the pain and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the pain and burning sensation to be related to Shingrix.  Additional Information: GSK Receipt Date: 28-MAR-2022 Reporter's Comment: The case was reported by the patient. The patient received Shingrix in his left arm and went directly home.  At 10:00 am, his whole body began to burn. The burning was present in his neck, shoulder, arms, and fingers and moved down to his thighs and that it did not resolve by the time and he got the 2nd dose which was received on 2nd January 2020.  The pain continued after his second dose and had still not resolved.  He described the pain as paralyzing and that he was currently in a nursing home due to the burning pain.  The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered Kinrix to a 1 year old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old male patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix 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: 29-MAR-2022 Additional Supportive Information: A 1 year old patient was inadvertently administered Kinrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up via phone.
Age: 54.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: administrated with an expired dose of Twinrix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 54-year-old female patient who received HAB (Twinrix) (batch number 57e3g, expiry date 20th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 29th March 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 29-Mar-2022 Reporter's Comment: No adverse event was reported. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional supportive information: The patient was administrated with an expired dose of Twinrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: vaccine was given incorrectly / gave the liquid part of SHINGRIX only; vaccine was given incorrectly / gave the liquid part of SHINGRIX only; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. 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: 29-MAR-2022 Reporter's Comments: Caller was a pharmacist calling to ask for more diluent for the shingrix vaccine that was given incorrectly.  The reporter was asking for another adjuvant of shingrix because the nurse who administered, only gave the adjuvant. She did not reconstitute the adjuvant with antigen. She gave the liquid part of shingrix only. The caller provided some of the information but did not have lot number or expiration. Call was disconnected and due to technical difficulty, reporter was not able to connect with this caller again. The reporter did not consent to follow up. No further information was provided. Additional Supportive Information: The nurse only gave liquid part of shingrix only which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administering Bexsero instead of Menveo; DOB:26-MAR-2022, administering Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 3-day-old male patient who received Men B NVS (Bexsero) (batch number ABXB36AA, expiry date 31st July 2022) 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.   In March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. In March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-Mar-2022 Reporter's Comments: Agency reported potential case of administering Bexsero instead of Menveo. Health care professional (HCP) said that the count of Bexsero and Menveo were off they realized the possible mistake. The reporter consented to follow up. Additional Supportive Information: The patient born on 26th March 2022, received Bexsero instead of Menveo, which led to wrong vaccine administered and inappropriate age at vaccine administration. This is one of four cases, reported by the same reporter. Note: Conservatively considered the DOB provided by the reporter. Clarification was raised.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022056732:same reporter US-GLAXOSMITHKLINE-US2022056734:same reporter US-GLAXOSMITHKLINE-US2022056735:same reporter
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: administering Bexsero instead of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB36AA, expiry date 31st July 2022) 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 Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-Mar-2022 Reporter's Comments: Agency reported potential case of administering Bexsero instead of Menveo. Health care professional (HCP) said that the count of Bexsero and Menveo were off they realized the possible mistake. The reporter consented to follow up. Additional Supportive Information: The patient received Bexsero instead of Menveo, which led to wrong vaccine administered. This is one of four cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022056731:same reporter US-GLAXOSMITHKLINE-US2022056735:same reporter US-GLAXOSMITHKLINE-US2022056734:same reporter