chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Asthma, Condition aggravated, Treatment noncompliance
Clinical narrative: Mom reports that pt has an asthma exacerbation within 2 hours of receiving his vaccine.  She thinks it was the HPV, but did not mention he had menactra that day as well. He was seen in the office and asthma exacerbation was attributed to poor compliance with allergy medication.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient's left arm became markedly swollen and red at the injection site. Patient noticed this about 24 hours following the vaccinations. Patient went to the urgent care and recived a cortisone shot and 2 prescriptions (Prednisone 50mg and Triamcinolone cream).
Age: 55.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received 3 vaccinations on 8/15/2020 around 2pm. Patient recived Pneumovax in Right arm and Fluarix and Shingrix in the left arm. Patient noticed that her right arm became markedly swollen (about the size of a softball) and red and painful to the touch around the injection sites. Patient took some Benadryl on 8/17/2020 and claims that the swelling and pain has started to subside.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Decreased appetite, Fatigue, Hypersomnia, Nausea
Clinical narrative: Part 1 of the Zoster Vaccine given in May 2019. About 12 hours after receiving vaccine felt weak, fatigued, nauseous. Arm was very sore. Could not eat all day. Slept for full day thereafter. The next day was fine.  Part 2 of the Zoster Vaccine given in August 2019. Again, 12 hours after receiving vaccine overcome by weakness, fatigue, nausea at a level twice of the previous experience, including arm soreness. This time recorded a fever of 101ºF. Also nausea so severe it caused one episode of vomiting. Lasted throughout the day. The next day was fine.  The good news is that in the one year since, I have not had a shingles break through since. With the previous one dose Zostavax vaccination received in October 2017, I continued to have small shingles outbreaks every few months for which I would take Valacyclovir.   Apologies for the delay in reporting.  At my 2020 physical, I told this to my doctor, who said to report it to the CDC.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Part 1 of the Zoster Vaccine given in May 2019. About 12 hours after receiving vaccine felt weak, fatigued, nauseous. Arm was very sore. Could not eat all day. Slept for full day thereafter. The next day was fine.  Part 2 of the Zoster Vaccine given in August 2019. Again, 12 hours after receiving vaccine overcome by weakness, fatigue, nausea at a level twice of the previous experience, including arm soreness. This time recorded a fever of 101ºF. Also nausea so severe it caused one episode of vomiting. Lasted throughout the day. The next day was fine.  The good news is that in the one year since, I have not had a shingles break through since. With the previous one dose Zostavax vaccination received in October 2017, I continued to have small shingles outbreaks every few months for which I would take Valacyclovir.   Apologies for the delay in reporting.  At my 2020 physical, I told this to my doctor, who said to report it to the CDC.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Pain, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Shortly after I got the vaccine, I developed severe local pain and local heat.  Over the ensuing 24 hrs, I developed severe pain, swelling and a red rash from my shoulder down to my elbow.  I was prescribed a medrol and doxycycline; my symptoms began to improve a day later.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous
Clinical narrative: Shortly after I got the vaccine, I developed severe local pain and local heat.  Over the ensuing 24 hrs, I developed severe pain, swelling and a red rash from my shoulder down to my elbow.  I was prescribed a medrol and doxycycline; my symptoms began to improve a day later.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Muscular weakness, Pain, Pyrexia, Swelling
Clinical narrative: significant redness, pain, swelling, pain, fever,  arm weakness, lasting for several days
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall, Loss of consciousness, Syncope
Clinical narrative: Pt had syncopal episode within 5 minutes of receiving vaccine. Lost consciousness and slumped to floor. RPh was able to elevate feet and pt came around promptly, declined offer to call 911 or a friend/relative. Reported lightheadedness, no nausea or other symptoms. RPh provided water and sat with patient until they were able to sit comfortably. Ascertained pt had not eaten anything all day and went to get Gatorade, which seemed to help. Pt was monitored another 20 minutes until they felt well and left.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Fatigue, Headache, Myalgia, Somnolence
Clinical narrative: Headache, muscle pain, dry cough, tiredness, sleepiness
Age: 41.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site infection, Injection site swelling
Clinical narrative: iNJECTION SITE REACTION - REDNESS, SWELLING - REPORTED INFECTION NEAR/AROUND SITE OF INFECTION
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Chills, Pyrexia, Urticaria
Clinical narrative: Patient had fever, hives, chills on Saturday treated with benadryl & Motrin per Mother. Child is better today 8/17/20
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Hypotonia, Pyrexia
Clinical narrative: Patient developed fever and was described as limp by parents and taken to ER same day
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Blood thyroid stimulating hormone, Differential white blood cell count, Full blood count, Irritability, Metabolic function test
Clinical narrative: Had the vaccines. Had cake that evening. He woke up about 1am-very fussy-until bedtime. Uncontrollable fits. Stopped basic things. Day 7 after vaccine "absent episode" & Day 8.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Petit mal epilepsy, Red blood cell sedimentation rate, Seizure, Thyroxine free
Clinical narrative: Had the vaccines. Had cake that evening. He woke up about 1am-very fussy-until bedtime. Uncontrollable fits. Stopped basic things. Day 7 after vaccine "absent episode" & Day 8.
Sex: U
Vaccine: DTAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: immunization given 12/6/2019 seen 2/3/20 c/o recurrent swelling and pain at injection site on LT upper arm since 12/6/2019.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, UNK
Symptoms: Urticaria
Clinical narrative: The patient experienced hives; This spontaneous report was identified from a line listing obtained on request by the Company from the food and drug administration (FDA) (HA No. 6230318) under the Freedom of Information Act. The primary reporter was a healthcare professional referring to a 16-year-old non-pregnant female patient. Her allergies to medications, food or other products included allergy to strawberries and watermelon; and allergy to ragweed. Other illness at the time of vaccination and up to one month prior included: summer cold. Her medical history and concomitant therapies were not provided.  On 14-JUN-2019, the patient was vaccinated with the second dose (vial) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R004689 (expiration date not reported, but upon internal validation established as 29-NOV-2020), intramuscularly in her right deltoid for prophylaxis. On that day, the patient was vaccinated with the second dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) lot #: V6219AB, intramuscularly in her right deltoid; hepatitis A virus vaccine inactivated (HAVRIX) lot #: 9374N, and meningococcal B vaccine (unspecified) lot #: ABX794AB, both administered intramuscularly in her left deltoid.  On 14-JUN-2019 at 18:00, the patient experienced hives. The patient was given hydroxyzine and prednisone as treatment for the event. At the reporting time, the patient had not recovered from the event. No causality assessment was provided.  As of 14-AUG-2020, a telephone attempt trying to obtain additional information was done, however, no further information was available.
Age: 72.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects reported.; an adult patient was inadvertently administered a dose of expired but properly stored VAQTA (lot S018419 & expiration date 7/12/2020).; This spontaneous report was received from a pharmacist referring to a 72 years old patient. The patient's pertinent medical history, concomitant medication and concurrent condition were not provided.     On 13-AUG-2020, the patient was vaccinated with a dose of expired but properly stored hepatitis a vaccine, inactivated (VAQTA) (strength 50/1.0 U/ml, lot# S018419, expiration date 12-JUL-2020; dose detail and route were not provided) for prophylaxis (expired product administered). No additional adverse effects were reported.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Influenza, Myalgia
Clinical narrative: chills, fever of 101  very sore L arm  stomach upset fatigue and general muscle pain  above reactions occurred 6 hours after vaccine I did take 400 mg Ibuprofen at 12 hours after vaccine to decrease fever and aches Next morning fever and chills were gone but milder flu symptoms of aches and fatigue remained and stomach upset I would estimate that reactions lasted 2 days and by day 3 I felt much better except for the sore arm. The sore arm lasted 3 to 4 days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: chills, fever of 101  very sore L arm  stomach upset fatigue and general muscle pain  above reactions occurred 6 hours after vaccine I did take 400 mg Ibuprofen at 12 hours after vaccine to decrease fever and aches Next morning fever and chills were gone but milder flu symptoms of aches and fatigue remained and stomach upset I would estimate that reactions lasted 2 days and by day 3 I felt much better except for the sore arm. The sore arm lasted 3 to 4 days.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Chills, Cough, Dyspnoea, Heart rate increased
Clinical narrative: Within an hour to a couple hours after receiving flu vaccine: - At injection site, experienced red swelling at least 3 inches in diameter, which became hot, hard, and itchy,     and was extremely sore to the touch.    This lasted for at least 10 days. - A little later in the day,  developed  fever at least 101 F.     Also began  sweating, but also experiencing chills and shivering at the same time. - Experienced fast heart beat, could feel palpitations in chest, which came with the fever. - Developed slight cough. - Felt weak and achy all over.  Within 2 weeks after receiving the flu shot: - Breathing difficulty, with audible wheezing at the base of the right lung.    Difficult breathing also trying to walk up stairs or to talk. - Coughing worsened. -  Felt pounding in chest (heartbeat).
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Hyperhidrosis, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Within an hour to a couple hours after receiving flu vaccine: - At injection site, experienced red swelling at least 3 inches in diameter, which became hot, hard, and itchy,     and was extremely sore to the touch.    This lasted for at least 10 days. - A little later in the day,  developed  fever at least 101 F.     Also began  sweating, but also experiencing chills and shivering at the same time. - Experienced fast heart beat, could feel palpitations in chest, which came with the fever. - Developed slight cough. - Felt weak and achy all over.  Within 2 weeks after receiving the flu shot: - Breathing difficulty, with audible wheezing at the base of the right lung.    Difficult breathing also trying to walk up stairs or to talk. - Coughing worsened. -  Felt pounding in chest (heartbeat).
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Injection site swelling, Injection site warmth, Pain, Palpitations, Pyrexia
Clinical narrative: Within an hour to a couple hours after receiving flu vaccine: - At injection site, experienced red swelling at least 3 inches in diameter, which became hot, hard, and itchy,     and was extremely sore to the touch.    This lasted for at least 10 days. - A little later in the day,  developed  fever at least 101 F.     Also began  sweating, but also experiencing chills and shivering at the same time. - Experienced fast heart beat, could feel palpitations in chest, which came with the fever. - Developed slight cough. - Felt weak and achy all over.  Within 2 weeks after receiving the flu shot: - Breathing difficulty, with audible wheezing at the base of the right lung.    Difficult breathing also trying to walk up stairs or to talk. - Coughing worsened. -  Felt pounding in chest (heartbeat).
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Wheezing
Clinical narrative: Within an hour to a couple hours after receiving flu vaccine: - At injection site, experienced red swelling at least 3 inches in diameter, which became hot, hard, and itchy,     and was extremely sore to the touch.    This lasted for at least 10 days. - A little later in the day,  developed  fever at least 101 F.     Also began  sweating, but also experiencing chills and shivering at the same time. - Experienced fast heart beat, could feel palpitations in chest, which came with the fever. - Developed slight cough. - Felt weak and achy all over.  Within 2 weeks after receiving the flu shot: - Breathing difficulty, with audible wheezing at the base of the right lung.    Difficult breathing also trying to walk up stairs or to talk. - Coughing worsened. -  Felt pounding in chest (heartbeat).
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; multiple unspecified patients were administered improperly stored M-M-R II. The M-M-R II was reconstituted with properly stored STERILE DILUENT; This non-valid spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On unknown dates since February 2020, the patients were vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) albumin status rHA, lot # S015428, expiration date 20-MAY-2021 (dose and route of administration were not provided) for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine was reconstitued with properly stored sterile diluent (lot # T001631, expiration date 11-JUN-2022).  It was reported that the doses of the product administered to the patients were not stored properly for the time frame of 1 hour in the temperature of 10.75 degrees Celsius (reported as above 9 degrees Celsius, 10.75 C) on an unknown date. There was no previous temperature excursion. Digital Data Logger was involved. No adverse effects were reported.  This is a non-valid report since it concerns unspecified patients.  As of 13-AUG-2020, all telephone attempts trying to obtain additional information has been unsuccessful.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: improperly stored temperature excursion; This spontaneous report has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 07-AUG-2020, the patient was vaccinated with vaccines which had improperly stored temperature excursion for prophylaxis. The vaccines included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #: S020160, expiration date: 30-JUN-2021, 1 dose; route and dose details were unknown) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot #: S038175, expiration date: 26-NOV-2021, 1 dose; route and dose details were unknown) (product storage error).   The vaccines were stored at the temperature between -6 degrees Fahrenheit to 14 degrees Fahrenheit (10 degrees Fahrenheit) for 1 hour and 15 minutes; 15 degrees Fahrenheit to 46 degrees Fahrenheit (44.8 degrees Fahrenheit) for 1 hour and 30 minutes; 47 degrees Fahrenheit to 77 degrees Fahrenheit (50 degrees Fahrenheit) for 2 hours and 30 minutes. There were no previous temperature excursions. The digital data logger was involved.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Pain in extremity
Clinical narrative: arm pain; This spontaneous report was received from an employee, referring to a 12 years old male patient (employee's son). The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.     On an unspecified date in 2020, the patient received his second dose of unidentified Merck hpv vaccine (name and lot number not provided) (strength, route and expiration date were not reported) injection for prophylaxis.    On an unspecified date in 2020, the patient experienced arm pain. There was no redness or inflammation and no swelling. The patient did not seek medical attention. On 05-AUG-2020 (also reported as 06-AUG-2020) (reported as today) the patient had no longer any arm pain. The causalty assessment was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: The nurse reported that the patient received a dose of MMR II that was reconstituted with expired diluent; The nurse reported that the patient received a dose of MMR II that was reconstituted with expired diluent; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 12-AUG-2020, the patient was vaccinated with a dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) injection (lot number S018595 which has been verified to be valid, expiration date reported and validated as 17-JUN-2021) (dosage, vaccination scheme, frequency, route of administration and anatomical site of injection were not reported), as prophylaxis. The vaccine was reconstituted with expired sterile diluent (DILUENT MRK) (lot number N029293 which has been verified to be valid, expiration date reported and validated as 25-APR-2020) (expired product administered and product preparation error).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation, referring a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medication was no provided. On an unknown date in 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (route, lot number, expiration date, strength and anatomical site of vaccination were unknown) for prophylaxis. On an unknown date, the patient experienced herpes zoster (shingles), patient received an unspecified treatment and was hospitalized on an unknown date. As a direct and proximate result of use of the vaccine, patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; other losses and damages; would continue to suffer such losses, and damages in the future. The outcome of herpes zoster was unknown. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; MMR II and VARIVAX were stored improperly and administered; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 11-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, at a dose of 0.5 milliliter (ml) (lot number S022753, expiration date: 22-JUL-2021) and varicella virus vaccine live (oka/merck) (VARIVAX) injection, at a dose of 0.5 ml (lot number S033539, which has been verified to be valid, expiration date reported and validated as 22-OCT-2021), both therapies administered as prophylaxis (strengths, vaccination schemes, anatomical sites of injection and routes of administration were not reported) (product storage error). No additional adverse event (AE).  On an unknown date, the vaccines experienced a temperature excursion of 27.44 degrees Fahrenheit (F) for 5 hours and 30 minutes, as recorded by a data logger. There was no previous temperature excursion.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no additional adverse event; temperature excursion for GARDASIL 9 that was administered; This spontaneous report was received from a registered nurse referring to a 18 year old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.    On 06-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # S020254 expiration date 09-DEC-2021, 0.5 milliliter for prophylaxis.  The vaccine was out range for accumulative time frame of 75 hours and 17 minutes at 11.2 Celsius degrees. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S020254; expirationdate: 09-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; MMR II was improperly stored then administered; This spontaneous report was received from a medical assistant, referring to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not provided.  On 11-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), at a dose of 0.5 milligrams (ml) (stenght, vaccination scheme frequency, route of administration, and anatomical site of vaccination were not reported; lot number S022753 has been verified to be valid, expiration date reported and validated as 22-JUL-2021) as prophylaxis (product storage error).  The administered dose of the vaccine experienced a temperature of 27.44 degrees Fahrenheit (F) for 5 hours and 30 minutes, as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported.
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PPV, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Patient have been administered doses of improperly stored vaccines; This spontaneous report as received from a registered nurse, referring to a patient (gender and age not reported).  No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 17-MAR-2020 at 09:49 hours, the patinet was vaccinated with an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) with a valid lot # S023219, at a dose of 0.5 mL intramuscularly (IM) on the left tight (LT) and with an improperly stored dose of rotavirus G1 P1 vaccine live (89-12) (ROTARIX) oral route and lot # Y5CN5, diphtheria toxoid, hepatitis B virus vaccine rHBsAg (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (Vero), tetanus toxoid (PEDIARIX) at a dose of 0.5 mL intramuscularly (IM) on the Right tight (RT) lot # YS4Z5 and an improperly stored dose of pneumococcal 13v conj vaccine (CRM197) dose of 0.5 mL intramuscularly (IM) on the Right tight (RT) lot # AT8585; for prophylaxis, however no adverse effects reported.   Administered dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) experienced the temperature excursion above 9 degrees Celsius (15.5C) for 4 hour and 6 minutes. Digital data logger was involved. There were no previous temperature excursions reported.  This is one of the several reports received from the same reporter.   This case comes from a case previously considered non-valid, but per new information received (patient identifiers) the case was splitted and determined to be valid for a specific patient.; Sender's Comments:  US-009507513-2003USA002275:
Sex: U
Vaccine: HPV9
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; This spontaneous report was received from a nurse referring to a child of unknown age. The patient's concurrent condition, medical history and concomitant therapy were unknown.  On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, frequency, lot number and expiration date were unknown) for prophylaxis (reported as childhood vaccine).   On an unknown date, the patient experienced Bell's palsy. It was unknown if treatment was given. The patient sought medical attention. The outcome of the event was unknown. Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not applicable. The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.      Upon internal review, Bell's palsy was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: The patient received an improperly stored dose of PROQUAD; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies were not provided.  On 03-AUG-2020, the patient was vaccinated an with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (dose and frequency were unknown by the reporter; strength, vaccination scheme, route of administration and anatomical site of vaccination were not provided; lot number T005401 has been verified to be valid, expiration date reported and validated as 12-AUG-2021) as prophylaxis (product storage error). It was reported that the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccine was properly stored (dose, frequency, lot number, and expiration date was unknown by the reporter).  The administered dose of the vaccine experienced a temperature of -5.3 degrees Celsius (C) for 65 hours and 21 minutes, and a temperature of 15.2 degrees C for 47 minutes, as recorded by a data logger. The previous temperature excursion reported was of -1.2 degrees C for 42 minutes.
Sex: U
Vaccine: MEN
Symptoms: Cellulitis
Clinical narrative: Cellulitis like reaction; This case was reported by a consumer via interactive digital media and described the occurrence of cellulitis in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, 1 week after receiving Meningococcal B vaccine, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown.   The reporter considered the cellulitis to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Meningococcal B vaccine, the patient experienced cellulitis like reaction.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Herpes zoster, Musculoskeletal discomfort, Pruritus
Clinical narrative: mild or small pustule; the area started as a small white center/on his left thigh; it does itch.; red inflamed tissue on his left thigh; red inflamed tissue / little red spot with a white spot / looked like a bug bite / continued to grow; something bothering him on his back; second dose of Shingrix on 8/6/2020 / diagnosed with shingles / case of shingles; having a chill; he may have had fever; This case was reported by a consumer via call center representative and described the occurrence of chills in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included heart transplant (heart transplant in February 2016) and shingles (Family History) (the patient's father had shingles). Previously administered products included Zostavax (received on an unknown date in 2015).   On 6th August 2020, the patient received the 2nd dose of Shingrix. On 6th August 2020, less than a day after receiving Shingrix, the patient experienced chills and fever. On 7th August 2020, the patient experienced pustule, skin discoloration, pruritus, shingles, soft tissue inflammation and erythema. In August 2020, the patient experienced back discomfort. The patient was treated with acetylsalicylic acid (Aspirin). On 6th August 2020, the outcome of the chills and fever were recovered/resolved. On an unknown date, the outcome of the pustule, skin discoloration, pruritus, soft tissue inflammation, erythema and back discomfort were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the chills, fever and back discomfort to be related to Shingrix. The reporter considered the pustule, skin discoloration, pruritus, shingles, soft tissue inflammation and erythema to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix at 8:30 or 9:00 AM, and later that day experienced chill. As per reporter, the patient might had a fever but he could not confirm because he did not take his temperature. The patient took one Aspirin and the incident resolved. On Friday, he noticed a a mild or small pustule, little red spot with a white spot in the middle on his left calf which was surrounded by red inflamed tissue. It was about the size of a dime and looked like a bug bite. Saturday it was the size of a nickel so he went to ER where he was told that it was a side effect of the Shingrix vaccine and that he had a mild case of shingles. He was released and they did not provide any treatment for him because he was a heart transplant patient. The patient says it does not hurt but it does itch. The patient also felt something bothering him on his back but he had not been able to look at it yet. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pustule, Pyrexia, Skin discolouration, Soft tissue inflammation
Clinical narrative: mild or small pustule; the area started as a small white center/on his left thigh; it does itch.; red inflamed tissue on his left thigh; red inflamed tissue / little red spot with a white spot / looked like a bug bite / continued to grow; something bothering him on his back; second dose of Shingrix on 8/6/2020 / diagnosed with shingles / case of shingles; having a chill; he may have had fever; This case was reported by a consumer via call center representative and described the occurrence of chills in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included heart transplant (heart transplant in February 2016) and shingles (Family History) (the patient's father had shingles). Previously administered products included Zostavax (received on an unknown date in 2015).   On 6th August 2020, the patient received the 2nd dose of Shingrix. On 6th August 2020, less than a day after receiving Shingrix, the patient experienced chills and fever. On 7th August 2020, the patient experienced pustule, skin discoloration, pruritus, shingles, soft tissue inflammation and erythema. In August 2020, the patient experienced back discomfort. The patient was treated with acetylsalicylic acid (Aspirin). On 6th August 2020, the outcome of the chills and fever were recovered/resolved. On an unknown date, the outcome of the pustule, skin discoloration, pruritus, soft tissue inflammation, erythema and back discomfort were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the chills, fever and back discomfort to be related to Shingrix. The reporter considered the pustule, skin discoloration, pruritus, shingles, soft tissue inflammation and erythema to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix at 8:30 or 9:00 AM, and later that day experienced chill. As per reporter, the patient might had a fever but he could not confirm because he did not take his temperature. The patient took one Aspirin and the incident resolved. On Friday, he noticed a a mild or small pustule, little red spot with a white spot in the middle on his left calf which was surrounded by red inflamed tissue. It was about the size of a dime and looked like a bug bite. Saturday it was the size of a nickel so he went to ER where he was told that it was a side effect of the Shingrix vaccine and that he had a mild case of shingles. He was released and they did not provide any treatment for him because he was a heart transplant patient. The patient says it does not hurt but it does itch. The patient also felt something bothering him on his back but he had not been able to look at it yet. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: can hardly move arm / arm feels as if it needs to be in a sling; Muscle pain; injection was painful; Headache; feeling tired; Arm Pain / arm is still very painful; difficulty sleeping; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 10th August 2020, immediately after receiving Shingrix, the patient experienced injection site pain, headache, tiredness, pain in arm and muscle pain. On 11th August 2020, the patient experienced injected limb mobility decreased. In August 2020, the patient experienced insomnia. The patient was treated with paracetamol (Tylenol) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site pain, headache, tiredness and insomnia were unknown and the outcome of the pain in arm, injected limb mobility decreased and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, headache, tiredness, pain in arm, injected limb mobility decreased, insomnia and muscle pain to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on right arm. It was reported that the injection was painful unlike any other vaccine ever received. Within 6 to 8 hours after receiving Shingrix, the patient was feeling tired and then developed a headache.  The patient went to bed but woke up in the night with arm pain. The arm pain was much worse on the second day (1 day later after administration of Shingrix) as she reported that holding her arm, could hardly move arm causing difficulty sleeping, and arm felt as if it needs to be in a sling. The patient reported taking Tylenol and icing kept on arm but arm was still very painful.  The patient reported not having shivers, fever or upset stomach. The onset date for mobility decreased was discrepantly reported as 10th August 2020, however it was updated to 11th August 2020 as per the description. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Myalgia, Pain in extremity
Clinical narrative: can hardly move arm / arm feels as if it needs to be in a sling; Muscle pain; injection was painful; Headache; feeling tired; Arm Pain / arm is still very painful; difficulty sleeping; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 10th August 2020, immediately after receiving Shingrix, the patient experienced injection site pain, headache, tiredness, pain in arm and muscle pain. On 11th August 2020, the patient experienced injected limb mobility decreased. In August 2020, the patient experienced insomnia. The patient was treated with paracetamol (Tylenol) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site pain, headache, tiredness and insomnia were unknown and the outcome of the pain in arm, injected limb mobility decreased and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, headache, tiredness, pain in arm, injected limb mobility decreased, insomnia and muscle pain to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on right arm. It was reported that the injection was painful unlike any other vaccine ever received. Within 6 to 8 hours after receiving Shingrix, the patient was feeling tired and then developed a headache.  The patient went to bed but woke up in the night with arm pain. The arm pain was much worse on the second day (1 day later after administration of Shingrix) as she reported that holding her arm, could hardly move arm causing difficulty sleeping, and arm felt as if it needs to be in a sling. The patient reported taking Tylenol and icing kept on arm but arm was still very painful.  The patient reported not having shivers, fever or upset stomach. The onset date for mobility decreased was discrepantly reported as 10th August 2020, however it was updated to 11th August 2020 as per the description. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia
Clinical narrative: Hair loss; This case was reported by a other health professional via call center representative and described the occurrence of hair loss in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number LD3NH, expiry date 11th December 2021) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced hair loss. On an unknown date, the outcome of the hair loss was unknown.   It was unknown if the reporter considered the hair loss to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced hair loss. The HCP did not give any diagnosis other than hair loss related to administration of shingrix and did not prescribe anything for the patient. The reporter consented to follow up. This case linked with US2020AMR160960, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR160960:same reporter
Sex: U
Vaccine: MENB
Symptoms: Dizziness, Headache, Nausea, Visual impairment
Clinical narrative: Dizziness; Vision Changes; Nausea; Headache; This case was reported by a other health professional via sales rep and described the occurrence of dizziness in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced dizziness, visual disturbance, nausea and headache. On an unknown date, the outcome of the dizziness, visual disturbance, nausea and headache were unknown.   It was unknown if the reporter considered the dizziness, visual disturbance, nausea and headache to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The caller was an HCP Field Representative called in the report on behalf of the Certified Medical Assistant.   The patient received Bexsero and had complaints of dizziness, vision changes, nausea and headache. The reporter did not consent to follow up. The Field Representative had no information regarding the two reported patients as for their gender or names or medication Lot Numbers or when the medication had been given.  The Field Representative stated she would give the Medical Assistant the case number I provided if she decided to call the GSK Response Center. This case linked with US2020AMR160355, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR160355:same reporter
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Rash maculo-papular
Clinical narrative: rash all over( macular- papular small lesions; Chills; sweating; shaking; HA; Fatigue; small lesions not resolved; This case was reported by a nurse via call center representative and described the occurrence of maculopapular rash in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2020, the patient received the 1st dose of Shingrix. In August 2020, couple of hours after receiving Shingrix, the patient experienced maculopapular rash, chills, sweating, tremor, headache, fatigue and skin lesion. On an unknown date, the outcome of the maculopapular rash, sweating, tremor and skin lesion were not recovered/not resolved and the outcome of the chills, headache and fatigue were recovered/resolved.   It was unknown if the reporter considered the maculopapular rash, chills, sweating, tremor, headache, fatigue and skin lesion to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and couple hours after developed shaking, chills, sweating, rash all over macular popular small lesions not resolved at time of report, fatigue, headache and chills. The reporter consented to follow up.  The HCP gave permission to contact and she did not have full information that was located at the pharmacy at the time of the call.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin lesion, Tremor
Clinical narrative: rash all over( macular- papular small lesions; Chills; sweating; shaking; HA; Fatigue; small lesions not resolved; This case was reported by a nurse via call center representative and described the occurrence of maculopapular rash in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2020, the patient received the 1st dose of Shingrix. In August 2020, couple of hours after receiving Shingrix, the patient experienced maculopapular rash, chills, sweating, tremor, headache, fatigue and skin lesion. On an unknown date, the outcome of the maculopapular rash, sweating, tremor and skin lesion were not recovered/not resolved and the outcome of the chills, headache and fatigue were recovered/resolved.   It was unknown if the reporter considered the maculopapular rash, chills, sweating, tremor, headache, fatigue and skin lesion to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and couple hours after developed shaking, chills, sweating, rash all over macular popular small lesions not resolved at time of report, fatigue, headache and chills. The reporter consented to follow up.  The HCP gave permission to contact and she did not have full information that was located at the pharmacy at the time of the call.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Cellulitis, Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling
Clinical narrative: Cellulitis; arm swollen; Redness in the Injection site; Swelling in the Injection site; This case was reported by a other health professional via call center representative and described the occurrence of cellulitis in a 11-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA201A, expiry date 30th October 2020), (batch number AMVA206A, expiry date 13th November 2020) and (batch number AMVA323A, expiry date 31st March 2020) for prophylaxis.   On 10th August 2020, the patient received the 1st dose of Menveo. In August 2020, less than a day after receiving Menveo, the patient experienced cellulitis (serious criteria GSK medically significant), extensive swelling of vaccinated limb, injection site erythema and injection site swelling. On an unknown date, the outcome of the cellulitis, extensive swelling of vaccinated limb, injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the cellulitis, extensive swelling of vaccinated limb, injection site erythema and injection site swelling to be related to Menveo.  Additional details were provided as follows: It was reported that, several patients had been experiencing redness and swelling in the injection site, whole arm swollen and cellulitis after receiving a dose of Menveo.  The symptoms were started within hours. The reporter was consented to follow up. The reporter did not know how many patients experienced the symptoms but agreed to follow up and look up the information.  The reporter only reported that one patient was 11 years old and other was 16 years old.  She reported 3 different lot numbers and expiration dates for the vaccines administered to different patients.  She had those details in hand because she was worried that the side effects were due to a lot issue. This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159654:same reporter US-GLAXOSMITHKLINE-US2020AMR160036:same reporter