chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse symptoms were reported; a patient was inadvertently given a dose of MMR II on 12/27/2019 after its expiration date; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not provided.  On 27-DEC-2019, the patient was inadvertently vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # N025892, expiration date 19-SEP-2019; route, strength unknown), albumin status rHA (recombinant Human albumin) for prophylaxis after its expiration date (expired product administered). No additional adverse symptoms were reported. No other information was available.
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: a patient currently in the office received two doses ofGARDASIL (quadrivalent) on unknown dates, and is currently in the office now to complete the series with GARDASIL-9.; No additional symptoms were reported; This spontaneous report has been received from an office manager who is also a nurse, referring to a patient of unknown age and gender. The patient's history condition, current condition and concomitant therapy were not provided.  On unknown dates, the patient received two doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, frequency, route, strength, lot# with expiration date not reported) for prophylaxis.   On 10-JAN-2020, the patient was currently in the office to complete the series with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route, strength, lot# with expiration date not reported) for prophylaxis (interchange of vaccine products). No additional symptoms were reported in the patient.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea
Clinical narrative: temporary difficulty with breathing; This spontaneous report was received from a lawyer and the patient and refers to a 66-year-old female patient. Medical history, concurrent conditions or concomitant therapies were not provided.   In February 2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot# and expiration date were not provided) for prophylaxis. In February 2019, the patient experienced temporary difficulty with breathing.   The outcome of the event was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).   This is one of two reports concerning the same patient (# 1902USA000883).; Sender's Comments:  US-009507513-1902USA000883:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: The patient received a dose of VARIVAX and a dose o PROQUAD during the same office visit; This spontaneous report has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. No information was provided regarding patient's medical history, concurrent conditions, drug and allergy history.    On 30-SEP-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration and frequency were not provided) lot # R002057, expiration date 22-JAN-2020 and during the same office visit, the patient also received a dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strength, dose, route of administration and frequency were not provided) lot #S003326, expiration date 02-AUG-2020 both for prophylaxis (overdose). An sterile diluent (MRK DILUENT) was used in the vaccination process.
Age: 58.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse symptoms reported; patient was administered the first dose of GARDASIL 9 in the series on an unknown date in April of 2019 when he was 58 years old; This spontaneous report was received from a pharmacist referring to a 58-year-old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On an unknown day in April 2019, the patient was vaccinated with a first dose od hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage schedule, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness below the deltoid muscle; Swelling below the deltoid muscle; This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number J352N, expiry date 11th December 2021) for prophylaxis.   On 29th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, couple of days after receiving Shingrix, the patient experienced localized erythema and local swelling. On an unknown date, the outcome of the localized erythema and local swelling were unknown.   It was unknown if the reporter considered the localized erythema and local swelling to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but it could be 63 or 64 years. The reporter stated that the patient after vaccination developed redness and 2.5 cm swelling below the deltoid muscle. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Pain
Clinical narrative: body aches, chills, sweats lasting 24 hours
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV1
Symptoms: Dyskinesia, Insomnia, Pyrexia
Clinical narrative: Patient had her vaccines in office 01/20/2020. She had a fever that day of 102 temporal. Mom states that she had given patient Tylenol over night and she did not sleep through out the night either.  Patient is taking normal bottles and having adequate amount of wet diapers. Mom states that at 5 am she did give her Ibuprofen. She states that after giving the Ibuprofen, patient slept 3 and a half hours. I advised her to call back at four pm after she checks her temp again and if it is over 102, head to ED, She has been alternating the Tylenol and motrin every 3 hours and a referral to Dr (allergiest) has been sent. Mom notices that she jerks when she falls asleep - may be her arm, head, leg - always a different extremity.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of product administration
Clinical narrative: Inadvertently gave MCV4 subcutaneously instead of intramuscularly.    Called the STATE Representative for agency and was told that the dose was still valid; no need to repeat the dose.   No adverse reactions occurred while client was in the health center
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Musculoskeletal pain, Pain
Clinical narrative: PATIENT EXPERIENCED SEVERE KNEE PAIN IN BOTH KNEES WHICH ARE ARTIFICIAL AND SHE WAS UNABLE TO WALK WITHOUT PAIN ABOUT ON THE SUNDAY FOLLOWING THE IMZ. SHE ALSO COMPLAINED OF RIGHT SHOULDER PAIN THAT WAS NEW AND MORE SEVERE THAN THE ORIGINAL INJURY. SHE ALSO WAS VERY FATIGUED. THESE SYMPTOMS LASTED ABOUT 3 DAYS AND THEN THE PATIENT SAID SHE FELT BETTER BUT KNEW IT WAS THE VACCINATION THAT CAUSED THE SYMPTOMS.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Injection site swelling, Loss of personal independence in daily activities, Musculoskeletal stiffness
Clinical narrative: Patient called with redness and pain with moving arm.  Patient seen by physician.  left shoulder pain, swelling subsequent to Pneumococcal 23 immunization 1/17/2020   She has stiffness, pain, difficulty getting dressed. No generalized rash, no swelling lips, face, tongue, or mouth.  She is worse from 3 days ago.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Patient called with redness and pain with moving arm.  Patient seen by physician.  left shoulder pain, swelling subsequent to Pneumococcal 23 immunization 1/17/2020   She has stiffness, pain, difficulty getting dressed. No generalized rash, no swelling lips, face, tongue, or mouth.  She is worse from 3 days ago.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Malaise, Nausea, Pyrexia, Vaccination site discomfort
Clinical narrative: Pain and discomfort at vaccination site Fever (99.6 axillary) Chills Nausea Malaise
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site pain
Clinical narrative: Pain and discomfort at vaccination site Fever (99.6 axillary) Chills Nausea Malaise
Age: 0.25
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported; a patient received a dose of improperly stored dose; This spontaneous report was received from a nurse and refers to a 12-week-old male patient. No information regarding patient's concurrent conditions, past medical history, concomitant medications, drug reactions or allergies was provided.  On 09-JAN-2020, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, intramuscular, lot number S006470, expiration date 15-JAN-2022 (exact dose was not provided) for prophylaxis. There was no adverse effect reported.  Administered dose of vaccine experienced the temperature excursion of 35.2 degrees Fahrenheit for 24 minutes. There was no previous temperature excursions. Data logger was involved.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Hives presented on the patient's face and chest; This case was reported by a other health professional via call center representative and described the occurrence of hives in a 34-year-old male patient who received HBV (Engerix B adult) (batch number BG92Z, expiry date 4th July 2022) for prophylaxis.   On 10th January 2020, the patient received Engerix B adult. On 10th January 2020, less than a day after receiving Engerix B adult, the patient experienced hives. On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to Engerix B adult.  Additional details were provided as follows: The patient experienced hives on the face and chest later in the day on the day of vaccination. The hives resolved within 2 hours. The reporter consented to follow up. This case has been linked with case US2020007365, reported by same reporter. .
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Mild hives; Itching; This case was reported by a other health professional via call center representative and described the occurrence of hives in a 55-year-old female patient who received HBV (Engerix B adult) (batch number BG92Z, expiry date 4th July 2022) for prophylaxis.   On 10th January 2020, the patient received Engerix B adult. On 10th January 2020, less than a day after receiving Engerix B adult, the patient experienced hives and itchy upper limbs. On an unknown date, the outcome of the hives and itchy upper limbs were recovered/resolved.   It was unknown if the reporter considered the hives and itchy upper limbs to be related to Engerix B adult.  Additional details were provided as follows: The patient experienced mild hives and itching on both upper arms after receiving the shingrix vaccine. The reporter stated that, it resolved without the need of treatment. The reporter consented to follow up. This case has been linked with case US2020007365, reported by same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Neoplasm malignant
Clinical narrative: Diagnosed with cancer; This case was reported by a other health professional via call center representative and described the occurrence of cancer in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced cancer (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the cancer was unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional details were provided as follows: The patient was diagnosed with cancer and was in the hospital for a while. On 11th November 2019, the patient received 2nd dose with batch number P57AA and expiry date 5th July 2021, a year apart from the first dose due to the events. The reporter was not sure if the patient was immunocompromised or not.  No further information was available during call regarding cancer type or hospital details. The reporter inquired about regarding administration of a 3rd dose of Shingrix but didn't stated would administer a 3rd dose. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Insomnia, Joint injection
Clinical narrative: Pain developed at the site of injection and continued for 7 months.  Arm was unable to be lifted above the shoulder, pain severe enough to interfere with sleep requiring sleeping in a recliner chair instead of the bed.  Could not do general exercises to maintain arm and shoulder strength.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities
Clinical narrative: Pain developed at the site of injection and continued for 7 months.  Arm was unable to be lifted above the shoulder, pain severe enough to interfere with sleep requiring sleeping in a recliner chair instead of the bed.  Could not do general exercises to maintain arm and shoulder strength.
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Chest pain, Injection site erythema, Injection site rash, Injection site reaction, Pallor
Clinical narrative: After immunizations patient began to leave He returned shortly after c/o Chest pain to Dad.  Oxygen 98%; HR 91 and regular.   Dr. into room.  Patient given tylenol Breathing appears normal.  No rash.  We monitoring at 10:48.   At 10:49 started c/o hands itching and getting rash to legs.  Dad thinks rash started to right leg where MMR was given.   Red and slightly raised blanches 3 areas to legs at this time.    At this point dad states mom says he's had allergic reaction to an immunization in past.  But think had to do with egg allergy??   Given Benadryl and it worked.  Giving Benadryl 25 mg at this time.    Rash continues to worsen to lower extremities and to abdomen Chest pain has improved.  No SOB Some facial blanching now and mild facial swelling We are giving 20 mg Pred Also giving epi 1mg/ml   Giving 0.15 mg SQ into right leg.   12:03:  No CP or SOB.  No tongue swelling.  Still has diffuse slightly raised red rash to lower extremities and lower abdomen.  Facial blanching has improved a little.  No facial swelling.  He appears calm.  VSS.       Patient discharged after monitoring one hour after epi injection  No RASH now.  No facial blanching.  No CP, No SOB No symptoms at this time Take above Rx's.     Strict ER warnings given.  Return of rash, SOB, CP, facial/lip swelling.  see continuation page >>>>
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Rash, Rash erythematous, Swelling face
Clinical narrative: After immunizations patient began to leave He returned shortly after c/o Chest pain to Dad.  Oxygen 98%; HR 91 and regular.   Dr. into room.  Patient given tylenol Breathing appears normal.  No rash.  We monitoring at 10:48.   At 10:49 started c/o hands itching and getting rash to legs.  Dad thinks rash started to right leg where MMR was given.   Red and slightly raised blanches 3 areas to legs at this time.    At this point dad states mom says he's had allergic reaction to an immunization in past.  But think had to do with egg allergy??   Given Benadryl and it worked.  Giving Benadryl 25 mg at this time.    Rash continues to worsen to lower extremities and to abdomen Chest pain has improved.  No SOB Some facial blanching now and mild facial swelling We are giving 20 mg Pred Also giving epi 1mg/ml   Giving 0.15 mg SQ into right leg.   12:03:  No CP or SOB.  No tongue swelling.  Still has diffuse slightly raised red rash to lower extremities and lower abdomen.  Facial blanching has improved a little.  No facial swelling.  He appears calm.  VSS.       Patient discharged after monitoring one hour after epi injection  No RASH now.  No facial blanching.  No CP, No SOB No symptoms at this time Take above Rx's.     Strict ER warnings given.  Return of rash, SOB, CP, facial/lip swelling.  see continuation page >>>>
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin, Ultrasound antenatal screen
Clinical narrative: Miscarried approximately 2 weeks after receiving the flu vaccine. Baby had been scanned and tested prior to vaccine, had a heartbeat and no genetic abnormalities at time of ultrasound.
Age: 41.0
Sex: F
Vaccine: HEPA
Symptoms: Cough, Paraesthesia, Pharyngeal swelling, Rhinorrhoea
Clinical narrative: Employee felt like her throat was swelling with a pins and needles sensation associated with it.  Employee began coughing and had a runny nose.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS, PAIN AND SWELLING OF THE WHOLE UPPER RIGHT ARM, 3-DAY COURSE OF PREDNISONE , BENADRYL PRN PAIN AND SWELLING AND COLD COMPRESS ON DAY 1 THEN WARM AFTER TODAY.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Discomfort, Injection site reaction, Muscle tightness, Neuralgia
Clinical narrative: Left arm muscle tightness, at site of injection, some nerve pain. Discomfort lasted about 2 months.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Pain in extremity, Periorbital swelling, Swelling face
Clinical narrative: 1 hour after administration pt experienced pain and cramping throughout her right arm. 2 days later, pt reports having minor facial swelling, particularly around the eyes. Pt also reports taking Advil sometime after the dose was administered but prior to experiencing the facial swelling. Pt also reports that these adverse events did not occur with her 1st dose.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Erythema, Fatigue, Pain
Clinical narrative: Pain, swelling, redness, hot to the touch, itch began next morning.  Next evening I had chills, body aches, stomach ache, tiredness
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin warm, Swelling
Clinical narrative: Pain, swelling, redness, hot to the touch, itch began next morning.  Next evening I had chills, body aches, stomach ache, tiredness
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Heart rate increased, Mobility decreased, Pyrexia
Clinical narrative: Not able to lift my right arm for four days, fever, chills, high heart rates 3 different times lasting ten minutes at a time 24 hrs after shot while sitting in a chair watching tv.
Age: 22.0
Sex: M
Vaccine: FLU4, HEPA, TYP, YF
Symptoms: Erythema
Clinical narrative: Patient left to have lunch after vaccines, and their supervisor noticed they started turning red.  They returned to clinic, was assessed by Allergist, vitals were taken, and Epi was administered.  Patient was observed for 1 hr and symptoms were resolved.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous
Clinical narrative: Red, non-raised rash appeared one day after vaccination on the arm a few inches below the injection site. Patient stated it lasted about 4 days and then went away
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Cardiomyopathy, Death, Dyspnoea, Failure to thrive
Clinical narrative: shortness of breath; congestion/congestive heart failure; frequent falls; failure to thrive; pneumonia; severe cardiomyopathy; pleural effusions secondary to congestive heart failure; died; This initial spontaneous information was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  On or about 02-OCT-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after, the patient suffered shortness of breath, congestion, frequent falls and failure to thrive requiring hospitalization. The patient was diagnosed with congestive heart failure, pleural effusions secondary to congestive heart failure, pneumonia and severe cardiomyopathy. As a direct and proximate result of these injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered significant medical expenses, severe pain and suffering, other damages, and ultimately death on 06-MAR-2018. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered serious and dangerous side effects, including death, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the events was considered to be not recovered. All of the events were considered to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events of cardiomyopathy, pneumonia, failure to thrive and congestive heart failure were considered to be medically significant. The events of congestive heart failure, pleural effusions secondary to congestive heart failure, pneumonia, severe cardiomyopathy, shortness of breath, congestion, frequent falls and failure to thrive were considered to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Pleural effusion, Pneumonia
Clinical narrative: shortness of breath; congestion/congestive heart failure; frequent falls; failure to thrive; pneumonia; severe cardiomyopathy; pleural effusions secondary to congestive heart failure; died; This initial spontaneous information was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  On or about 02-OCT-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after, the patient suffered shortness of breath, congestion, frequent falls and failure to thrive requiring hospitalization. The patient was diagnosed with congestive heart failure, pleural effusions secondary to congestive heart failure, pneumonia and severe cardiomyopathy. As a direct and proximate result of these injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered significant medical expenses, severe pain and suffering, other damages, and ultimately death on 06-MAR-2018. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered serious and dangerous side effects, including death, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the events was considered to be not recovered. All of the events were considered to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events of cardiomyopathy, pneumonia, failure to thrive and congestive heart failure were considered to be medically significant. The events of congestive heart failure, pleural effusions secondary to congestive heart failure, pneumonia, severe cardiomyopathy, shortness of breath, congestion, frequent falls and failure to thrive were considered to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Joint swelling, Rash, Systemic lupus erythematosus
Clinical narrative: achy, swollen joints, skin rash and fatigue/diagnosed with lupus; This initial spontaneous information was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the patient suffered achy swollen joints, skin rash and fatigue. As a result of these symptoms, the patient was seen and treated by medical providers and was diagnosed with lupus and at the time of the report, was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered not recovered/not resolved. The event was considered to be related to zoster vaccine live (ZOSTAVAX).  Lupus was considered to be disabling. Upon internal review, the event of lupus was considered to be medically significant.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Lethargy, Pain, Pyrexia
Clinical narrative: chills; fever /Temperature 101.0 f; aches; lethargy; feel really awful; This case was reported by a consumer via call center representative and described the occurrence of chills in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2020, the patient received the 2nd dose of Shingrix. On 15th January 2020, 1 days after receiving Shingrix, the patient experienced chills, fever, pain, lethargy and feeling abnormal. On an unknown date, the outcome of the chills, fever, pain, lethargy and feeling abnormal were unknown.   It was unknown if the reporter considered the chills, fever, pain, lethargy and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had fever, aches, chills, lethargy and feel really awake full. The patient understand that these are normal side effects. The reporter asked how long should expect this to last.
Age: 86.0
Sex: U
Vaccine: VARZOS
Symptoms: Tendonitis
Clinical narrative: bicep tendonitis in the left arm; This case was reported by a consumer via call center representative and described the occurrence of tendonitis in a 86-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced tendonitis. On an unknown date, the outcome of the tendonitis was unknown.   It was unknown if the reporter considered the tendonitis to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed a case of bicep tendonitis in the left arm which received the vaccine. The reporter asked could there have been a slip up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: rash at the injection site; rash has since spread throughout her body; This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site rash and rash. The patient was treated with prednisone. On an unknown date, the outcome of the injection site rash and rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed a rash at the injection site the day after getting Shingrix. The rash has since spread throughout her body and was still present. The patient has been treated with prednisone.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza
Clinical narrative: Flu symptoms; This case was reported by a physician via call center representative and described the occurrence of flu symptoms in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced flu symptoms. On an unknown date, the outcome of the flu symptoms was unknown.   It was unknown if the reporter considered the flu symptoms to be related to Shingrix.  Additional details were reported as follows: No lot number or expiration date of the vaccine was provided. The patient did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: had a bad reaction; This case was reported by a nurse via call center representative and described the occurrence of adverse reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had a bad reaction. The follow up consent was not granted
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Differential white blood cell count, Full blood count, Injection site pain
Clinical narrative: 01/17/2020 - Right arm/hand pain with movement, pain on touch 01/18/2020 - Left leg pain, fever/chills, left arm/shoulder pain, too weak to walk or get out of chair without help,  01/19/2020 - need to use a walker 01/20/2020 - Left leg much better, knee much better, continued left arm, but a little better too. shoulder still very painful even on Aleve every 8 hours
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Metabolic function test, Pain, Pain in extremity, Pyrexia, Red blood cell sedimentation rate
Clinical narrative: 01/17/2020 - Right arm/hand pain with movement, pain on touch 01/18/2020 - Left leg pain, fever/chills, left arm/shoulder pain, too weak to walk or get out of chair without help,  01/19/2020 - need to use a walker 01/20/2020 - Left leg much better, knee much better, continued left arm, but a little better too. shoulder still very painful even on Aleve every 8 hours
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness, Walking aid user
Clinical narrative: 01/17/2020 - Right arm/hand pain with movement, pain on touch 01/18/2020 - Left leg pain, fever/chills, left arm/shoulder pain, too weak to walk or get out of chair without help,  01/19/2020 - need to use a walker 01/20/2020 - Left leg much better, knee much better, continued left arm, but a little better too. shoulder still very painful even on Aleve every 8 hours
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Inappropriate schedule of product administration, Pollakiuria, Product supply issue, Renal function test normal
Clinical narrative: 1st dose was given by Family Physicians on 04/26/2018. She was also administered Pneumovax 23 at that time. Per patient, after these two vaccines, she was very tired and slept for 2 days.  Patient signed up for 2nd dose at pharmacy and waited several month on the waiting list due to product shortage. She was administered 2nd dose on 08/29/2019 at pharmacy.  After 2nd dose, she had high chills and increased need to urinate starting approximately 8 hours or so following administration.  Patient says she lost approximately 2 pounds from the increased urination.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Weight decreased
Clinical narrative: 1st dose was given by Family Physicians on 04/26/2018. She was also administered Pneumovax 23 at that time. Per patient, after these two vaccines, she was very tired and slept for 2 days.  Patient signed up for 2nd dose at pharmacy and waited several month on the waiting list due to product shortage. She was administered 2nd dose on 08/29/2019 at pharmacy.  After 2nd dose, she had high chills and increased need to urinate starting approximately 8 hours or so following administration.  Patient says she lost approximately 2 pounds from the increased urination.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Tremor
Clinical narrative: At noon on Wednesday 1/8 patient noticed a number of GI upset side effects, possibly even a stiff neck. Patient then reported severe tremors from 5-6:30PM but woke up half way through the night feeling totally normal and well
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pain, Injection site reaction, Skin tightness
Clinical narrative: Pt called Pharmacy on 1/22/20 stating she had received Boostrix vaccine 1/17/20.  She stated the previous evening (1/21/20) the arm where the vaccine was administered felt tight/hard and was painful to the touch.  She had consulted a friend who was a nurse and was advised to apply heat stating that it might loosen up the area and that the vaccine may have stayed locally.  Pt did as advised but described in phone call to pharmacist that heat did not help and the arm felt worse (felt hard as a rock by 1/22/20 and was painful to touch).  She stated she was concerned an abscess may have formed.  Pharmacist advised pt to seek medical attention and that she would be in contact with her Manager and the immunization manufacturer.  At this time, there is no more information, as pharmacist has contacted market manager and patient is waiting for call back once pharmacist has more information.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Pyrexia
Clinical narrative: REDNESS AND PAIN IN ADMINISTRATION ARM, FEVER FOR TWO CONSECUTIVE DAYS. SYMPTOMS RESOLVE THEMSELVES.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Headache, Myalgia
Clinical narrative: Headache, dizziness, weakness, muscle soreness, shivering (chills),
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: After 10 days patient developed an extreme head to toe rash and fever.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Inflammation, Insomnia, Pain, Pain in extremity
Clinical narrative: Pt reports throbbing, arm pain, inflammation, fatique and trouble sleeping within 24 hours of injection.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: SkinRash & URTICARIA; RASH (8/23/19@12:27)
Age: 2.75
Sex: M
Vaccine: FLU4
Symptoms: Febrile convulsion, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Red rash lateral aspect (R) thigh ~ 5mm x 3mm in size = Red, warm to touch Possible fever which resulted (secondarily) in a febrile seizure = initially seen @ ER by ambulance & F/U @ Dr. Office
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse symptom were reported; a patient received a dose of ROTATEQ following a temperature excursion; This spontaneous report has been received from a medical assistant regarding an unknown age and gender patient. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.  On 13-JAN-2020, the patient was vaccinated with improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial orally (dose and frequency were not reported) lot # S010566 expiration date 19-JAN-2021 as prophylaxis following a temperature excursion. The lowest temperature was below 36°F/2°C (34F) in a time frame of 48 hours. There was no previous temperature excursion. Call was because of a data logger. No additional adverse symptoms were reported.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse events; the patient was inadvertently administered PREVNAR 13 and PNEUMOVAX 23; This spontaneous report was received from a pharmacist technician, referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant medication were not reported.     On an unknown date, the patient was inadbertently vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)  for prophylaxis (strength, dose, frequency, route of administration, and anatomical location was not reported) (lot number S012244 had been verified to be a valid number; expiration date 09-FEB-2021), and pneumococcal 13v conj vaccine (crm197) (PREVENAR 13) (duplicate therapy error).  No additional adverse event.
Sex: U
Vaccine: HPV9, MMR, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Multiple patients were administered a dose of improperly stored GARDASIL 9, MMR II, PNEUMOVAX 23, ROTATEQ; no adverse symptoms were reported; This spontaneous report Was received from a nurse referring to a multiple patient of unknown age and gender. The patients pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant medications were not provided.     On an unknown date, a unspecified patients was inadvertently administered with an improperly stored dose (product storage error) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot numbers r025729 and r025728 have been verified to be a valid number; expiration date: 18-JUN-2021), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (lot numbers R030813 and S007813 have been verified to be a valid number; expiration dates: 24-OCT-2020 and 14-MAR-2021 respectively),  pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot number S012244 had been verified to be a valid number; expiration date 09-FEB-2021), (strength, dose, frequency, route of administration, and anatomical location was not reported) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral (S001101 and s005875 have been verified to be a valid number; expiration dates: 21-OCT-2020 and 30-NOV-2020 respectively) (strength, dose, and frequency was not reported), all vaccines for prophylaxis. The  temperature  excursion was at above 9 degree Celsius (C) (18 C), for a time frame of 28 hours and 30 minutes, and  no had the previous temperature excursion. It was reported that the call was due to data logger. No adverse symptoms were reported.  This case was determined as non-valid due to lack of patient identifiers.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Death, General physical health deterioration, Laboratory test, Life support, Organ failure
Clinical narrative: Given while ill with fever and flu. Quick deterioration. Lung and blood infection. Sepsis within 24 hours. Life support with organ failure. Death in one week time.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pneumonia, Sepsis
Clinical narrative: Given while ill with fever and flu. Quick deterioration. Lung and blood infection. Sepsis within 24 hours. Life support with organ failure. Death in one week time.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Oedema peripheral
Clinical narrative: Extreme swelling in underarm area (on the right side, the same side as the injection).
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Body ache, low grade fever 99.7, slight congestion, shivering, extreme tiredness
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Swollen, red, itchy patch aprx 4 inches in diameter.  Very hot to the touch.  Gave her Benadryl and she used Benadryl Cream for itch
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Rash observed in patient's arm after administering Flu vaccine. Patient complained of pruritus.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site swelling
Clinical narrative: On 1/2/2020 client received first dose of Varicella vaccine. Client states that 4 days later, area where vaccine was given became redden and progressed to swelling and ecchymosis. Site, left arm assessed today and there is still some swelling and ecchymosis. Client instructed, if needed to place ice for no longer than 10 minutes to area on and off. Client educated about vaccines. Client provided with this writer phone # to call agency if area worsens. Client verbalized understanding.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site inflammation, Injection site swelling
Clinical narrative: immediate swelling, some bleeding at sight. It looked like maybe blood pooling at site which caused inflammation and swelling. I had patient stay around for 20 minutes. After checking on him, the swelling did go down and it was just a bump around a pea size.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Fatigue, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Patient reports extreme fatigue, malaise, nausea, and body pains that persisted for 7 days and kept her bed-bound for most of that time. She reports that the administration site became very red, and that her upper arm became swollen "to the size of a saucer." She now remembers that she had a similar, less severe, reaction after the first dose of the vaccine, but did not tell anyone at the time and did not remember to tell the pharmacist before getting her second dose. She did not call her doctor, and is feeling much better today.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Patient reports extreme fatigue, malaise, nausea, and body pains that persisted for 7 days and kept her bed-bound for most of that time. She reports that the administration site became very red, and that her upper arm became swollen "to the size of a saucer." She now remembers that she had a similar, less severe, reaction after the first dose of the vaccine, but did not tell anyone at the time and did not remember to tell the pharmacist before getting her second dose. She did not call her doctor, and is feeling much better today.
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, Immunodeficiency, Product administered to patient of inappropriate age, Product use in unapproved indication, Wrong product administered
Clinical narrative: Medical assistant reported in december of 2019, the patient had a change in her diagnosis to immunocompromised and was supposed to be administered a dose of PREVNAR 13 but was administered a second dose of PNEUMOVAX23; the patient was administered a dose of PNEUMOVAX23 two years ago/but was administered a second dose of PNEUMOVAX23 instead by mistake in December of 2019; was supposed to administered a  dose of PREVNAR 13 but was administered a second dose of PNEUMOVAX23 instead by mistake in December of 2019; Medical assistant reported the patient was administered a dose of PNEUMOVAX23 two years ago when the patient was 30 years old because she was a smoker; Medical assistant reported the patient was administered a dose of PNEUMOVAX23 two years ago when the patient was 30 years old; This spontaneous report was received from a medical assistant regarding a female patient in her thirties. The patient's pertinent medical history, previously drug reactions, allergies, and concomitant therapies were unknown by the reporter.   On an unspecified date in 2018 (reported as " two years ago"), when the patient was 30 years old was vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection, because she was a smoker (reported as  indication)(product use in unapproved indication) (strength, frequency, anatomical location of vaccination,route of administration, lot number, and expiration date were unknown by the reporter) (product administered to patient of inappropriate age).   It was reported that in December 2019, the patient had a change in her diagnosis to immunocompromised (immunodeficiency), and it was supposed to be administered to the patient a dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13),  but received a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) by mistake (extra dose administered, and wrong product administered). It was unknown if the patient received some treatment, laboratory diagnostics/studies were performed or if the patient received sought medical attention. The outcome of the event immunodeficiency was not reported.   The causality assessment between therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23), and the aforementioned event was not provided.   Upon internal review, the event immunodeficiency was considered to be medically significant.