chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: patient was administered improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a 4-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 14-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) injection, lot # T005406 was valid with an expiration date of 12-AUG-2021, subcutaneously (strength and exact dose were not reported) for prophylaxis (also reported as: well check). Properly stored sterile diluent was used for vaccine reconstitution. The temperature excursions were reported as: from -9 degrees Celsius (C) to 8 degrees C (-6.1 C), multiple excursions, for 13 hours. Time frame was reported as 129 hours. There were no previous temperature excursions. A digital data logger was used to capture the temperatures. The outcome of the event was not reported.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2009USA005097: US-009507513-2009USA005124: US-009507513-2009USA005141: US-009507513-2009USA005142: US-009507513-2009USA005353: US-009507513-2009USA005382: US-009507513-2009USA005515: US-009507513-2009USA005526:
Sex: U
Vaccine: HPV9
Symptoms: Anxiety, Inappropriate schedule of product administration
Clinical narrative: nine months have passed since my first injection of 9-valent HPV vaccine. I still need two more injections; I am worried that it will exceed the recommended injection cycle; Due to the outbreak of 2019-nCoV this year, the hospital suspended the injection of HPV vaccine; This spontaneous report was received from a patient of unknown age and gender, who refers to himself. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On an unknown date in 2019 (reported as nine months had passed), the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. Due to the outbreak of 2019-nCoV this year, the hospital suspended the injections with human papillomavirus (HPV) vaccine. The patient was worried that it would exceed the recommended injection cycle, as the patient still needed two more doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The outcome of the patient's worry was not reported.  The relatedness between the patient's worry and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiovascular disorder, Hypoacusis
Clinical narrative: other severe and permanent health consequences; cardiovascular event; hearing difficulties; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. The pt's concurrent conditions, medical history and concomitant medications were not reported. On 31-MAY-2009, the pt was inoculated (at 72 years (inconsistent information as it was reported as at 76 years)) at the pharmacy with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions. As a result of the inoculation, the pt suffered in or about 2009, a cardiovascular event (cardiovascular disorder) and hearing difficulties (deafness), including any, and all its sequelae; and was treated by a health care provider (HCP) for such conditions. As a result of the inoculation, the pt suffered severe personal injuries, pain, suffering, and emotional distress, as well as incurred substantial economic damages. As a direct and proximate result of the vaccine's alleged defect, the pt suffered severe and permanent physical injuries, including but not limited to a cardiovascular event and hearing difficulties, as well as other severe and permanent health consequences (ill-defined disorder). The pt endured substantial pain and suffering and incurred significant expenses for medical care and treatment and would continue to incur such expenses in the future. The pt has lost past earnings and suffered a loss of earning capacity. The pt suffered and would continue to suffer economic loss, and has otherwise been physically, emotionally and economically injured. The pt's injuries and damages were permanent and would continue into the future. The pt sought actual and punitive damages from the company as alleged herein.  The reporter considered cardiovascular disorder, deafness and ill-defined disorder to be disabling events.  Upon internal review, deafness was determined to be a medically significant event.
Age: 59.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain, Malaise
Clinical narrative: not feeling great; sore at the site of injection; has been over a year since her first Shingrix administration; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Shingrix (received 1st dose a year ago).   On 10th September 2020, the patient received the 2nd dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2020-2021 season. On 10th September 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site pain and drug dose administration interval too long. On 11th September 2020, the patient experienced malaise. On an unknown date, the outcome of the malaise and injection site pain were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the malaise and injection site pain to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she got  a flu shot and Shingrix shot. The patient experienced sore at the site of injection (left deltoid). The patient was not feeling great although she did work physically hard. The patient reported it had been over a year since her first Shingrix administration, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Sex: U
Vaccine: FLUX
Symptoms: Adverse reaction
Clinical narrative: aended up in hospital with a very bad reaction; This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in a child patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse reaction (serious criteria hospitalization). On an unknown date, the outcome of the adverse reaction was unknown.   The reporter considered the adverse reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient had a flu shot a few years back aended up in hospital with a very bad reaction then found out I had bad reactions from vaccines.
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Glucose tolerance impaired, Hypertension, Injection site erythema, Injection site mass
Clinical narrative: Chronic fatigue; A warm, red lump where injection was administered; A warm, red lump where injection was administered; A warm, red lump where injection was administered; hypertension; sleep apnea; pre-diabetic; This is a spontaneous report from a contactable Nurse. A 71-year-old female patient received pneumococcal 13-val conj vac (DIPHT CRM197 PROTEIN) (PREVNAR 13) on unknown date at single dose via unknown route of administration for immunization. Medical history was not reported. Concomitant medications were not reported. Patient experienced chronic fatigue and a warm, red lump where injection was administered; hypertension, sleep apnea and pre-diabetic. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/ batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Sleep apnoea syndrome
Clinical narrative: Chronic fatigue; A warm, red lump where injection was administered; A warm, red lump where injection was administered; A warm, red lump where injection was administered; hypertension; sleep apnea; pre-diabetic; This is a spontaneous report from a contactable Nurse. A 71-year-old female patient received pneumococcal 13-val conj vac (DIPHT CRM197 PROTEIN) (PREVNAR 13) on unknown date at single dose via unknown route of administration for immunization. Medical history was not reported. Concomitant medications were not reported. Patient experienced chronic fatigue and a warm, red lump where injection was administered; hypertension, sleep apnea and pre-diabetic. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/ batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Albumin urine, Blood creatine phosphokinase, Blood thyroid stimulating hormone, Full blood count, Glycosylated haemoglobin
Clinical narrative: A large knot approximately the size of a golf ball at the site of injection; patient received pneumococcal 13-valent conjugate vaccine intravenously; patient received pneumococcal 13-valent conjugate vaccine intravenously; This is a spontaneous report from a contactable nurse. A 70-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13; Lot number: CG9017), intravenously, on 11Sep2020 at the age of 70-years-old, at 0.5 mL, single as a preventative. Medical history included joint pain, gastric reflux, and cholesterol. Concomitant medications included valproate semisodium (DEPAKOTE); meloxicam (MOBIC) taken for joint pain; bifidobacterium bifidum, bifidobacterium infantis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus casei, lactobacillus paracasei, lactobacillus rhamnosus, streptococcus lactis, streptococcus thermophilus (PROBAC10PLUS) taken for gastric reflux; and simvastatin (MANUFACTURER UNKNOWN) taken for cholesterol. The patient experienced a large knot approximately the size of a golf ball at the site of injection and patient received pneumococcal 13-valent conjugate vaccine intravenously on 11Sep2020. The large knot occurred a few hours after the injection on her right arm at the site of injection. The patient underwent lab tests and procedures on 11Sep2020 which included microalbumin, creatine phosphokinase (CK), A1C, thyroid stimulating hormone (TSH), complete blood count (CBC), lipid panel, comprehensive metabolic panel (CMP), and vitamin D; all with unknown results. The outcome of a large knot approximately the size of a golf ball at the site of injection and patient received pneumococcal 13-valent conjugate vaccine intravenously was unknown.   No follow-up attempts are needed.  No further information is expected.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site nodule, Lipids, Metabolic function test, Vitamin D
Clinical narrative: A large knot approximately the size of a golf ball at the site of injection; patient received pneumococcal 13-valent conjugate vaccine intravenously; patient received pneumococcal 13-valent conjugate vaccine intravenously; This is a spontaneous report from a contactable nurse. A 70-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13; Lot number: CG9017), intravenously, on 11Sep2020 at the age of 70-years-old, at 0.5 mL, single as a preventative. Medical history included joint pain, gastric reflux, and cholesterol. Concomitant medications included valproate semisodium (DEPAKOTE); meloxicam (MOBIC) taken for joint pain; bifidobacterium bifidum, bifidobacterium infantis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus casei, lactobacillus paracasei, lactobacillus rhamnosus, streptococcus lactis, streptococcus thermophilus (PROBAC10PLUS) taken for gastric reflux; and simvastatin (MANUFACTURER UNKNOWN) taken for cholesterol. The patient experienced a large knot approximately the size of a golf ball at the site of injection and patient received pneumococcal 13-valent conjugate vaccine intravenously on 11Sep2020. The large knot occurred a few hours after the injection on her right arm at the site of injection. The patient underwent lab tests and procedures on 11Sep2020 which included microalbumin, creatine phosphokinase (CK), A1C, thyroid stimulating hormone (TSH), complete blood count (CBC), lipid panel, comprehensive metabolic panel (CMP), and vitamin D; all with unknown results. The outcome of a large knot approximately the size of a golf ball at the site of injection and patient received pneumococcal 13-valent conjugate vaccine intravenously was unknown.   No follow-up attempts are needed.  No further information is expected.
Sex: U
Vaccine: UNK
Symptoms: Myalgia, SARS-CoV-2 test negative
Clinical narrative: fleeting myalgias; Initial information was received on 12-Sep-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a an unknown demographic patient who experienced fleeting myalgias (myalgia), when received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious mild fleeting myalgias (myalgia) several weeks following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The patient did not have other likely etiology or other associated signs or symptoms.  Relevant laboratory test results included (Severe acute respiratory syndrome coronavirus 2) SARS-CoV-2 test on an unknown date which was negative.  It was not reported if the patient received any corrective treatment.  The outcome of event fleeting myalgia's was unknown.  There will be no information available on the batch number for this case.
Age: 63.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Chills, Dysaesthesia, Fatigue, Headache, Injection site pain
Clinical narrative: Typical soreness in left shoulder that lasted 2 days but then everything was fine. On August 31st I developed symptoms of muscle aches, headache, chills and fatigue. These symptoms were consistent for 2 weeks with intensity dropping the last 4 days. I also started (09/01/2020) with a rash on my left forehead and sensitivity/discomfort along the left side of my scalp to my left eye region. Dyesthetic sensations along the same area
Age: 63.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Myalgia, Rash, SARS-CoV-2 antibody test negative, SARS-CoV-2 test negative, Sensitive skin
Clinical narrative: Typical soreness in left shoulder that lasted 2 days but then everything was fine. On August 31st I developed symptoms of muscle aches, headache, chills and fatigue. These symptoms were consistent for 2 weeks with intensity dropping the last 4 days. I also started (09/01/2020) with a rash on my left forehead and sensitivity/discomfort along the left side of my scalp to my left eye region. Dyesthetic sensations along the same area
Age: 63.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Skin discomfort
Clinical narrative: Typical soreness in left shoulder that lasted 2 days but then everything was fine. On August 31st I developed symptoms of muscle aches, headache, chills and fatigue. These symptoms were consistent for 2 weeks with intensity dropping the last 4 days. I also started (09/01/2020) with a rash on my left forehead and sensitivity/discomfort along the left side of my scalp to my left eye region. Dyesthetic sensations along the same area
Age: 59.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: RAsh all over stomach and back.  Rash itches and is red
Age: 5.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Erythema, Swelling
Clinical narrative: Patient received the vaccines on 9/14/20 on his left tight. Next day after the vaccine patient presented with swollen on the back of his left call the size of a golf ball with some redness. No bug bites or trauma reported. Per mom patient progressed with improvement and at the time of the evaluatio by telemedicine ( 3 days after the event) no more concerns.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Disorientation, Dizziness, Pyrexia
Clinical narrative: Patient reported experiencing fever of 102 degrees, chills, feeling dizzy and disoriented 24 hours after receiving vaccine.  This continued for 48 hours.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event at this time, This is just to report that pt may have received flu vaccine twice
Age: 71.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia, SARS-CoV-2 test negative, Septic screen
Clinical narrative: Pt went to the er due to having an temperature of 104.  She was tested for covid and sepsis. Both were negative. Er doctor believed that the fever was due to the vaccines. Pt is taking tylenol every 4 hours or else the fever goes up.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Chills, Headache
Clinical narrative: Severe chilling, violent shivering that lasted, non-stop, for about 90 minutes, beginning about 9:30 p.m. on the evening of having received injection.  Only other symptoms were moderate headache and upset stomach.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Cellulitis, Product administered at inappropriate site
Clinical narrative: Patient received Fluzone HD NDC 49281 0120 65 on 9/10/20. She says she got a cellulitis from the flu shot, which required an ER visit and is currently taking Keflex. Patient showed me the area of cellulitis, which was not in the deltoid muscle, but about 2 to 3 inches below, indicating the shot was given at an inappropriate site.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Cellulitis
Clinical narrative: Patient received Fluzone HD NDC 49281 0120 65 on 9/10/20. She says she got a cellulitis from the flu shot, which required an ER visit and is currently taking Keflex. Patient showed me the area of cellulitis, which was not in the deltoid muscle, but about 2 to 3 inches below, indicating the shot was given at an inappropriate site.
Age: 75.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Chills, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Patient got redness, hot to touch on her left arm (flu shot location), she also had fever and chills the night of the shot.  Patient went to Urgent Care center, they prescribed cephalexin
Age: 89.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Hyperaesthesia, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: pt came in on 9/16 stating that the arm was painful to the touch. Upon inspection, reaction was not at site of injection, but more medial. Reaction included radiating heat, swollen, red, and painful to the touch. Advised pt to take 2 doses of tylenol and use an ice pack. Pt returned to the store on 9/17/20. Reaction has significantly been reduced. No redness or heat observed and patient states that it is only a little painful.
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Chills, Tremor
Clinical narrative: Patient had Chills and uncontrollable shaking that started approx. 24 hours after the vaccine was given patient did not provide information on how long before the symptoms resolved
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Blood creatine phosphokinase normal, Blood potassium decreased, Blood urine present, Full blood count normal, Gait inability
Clinical narrative: Child developed fever to 102 nest am and Henoch Schoenlein Purpura rash starting the next morning, and progressing to the point of not being able to walk the following evening, resulting in overnight hospitalization.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Henoch-Schonlein purpura, Pyrexia, Urine analysis abnormal
Clinical narrative: Child developed fever to 102 nest am and Henoch Schoenlein Purpura rash starting the next morning, and progressing to the point of not being able to walk the following evening, resulting in overnight hospitalization.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction; after admin, this LPN realized vaccination had expiration date of 02-SEP-2020; route/site: IM Vastus Lateralis; This spontaneous report was received from a Licensed Practical Nurse, referring to a 5-year-old female patient. The patient's pertinent medical history, concurrent conditions and previous drug allergies or reactions were not reported. Concomitant therapies included diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid(KINRIX) and sterile diluent (MERCK STERILE DILUENT).  On 09-SEP-2020, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)  intramuscular in the left vastus lateralis (incorrect route of product administration) as prophylaxis (dosage regimen was not provided; lot number S006829 and expiration date 02-SEP-2020, which have been verified to be valid). After administration, the nurse realized vaccination had expiration date of 02-SEP-2020 (expired vaccine used). No adverse reactions after vaccination.
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored PROQUAD; Information has been received from a medical assistant referring to a 4 years old male patient. The patient's medical history, concurrent conditions and concomitant medications were not provided.      On 11-AUG-2020, the patient was administered improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T001187, expiration date 11-JUL-2021; dose, strength and route were unknown), which was reconstituted with properly stored Merck sterile diluent. The vaccine was exposed to multiple temperature excursions between minus 15 to 8 degrees Celsius (minus 6.1 degrees Celsius) (product storage error). There was no previous temperature excursion. The call was due to digital data logger.
Sex: M
Vaccine: HPV9
Symptoms: Electroencephalogram, Seizure
Clinical narrative: have seizures is gut wrenching; This spontaneous report was received from a consumer referring to a male patient of unknown age. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were unknown.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, batch/lot# and expiration date were unknown) for prophylaxis.  The reporter stated that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) has altered the patient's life irrevocably. The reporter was guilt for allowing pediatrician to give the patient that shot. In 2014, the patient started having seizures. The event of seizures caused hospitalization. The reporter did not inform Merck at the time. The reporter stated that the patient was up to date on vaccines, including the meningitis shot. The reporter stated that human papillomavirus (HPV) was a sexually transmitted disease that could be detected and treated. Limiting sexual partners (what a novel idea!) and having regular physicals and living in a healthy way was so much more sensible than injecting this poison. The healthy young patient had his dreams of playing college sports and going away to college stepped on due to unexpected, vicious seizures was not how preventative medicine was supposed to work. The patient was strapped to electroencephalogram (EEG)s waiting to see if a seizure happens, paid over $1800 out of pocket with insurance just to drive him 2 blocks from the emergency room (ER) to the best epilepsy unit, paid $1000/month for a name brand medication that worked the best because insurance won't pay because "there was another anti-seizure medication, just use it". The reporter stated that the healthy, smart young man was a victim of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The reporter wished that Merck would take that money and help some family that has also been damaged by hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Medical attention was sought. Treatment was given to the patient. The outcome of the event was unknown. The causality assessment was related.  Upon internal review, the event of seizure was determined to be medically significant.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Condition aggravated, Grip strength decreased, Ill-defined disorder, Injected limb mobility decreased, Loss of personal independence in daily activities
Clinical narrative: ShoT was given in UPPER Left Arm -close to shoulder - when I got home - 2 Hrs after couldn't move my left arm & pain was horrific for 4 days. Couldn't Do Anything - my daughter had to help me dress etc. Couldn't even hold a phone eTc. my daughter is a P.T. & was Try to make sure arm didn't freeze. I have Trouble with that arm Anyway & this Just agitated iT. My arm still bothers me. Developed Tendintes - Hoping iT will Get Better.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Tendonitis
Clinical narrative: ShoT was given in UPPER Left Arm -close to shoulder - when I got home - 2 Hrs after couldn't move my left arm & pain was horrific for 4 days. Couldn't Do Anything - my daughter had to help me dress etc. Couldn't even hold a phone eTc. my daughter is a P.T. & was Try to make sure arm didn't freeze. I have Trouble with that arm Anyway & this Just agitated iT. My arm still bothers me. Developed Tendintes - Hoping iT will Get Better.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: While administering the dose of vaccine running down the patient's arm from the injection site/No AE; While administering the dose of vaccine running down the patient's arm from the injection site/No AE; Initial information was received on 11-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 56-years-old male patient received vaccine 0.5 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (single dose syringe, lot UT7005JA and expiry date 30-Jun-2021) via unknown route in the arm for prophylactic vaccination and while administering the dose of vaccine running down the patient's arm from the injection site (underdose and syringe issue) on an unknown date.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  It was case of actual medication error due to vaccine underdose. It was also a case of syringe leak (on same day).  At the time of reporting no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Age: 0.33
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4 month old male was administered ADACEL instead of PENTACEL, no AE; 4 month old male was administered ADACEL, no AE; Initial information received on 14-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a four month old male patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered and product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 14-Sep-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6737AA and expiry date: 09-Jul-2022) via an intramuscular route in the left leg for prophylactic vaccination.  It was a case of actual medication error due to wrong product administered and product administered to patient of inappropriate age (same day latency).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 67 year old female patient administered of Fluzone Quadrivalent instead of Fluzone High Dose , no AE; Initial information received on 14-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 67 year old female patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (wrong product administered and product administered to patient of inappropriate age).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 14-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot QFAA2021 and expiry date: 30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong product administered (same day latency).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Heart rate decreased, Peripheral coldness, Syncope
Clinical narrative: Pt was fine after Immunization. Fainted in aisle. Was given orange juice, recovered pulse low, clammy skin, cold skin. Recovered and left here.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chest pain, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: c/o headache, fatigue, muscle pain / chest pain that did not allow sleep last night. No redness at injection site. 24 hrs after shot has severe muscle pain / headache / malaise. Tylenol 1000mg given PO in office.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Sleep disorder
Clinical narrative: c/o headache, fatigue, muscle pain / chest pain that did not allow sleep last night. No redness at injection site. 24 hrs after shot has severe muscle pain / headache / malaise. Tylenol 1000mg given PO in office.
Age: 91.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Blood pressure increased, Chest pain, Dyspnoea, Feeling hot
Clinical narrative: Within minutes of receiving flu vaccine pt began groaning in distress, c/o severe pain radiating from base of sternum into her lower back. Face became very flushed, hot, c/o SOB. BP elevated 189/74, HR 82. Oxygenation was stable at 98 %, HR remained steady. Temp 98.4. RR 20. Cool compresses to face, ice to back. after 15 mins patient was calmer, flushed, pain in back starting to dissipate. BP continued to be elevated 185/67, HR 73. Oxygen 98%. At 10:41 am patient reports she was feeling better and hungry, face pink, discharged home in care of daughter. Follow up phone call with daughter at 3:33 pm, she reports patient was feeling much better, had eaten lunch and taken her BP meds, blood pressure 126/57.
Age: 91.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Moaning, Pain
Clinical narrative: Within minutes of receiving flu vaccine pt began groaning in distress, c/o severe pain radiating from base of sternum into her lower back. Face became very flushed, hot, c/o SOB. BP elevated 189/74, HR 82. Oxygenation was stable at 98 %, HR remained steady. Temp 98.4. RR 20. Cool compresses to face, ice to back. after 15 mins patient was calmer, flushed, pain in back starting to dissipate. BP continued to be elevated 185/67, HR 73. Oxygen 98%. At 10:41 am patient reports she was feeling better and hungry, face pink, discharged home in care of daughter. Follow up phone call with daughter at 3:33 pm, she reports patient was feeling much better, had eaten lunch and taken her BP meds, blood pressure 126/57.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Eye swelling, Immediate post-injection reaction, Injection site swelling
Clinical narrative: Immediately after patient received the shot, the injection site swelled up and the patient reported dizziness and eye swollen.
Age: 32.0
Sex: M
Vaccine: FLUR4
Symptoms: Erythema, Skin warm
Clinical narrative: On 9/17/20, the patient presented with a very red and warm to the touch arm.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Influenza, Nausea, Pyrexia, Vomiting
Clinical narrative: Flu symptoms--high fever 103.5,  vomiting, chills, nausea. Time--still ongoing
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Patient came to a follow up appointment one week after she was given her administration. She stated that she had swelling, redness and tenderness from the injection site down to almost her elbow, and swelling under the arm. She stated this occurred the next morning. The swelling, redness and tenderness has gone away since but there is a quarter sized lump at administration site. There was no treatment given and patient was asked to call if the site changes or worsens or any other symptoms starts up.
Age: 76.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Neck mass, Neck pain, Odynophagia, Swelling face
Clinical narrative: Right side of my face  blew up , my neck had a lump the size of orange and was extremely sore. When I swallowed it hurt like the mumps. My neck is still has a lump the size of an walnut.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site paraesthesia, Pain, Paraesthesia
Clinical narrative: HPV vaccines given left upper arm on 9/1/2020.  Persistent pain.  Numbness and tingling at the injection site.  Sometimes radiating down to the left of her wrist.  No fever. Persistent pain after vaccination > 2 weeks prior.  Warm compress to area  NSAID x 1-2 weeks.  If no improvement in 1 week, patient to contact PCP Given prolonged symptoms, PCP does not advise patient to get #2 and #3 boosters.
Age: 66.0
Sex: M
Vaccine: FLUA4, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Patient reported that his left arm was red and swollen and painful from the area of the shot down to his elbow. He reported no fever. He was taken naproxen for the pain and inflammation.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Dysstasia, Gait disturbance, Hot flush
Clinical narrative: extreme dizziness making it difficult to stand or move, severe vomiting, bowel movements, chills/shivers, hot/flushed feeling.  No treatments, just lay down and try to wait for it to pass and vomiting to stop.  After several hours (4-6) I was able to go to sleep.  When I got up during the night to pee, I was still dizzy, but not as severe.  When I awoke this morning, most of the dizziness was gone and my stomach felt good enough to have cereal.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: extreme dizziness making it difficult to stand or move, severe vomiting, bowel movements, chills/shivers, hot/flushed feeling.  No treatments, just lay down and try to wait for it to pass and vomiting to stop.  After several hours (4-6) I was able to go to sleep.  When I got up during the night to pee, I was still dizzy, but not as severe.  When I awoke this morning, most of the dizziness was gone and my stomach felt good enough to have cereal.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: Patient received a duplicate vaccine due to patient reporting and inaccurate information from reporting system
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: leg was red and swelled at injection site
Age: 50.0
Sex: F
Vaccine: FLUR4
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Red / raised/ warm / hard area at injection site (1 1/2 mo) Muscle aches/pains/spasms (1 1/2 mo) Headache 1 month tried cold compresses, tylenol, ibuprofen, tramadol, methocarbamol to relieve s/s
Age: 50.0
Sex: F
Vaccine: FLUR4
Symptoms: Muscle spasms, Myalgia
Clinical narrative: Red / raised/ warm / hard area at injection site (1 1/2 mo) Muscle aches/pains/spasms (1 1/2 mo) Headache 1 month tried cold compresses, tylenol, ibuprofen, tramadol, methocarbamol to relieve s/s
Age: 90.0
Sex: F
Vaccine: FLUA3
Symptoms: Death
Clinical narrative: Death 11/04/2019
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Presyncope, Tinnitus
Clinical narrative: shortly after vaccination, patient experienced what I believe may be a vagal response --dizziness, ringing in the ear and feeling faint.  Asked if he has shortness of breath to which he says no.  Informed parents that urgent care is right across the street and to bring him there if other symptoms arise.  He drank some water, sat in our pharmacy lobby for about 15 minutes with his family.  He says that he feels a little better after some time and left with his family.  I called twice to check in with family, no answer, had to leave a message
Age: 42.0
Sex: F
Vaccine: FLUR4
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Vomiting
Clinical narrative: Approx 7 hours after injection,  started experiencing diarrhea.  Around 14 hours post junction, nausea and fatigue. 24 hour after injection,  vomiting and headache. It is now 72 hours after injection,  still experiencing nausea, vomiting, diarrhea,  fatigue, headache.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Urticaria
Clinical narrative: The morning of 9/15/20, the pt. awoke and noticed redness, soreness and pain at the site of the injection.  Over the next 2 days, the redness progressed to a welt approx.  2 in. x 3 in. in size and was very tender to touch.  This welt (rash?) was posterior and inferior to the injection site.  I (the patient) took Benadryl at night and continued with the Zyrtec (daily in the morning) and Montelukast at HS which had just been prescribed.  There was no fever, no dyspnea, so no need to see a physician.  The meds were continued and at HS on 9/16/20 cortisone cream was applied to the welt.  The morning of 9/17/20 the redness had almost gone and there was no more pain.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever initiated approximately 4 hours after injection.  I took 2 regular dose Tylenol 5 hours after injection.  Fever continued to increase.  I experienced involuntary shivers for about 30 minutes.  I also experienced aches throughout my entire body, from my head to the tips of fingers and to the soles of my feet.  My fever was 100.3 (3 degrees over my normal temperature of 97 or below)  approximately 14 hours after injection.  After a dose of 1 regular Tylenol at that time, fever started to reduce.  I was without fever approximately 24-28 hours after fever started.
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Arthralgia, Lethargy, Myalgia
Clinical narrative: Pt's wife called back saying that the patient was experiencing severe arthralgia and myalgia and was lethargic. This is the patient's first flu vaccine in a number of years and I presumed it might be due to the adjuvant. I instructed the patient to take OTC medications for the pain and I will follow up at 24 hours.
Age: 54.0
Sex: F
Vaccine: FLUA3
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: PT REPORTS HAD TINNITUS IN LEFT EAR OCCURING 5-6 HOURS AFTER RECEIVING INFLUENZA VACCINATION AT THE CLINIC WHICH SHE WORKS FOR.  PRESENTED TO ANOTHER CLINIC WITH C/O TINNITUS IN LEFT EAR ONLY, REPORTS HEARING SLIGHTLY REDUCED, DENIED PAIN.  AFEBRILE.  REQUESTING "STEROID SHOT FOR ALLERGIC REACTION TO FLU VACCINE".  COLLECTION OF FLUID NOTED TO MIDDLE EAR BILATERALLY; PREDNISONE GIVEN AND RECOMMEND FLONASE OTC NASAL SPRAY DAILY.  DECLINED HEARING TEST AT TIME OF VISIT, RECOMMEND F/U WITH PCP OR EAR, NOSE, & THROAT SPECIALIST.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Patient reported two days post injection a lump, redness and hot to the touch at the site of injection
Age: 71.0
Sex: M
Vaccine: FLUA3
Symptoms: Joint swelling, Peripheral swelling, Pruritus, Swollen tongue
Clinical narrative: The patient woke up at 2am on 09/17/2020 with itchy hands that progressed to swollen wrists and feet.  Patient took benadryl reported feeling better.  Upon waking in the morning patient reported a swollen tongue.  The patient went to an urgent care and was given an rx of prednisone.  Upon consulting with the patient's allergist, patient did not take prednisone that was dispensed on 09/17/2020.  The reported to the pharmacist at 230pm on 09/17/2020 that he was feeling better and the side effects were almost gone.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Blood glucose normal, Dyskinesia, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: Patient became pale, diaphoretic, and jerked back into chair. Then head leaned forward and when mom called his name he responded, lifted his head, opened his eyes and said "what". Patient complained of feeling hot and nauseated afterwards. Patient was monitored for one hour post injection. VS taken every 15 minutes, pulse-ox monitored throughout. Patient was given a snack and water, and was able to tolerate prior to discharge.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Pallor, Posture abnormal
Clinical narrative: Patient became pale, diaphoretic, and jerked back into chair. Then head leaned forward and when mom called his name he responded, lifted his head, opened his eyes and said "what". Patient complained of feeling hot and nauseated afterwards. Patient was monitored for one hour post injection. VS taken every 15 minutes, pulse-ox monitored throughout. Patient was given a snack and water, and was able to tolerate prior to discharge.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm, Urticaria
Clinical narrative: Hives right arm Redness  Swelling Warm to touch
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Patient received the vaccine on 9/9/20.  She reports a penny sized bruise where she received the vaccine and that it sore to the touch 8 days after receiving the vaccine.  She would like a follow up call from a person from the manufacture.  Please contact patient
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Pain, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Developed pain to the left arm on 8/20/2020.   Is mildly swollen and tender on 9/17/2020 exam.  Is losing shoulder motion secondary to the pain.
Age: 67.0
Sex: F
Vaccine: FLUA4
Symptoms: Urticaria
Clinical narrative: Patients has hives all over torso.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left arm was sore in the shoulder and hot at the injection site the next day. The arm became red and the heat and redness spread from the injection site around the bicep and behind the arm. The area was slightly swollen and continued to be red and hot for 6 days
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Skin warm
Clinical narrative: patient had a red arm, hot to the touch, bruised also
Age: 0.25
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Back pain, Blood test, Scan
Clinical narrative: Severe pain in abdominal area and back lasting several days
Age: 22.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: none
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: Patient moved her arm out of the way during immunization, needle went into arm, did not receive any of the dose as the plunger was not deployed.  Mother will repeat at drs office
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient called the pharmacy on 9/17/2020 at 5:00 pm to tell me he has had soreness and swelling  at the injection site for 2 weeks now. He stated the area is not red but it is swollen. He is coming in to show me this weekend. In the meantime I told him to use benadryl at night and cold compress throughout the day. He gets the flu shot every year and has never had a reaction. His wife got hers at the same time and was fine.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Musculoskeletal stiffness, Pain
Clinical narrative: Unusually stiff and sore at injection site (left shoulder) shortly after injection; felt like shoulder had received a very strong punch unlike other years' flu injections. The stiffness and soreness then spread to the forearm (left) and hand starting at 4:30 pm (90 minutes after injection.) Thirty minutes later, stiffness and soreness spread to left leg (top). Was difficult and very uncomfortable to fully raise left arm overhead. Noted that I was not able to do so until some time later that evening. Stiffness/soreness in mentioned sites continued eight hours later until I went to sleep at midnight. Soreness/stiffness had lessened some by morning, but remained noticeable at all sites mentioned. Soreness did not abate until later that day. Injection site remains lightly sore at touch today, five days later.