chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Seizure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of seizure in a male patient who received SHINGRIX. Concurrent medical conditions included convulsion disorder (well controlled, therapeutic drug level). On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was recovered/resolved. It was unknown if the reporter considered the seizure to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter wanted to know if any information could be provided specifically regarding SHINGRIX and seizures. The patient had a witnessed 2.5 minute seizure after receiving SHINGRIX. The reporter had submitted the report to VAERS. The reporter wanted to know if there was any information correlating SHINGRIX to seizure and wanted recommendation on whether the patient should receive the second dose of the series. If the patient did not receive the 2nd dose, what was the efficacy if only one dose was received. No further information (patient or vaccine information) was available at the reporting time.
Sex: F
Vaccine: MENB
Symptoms: Meningitis, Vaccination failure
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of vaccination failure in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningitis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the meningitis was recovering/resolving. It was unknown if the reporter considered the vaccination failure and meningitis to be related to BEXSERO. Additional details were reported as follows: The case was reported by a medical director who was a physician at department of Health. The age at vaccination was not reported. The reporter stated that the patient was a student. The patient received BEXSERO approximately in 2016. The patient developed Meningitis Men B and was currently hospitalized in hospital, at the time of reporting. The reporter provided very limited information. This was considered as suspected vaccination failure case since the laboratory test confirmation and time to onset for Meningitis Men B was unknown.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dyspnoea, Erythema, Pruritus, Scratch, Urticaria
Clinical narrative: Patient received 2nd dose of HPV vaccine on 3/26/2018, on 3/30/18 she presented to a walk in clinic with trouble breathing and welts on entire body. Was given BENADRYL and now still has some red areas from where patient had scratched.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: No adverse event, Product preparation error
Clinical narrative: PT WAS IN THE ROOM TO GET VACCINES WITH AN OLDER SIBLING. VACCINES WERE PULLED FOR ALL CHILDREN. MENINGICCOCAL (PULLED FOR AN OLDER SIBLING) WAS USED AS THE DILUENT FOR THE PROQUAD. PT SHOWED NO ADVERSE SIGNS OR SYMPTOMS.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Moderate pain in left arm, redness and swelling at injection site, muscle pain, shivering, stomach pain. The moderate arm pain, redness and swelling started on 4/11, the same day as the injection. Shivering, muscle pain and stomach pain started during the night.  All symptoms are ongoing as of today, 4/12 at 6:30am.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Moderate pain in left arm, redness and swelling at injection site, muscle pain, shivering, stomach pain. The moderate arm pain, redness and swelling started on 4/11, the same day as the injection. Shivering, muscle pain and stomach pain started during the night.  All symptoms are ongoing as of today, 4/12 at 6:30am.
Age: 1.17
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Area of redness, edema and warmth approx 8cm x 5cm noted to LUE over deltoid muscle, 2 areas consistent with needle insertion sites visible over L upper arm.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Immediate post-injection reaction, Injection site pain, Pain, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a adult male patient who received SHINGRIX. On 5th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 5th April 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 6th April 2018, the patient experienced general body pain, fever and feeling bad. On an unknown date, the outcome of the injection site pain, general body pain, fever and feeling bad were unknown. It was unknown if the reporter considered the injection site pain, general body pain, fever and feeling bad to be related to SHINGRIX. Additional information was reported as follows: This case was reported by the physician who himself was the patient. The age at vaccination was not reported. The patient received SHINGRIX in the morning. The patient experienced pain immediately at the injection site, then 24 hours later experienced systemic pain, aches, suspected fever and felt lousy.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of headache in a 53-year-old female patient who received SHINGRIX. In March 2018, the patient received SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced headache, pain in arm, injection site swelling and fever. On an unknown date, the outcome of the headache, pain in arm, injection site swelling and fever were recovered/resolved. It was unknown if the reporter considered the headache, pain in arm, injection site swelling and fever to be related to SHINGRIX. Additional details were reported as follows: The patient experienced a headache, fever of 101.7, sore arm that lasted 3 to 4 days and puffiness as the injection site. The patient was feeling better a week after receiving the vaccination. The reporter sent an email to the field representative to provide the information. The adverse event was reported in after hours by the field representative. The reporter was unable to provide any additional details other than that the reporter received the vaccination a week prior of reporting.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 51-year-old female patient who received the 1st dose of SHINGRIX. In April 2018, 18 hrs after receiving SHINGRIX, the patient experienced general body pain, fatigue and fever. On an unknown date, the outcome of the general body pain, fatigue and fever were recovered/resolved. The reporter considered the general body pain, fatigue and fever to be related to SHINGRIX. Additional details were provided as follows: On 4th April 2018 at 01.00, the patient received the 1st dose of SHINGRIX on left arm. On 5th April 2018, the patient experienced body aches, fatigue and fever. The employee stated that she knew of the possible side effects, which she experienced, were listed in the prescribing information. She was advised to report the side effects anyway.
Age: 73.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Chills, Injection site erythema, Injection site pruritus, Injection site swelling, Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 73-year-old male patient who received SHINGRIX. Concomitant products included Aspirin, Atorvastatin, clopidogrel, finasteride, Levothyroxine, pantoprazole, HUMIRA, metoprolol succinate, enalapril, PNEUMOVAX and tamsulosin. On 31st March 2018 11:00, the patient received the 1st dose of SHINGRIX. On 31st March 2018, less than a day after receiving SHINGRIX, the patient experienced chills and difficulty sleeping. On an unknown date, the patient experienced injection site swelling, injection site itching and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site itching, injection site erythema and chills were recovered/resolved and the outcome of the difficulty sleeping was unknown. The reporter considered the injection site swelling, injection site itching, injection site erythema and chills to be related to SHINGRIX. It was unknown if the reporter considered the difficulty sleeping to be related to SHINGRIX. Additional details were reported as follows: The patient stated half day after vaccination, the patient developed chills at night and was not able to sleep. Less than a month after vaccination, the patient stated the injection site was red, swollen, and itchy which lasted about approximately for a week. The patient gave the permission to contact their health care provider. The reported provided limited information in regards to lot number and expiration date of the product.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash morbilliform
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of measles-like rash in a male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 2 hrs after receiving SHINGRIX, the patient experienced measles-like rash. The patient was treated with BENADRYL. On an unknown date, the outcome of the measles-like rash was recovering/resolving. It was unknown if the reporter considered the measles-like rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the field representative (account manager) who received an email from the director of clinical within the pharmacy chain. The pharmacist was contacted by the wife and the pharmacist told her to take the patient to the emergency room. The age at vaccination was not reported. Two hours after the injection, the patient experienced a rash on the upper torso and was described as measles-like. The patient went to the emergency room and was given an injection of (IM) BENADRYL intramuscularly and famotidine and went home that evening. The PA stated that they have not seen any other reaction to the vaccination as of yet. After doing follow up with the patient's wife, she informed that the patient condition was improving.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Perfect circle around injection site measuring 4.1 long and 3.5 wife. Severely itchy, complaining of pain. Mom gave detox bath (epson salt/baking soda bath). Mom gave 2.5ml of Zyrtec on 04/10/2018 @ 4pm. Called Dr numerous times on 04/10/2018 and was told to give Tylenol and ice pack. Site proceeded to get worse. Called Dr again on 04/11/2018 and as of 04/12/2018 mom is still waiting to hear from Dr. Mom gave second detox bath on 04/12/2018 and gave Zyrtec at 8am on 04/12/2018.  As of 04/12/2018 @ 9:53am, the area around the site has faded and swelling has gone down.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Influenza like illness, Malaise
Clinical narrative: Patient claimed to have breathing problems and felt generally ill. She described it as flu-like and went to an urgent care. She said she was ill for 5 days since getting the vaccine.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient complained about soreness of the arm and injection site pain.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The information regarding medical history, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # N013504, expiration date: 08-DEC-2019 (dose and route of administration were not reported). No adverse effects were reported. The vaccine was stored in temperature of 32 Fahrenheit degrees (F) to 35 F (35.4 F) for 8 hours. The call was not because of a data logger.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 23-year-old patient of unknown gender. Information on pertinent medical history, drug allergies and concomitant medications were not reported. On 06-OCT-2017, the patient received the first dose of GARDASIL 9 intramuscularly for prophylaxis. The pharmacist reported that on 30-MAR-2018, the same patient returned to pharmacy to receive the 2nd dose of GARDASIL 9 lot# N019104 with expiry date of 03-FEB-2020 for prophylaxis. No adverse effect was reported. No product quality complaint was reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 22-MAR-2018 and 03-APR-2018, the patient was vaccinated with a dose of GARDASIL 9 injection (strength, dose, lot # and expiration date were not reported) intramuscularly for prophylaxis. No known adverse effects was reported. No further information was provided. There was no product quality complaint (PQC) reported.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 month old patient of unknown gender. The patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication were unknown. On an unknown date the patient was inadvertently vaccinated with (wistar ra 27-3) M-M-R II (lot number and expiry date unknown) (dosing regimen and frequency unknown) and Oka-Merck PROQUAD (lot number and expiry date unknown) (dosing regimen and frequency unknown) for prophylaxis (inappropriate schedule of drug administration). It was unknown if this medication error was due to a product confusion. It was reported that the vaccines were administered with a sterile diluent (manufacturer unknown). No adverse event (reported as no adverse effect) was reported. The action taken with suspect products and the outcome of the event was unknown. There was no product quality compliant was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 06-APR-2018 the patient was vaccinated with expired dose of ZOSTAVAX 19400 PFU (dosing details were not reported) (lot # M010472, expiry date: 01-JUN-2017) for prophylaxis that was prepared with MERCK STERILE DILUENT)(lot # R002715, expiry date: 20-FEB-2020) (expired product administered). No known adverse effects. No product quality complaint involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 15-OCT-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), administered by a physician for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster. On an unknown date during 2016, the patient was treated by the physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies were not reported. Concomitant therapies included sterile diluent (STERILE DILUENT) (lot# L030306 and expiration date: 08-APR-2018) which was properly stored. On 05-APR-2018, the patient was vaccinated with improperly stored injection VARIVAX (dose, units and frequency not reported) (lot # N021722 and expiration date: 08-APR-2018) subcutaneously at the temperature from -9 degree Celsius (C) to 8 C for 25 hours. It was reported that, the vaccines had previous temperature excursion in the range from -14 C to -10 C for 37 hours 3 minutes. Digital data logger was involved. No product quality complaint was involved.
Age: 15.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 year old patient of unknown gender. No medical history, concurrent condition and concomitant medications were reported. On 09-APR-2018, at the age of 15 years, the patient was vaccinated with second dose of Oka-Merck PROQUAD for prophylaxis (drug administered to patient of inappropriate age). Patient received first dose on an unspecified date. No adverse effect was reported. No product quality complaint was involved.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Certified medical assistant (also reported as administrator) refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 10-APR-2018, the patient was inadvertently administered with a expired dose of VAQTA injection lot # N005605 (expiry date: 08-APR-2018) for prophylaxis (dose not reported) (expired vaccine used). No adverse effects reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a medical assistant regarding an adult patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-APR-2018 the patient was vaccinated with pediatric dose of VAQTA 50/1.0 U/ml (lot# and expiration date was not reported), intramuscularly for prophylaxis (incorrect dose administered). No adverse effect was reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 04-APR-2018, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (dose, frequency and route were not reported) (lot # N034005, expiry date: 31-JAN-2020) for prophylaxis. No adverse effect reported. No product quality complaint involved. The LIQUID PEDVAXHIB was stored in temperature of 32 degree Fahrenheit (F) to 35 F (32 F) for 8 minutes. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Incorrect route of drug administration, Injection site bruising, Injection site haemorrhage, Injection site pain
Clinical narrative: Initial unsolicited report received from a consumer on 30-Mar-2018 and additional information received on 30-Mar-2018. This case involves a female patient of unknown age who was vaccinated with 0.5 ml of ADACEL (batch number, expiry date and dose in series were not reported) via subcutaneous route incorrectly at the back of the right arm on 28-Mar-2018. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced pain at the injection site immediately and there was bleeding immediately after the vaccine that required brief pressure and a band aid. States that now the whole back of her right arm is bruised. Says it's not painful and doesn't feel it requires medical attention at this time. It was also reported Site bled quite a bit, and patient now have 1" diameter bruise on upper arm. patient asked that Was vaccine actually delivered into my body, or did it flow out with blood? Patient was concerned that she was not protected, and that pharmacist didn't know correct was to inject vaccine. It was also a case of actual medication error due to vaccine administered at inappropriate site as pharmacist who administered the vaccine placed the shot incorrectly to the back of the right arm and also inappropriate route of vaccination as vaccine administered subcutaneously. Lab data and corrective treatment were not reported. On unknown date, patient recovered from the event vaccination site pain. Outcome of the events bruise, vaccination site bleeding, vaccination site reaction were recovering. 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. List of documents held by sender: none
Sex: F
Vaccine: TDAP
Symptoms: Product administered at inappropriate site
Clinical narrative: Initial unsolicited report received from a consumer on 30-Mar-2018 and additional information received on 30-Mar-2018. This case involves a female patient of unknown age who was vaccinated with 0.5 ml of ADACEL (batch number, expiry date and dose in series were not reported) via subcutaneous route incorrectly at the back of the right arm on 28-Mar-2018. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced pain at the injection site immediately and there was bleeding immediately after the vaccine that required brief pressure and a band aid. States that now the whole back of her right arm is bruised. Says it's not painful and doesn't feel it requires medical attention at this time. It was also reported Site bled quite a bit, and patient now have 1" diameter bruise on upper arm. patient asked that Was vaccine actually delivered into my body, or did it flow out with blood? Patient was concerned that she was not protected, and that pharmacist didn't know correct was to inject vaccine. It was also a case of actual medication error due to vaccine administered at inappropriate site as pharmacist who administered the vaccine placed the shot incorrectly to the back of the right arm and also inappropriate route of vaccination as vaccine administered subcutaneously. Lab data and corrective treatment were not reported. On unknown date, patient recovered from the event vaccination site pain. Outcome of the events bruise, vaccination site bleeding, vaccination site reaction were recovering. 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. List of documents held by sender: none
Sex: F
Vaccine: RAB
Symptoms: Decreased appetite, Lethargy, Mobility decreased, Vomiting
Clinical narrative: Initial unsolicited report received from Pharmacist (also consumer) on 02-Apr-2018. This case involves female patient who was vaccinated with 0.1 ml third dose of IMOVAX (Batch number, expiration date, site not reported) intramuscularly on 29-Mar-2018. The patient's medical history and concomitant medications were not reported. On 30-Mar-2018, one day following the vaccination, the patient began to have vomiting which continued into Saturday, 31-Mar-2018. On an unknown date, following vaccination patient was lethargic continued to feel lethargic to the point where she was unable to be up out of bed except to use bathroom and had no appetite, did not feel like eating. It was also reported that will be returning to own physician for evaluation and treatment as needed on 03-Apr-2018. Lab data was not reported. Corrective treatment was not reported. On an unknown date patient got recovered from vomiting. Outcome of the other events were not recovered. List of documents held by sender: none.
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Cellulitis, Erythema, Pyrexia, Swelling
Clinical narrative: Initial unsolicited report received from health authority (under the reference number: 725697) on 03-Apr-2018. This case involves 33-year-old female patient who was vaccinated with a dose of FLUBLOK QIV (batch number: QFAA1703) and PNEUMOVAX (manufacturer: Merck) (Batch number: N022303) (expiration date, dose was not reported) via intramuscular route in the left arm on 02 Nov 2017. The patient's medical history and concomitant medications were not reported. On 03 Nov 2017, one day following the vaccination, the patient experienced redness (erythema), pyrexia (fever of 104 degree C), swelling and diagnosed as cellulitis (reported as patient reported to urgent care and diagnosed with cellulitis). Lab data and corrective treatment were not reported. On an unspecified date, patient recovered from the events. Upon internal review, the company decided to consider the event serious due to important medical event cellulitis. List of documents held by sender: none.; Sender's Comments: This patient developed cellulitis with erythema, fever and swelling following vaccination with FLUBLOK QIV. Time to onset was compatible. Additional information including condition at the time of vaccination, medical history, previous vaccinations and tolerance, lab test ruling out other infectious etiology is needed to confirm the causality. Moreover the patient had also received Pneumovax concomitantly, hence the role of individual vaccine cannot be assessed separately.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Full blood count normal, Petechiae, Rash generalised, Skin lesion
Clinical narrative: Diffuse rash from neck to feet, sparing palms and soles starting 6 days after receiving the vaccine. Patient reported they initially looked like small blisters. On my exam about 24 hours after it started, these were pinpoint too numerous to count lesion, some petechial, some coalescing on the backs of the arms and the back that appeared hive-like.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Diffuse rash from neck to feet, sparing palms and soles starting 6 days after receiving the vaccine. Patient reported they initially looked like small blisters. On my exam about 24 hours after it started, these were pinpoint too numerous to count lesion, some petechial, some coalescing on the backs of the arms and the back that appeared hive-like.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Back pain, Chest X-ray, Chest pain, Echocardiogram, Electrocardiogram
Clinical narrative: Dull left sided chest pain began on 3/20/2018, occasionally radiated to the back, and was relieved with position change, primarily leaning forward. The pain continued and worsened on 3/23/2018 when the patient sought care at a local ED. The left sided chest pain became sharper and more severe and was not relieved with position changes any longer. The patient was admitted to the hospital for suspected peri- vs myocarditis secondary to smallpox vaccine. The patient was discharged on 3/28/2018 with a diagnosis of acute myocarditis and is scheduled to follow-up with outpatient cardiology for a repeat echocardiogram in 4 weeks.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Face and mouth X-ray, Myocarditis, Nuclear magnetic resonance imaging heart, Pericarditis, Scan with contrast
Clinical narrative: Dull left sided chest pain began on 3/20/2018, occasionally radiated to the back, and was relieved with position change, primarily leaning forward. The pain continued and worsened on 3/23/2018 when the patient sought care at a local ED. The left sided chest pain became sharper and more severe and was not relieved with position changes any longer. The patient was admitted to the hospital for suspected peri- vs myocarditis secondary to smallpox vaccine. The patient was discharged on 3/28/2018 with a diagnosis of acute myocarditis and is scheduled to follow-up with outpatient cardiology for a repeat echocardiogram in 4 weeks.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Troponin, Vaccination complication
Clinical narrative: Dull left sided chest pain began on 3/20/2018, occasionally radiated to the back, and was relieved with position change, primarily leaning forward. The pain continued and worsened on 3/23/2018 when the patient sought care at a local ED. The left sided chest pain became sharper and more severe and was not relieved with position changes any longer. The patient was admitted to the hospital for suspected peri- vs myocarditis secondary to smallpox vaccine. The patient was discharged on 3/28/2018 with a diagnosis of acute myocarditis and is scheduled to follow-up with outpatient cardiology for a repeat echocardiogram in 4 weeks.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Chest pain, Echocardiogram, Myocarditis, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging heart
Clinical narrative: Dull left sided chest pain began on 3/20/2018, occasionally radiated to the back, and was relieved with position change, primarily leaning forward. The pain continued and worsened on 3/23/2018 when the patient sought care at a local ED. The left sided chest pain became sharper and more severe and was not relieved with position changes any longer. The patient was admitted to the hospital for suspected peri- vs myocarditis secondary to smallpox vaccine. The patient was discharged on 3/28/2018 with a diagnosis of acute myocarditis and is scheduled to follow-up with outpatient cardiology for a repeat echocardiogram in 4 weeks.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Vaccination site scab
Clinical narrative: Dull left sided chest pain began on 3/20/2018, occasionally radiated to the back, and was relieved with position change, primarily leaning forward. The pain continued and worsened on 3/23/2018 when the patient sought care at a local ED. The left sided chest pain became sharper and more severe and was not relieved with position changes any longer. The patient was admitted to the hospital for suspected peri- vs myocarditis secondary to smallpox vaccine. The patient was discharged on 3/28/2018 with a diagnosis of acute myocarditis and is scheduled to follow-up with outpatient cardiology for a repeat echocardiogram in 4 weeks.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Injection site cellulitis, Injection site erythema, Injection site movement impairment, Injection site pain
Clinical narrative: Patient complained of pain and stiffness at injection site on the evening of the injection (09-Apr-2018). Acetaminophen was given at bedtime. Patient woke up on 10-Apr-2018 with an extremely swollen upper right arm and shoulder from elbow to collar bone. Arm was red, swollen, and hot to the touch. Patient had low grade fever and complained of painful arm and headache. Ice pack was applied to the arm and acetaminophen was given throughout the day. On 11-Apr-2018, patient's arm continued to be swollen, red, hot, and painful. Ice pack and acetaminophen regimen continued to be followed per doctor's orders. On 12-Apr-2018, patient awoke with cellulitis-type swelling of the arm. Arm is still swollen, painful, and hot to the touch. Patient is returning to the doctor today.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient complained of pain and stiffness at injection site on the evening of the injection (09-Apr-2018). Acetaminophen was given at bedtime. Patient woke up on 10-Apr-2018 with an extremely swollen upper right arm and shoulder from elbow to collar bone. Arm was red, swollen, and hot to the touch. Patient had low grade fever and complained of painful arm and headache. Ice pack was applied to the arm and acetaminophen was given throughout the day. On 11-Apr-2018, patient's arm continued to be swollen, red, hot, and painful. Ice pack and acetaminophen regimen continued to be followed per doctor's orders. On 12-Apr-2018, patient awoke with cellulitis-type swelling of the arm. Arm is still swollen, painful, and hot to the touch. Patient is returning to the doctor today.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None reported.
Age: 26.0
Sex: F
Vaccine: FLU4, HEP, MMR, VARCEL
Symptoms: Erythema, HIV antibody negative, HIV antigen negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative
Clinical narrative: Approximately one week after she received her MMR, Hepatitiis B, and Varicella vaccinations on 2-01-18, she noticed red, raised circular lesions, approximately 2 mm in size started to appear on employee's body. These lesions starting on her arms, thighs, and legs. She denies any itching but describes them as "stinging or burning." They progressively got worse and spread to her arms and hands. Some of the lesions are scabbed over. Pateint was seen at ER on 3/23/18, which she was prescribed Prednisone. Patient called on 3/30 because she still has these lesions. On 3/30/18 patient was seen in clinic by provider, who ordered, During employee's  the following labs: Hepatitis B Surface Antibody, Qualitative/Quantitative, Serum Hepatitis B Surface Antigen, Serum Hepatitis C Antibody Screen with Reflex to HCV RNA by PCR, Serum. HIV-1 and HIV-2 Antigen and Antibody Evaluation, Serum The labs listed above were all resulted as negative, except HBsAb was positive. A dermatologist appointment was then made for 4/05/18, triamcinolone 0.1% cream was given to the patient so she can apply to the small red bumps when they initially present to try to abort them from turning into full-blown lesions and then the subsequent post inflammatory hyperpigmentation.  She can do this twice a day to the affected areas for up to a few days at a time. Diagnosis: reactive dermatitis.
Age: 26.0
Sex: F
Vaccine: FLU4, HEP, MMR, VARCEL
Symptoms: Hepatitis C antibody negative, Pain of skin, Polymerase chain reaction, Scab, Skin burning sensation
Clinical narrative: Approximately one week after she received her MMR, Hepatitiis B, and Varicella vaccinations on 2-01-18, she noticed red, raised circular lesions, approximately 2 mm in size started to appear on employee's body. These lesions starting on her arms, thighs, and legs. She denies any itching but describes them as "stinging or burning." They progressively got worse and spread to her arms and hands. Some of the lesions are scabbed over. Pateint was seen at ER on 3/23/18, which she was prescribed Prednisone. Patient called on 3/30 because she still has these lesions. On 3/30/18 patient was seen in clinic by provider, who ordered, During employee's  the following labs: Hepatitis B Surface Antibody, Qualitative/Quantitative, Serum Hepatitis B Surface Antigen, Serum Hepatitis C Antibody Screen with Reflex to HCV RNA by PCR, Serum. HIV-1 and HIV-2 Antigen and Antibody Evaluation, Serum The labs listed above were all resulted as negative, except HBsAb was positive. A dermatologist appointment was then made for 4/05/18, triamcinolone 0.1% cream was given to the patient so she can apply to the small red bumps when they initially present to try to abort them from turning into full-blown lesions and then the subsequent post inflammatory hyperpigmentation.  She can do this twice a day to the affected areas for up to a few days at a time. Diagnosis: reactive dermatitis.
Age: 26.0
Sex: F
Vaccine: FLU4, HEP, MMR, VARCEL
Symptoms: Skin lesion, Skin reaction
Clinical narrative: Approximately one week after she received her MMR, Hepatitiis B, and Varicella vaccinations on 2-01-18, she noticed red, raised circular lesions, approximately 2 mm in size started to appear on employee's body. These lesions starting on her arms, thighs, and legs. She denies any itching but describes them as "stinging or burning." They progressively got worse and spread to her arms and hands. Some of the lesions are scabbed over. Pateint was seen at ER on 3/23/18, which she was prescribed Prednisone. Patient called on 3/30 because she still has these lesions. On 3/30/18 patient was seen in clinic by provider, who ordered, During employee's  the following labs: Hepatitis B Surface Antibody, Qualitative/Quantitative, Serum Hepatitis B Surface Antigen, Serum Hepatitis C Antibody Screen with Reflex to HCV RNA by PCR, Serum. HIV-1 and HIV-2 Antigen and Antibody Evaluation, Serum The labs listed above were all resulted as negative, except HBsAb was positive. A dermatologist appointment was then made for 4/05/18, triamcinolone 0.1% cream was given to the patient so she can apply to the small red bumps when they initially present to try to abort them from turning into full-blown lesions and then the subsequent post inflammatory hyperpigmentation.  She can do this twice a day to the affected areas for up to a few days at a time. Diagnosis: reactive dermatitis.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Axillary pain, Chills, Contusion, Diarrhoea
Clinical narrative: This dose was not as painful at time of injection as the first but as the night progressed the pain began to radiate down my arm to wrist, over my shoulder, into my scapula and lymph nodes in L Axilla and Cephalic areas. The wrist and back resolved but the nodes are still very tender, site is bruised, reddened and axilla has bruising. By 10pm I began to have nausea, diarrhea, fever and chills. The following two days these persisted, with very unusual and frequent diarrhea. Maybe I just picked up a virus at the wrong time but it seemed odd to me.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Lymph node pain, Musculoskeletal pain, Nausea
Clinical narrative: This dose was not as painful at time of injection as the first but as the night progressed the pain began to radiate down my arm to wrist, over my shoulder, into my scapula and lymph nodes in L Axilla and Cephalic areas. The wrist and back resolved but the nodes are still very tender, site is bruised, reddened and axilla has bruising. By 10pm I began to have nausea, diarrhea, fever and chills. The following two days these persisted, with very unusual and frequent diarrhea. Maybe I just picked up a virus at the wrong time but it seemed odd to me.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This dose was not as painful at time of injection as the first but as the night progressed the pain began to radiate down my arm to wrist, over my shoulder, into my scapula and lymph nodes in L Axilla and Cephalic areas. The wrist and back resolved but the nodes are still very tender, site is bruised, reddened and axilla has bruising. By 10pm I began to have nausea, diarrhea, fever and chills. The following two days these persisted, with very unusual and frequent diarrhea. Maybe I just picked up a virus at the wrong time but it seemed odd to me.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Headache, Pain
Clinical narrative: Chills, headache, body ache.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pruritus, Laboratory test
Clinical narrative: REDNESS, ITCH, HARD KNOT ON AREA.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Pain
Clinical narrative: Arm swollen at LD injection site and client c/o pain since yesterday.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy site unspecified abnormal, Blood glucose decreased, Blood lactate dehydrogenase increased, Haemangioma of skin, Mycosis fungoides
Clinical narrative: At my annual dermatologist appointment on 4/5/2017, he saw 2 areas of rash on my abdomen and 1 on each breast. He took a biopsy. On 4/20/2017, the report showed mycosis fungoides, a rare non-Hodgkin's lymphoma also known as cutaneous T cell lymphoma, or cancer. It is incurable, treatable, and chronic. I am stage 1A. I went to the Hospital clinic on 10/30/17. I have flare ups of painful rashes on my waist and upper legs, cherry angiomas rash under jewelry. I am on clobetasol cream, next is nitrogen mustard ointment. Treatments for cancer tests and doctor visits are very expensive! There is no cure, the rashes come and go forever, get thicker, more percentage of skin, and possibly tumors, and death. The rash is usually itchy, but mine is painful to the touch, similar to shingles. I hope no one else gets or has gotten this cancerous rash after a ZOSTAVAX vaccination.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Non-Hodgkin's lymphoma, Rash
Clinical narrative: At my annual dermatologist appointment on 4/5/2017, he saw 2 areas of rash on my abdomen and 1 on each breast. He took a biopsy. On 4/20/2017, the report showed mycosis fungoides, a rare non-Hodgkin's lymphoma also known as cutaneous T cell lymphoma, or cancer. It is incurable, treatable, and chronic. I am stage 1A. I went to the Hospital clinic on 10/30/17. I have flare ups of painful rashes on my waist and upper legs, cherry angiomas rash under jewelry. I am on clobetasol cream, next is nitrogen mustard ointment. Treatments for cancer tests and doctor visits are very expensive! There is no cure, the rashes come and go forever, get thicker, more percentage of skin, and possibly tumors, and death. The rash is usually itchy, but mine is painful to the touch, similar to shingles. I hope no one else gets or has gotten this cancerous rash after a ZOSTAVAX vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The health care professional reported that a patient experienced a fever of 102.8 degree F. No additional information could be obtained. The health care professional ended the click to chat prior to providing patient, product and adverse event details.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Facial pain, Sunburn, Swelling face
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 74-year-old female patient who received SHINGRIX. On 26th February 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 12th March 2018, 14 days after receiving SHINGRIX, the patient experienced sunburn. In March 2018, the patient facial swelling, red face and facial pain. The patient was treated with Antibiotic (Drug Name Unknown). On an unknown date, the outcome of the facial swelling, red face and sunburn were unknown and the outcome of the facial pain was unchanged. It was unknown if the reporter considered the facial swelling, red face, facial pain and sunburn to be related to SHINGRIX. Additional details were provided as follows: The patient via chat reported the adverse event. The patient requested the agent call her in relation to reactions to SHINGRIX. The patient stated no additional vaccines were provide at the time of the SHINGRIX vaccine or 4 weeks prior. For seventeen days the patient was fine. The patient received SHINGRIX 17 days later her left side of face swelled, and redness, and slight pain (around 3/4 out of 10). The physician treated her with anti-biotic. The patient did not tell physician about shot (did not occur to her). The physician now wanted to do CT scan of left side of face. The patient stated she will contact physician. The patient had the swelling, redness, pain before she had an anti-biotic. The patient get some sunburn around 12th March 2018. The patient was asking whether the sun affect the shot. The agent informed patient to contact health care professional. The patient had denied permission to contact their physician. Due to call flow, no additional information was available.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: CSF test, Demyelination, Muscular weakness, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: The patient presented with acute onset of left arm weakness 4 days after vaccination. It progressed to significant weakness within a week and she was found to have acute central demyelination on MRI.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Balance disorder, Chest X-ray, Cognitive disorder, Computerised tomogram head
Clinical narrative: Various medical complications twitching, weakness, numbness, tingling, blue fingers, hand swelling, difficulty walking, head nodding and excessive sleepiness. Double vision, vibrations, extreme arm pain. Excessively biting lips while trying to eat, stumbling and tripping right arm and leg severe weakness, paresthesias of right arm and right leg. Difficulty walking, writing, thinking, uncontrolled gait/balance. Difficulty controlling bladder and extreme constipation. Decreased cognitive astuteness. Insomnia. Treatment at hospital ER visit. Outcome pending symptoms continue primary care visit. Each and every time I have an influenza shot I have some strange neurological symptoms of the sorts.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Constipation, Cyanosis, Diplopia, Dysgraphia, Echocardiogram
Clinical narrative: Various medical complications twitching, weakness, numbness, tingling, blue fingers, hand swelling, difficulty walking, head nodding and excessive sleepiness. Double vision, vibrations, extreme arm pain. Excessively biting lips while trying to eat, stumbling and tripping right arm and leg severe weakness, paresthesias of right arm and right leg. Difficulty walking, writing, thinking, uncontrolled gait/balance. Difficulty controlling bladder and extreme constipation. Decreased cognitive astuteness. Insomnia. Treatment at hospital ER visit. Outcome pending symptoms continue primary care visit. Each and every time I have an influenza shot I have some strange neurological symptoms of the sorts.