chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PPV
Symptoms: Arthropathy, Injection site reaction
Clinical narrative: This spontaneous report was received from a male patient of unknown age with diabetes mellitus, reporting on herself. The patient reported that he went to an unspecified Orthopedic Dr. because he had lots of problems and issues with both of his arms from years of multiple insect bites. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. The patient stated that at injection site the skin looked and felt healthy, no joint breaks. Subsequently, the patient stated that he went to a fast food restaurant on an unspecified date and that he had a salad with bad bacteria from tomatoes and iceberg lettuce. The patient reported that the injection site did not look good anymore, there were breaks in the joints and it does not feel healthy anymore (arthropathy and injection site reaction). At the time of the report, the outcome of arthropathy and injection site reaction was unknown. The patient did not mention the causality assessment between the events and PNEUMOVAX 23 vaccination. Consumer left voicemail on SRP voicemail on 06/25/2018 at 9:43 PM. The primary reporter is Consumer. Consumer reporting that he goes to an unspecified Orthopedic Dr. because he has lots of problems and issues with both of his arms from years of multiple insect bites. Consumer reported receiving PNEUMOVAX 23 on an unspecified date and at the injection site "the skin looked and felt healthy, no joint breaks" on unspecified dates. Consumer reported "going to a fast food restaurant on an unspecified date and had a salad with bad bacteria from tomatoes and iceberg lettuce." The consumer reported the "injection site does not look good anymore, there are breaks in the joints and it does not feel healthy anymore." No additional information provided on SRP voicemail. This spontaneous report as received from a consumer refers to a male patient of unknown age with limb discomfort and diabetes mellitus. The patient's medical history included arthropod bite. On an unknown date the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On an unknown date the patient experienced arthropathy and injection site reaction. The outcome of arthropathy and injection site reaction is unknown. {Additional information has been requested. / Additional information is not expected.}
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (strength, dose and route were not reported) (lot # N023828 and expiration date: 25-JUN-2020) for prophylaxis (product storage error). The vaccine was stored in below 32 degrees Fahrenheit (F) / 0 degree Celsius (C) (-0.3 C) for 64 hours. The digital data logger was not involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1806USA012211: US-009507513-1806USA012212: US-009507513-1806USA012213.
Age: 33.0
Sex: M
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 33 year old male patient. Past medical history and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with (wistar ra 27-3) M-M-R II for prophylaxis. On 22-JUN-2018, the patient visited the nurse's office and inquired about receiving an (wistar ra 27-3) M-M-R II vaccination. Nurse reported that it was unknown if the patient will follow through and receive the (wistar ra 27-3) M-M-R II dose (circumstance or information capable of leading to medication error). No adverse event was reported. Nurse also reported that (wistar ra 27-3) M-M-R II and diluent were stored properly.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 27-JUN-2018, the patient inadvertently received an expired dose of ROTATEQ vial, orally, lot # M041768, expiry date 25-JUN-2018, for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (strength, dose and route were not reported) (lot # N023828 and expiration date: 25-JUN-2020) for prophylaxis. The vaccine was stored in below 32 degrees Fahrenheit (F)/0 degree Celsius (C) (-0.3 C) for 64 hours. The digital data logger was not involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1806USA012212: US-009507513-1806USA012213: US-009507513-1806USA011719.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (strength, dose and route were not reported) (lot # N023828 and expiration date: 25-JUN-2020) for prophylaxis (product storage error). The vaccine was stored in below 32 degrees Fahrenheit (F) / 0 degree Celsius (C) (-0.3 C) for 64 hours. The digital data logger was not involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1806USA012211: US-009507513-1806USA012213: US-009507513-1806USA011719.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with LIQUID PEDVAXHIB (strength, dose and route were not reported) (lot # R000877 and expiration date: 24-SEP-2020) for prophylaxis (product storage error). The vaccine was stored in below 32 degrees Fahrenheit (F) / 0 degree Celsius (C) (-0.3 C) for 64 hours. The digital data logger was not involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1806USA012211: US-009507513-1806USA012212: US-009507513-1806USA011719.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a 12 month old patient of an unknown gender. The patient's medical history, concurrent conditions or concomitant medication were not reported. On 05-JUN-2018, the patient was vaccinated with improperly stored doses of Oka/Merck VARIVAX lot # N024568, expiration date 07-SEP-2019 or lot # N029631, expiration date 23-OCT-2019, for prophylaxis (dosage information and route of administration were not informed). Other suspect therapies included MERCK STERILE DILUENT lot # M029682, expiration date 12-JAN-2019. No adverse effects were reported. It was also reported that the temperature and time frame were -14°C to -10°C (-12.7°C) for 20 minutes. There was no previous temperature excursion. A "data logger" was involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1806USA012318:Original Case : 1806USA005053 US-009507513-1806USA012317:Original Case : 1806USA005053 US-009507513-1806USA012319:Original Case : 1806USA005053 US-009507513-1806USA005053:Original Case : 1806USA005053.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a 12 month old patient of an unknown gender. The patient's medical history, concurrent conditions or concomitant medication were not reported. On 07-JUN-2018, the patient was vaccinated with improperly stored doses of Oka/Merck VARIVAX lot # N024568, expiration date 07-SEP-2019 or lot # N029631, expiration date 23-OCT-2019, for prophylaxis (dosage information and route of administration were not informed). Other suspect therapies included MERCK STERILE DILUENT lot # M029682, expiration date 12-JAN-2019. No adverse effects were reported. It was also reported that the temperature and time frame were -14°C to -10°C (-12.7°C) for 20 minutes. There was no previous temperature excursion. A "data logger" was involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1806USA012318: US-009507513-1806USA005053: US-009507513-1806USA012319: US-009507513-1806USA012316.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a 12 month old patient of an unknown gender. The patient's medical history, concurrent conditions or concomitant medication were not reported. On 08-JUN-2018, the patient was vaccinated with improperly stored doses of Oka/Merck VARIVAX lot # N024568, expiration date 07-SEP-2019 or lot # N029631, expiration date 23-OCT-2019, for prophylaxis (dosage information and route of administration were not informed). Other suspect therapies included MERCK STERILE DILUENT lot # M029682, expiration date 12-JAN-2019. No adverse effects were reported. It was also reported that the temperature and time frame were -14°C to -10°C (-12.7°C) for 20 minutes. There was no previous temperature excursion. A "data logger" was involved. This is one of several cases from the same reporter. Sender's Comments:  US-009507513-1806USA005053: US-009507513-1806USA012317: US-009507513-1806USA012319: US-009507513-1806USA012316.
Age: 1.58
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a 19 month old patient of an unknown gender. The patient's medical history, concurrent conditions or concomitant medication were not reported. On 08-JUN-2018, the patient was vaccinated with improperly stored doses of Oka/Merck VARIVAX lot # N024568, expiration date 07-SEP-2019 or lot # N029631, expiration date 23-OCT-2019, for prophylaxis (dosage information and route of administration were not informed). Other suspect therapies included MERCK STERILE DILUENT lot # M029682, expiration date 12-JAN-2019. No adverse effects were reported. It was also reported that the temperature and time frame were -14°C to -10°C (-12.7°C) for 20 minutes. There was no previous temperature excursion. A "data logger" was involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1806USA012318: US-009507513-1806USA012317: US-009507513-1806USA005053: US-009507513-1806USA012316.
Age: 15.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a 15 year old patient of unknown gender. No medical history, concurrent condition and concomitant medications were reported. On 18-NOV-2017 the patient was vaccinated with improperly stored dose of VAQTA (lot # N008823, expiry date 26-MAY-2018), in the right upper arm for prophylaxis. VAQTA was unsupported. The vaccine had underwent a temperature excursion of 31 degrees Fahrenheit during 37 hours and 30 minutes. No adverse effects were reported. Digital data logger was involved and no product quality complaint was involved. There was no previous temperature excursion reported. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1712USA000569.
Age: 11.0
Sex: M
Vaccine: HPV9, MEN, TDAP
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a nurse via employee refers to a 11 year old male patient. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 20-JUN-2018, the patient was vaccinated with GARDASIL 9 for prophylaxis (lot#, expiry date and dosage details were not provided). Other suspect therapies included TDAP and meningococcal vaccine (MCV), which were administered along with GARDASIL 9 on the same day. On the same day of vaccination, the patient experienced "fainting" after the use of GARDASIL 9. The patient did not receive any treatment. No product quality complaint (PQC) was involved. The patient recovered from the event. The reporter did not provide any causality assessment. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1806USA010727.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of raised rash in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced raised rash. On an unknown date, the outcome of the raised rash was unknown. It was unknown if the reporter considered the raised rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a raised rash underneath the arm. The patient had been referred to their health care provider. The field representative provided very limited information. All questions were asked, no further details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a adult patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced itchy rash and erythematous rash. On an unknown date, the outcome of the itchy rash and erythematous rash were unknown. It was unknown if the reporter considered the itchy rash and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the age group was captured as adult based on vaccine indication. The patient presented about 2 weeks after vaccination with SHINGRIX to the pharmacist with a very light itchy red rash and the patient stated it had previously been more red and itchy. The patient's physician did not seem concerned. The pharmacist was asking if this was considered normal for this vaccine (seems prolonged) and based on having a prolonged rash and itchiness, would that prevent the patient from getting the second dose? No additional information was obtained.
Sex: U
Vaccine: MENB
Symptoms: Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's mother) via a Pfizer sales representative. A patient of unspecified age and gender received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient got sick and went to the hospital on an unspecified date with outcome of unknown. Patient's mother thought it was the vaccine.
Age: 38.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial information received on 29-May-2018 regarding an unsolicited valid non-serious case received from other health professional (Medical assistant). This case involves a 38 years old patient (gender unknown) who received vaccine FLUZONE HIGH DOSE. The patients past medical history, medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, lot UI876AB, expiry date, dose not reported via unknown route in unknown administration site. It was an actual medication error due to inappropriate age at vaccine administration. It was unknown whether patient experienced any adverse reaction after the injection. 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 and Module VI of the 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.
Age: 42.0
Sex: U
Vaccine: MNQ
Symptoms: Wrong drug administered
Clinical narrative: Initial information received on 30-May-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 42 years old patient who experienced patient who received a dose of MENACTRA (lot U5948AB, expiry date not reported) via intramuscular route (frequency once) vaccine instead of MMR vaccine (lot number and expiry date not reported). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to wrong vaccine administered. Laboratory investigation was not reported. It was not reported if the patient received a corrective treatment. 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 and Module VI of the 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.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 06-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an 11-year-old child patient who received MENACTRA (expiry date 18 April 2015, batch number, route and site of administration were not reported) on 19 April 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Expired vaccine used as patient received expired MENACTRA in 2015. The incident took place on April 19th of 2018. The medication expired on April 18th. It was unknown if any adverse event occurred. 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 and Module VI of the 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. Documents held by sender: none.
Age: 18.0
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 11-Jun-2018 regarding an unsolicited valid non-serious case received from another health professional. This case involves an 18 years old patient who was vaccinated with an expired vaccine vaccine MENACTRA. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient received a dose of suspect MENACTRA (lot number: U5416AA, expiry date: 20-OCT-2017) via intramuscular route on an unknown administration site. It was an actual medication error due to expired product administered. It was not reported if the patient received a corrective treatment. 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 and Module VI of the 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.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 06/19- Client contacted immunizations spoke to report redness, swelling, and pain at injection site. Client advised to return to clinic on 06/21 to be evaluated by PHC, IAP Client did not show. 06/21- Immunization nurse contacted client to follow up Client reports area of injection site has improved.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received vaccines at well check on 6/26/18. Mom noted redness and swelling around the injection sites that had increased until seen for follow up on 6/28/18. At follow up, IM injection site (KINRIX) noted to have area of redness 9 cm in diameter and SQ injection site (PROQUAD) noted to have area of redness 3 cm in diameter; these areas were slightly raised. Sites are painful when more active. Parent instructed by MD to give BENADRYL and MOTRIN q 6-8 h prn and symptoms should gradually improve.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Chills, Erythema, Headache, Pain in extremity
Clinical narrative: Pain, swelling, redness around half of arm. Stomach cramps, vomiting, fever, shivering, headache.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: Pain, swelling, redness around half of arm. Stomach cramps, vomiting, fever, shivering, headache.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Injection site swelling, Nausea, Vomiting
Clinical narrative: Pain, swelling, redness around half of arm. Stomach cramps, vomiting, fever, shivering, headache.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Malaise, Myalgia
Clinical narrative: The patient stated that they experience extreme flu-like symptoms, including chills, malaise and muscle aches. It lasted only one day, but the patient says that it kept them in bed for the day.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pain in extremity
Clinical narrative: Sore arm, extreme myalgias and shivers/chills (no fever or rash) lasting 36 hrs.
Age: 31.0
Sex: M
Vaccine: HEPA
Symptoms: Blood glucose normal, Fall, Hyperhidrosis, Loss of consciousness, Vision blurred
Clinical narrative: Patient taking part in Hepatitis A clinic. 955am HepA shot given right deltoid IM. 10am Patient fell/passed out in hallway, Unknown if he hit head. 1015am BP 68/44, HR 39, BS 107, O2 97% RA, Very diaphoretic, blurry vision. Encouraged to drink water. 1020am vomited. 1034am ambulance called. 1051am 56/342 HR, O2 99%. 11am Ambulance arrived and transported patient to ER.
Age: 31.0
Sex: M
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Patient taking part in Hepatitis A clinic. 955am HepA shot given right deltoid IM. 10am Patient fell/passed out in hallway, Unknown if he hit head. 1015am BP 68/44, HR 39, BS 107, O2 97% RA, Very diaphoretic, blurry vision. Encouraged to drink water. 1020am vomited. 1034am ambulance called. 1051am 56/342 HR, O2 99%. 11am Ambulance arrived and transported patient to ER.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Feverish first day, headaches and nausea for three days so far.
Age: 24.0
Sex: M
Vaccine: ANTH, JEV1
Symptoms: Fall, Head injury, Limb injury, Seizure
Clinical narrative: PT stood up after receiving vaccines and having blood drawn for HIV testing. PT fell and hit the right side of his head and shoulder then began convulsing. Area was cleared to allow PT room to breathe and prevent any harm to PT. PT was sat upward after convulsing, then laid into lab chair. Chair was leaned backward to put PT's feet above head. PT was given water upon request, ice packs to cool down and fan turned on towards him to help cool down. PT was monitored for 15 minutes prior to releasing to battle buddy to be taken to clinic for further treatment. PT and event info was given to unit's PA.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Malaise, Myalgia
Clinical narrative: The patient's spouse stated that they experienced extreme flu-like symptoms, including chills, malaise and muscle aches. It lasted only one day, but the spouse says that it kept them in bed for the day.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Crying, Injection site reaction, Weight bearing difficulty
Clinical narrative: Child cried for 4 solid hours after vaccination. Could not bear weight on left leg for 4 days.
Age: 72.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Axillary mass, Axillary pain, Contusion
Clinical narrative: Patient said she developed a ball under her left armpit next day (She noticed it at night) after she got the vaccine. It was painful at that time. Bump became smaller in two days but there is a bruise around the bump now. It's not painful.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Fever, Diarrhea, body aches, swelling, redness, and pain from shoulder to elbow of (L) arm.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fever, Diarrhea, body aches, swelling, redness, and pain from shoulder to elbow of (L) arm.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site oedema, Oedema peripheral, Pain
Clinical narrative: Pain began a few hours after the vaccine and swelling was noted the next morning. Red and edematous swelling involving the upper and lower arm of the left side.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Swelling
Clinical narrative: Pain began a few hours after the vaccine and swelling was noted the next morning. Red and edematous swelling involving the upper and lower arm of the left side.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Lip swelling, Swelling face
Clinical narrative: Woke up from nap with swelling right upper lip. Swelling spread to right side of face within an hour. Mother gave BENADRYL and took child to be evaluated. He was given oral prednisone and swelling significantly decreased in an hour and was gone by evening.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site vesicles, Musculoskeletal pain
Clinical narrative: Patient had swelling, redness at injection site. Pain in Left arm and shoulder, several red blistering bumps around injection site a month after injection given.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient had swelling, redness at injection site. Pain in Left arm and shoulder, several red blistering bumps around injection site a month after injection given.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Joint range of motion decreased, Muscular weakness, Pain in extremity
Clinical narrative: Extreme finger pain and joint pain. Inability to bend fingers. Muscle weakness.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEP, HEPA, PNC13, VARCEL
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Per client's Mother, she developed hives all over her arms and chest.
Age: 58.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, Foreign travel, No adverse event
Clinical narrative: NO ADVERSE EVENTS. Given off label for international travel.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Blood creatine phosphokinase, C-reactive protein, Cough, Culture urine, Decreased appetite
Clinical narrative: Day 1 after vaccination developed fatigue, diarrhea, body aches, headaches, dry non productive cough, odd taste in mouth, low grade fever, decreased appetite, strong cough with post-tussive emesis, sore throat, (L) earache.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Dysgeusia, Ear pain, Fatigue, Full blood count
Clinical narrative: Day 1 after vaccination developed fatigue, diarrhea, body aches, headaches, dry non productive cough, odd taste in mouth, low grade fever, decreased appetite, strong cough with post-tussive emesis, sore throat, (L) earache.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Influenza virus test, Legionella test, Metabolic function test, Oropharyngeal pain
Clinical narrative: Day 1 after vaccination developed fatigue, diarrhea, body aches, headaches, dry non productive cough, odd taste in mouth, low grade fever, decreased appetite, strong cough with post-tussive emesis, sore throat, (L) earache.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Post-tussive vomiting, Pyrexia, Red blood cell sedimentation rate, Respiratory syncytial virus test
Clinical narrative: Day 1 after vaccination developed fatigue, diarrhea, body aches, headaches, dry non productive cough, odd taste in mouth, low grade fever, decreased appetite, strong cough with post-tussive emesis, sore throat, (L) earache.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warm to touch at area of injection.
Age: 19.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 19-year-old patient of unknown gender. The patient's medical history, concurrent conditions and medical history were not provided. The reporting nurse stated that it might be possible that the patient received two doses of (Wistar RA 27-3) M-M-R I (dose, the dose number, albumin status, route of administration, lot number/expiration date were not provided) and two doses of Oka/Merck VARIVAX (dose, the dose number, route of administration, lot number/expiration date were not provided) on the same unspecified date. No adverse effects were reported.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12 year old male patient. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 13-MAR-2018, the patient started series of GARDASIL 9 and on 27-JUN-2018 was vaccinated with a second dose of GARDASIL 9 lot # N022952, expiry date 14-JUN-2020 (route of administration was not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial information received on 20-Jun-2018 regarding an unsolicited valid non-serious case received from an office person medical assistant. This case involves a patient (age and gender not reported) who was vaccinated with a ACT-HIB (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was case of an actual medication error due to wrong solution used in drug reconstitution. It was reported that ACTHIB was mixed with sterile water and given to one patient. 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 and Module VI of the 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. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial unsolicited report received from nurse on 20 Jun 2018. This case was linked to 2018SA168262 (same reporter). This case involves a patient (age and gender not reported) who was vaccinated with a fourth dose of ADACEL instead of DAPTACEL (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered. No adverse event 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 and Module VI of the 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.
Age: 17.0
Sex: F
Vaccine: HEP, HPVX, IPV, MMR
Symptoms: Infectious mononucleosis
Clinical narrative: Initial information received on 04-Jun-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 17 years old female patient who experienced mononucleosis, while she received 0.5 ml once dose of vaccines HEPATITIS B VACCIN, HPV VACCINE, MMR and IPOL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect HEPATITIS B VACCIN not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect MMR not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect HPV VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect IPV (VERO) lot N1K931M via unknown route in unknown administration site. The patient developed a non-serious mononucleosis (infectious mononucleosis) following the administration of IPV (VERO), following the administration of MMR, following the administration of HPV VACCINE and following the administration of HEPATITIS B VACCINE. (Other relevant tests included No lab data.) Final diagnosis was mononucleosis. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for mononucleosis.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial information received on 21-Jun-2018 regarding an unsolicited valid non-serious case received from a doctor. This case involves Child female patient (age and gender not reported) who received a dose of vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique because the aide mixed the ActHib with sterile water and gave the dose and did not use the DTaP/IPV. 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 and Module VI of the 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. Documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 13-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 17 years old female patient who received second dose of vaccine MENACTRA (Batch number: expiry date: 13-May-2018) in right deltoid on 13-Jun-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used as patient received a dose of expired MENACTRA, the date of expiration was 13May2018. The dose was given on 13Jun2018. It was not reported if the patient experienced any adverse event or not. 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 and Module VI of the 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. Documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 06-Jun-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves an 18 years old patient who was to vaccinate with an expired dose of MENACTRA (lot number U5508AA) via intramuscular route in the deltoid NOS. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient was on NEXPLANON contraception. It was an actual medication error due to expired vaccine used. On 06-June-2018, the patient received an expired dose of MENACTRA (expiry date: 03-June-2018). The patient was notified about this. The patient was in good health otherwise. Lab test and corrective treatment: not applicable. 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 and Module VI of the 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. Follow-up information received on 08-June-2018 by Nurse: Vaccination date and expiry date was updated. List of documents held by sender: none.
Age: 29.0
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Grip strength decreased, Lethargy, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: Extreme tiredness and lethargy and weakness in both arms. Unable to open things using hands and wrists.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Fever, chills, malaise, redness/swelling, pain at injection site starting within 24 hours.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, chills, malaise, redness/swelling, pain at injection site starting within 24 hours.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Myalgia
Clinical narrative: Patient reported significant muscle pain that started the morning after having the vaccine. She reports that the pain started in her back. She denies having any other significant symptoms.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Fatigue, Feeling cold, Feeling hot, Headache
Clinical narrative: 10:00 PM stiffness from injection site moves across back and shoulder area, shaking/hard to get warm, was able to fall asleep. 11:30 PM awaken to violent shaking, skin on upper body (arms/torso) feels tingly, hard to breathe (apprx. 10-15 minutes), then hot like a woman's hot flash, shaking stops and breathing returns to normal. (More pronounced than when fighting an illness with fever). Several less severe rounds of shaking then hot during the night. A mild headache not calmed with MOTRIN. Next morning 5:00 AM still a mild headache, very tired/achy. Stiffness is now back to injection site only.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Musculoskeletal stiffness, Pain, Paraesthesia, Tremor
Clinical narrative: 10:00 PM stiffness from injection site moves across back and shoulder area, shaking/hard to get warm, was able to fall asleep. 11:30 PM awaken to violent shaking, skin on upper body (arms/torso) feels tingly, hard to breathe (apprx. 10-15 minutes), then hot like a woman's hot flash, shaking stops and breathing returns to normal. (More pronounced than when fighting an illness with fever). Several less severe rounds of shaking then hot during the night. A mild headache not calmed with MOTRIN. Next morning 5:00 AM still a mild headache, very tired/achy. Stiffness is now back to injection site only.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose normal, Cyanosis, Drooling, Dyskinesia, Electroencephalogram normal
Clinical narrative: Child in back seat returning from weekend trip. Child let out loud, guttural scream/moan. Mom turned around to find child folded over, head in lap. Dad pulled over and mom had to lift child, who was unresponsive, pale, slightly blue. Child was drooling, which was mixed with blood (possibly bit lip when falling over). Child started jerking arms, twisting head. Event lasted approximately 1-2 minutes. Child very "floppy" but could make fists and hold arms above head. Transported by EMS to Hospital ER. Vitals and physical neuro exam were ok. Child vomited upon returning home (approximately 3:00 pm) and had two or three other vomiting episodes (last one at approximately 11 pm).
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Hypotonia, Moaning, Mouth haemorrhage, Neurological examination normal, Pallor
Clinical narrative: Child in back seat returning from weekend trip. Child let out loud, guttural scream/moan. Mom turned around to find child folded over, head in lap. Dad pulled over and mom had to lift child, who was unresponsive, pale, slightly blue. Child was drooling, which was mixed with blood (possibly bit lip when falling over). Child started jerking arms, twisting head. Event lasted approximately 1-2 minutes. Child very "floppy" but could make fists and hold arms above head. Transported by EMS to Hospital ER. Vitals and physical neuro exam were ok. Child vomited upon returning home (approximately 3:00 pm) and had two or three other vomiting episodes (last one at approximately 11 pm).
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Posture abnormal, Screaming, Unresponsive to stimuli, Vomiting
Clinical narrative: Child in back seat returning from weekend trip. Child let out loud, guttural scream/moan. Mom turned around to find child folded over, head in lap. Dad pulled over and mom had to lift child, who was unresponsive, pale, slightly blue. Child was drooling, which was mixed with blood (possibly bit lip when falling over). Child started jerking arms, twisting head. Event lasted approximately 1-2 minutes. Child very "floppy" but could make fists and hold arms above head. Transported by EMS to Hospital ER. Vitals and physical neuro exam were ok. Child vomited upon returning home (approximately 3:00 pm) and had two or three other vomiting episodes (last one at approximately 11 pm).
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Muscle twitching, Musculoskeletal pain, Myalgia
Clinical narrative: About 5 days after the vaccination, experienced very sore muscle pain in right arm that has continued to this date. Pain subsequently migrated to the shoulder area. Lower lip twitches sporadically which continues to this date. Occasional chills and tinkling of the head area that continues.
Age: 0.92
Sex: M
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: BENADRYL as needed TYLENOL.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: Erythematous macular rash surrounding injection site beginning 1 day post injection with increased warmth. Maximum size to date 9 cm x 7.5 cm. Not tender, no itchiness, non fluctuant. BENADRYL given to patient. Unknown outcome at this point.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Pain, Swelling, Tenderness
Clinical narrative: Swollen, red, soreness, hurts to touch.u
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Cold sweat, Dizziness, Hyperhidrosis, Injected limb mobility decreased
Clinical narrative: Can't move (L) arm after pneumonia 23 vaccine. Chills with sweats. Nausea and vomiting. Left arm deltoid measuring 11.5". Vaccine reaction and medication info. I wanted to let you know that I had a severe reaction to the pneumonia vaccine I received Tuesday. About three hours after receiving the vaccine I began having severe pain in my left arm. It became so bad by late afternoon that I could not use my arm. Also that night I experienced cold sweats, chills, dizziness and vomiting. Someone called a personal friend as it was after hours. He recommended taking an antihistamine. I did and all the symptoms except the pain and soreness began to subside. Yesterday was better but I was still unable to use my arm due to pain. I still have pain this morning but not to the same degree as I am able to use my arm. Adverse reaction after PNEUMOVAX adm on 6/19/18. Pt sent message via portal on 6/21/18 that had had reaction after PNEUMOVAX given in left arm in office on 6/19. Had chills/nausea and vomiting and could not move arm from left elbow to shoulder and exquisite pain that she compare to childbirth. There is swelling below the injection site today 3 days later-size of left upper arm 11.5 inches compared to 11 inches on right. There is mild erythema of the area below the injection site. She grimaces with movement of left shoulder. Has been taking 2 ALEVE BID and not helping much but feels movement is much better. I will send in meloxicam as well as gabapentin and she will let me know if not improved-will order MRI. Patient-I am on call this weekend. Please let me know how you are doing tomorrow. I might want to start prednisone to settle this faster.