chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 11-MAY-2011, the patient was inoculated with the ZOSTAVAX vaccine at the health department for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. In July 2015, the patient was treated by a family physician at the office for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, 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 was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Precancerous mucosal lesion, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a female patient in her 20's. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with an unidentified Merck HPV vaccine (name, dose, number of doses, route, frequency, lot # and expiration date were not reported) to prevent Human Papilloma Virus (HPV). On an unknown date, the patient had a Papanicolaou (PAP) Smear on an unspecified location, and she was diagnosed with precancerous lesion. It was reported that the patient was receiving an unspecified treatment for the event. No additional information was provided. The outcome of the event precancerous mucosal lesion was unknown. The reporter did not provide a causality assessment.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 79-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included levodopa for an unknown indication and carbidopa for an unknown indication. On 3rd May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient started levodopa at an unknown dose and frequency and carbidopa at an unknown dose and frequency. On an unknown date, several weeks after receiving SHINGRIX, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was recovering/resolving. It was unknown if the reporter considered the itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she developed rash across her back that that was itchy. The patient did not think it was shingles occurrence due to lack of pain. The patient thought that it might be related to carbidopa or levodopa that she recently began taking. The reporter did not wish to have follow-up regarding the report and asked that her address be anonymous. The reporter was unable to provide full demographics for the pharmacy or her physician. However, she did provide contact details of her physician.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received SHINGRIX for prophylaxis.  Concomitant products included atenolol and triamterene. On 7th June 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 7th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site warmth and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site warmth were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site erythema, injection site pain and injection site warmth to be related to SHINGRIX. Additonal details were reported as follows:  At 09:00, the patient received SHINGRIX on left arm. The patient received SHINGRIX at her physician's office the day before reporting and the nurse administered it subcutaneously instead of intramuscularly, which led to inappropriate route of vaccination. The nurse seemed to believe SHINGRIX should be given subcutaneously. Later the reporting day she developed redness, heat and soreness at the injection site. The reporting morning the red area was 3 inches wide by 2 inches long and was getting bigger. The reporter read in morning on the reporitng day that SHINGRIX was supposed to be given intramuscularly.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Conjunctivitis, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of erythematous rash in a 70-year-old male patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020) and (batch number X3M27, expiry date unknown) for prophylaxis. On 19th March 2018, the patient received the 1st dose of SHINGRIX. On 19th March 2018, the dose was an unknown dose. In March 2018, 3 days after receiving SHINGRIX, the patient experienced erythematous rash, raised rash, itchy rash and rash. On an unknown date, the patient experienced conjunctivitis. In April 2018, the outcome of the erythematous rash, raised rash, itchy rash and rash were recovered/resolved. On an unknown date, the outcome of the conjunctivitis was unknown.  The reporter considered the erythematous rash, raised rash, itchy rash and rash to be possibly related to SHINGRIX. It was unknown if the reporter considered the conjunctivitis to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported, that patient experienced red, raised, itchy, stingy rash to his bilateral plank that occurred approximately 3 days after vaccination with SHINGRIX lasting for 3 weeks. Less than a year after receiving vaccination, the patient went to emergency room for conjunctivitis, not for the rash and emergency room did not examine the patient's trunk area for rash during this visit. The health care professional also stated, that patient had a radiological procedure where he got dye. The batch number of the adjuvant was reported as X3M27. The batch number of SHINGRIX 53982 does not exist and was updated to 539A2, as per sales data sheet.
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, Off label use
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of drug prescribing error in a adult female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included systemic lupus erythematosus. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced drug prescribing error and off label use. On an unknown date, the outcome of the drug prescribing error and off label use were unknown. Additional details were provided as follows: The age at vaccination was not applicable for the case. The patient reported that physician prescribed SHINGRIX even though she was 28 years old. The patient was not received the vaccine because she was unable to locate any at her local pharmacies but would receive it once it available again. The patient was lupus and was told she could not start methotrexate until she receive SHINGRIX. The patient had denied permission to contact their physician.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of redness in a 64-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Atorvastatin, Magnesium, Vitamin C, vitamin D, SYNTHROID, hydrochlorothiazide + valsartan and fish oil. On 4th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 4th June 2018, less than a day after receiving SHINGRIX, the patient experienced redness, pain, swelling, tenderness and itching. On an unknown date, the outcome of the redness, pain, swelling, tenderness and itching were not recovered/not resolved. It was unknown if the reporter considered the redness, pain, swelling, tenderness and itching to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she followed up with her physician.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of myalgia in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was recovered/resolved. It was unknown if the reporter considered the myalgia to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The reporter developed myalgia the night after receiving the SHINGRIX vaccination. The patient also described that the myalgia felt like he would feel after having worked out. The myalgia lasted for two days. The reporter was unable to provide additional information.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 06-Jun-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves four-year-old patient (gender not reported) who was inadvertently vaccinated with PENTACEL as 5th dose (batch number, Expiry date, dose, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to Extra dose administered. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: DTAPHEPBIP, DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 06-Jun-2018 regarding an unsolicited valid non-serious case received from a Nurse via other company (Merck). This case involves a patient (gender and age was not reported) who was administered a dose of PENTACEL (batch number, expiry date, route and site of administration were not reported) and a dose of PEDIARIX on an unspecified date. This is an actual medication error case due to extra dose administered to the patient. No medical history was reported. No details of concomitant therapy were reported. No adverse event reported. Lab data 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 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. Documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 07-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 years old patient (unknown gender) who was given expired MENACTRA vaccine (expiry date 03 Jun 2018), with vaccine MENACTRA. The patient's past medical history, medical treatment, vaccination, concomitant medication and family history were not provided. It was an actual medication error due to expired vaccine used. On 06-Jun-2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE with expiry date 03 Jun 2018 (Lot number not reported) via unknown route in unknown administration site. No lab data provided. 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 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: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial information received on 07-Jun-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a five months old patient (gender not reported) who was vaccinated with QUADRACEL instead of PENTACEL (batch number, expiry date, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to Wrong vaccine administered as five months old pt. inadvertently received QUADRACEL instead of PENTACEL. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: RAB
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 08-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age patient who experienced IMOVAX: administered to pt. that had been reconstituted 24 hrs prior to administration. Pt. on post exposure rabies vaccine series, a 4 dose series and this was 3rd dose/ no adverse event, while he/she received vaccine IMOVAX RABIES. On an unknown date, the patient received a third dose of suspect IMOVAX RABIES (Lot number, expiry date not reported) via unknown route in unknown administration site. Patient received IMOVAX vaccine that had been reconstituted 24 hrs prior to administration. Patient on post exposure rabies vaccine series, a 4 dose series and this was the 3rd dose in the series. It was an actual medication error due to inappropriate reconstitution technique. 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 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: U
Vaccine: TD
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 08-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and gender patient who was inadvertently administered product that was too long in transit, TENIVAC. On an unknown date, the patient received a dose of suspect TENIVAC, Lot number, expiry date, dose not reported via unknown route in unknown administration site. It was a case of actual medication error due to incorrect product storage error. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Peripheral swelling
Clinical narrative: Initial unsolicited report received from physician on 11 Jun 2018. This case involves 12-year-old female patient who was vaccinated with a dose of FLUZONE QIV (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications was not reported, but it was reported that the physician thinks that, the patient has an egg allergy but has not had a blood test done to confirm it. On an unspecified date, following the vaccination, the patient has swelling that affected her whole arm and the patient felt very sick. It was reported that, last year patient had FLUZONE QIV and had swelling really bad at administration sight. Lab data and corrective treatment were not reported. The outcome of the events was not reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial unsolicited report received from a nurse on 11-Jun-2018. This case involves a patient (age and gender not reported) who was vaccinated with a dose of ACT-HIB (Batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to wrong solution used in drug reconstitution and it was reported that patient received dose reconstituted with sterile water instead of supplied diluent. 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 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: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial unsolicited report received from a Nurse on 11-Jun-2018. This case involves two-year-old patient (gender not reported) who was vaccinated with a dose of ADACEL (reported as dose 4, batch number, expiry date, dose, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to inappropriate age at vaccine administration. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 09-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 years old male patient who experienced "they gave one 18 year old and he had one when the records were checked 6 month ago/no adverse event", while he received vaccine MENACTRA. 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 MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported. It was a case of actual medication error due to extra dose administered. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Electromyogram, Injection site pain, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: 05/15 ..severe left arm and shoulder pain.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Fatigue, Pain, Pain in extremity, Tenderness
Clinical narrative: Extreme weakness and full body aches started approx. 8 hours after shot, Arm was very tender for 3 days, very sore. Extreme fatigue for approx. 4 days. This did completely clear up in approx. 5 days, so I didn't feel the need for medical treatment.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Vaginal haemorrhage
Clinical narrative: About four hours after the dosage was administered my mother had vaginal bleeding.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Pyrexia, Rash, Sepsis, Tachycardia
Clinical narrative: Showed up at an ED with fever and pain at the site on 6/15/18.....Diagnosed with UTI, Sepsis, Rash, Tachycardia.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Urinary tract infection
Clinical narrative: Showed up at an ED with fever and pain at the site on 6/15/18.....Diagnosed with UTI, Sepsis, Rash, Tachycardia.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray abnormal, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Fatigue, headache, ringing in my ears, decreased appetite, productive cough, sore throat, chills, daily fevers off 100 to 10. Pneumonia identified in the lingula--identified on x-ray report 6/15/2018, treated with LEVAQUIN x 10 days.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Oropharyngeal pain, Pneumonia, Productive cough, Pyrexia, Tinnitus
Clinical narrative: Fatigue, headache, ringing in my ears, decreased appetite, productive cough, sore throat, chills, daily fevers off 100 to 10. Pneumonia identified in the lingula--identified on x-ray report 6/15/2018, treated with LEVAQUIN x 10 days.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Vomiting
Clinical narrative: Patient became nauseated and vomited one time within an hour after receiving vaccine.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Oedema peripheral, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: Pain that radiates down arm to the fingers. Swelling of the arm, swelling in armpit and on chest. Swelling that is hard as a rock and visible by sight. Doctor prescribed prednisone for 7 days with tapering dosage. Only on 2nd day of those meds currently.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Crying, Decreased appetite, Diarrhoea, Fatigue, Immediate post-injection reaction
Clinical narrative: My child became irritable immediately following her MMR vaccine. About 1-2 days after receiving her vaccine, she running a on and off low grade fever. She went from 98.6 to 99.4 to 99.7 back down to 98.6 within the first week of receiving the vaccine. Within the first 7 to 9 days of receiving the vaccine, she would just start crying for no reason, which is highly uncharacteristic for my child. On day 10, I took her temperature in the morning and it was 98.6. By the afternoon, it was 99.2. Then she woke from her afternoon nap at about 2:30pm and she had a bought of diarrhea. I took her temperature and it was still hovering in the 99 range. We played, but she was a little tired and very cranky. I set her up in her high chair for her snack around 3:30pm. She grazed her snacks and didn't show much interest. I took her out to let her play by 4pm. And then around 430pm she just started to cry, sob for no reason. I picked her up and could feel she was burning up. I took her temperature and it was 102. I immediately called the nurses line and was instructed to give her baby TYLENOL or MOTRIN to help get her fever down. I treated her fever and it brought it down right away. Patient had a little dinner and went to sleep like normal. When she woke in the morning (day 11), she had more diarrhea and a red rash on the backs of her thighs and the right injection site was red and swollen. From there, I called her doctor and got an appointment to see her pediatrician later that same afternoon. Throughout the day, her rash grew and spread, but not fever. She did have liquid diarrhea after her afternoon nap. The doctor saw my daughter and confirmed it was a reaction to MMR and instructed that symptoms should resolve in 5 days. Day 12, patient woke up and her rash was significantly worse. By the end of the day, her rash had spread to her entire body (face, ears, arms, hands, private areas, the spots on her legs were the size of sand dollars, and feet. Her injection site also seems more swollen. I made an after-hours appointment for Sunday, June 17 (day 13) just to be safe. On Sunday (day 13), her rash appeared to be resolving when she woke. She did not have a bowel movement on Day 13 and has not had a bowel movement so far on Day 14. Her rash is much improved from Day 12.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Irritability, Pyrexia
Clinical narrative: My child became irritable immediately following her MMR vaccine. About 1-2 days after receiving her vaccine, she running a on and off low grade fever. She went from 98.6 to 99.4 to 99.7 back down to 98.6 within the first week of receiving the vaccine. Within the first 7 to 9 days of receiving the vaccine, she would just start crying for no reason, which is highly uncharacteristic for my child. On day 10, I took her temperature in the morning and it was 98.6. By the afternoon, it was 99.2. Then she woke from her afternoon nap at about 2:30pm and she had a bought of diarrhea. I took her temperature and it was still hovering in the 99 range. We played, but she was a little tired and very cranky. I set her up in her high chair for her snack around 3:30pm. She grazed her snacks and didn't show much interest. I took her out to let her play by 4pm. And then around 430pm she just started to cry, sob for no reason. I picked her up and could feel she was burning up. I took her temperature and it was 102. I immediately called the nurses line and was instructed to give her baby TYLENOL or MOTRIN to help get her fever down. I treated her fever and it brought it down right away. Patient had a little dinner and went to sleep like normal. When she woke in the morning (day 11), she had more diarrhea and a red rash on the backs of her thighs and the right injection site was red and swollen. From there, I called her doctor and got an appointment to see her pediatrician later that same afternoon. Throughout the day, her rash grew and spread, but not fever. She did have liquid diarrhea after her afternoon nap. The doctor saw my daughter and confirmed it was a reaction to MMR and instructed that symptoms should resolve in 5 days. Day 12, patient woke up and her rash was significantly worse. By the end of the day, her rash had spread to her entire body (face, ears, arms, hands, private areas, the spots on her legs were the size of sand dollars, and feet. Her injection site also seems more swollen. I made an after-hours appointment for Sunday, June 17 (day 13) just to be safe. On Sunday (day 13), her rash appeared to be resolving when she woke. She did not have a bowel movement on Day 13 and has not had a bowel movement so far on Day 14. Her rash is much improved from Day 12.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash erythematous, Rash generalised, Skin warm, Vaccination complication
Clinical narrative: My child became irritable immediately following her MMR vaccine. About 1-2 days after receiving her vaccine, she running a on and off low grade fever. She went from 98.6 to 99.4 to 99.7 back down to 98.6 within the first week of receiving the vaccine. Within the first 7 to 9 days of receiving the vaccine, she would just start crying for no reason, which is highly uncharacteristic for my child. On day 10, I took her temperature in the morning and it was 98.6. By the afternoon, it was 99.2. Then she woke from her afternoon nap at about 2:30pm and she had a bought of diarrhea. I took her temperature and it was still hovering in the 99 range. We played, but she was a little tired and very cranky. I set her up in her high chair for her snack around 3:30pm. She grazed her snacks and didn't show much interest. I took her out to let her play by 4pm. And then around 430pm she just started to cry, sob for no reason. I picked her up and could feel she was burning up. I took her temperature and it was 102. I immediately called the nurses line and was instructed to give her baby TYLENOL or MOTRIN to help get her fever down. I treated her fever and it brought it down right away. Patient had a little dinner and went to sleep like normal. When she woke in the morning (day 11), she had more diarrhea and a red rash on the backs of her thighs and the right injection site was red and swollen. From there, I called her doctor and got an appointment to see her pediatrician later that same afternoon. Throughout the day, her rash grew and spread, but not fever. She did have liquid diarrhea after her afternoon nap. The doctor saw my daughter and confirmed it was a reaction to MMR and instructed that symptoms should resolve in 5 days. Day 12, patient woke up and her rash was significantly worse. By the end of the day, her rash had spread to her entire body (face, ears, arms, hands, private areas, the spots on her legs were the size of sand dollars, and feet. Her injection site also seems more swollen. I made an after-hours appointment for Sunday, June 17 (day 13) just to be safe. On Sunday (day 13), her rash appeared to be resolving when she woke. She did not have a bowel movement on Day 13 and has not had a bowel movement so far on Day 14. Her rash is much improved from Day 12.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial nerve disorder, Vertigo
Clinical narrative: Patient states: About eight days after receiving SHINGRIX vaccine the nerves on right side of face started to bother him. A few days after that, he started to experience very bad vertigo. More than 3 weeks after the injection, he still had not fully recovered. He cancelled the date to receive the second dose in the series.
Age: 0.5
Sex: M
Vaccine: DTAPIPV, HEP, HIBV, IPV, PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: DTaP KINRIX was given to the patient instead of DTaP PEDIARIX in addition to the polio immunization. Patient showed no adverse effects from the injection.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash, Rash vesicular
Clinical narrative: Blistering vesicular rash on both hands 2 days after first dose of SHINGRIX vaccine.
Age: 37.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Gave the vaccine that had expired 4 days prior to administration.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Presyncope, Pyrexia
Clinical narrative: Booster dose SHINGRIX caused near syncope, extreme weakness, fever, chills, vigor.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Malaise, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 20-year-old female patient. The patient's medical history included anxiety issues, nausea and fainting. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. During the administration of the vaccine, the patient flinched and received a partial dose of GARDASIL 9. After receiving the vaccine, the patient became instantly ill and vomited. The outcome of the events was not reported. The relatedness between the events and GARDASIL 9 was not provided.
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown ages and genders. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot number M032493 and expiration date of 06-JUL-2018 for prophylaxis (dose and route of administration were not reported). The vaccine was exposed to a temperature excursion of 15°F to 46°F with a time frame of 17 hours and 4 minutes, while the sterile water diluent did not undergo a temperature excursion. There was no previous temperature excursion. The digital data logger was involved in the temperature excursion measurement. This is a non-valid case due to the lack of patient identifier. Follow-up information has been received from a registered nurse on 31-MAY-2018. The details of on of the vaccinated patient were updated. The patient was male, he was 15 years old. On 08-MAY-2018, the patient was vaccinated with his second dose of VARIVAX, subcutaneously, in the right arm, lot # M032493 and expiration date: 06-JUL-2018. The vaccine was improperly stored in a clinical practice. There was no adverse event. The patient did not seek any prescription drug treatment.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided. On 30-MAY-2018, the patient was inadvertently administered with PROQUAD (lot number N024562, expiration date 06-MAR-2019) and VARIVAX (lot number N027000, expiration date 28-SEP-2019), by subcutaneous route (strengths, doses and dose numbers were not reported), for prophylaxis.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager regarding an unknown age female patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. In approximately May 2018, the patient received an expired dose of VAQTA Lot# N012324 and 05-APR-2018 expiration date for prophylaxis (strength, frequency and route of administration were not reported). The reporter confirmed there was no temperature excursion prior the vaccine administration. No adverse effects reported. No product quality complain was reported.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from an office manager and refers to a 75 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. She had no known allergies. On 12-JUN-2018, the patient was vaccinated with a properly stored dose of PNEUMOVAX 23, 1 injection intramuscularly in the left deltoid for vaccine prevention (lot # R009408, expiration date 07-MAR-2020). On 14-JUN-2018, the patient noted that her left arm became "swollen, warm and itchy with purple/red markings noted from the armpit down to the elbow". On the same day, the patient was seen in the physician office. She received unspecified antibiotics as treatment and no laboratory tests were performed. At the reporting time, the patient was recovering from Peripheral swelling, erythema, pruritus and feeling hot. The causality between the events and PNEUMOVAX 23 was not reported. The reporter requested a lot investigation. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1806USA006939.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 29-SEP-2016, the patient was inoculated with the ZOSTAVAX vaccine at a medical center as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain herpes zoster. Later in 2016, she was treated at the same medical center for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, 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 was unknown. Causality assessment was related. Additional information has been requested.
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 received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 12-DEC-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 08-JUL-2016, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, 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. Additional information has been requested.
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Head discomfort, Muscular weakness, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's mother). A male patient of an unspecified age received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the physician who administered the vaccine had troubles administering the product; like it was stuck on the syringe because the physician had to change the needle at least twice. After that (which was the first dose administration), the patient experienced muscle weakness, muscle soreness, fatigue, and a heavy head on an unspecified date. The outcome of the events was unknown. Follow-up activities are possible and information on the batch number has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist, received via a Pfizer sales representative. A male patient of an unspecified age receive PREVNAR 13, via an unspecified route of administration on unspecified date at single dose for immunization. Medical history included kidney transplant. The patient's concomitant medications were not reported. On unspecified date after having a pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) shot, the patient had swelling at the injection site. Since the patient had had a kidney transplant, he couldn't take Ibuprofen. The outcome of the event was unknown. Information on the batch number has been requested.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial unsolicited report received from a Nurse on 11-Jun-2018. This case involves a patient (age and gender not reported) who was vaccinated with a dose of IPOL (batch number, expiry date, dose, route and site of administration were not reported) instead of TUBERSOL (batch number and expiry date were not reported) on an unspecified date. It was a case of actual medication error due to wrong vaccine administered. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test negative, Blood test normal, Fatigue, Gastric disorder, Gynaecological examination normal
Clinical narrative: I took my daughter, who was 13 at the time, to the pediatrician to get her "vaccines for middle school". I don't know the exact dates, but if I need to, I can get request her files. Once there, the doctor insisted that she get the new GARDASIL shots as well. She had me feeling that if I didn't, I wouldn't be a good mother, etc. Anyway, within a month of getting the shots, my daughter, began to have stomach issues that she never had before. It took me quite a while to connect it with the GARDASIL shots, but I can't think of anything else that it might be. We went to 3 different pediatricians, an allergist, 2 different gynecologists, and a gastroenterologist. All testing came up that she was ok, yet she had constant gastrointestinal issues (especially but not only whenever she ate), extreme fatigue, and migraines. She eats very healthy (has no choice since almost everything including healthy food makes her sick). After reading about the side effects that some girls are having after the shots, it appears that short of the paralysis (thank God), she has so many of what I am reading about. When confronting the doctors about whether it could be or not, they refuse to commit an answer to me. I begged them to stop pushing the shots on all of their patients fearing that someone else will respond the way my daughter has. She is 22 now and has been trying to live with her health issues, but she should not have to because people are making money off of families like mine. I refused to allow my son or younger daughter to get the shots after that and they are in good health. No one in my family has the same issues that my daughter does. I'm at my wits end and don't know what to do or how to help her. I feel as if everyone has given up on her. It's breaking my heart. I feel breaking my heart. I feel powerless. It tried to contact the maker of the drug, Merck, but I couldn't find a place to place my claim and since there are no doctors that will say anything negative about GARDASIL (I cant understand why), they made me feel like I was on the wrong track. But I don't feel as if I am so I'm starting here.