chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPVX
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from an unspecified reporter via an online article published and Vaccine Adverse Event Reporting System and refers to a 713 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of quadrivalent HPV vaccine (manufacturer unknown) (route, dose, lot # and expiration date not reported). On unknown dates, the patients experienced a life threatening adverse event. The outcome of adverse event was unknown. The relatedness between the event and quadrivalent HPV vaccine (manufacturer unknown) was not reported. This is one of several reports received from the same reporter. Additional information is not expected as no contact details were provided.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Clostridium test, Cryptococcus test, Culture stool, Diarrhoea, Faeces discoloured
Clinical narrative: Diarrhea. Black stool. Gray/clay colored stool.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Giardia test, Rotavirus test
Clinical narrative: Diarrhea. Black stool. Gray/clay colored stool.
Sex: U
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report was received from an unspecified reporter via an online article published and Vaccine Adverse Event Reporting System and refers to 236 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of quadrivalent HPV vaccine (manufacturer unknown) (route, dose, lot # and expiration date not reported). On unknown dates, the patients experienced death. It was unknown whether the autopsy was performed. The relatedness between death and quadrivalent HPV (manufacturer unknown) was not reported. This is one of several reports received from the same reporter. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 14-JAN-2016, the patient was vaccinated with an expired dose of ZOSTAVAX lot # K016325, expiration date 24-DEC-2015, (route and dose were not provided). There was no concomitant medication described. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Rash pruritic
Clinical narrative: Pain in shoulder of the arm where shot given and then developed itchy rash. Given triamcinolone cream for the rash.
Age: 15.0
Sex: F
Vaccine: IPV, MMR, MNQ, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Pt. c/o pain, swelling and redness in left arm within 1 1/2 hours of injection on 1/11/16, took TYLENOL, BENADRYL and applied ice. Repeated treatment 1/12/16 but says left arm continues to swell, have erythema and pain. Measured left deltoid at 15.75", compared to unaffected arm at 14.5". Hot to touch, but very little erythema today. Will continue BENADRYL, ibuprofen and elevation of left arm, talked to PCP today with those recommendations.
Age: 15.0
Sex: F
Vaccine: IPV, MMR, MNQ, VARCEL
Symptoms: Peripheral swelling
Clinical narrative: Pt. c/o pain, swelling and redness in left arm within 1 1/2 hours of injection on 1/11/16, took TYLENOL, BENADRYL and applied ice. Repeated treatment 1/12/16 but says left arm continues to swell, have erythema and pain. Measured left deltoid at 15.75", compared to unaffected arm at 14.5". Hot to touch, but very little erythema today. Will continue BENADRYL, ibuprofen and elevation of left arm, talked to PCP today with those recommendations.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient's mother brought patient into office on 1-20-16 and stated that patient's left arm was swollen and red at the site that injections were given on 1-18-16. Denies fever. Mother states she gave patient Ibuprofen for pain on 1-18-16.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Laboratory test abnormal, Pertussis
Clinical narrative: Initial unsolicited report received from a consumer (patient's parent) on 7 January 2016. This case involves an 11-year-old male patient who had received intramuscular fifth dose of DTAP (batch number and site of administration not reported) on an unspecified date. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as multiple food allergies, environmental and chemical allergies. No medical issues and illness at time of vaccination was none. Concomitant medications were not reported and vaccination within four week of vaccination was unknown. On an unspecified date after the vaccination the patient experienced whooping cough. The patient required ER visit. Laboratory investigations were reported as the patient had nasal swabs and whooping cough was confirmed. The patient was treated with antibiotics and steroids and the patient's family was also treated prophylactically with antibiotics without confirming diagnosis. The event outcome was recovered on an unspecified date. Upon internal review the case was assessed as serious due to important medical event whooping cough. Documents held by sender: none.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Altered state of consciousness, Tremor, Vomiting
Clinical narrative: About 30 hrs after getting MMR, V, Hep A, Flu vaccine, pt has brief period of altered level of consciousness while bathing, possible mild seizure (mom reported some brief shaking), f/b vomiting and then promptly fell asleep. Responsive at time of mom's call with NL breathing and temp.
Age: 61.0
Sex: U
Vaccine: FLU4
Symptoms: Product label confusion, Wrong drug administered
Clinical narrative: Influenza vaccine FLUARIX quadrivalent syringes, NDC 58160-901-52, 2014/2015 formulation inadvertently returned to stock and administered to 1 or 2 patients. Boxes of 2014/2015 and 2015/2016 vaccine differ only by the year in the upper right corner of the labeling.
Age: 2.0
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: Patient given PEDIARIX, and has already received 4 doses of DTAP.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient was here for shingles vaccine on 01/08/2014 then patient came in on 2015 and requested shingles meaning pneumonia and extra dose of shingles was given. Old records from 2014 was not found on this day so patient received extra vaccine.
Age: 7.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Injection was given to a 7 year old and requirement for vaccine is 4-6, patient parent has been notify.
Age: 0.4
Sex: U
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This vaccine was actually a quadrivalent vaccine but that was not an option listed above. An infant born was administered a 0.25 dose of influenza at 4 months 26 days (5 months). This was one month earlier than recommended. There was no adverse reaction, however the child will need an additional dose.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Gave 0.5 ml dose of flu vaccine to a child who was 2 1/2 years of age, instead of the dose she should have received was a 0.25 ml (6-35 month) flu vaccine.
Age: 17.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Inadvertently gave 6 month-35 month dose to a 17 year old. Spoke with Public Health Nurse and an additional dose of the same vaccine given to make it equivalent to correct dose.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Dose of HPV was given to soon.
Age: 0.2
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A pediatric shot was accidentally given to a 3 month old infant.
Age: 43.0
Sex: U
Vaccine: FLU3
Symptoms: Contusion, Erythema, Headache, Nausea, Nodule
Clinical narrative: Employee flu vaccine was administered on Friday. Reported through the weekend, had a large knot approx., 5 cm in diameter with redness/bruising, painful/warm to touch. Also experienced nausea and headache following vaccination. Reaction started to improve following 2-3 days after immunization.
Age: 43.0
Sex: U
Vaccine: FLU3
Symptoms: Pain, Skin warm
Clinical narrative: Employee flu vaccine was administered on Friday. Reported through the weekend, had a large knot approx., 5 cm in diameter with redness/bruising, painful/warm to touch. Also experienced nausea and headache following vaccination. Reaction started to improve following 2-3 days after immunization.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Accidentally grabbed MMRV and administered it instead of Varicella to a 1 year old. Also administered MMR at same visit.
Age: 7.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Child was given vaccine out of recommended age range.
Age: 60.0
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Pt. given FLUZONE, given at other location.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: Patient was given MMRV (PROQUAD) along with the varicella vaccine.
Age: 3.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Under 36 month old flu vaccine was given to a 3 year old patient.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Incorrect dose administered
Clinical narrative: Child with (age 26 mos) should have been given .25ml dose but received a .5 ml dose. Age of patient at time of event: 2 years 3 months 4 days. Type of Event: Wrong age.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 23 mo was given 3+ flu.
Age: 1.6
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was 18 mo and given 3+ flu.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient was given 3+ flu. pt is 2 years old.
Age: 1.3
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient was given the correct 0.25mL of preservative free flu and an extra 0.5mL dose of preservative free flu by mistake at the same office visit.
Age: 50.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient given high dose flu vaccine, pt is only 50 y/o.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was given 3rd Varicella vaccine in error. Staff was reviewing the wrong patient's chart when preparing the medication and during administration. Error caught after administration when documenting, that this was the wrong patient.
Age: 18.0
Sex: U
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Expired vaccine inadvertently given to pt.
Age: 50.0
Sex: U
Vaccine: FLU3
Symptoms: Contusion, Erythema, Headache, Nausea, Nodule
Clinical narrative: Employee Flu vaccine was administered on 2015. The following morning (2015) was reporting nausea, headache, a knot with redness/bruising, approx. 9cm in diameter was present. This was painful and hot to touch. Was followed up by Occupational Health.
Age: 50.0
Sex: U
Vaccine: FLU3
Symptoms: Pain, Skin warm
Clinical narrative: Employee Flu vaccine was administered on 2015. The following morning (2015) was reporting nausea, headache, a knot with redness/bruising, approx. 9cm in diameter was present. This was painful and hot to touch. Was followed up by Occupational Health.
Age: 4.0
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Two siblings were in for well childs. A one year old and a 4 year old. Both children needed 4 vaccines. The correct vaccines were pulled from the refrigerator and drawn up. When going to administer the vaccines in the room, the 1 year old vaccines were grabbed and given to the 4 year old. This was caught immediately after giving the shots. The parents were notified and the 1 year old received the correct vaccines. The 4 year old received a Hepatitis A and HIB that he was not due for. The local health department was contacted and told us that the extra vaccines would not harm the child.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Product label issue, Wrong drug administered
Clinical narrative: This was the very first 2 year child this season I was going to vaccinate for Flu shot. The whole family of 4 came in for the vaccines. I knew the other 3 would have the same vaccine and were given the FLUARIX. The father got the shot first, then the little girl but she was very scared, screaming in the room. While approaching her with the shot, she waved her hand in front of the needle and got a scratch kind of injury. This distracted me. I meant to check the dose of the shot before I gave the younger child but by this time he was confused and getting scared. So the parents and I decided we would give the shot to him quickly and then proceed with the documentation to prevent further agitation. I reached for FLUVIRIN, checked the expiry date, but forgot to check the age range, and gave the child the vaccine. I did not realize my mistake until the next day when I usually go over my day and think of how I could improve myself. I called my manager and let her know and following her advice called the CDC first to know of what to do. I did not have access to the child's information until 3 days and my manager was aware of that. By the next day I received feedback from CDC that no exaggerated adverse events were anticipated and no further vaccination was recommended. The next day I informed the mother who was very upset and angry as to why she wasn't informed as soon as I came to know. I explained to her that it was because my manager told me that the policy was to first check with CDC what their advice was and inform VAERS which was also done by myself. I think this happened partly because the label only had the age information in small letter unlike FLUARIX which had that in big fonts to draw my attention to it. Also last year we did have FLUZONE MDV which looks like FLUVIRIN, so that was in my mind.
Age: 69.0
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A pediatric dose was given to an adult client. The client was informed (called at home) and offered to come back at their convenience for to have the adult dose administered. Then client returned the following week and the adult dose was given.
Age: 0.6
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: A Medical Assistant administered the over 3 prefilled syringe dose, instead of the 6-36 month prefilled dose syringe.
Age: 2.0
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered.
Age: 0.6
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given the wrong vaccine at a mass community flu clinic.
Age: 0.3
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to child.
Age: 16.0
Sex: U
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Expired vaccine inadvertently given to patient.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, Overdose
Clinical narrative: Administered 0.5 mL of FLUZONE to 2 year 3 month old child instead of 0.25 mL.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient asked for a flu shot and indicated on the form at the pharmacy that he had never had a flu shot before. The injection was administered and patient left. When the technician went to post the information on the reporting site she found that the patient had received a flu shot two weeks before at another pharmacy.
Age: 0.8
Sex: U
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Wrong drug administered
Clinical narrative: Vaccines were administered to 9 month old female, no history of immunocompromise, who had previously received these vaccines at her 6 month visit, instead of being given to a 6 month old in the next room. The mother received a safety sheet prior to the vaccines being given which had the wrong patients name at the top of the sheet. 2 patient identifiers were on the sheet but the nurse and patient's mother have conflicting stories about whether these were verbalized. The mother had marked off the safety questions on this sheet. The patient received 4 shots, two to each thigh. She was also given the flu vaccine at the same time FLUZONE QUADRIVALENT which we had intended to administer.
Age: 2.0
Sex: U
Vaccine: FLUN4
Symptoms: Extra dose administered
Clinical narrative: Pt received FLUMIST on 2015 and 2015.
Age: 0.9
Sex: U
Vaccine: MNQ
Symptoms: Wrong drug administered
Clinical narrative: PREVNAR 13 ordered, MENACTRA given.
Age: 13.0
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: 13 year old client in for vaccines. Reviewed record and discussed MCV4 vaccine. Family agreed for child to have vaccine. Vaccine drawn up and administered. After vaccine administered was reviewing record with family and noted that child had MCV4 dose 2014 so this was given in error. Informed family right away when mistake was noted. Let them know that client will still need booster dose at 16-17.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 1.7
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Gave FLUZONE QUADRIVALENT 0.5 mL prefilled to 20 month old instead of the prefilled 0.25 mL dose. Was not aware that prefilled even came in 0.5 mL dosing. (This was private purchase stock). Just grabbed the prefilled and proceeded thinking it was the 0.25mL.
Age: 15.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: I have 2 sons ages 15 and 12 that are on a modified vaccine schedule to accommodate severe allergies. They were to receive Tdap doses and instead received 2 consecutive doses (2 weeks apart) or D-Tap vaccine instead.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Patient began having breathing issues 3 days after the vaccine.  Was admitted to the hospital and received breathing treatments and steroids.  Full recovery occurred.  The patient reports that the connection to the flu shot was questionable, according to the doctor.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Mobility decreased, Nausea, Pain
Clinical narrative: Extreme pain, arm could not be lifted, Nausea and feeling of fainting. Followed by chills and fever. Lasted 17 plus hours.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Extreme pain, arm could not be lifted, Nausea and feeling of fainting. Followed by chills and fever. Lasted 17 plus hours.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Lymph node pain
Clinical narrative: Patient noticed a tender lymph node at her left clavicle the morning after her flu vaccination. She saw her doctor.  The doctor was uncertain whether or not the tender node was related to the vaccination.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Injection site erythema, Pain
Clinical narrative: Body ache head to toe, temperature 100.9 Friday through Saturday, her normal temp is 97.  She came into the pharmacy today 1/20/2016 at 9:50 am showed me (Pharmacist) her arm, Baseball sized red circle on Right arm on Deltoid, very distinct.  Proper placement for where the vaccine should have been given.  Patient showed her doctor yesterday and doctor was not concerned patient told me.
Age: 16.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Abdominal pain upper, Acne, Asthma, Biopsy, Blood cortisol decreased
Clinical narrative: Increase in asthma symptoms, acne, cysts, stomach pain, chronic fatigue, weightloss, warts, ear infections/abscess, weakened immune.
Age: 16.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Blood cytokine test, C-reactive protein increased, Condition aggravated, Cyst, Ear infection
Clinical narrative: Increase in asthma symptoms, acne, cysts, stomach pain, chronic fatigue, weightloss, warts, ear infections/abscess, weakened immune.
Age: 16.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Endoscopy, Fatigue, Immune system disorder, Laboratory test abnormal, Skin papilloma
Clinical narrative: Increase in asthma symptoms, acne, cysts, stomach pain, chronic fatigue, weightloss, warts, ear infections/abscess, weakened immune.
Age: 16.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Subcutaneous abscess, Thyroid function test abnormal, Weight decreased
Clinical narrative: Increase in asthma symptoms, acne, cysts, stomach pain, chronic fatigue, weightloss, warts, ear infections/abscess, weakened immune.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Bacterial infection, Dizziness, Laboratory test, Pain, Pyrexia
Clinical narrative: Became very dizzy, lightheaded, achy, and feverish.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Enema administration, Intussusception, Ultrasound abdomen
Clinical narrative: HOSPITALIZED FOR INTUSSUSCEPTION.
Age: 0.2
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Patient was in for a 2 month well child. She was supposed to get the combination vaccine PENTACEL but instead was given PEDIARIX-which was okay, except for she received an extra Hepatitis B vaccine.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Wrong drug administered
Clinical narrative: The nurse prepared FLUZONE vaccine for patient and another family member before interviewing patient. When patient and family member came into shot room, the nurse got distracted with talk about Tdap vaccine and forgot to ask patient about pregnancy status. The nurse proceeded to administer FLUZONE vaccine to patient. Just before finishing injecting the patient, the nurse got the sensation that the syringe was empty, but it was too late since she had already pushed the plunger to retract the needle. If that were the case, patient did not get the dose of FLUZONE. After patient left shot room, the nurse realized she should have prepared a dose of FLUVIRIN since the patient was pregnant.
Age: 10.0
Sex: U
Vaccine: DTAPIPV, FLUX, MMRV
Symptoms: Extra dose administered
Clinical narrative: Pt received KINRIX and PROQUAD along with flu shot. Pt already complained the KINRIX and PROQUAD series and did not need to receive vaccines. There was a mix up with the MICR and the error was found when documenting injections.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: 0.50ml flu vaccine was erroneously administered to a 32 month old pt.
Sex: M
Vaccine: HPV4
Symptoms: Injection site extravasation, Underdose
Clinical narrative: This spontaneous report as received from patient's mother refers to her son who is a male patient of an unknown age. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL (dose, route and lot number not reported) by an unknown nurse. There were no adverse effects with the first dose of GARDASIL. On an unknown date, the patient was vaccinated with second dose of GARDASIL by an unknown nurse. During the administration process of the second dose of GARDASIL (dose, route and lot number not reported), patient's mother stated that the medication from the vaccine was dripping down her son's arm all the way to his elbow. In addition, patient's mother stated that the vaccine was given 'way to flipping fast'. There was no product quality complaint reported. Patient's mother did not provide any other adverse event information. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of VARIVAX (Merck) Lot # K011801, expiry date 21-AUG-2016; Lot # reported as L026413, expiry date 15-JUL-2017; Lot # L001330, expiry date 13-JAN-2017 and Lot # reported as L029471, expiry date 06-AUG-2017 (dose and route were not reported), were given to unspecified patients on unspecified dates. It was reported that the nurse did not know which of the above lots were actually administered. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date in 2013, the patient was vaccinated with the first dose of GARDASIL, then the patient received the second dose of GARDASIL about 3 months later on an unspecified date and finally, on 19-JAN-2016 (reported as today), the patient was vaccinated with the third dose of GARDASIL, (dose, route, anatomical location, lot number and expiration date were not reported for the vaccines above described). No adverse effect was reported. There was no concomitant medication reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist referring to a male patient of unknown age. No concurrent condition or historical conditions were reported. On 07-DEC-2015, the patient was vaccinated with ZOSTAVAX (lot # and expiration date were not provided) 0.65 ml, subcutaneous (anatomical location was unknown). No concomitant medications were reported. On an unspecified date in December 2015 (also reported as "1-2 weeks" after receiving ZOSTAVAX) the patient experienced a rash on the back of his leg. At the time of the report, the outcome of rash was unknown. This is one of two cases received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This spontaneous report was received from a 66 year old female consumer regarding herself with hypothyroidism and none drug reactions or allergies. On 14-JAN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23, one time injection, intramuscular, (dose, anatomical location, lot number and expiration date were not reported) for immunization for pneumonia. The patient's concomitant therapies included SYNTHROID. On the same date, approximately 8 hours after vaccination, the patient experienced pain and noticed a rash at the injection site. The rash was treated with a unspecified dose of BENADRYL, additionally none lab diagnostics studies were performed. The patient sought medical attention by contacting the nurse practitioner on 18-JAN-2016. At the time of the report, the outcome of the pain was recovering and the outcome of the rash at the injection site was reported as recovered described as the patient's condition improved as the rash went away on 18-JAN-2016. The relatedness between the events and therapy with PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a consumer referring to his wife (a female patient of unknown age). No concurrent or historical conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # and expiration date were not provided) dose, route, anatomical location and indication were not provided. No concomitant medications were reported. On an unknown date, the patient experienced a rash on her arm after vaccination. At the time of the report, the outcome of rash was unknown. This is one of two cases received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 12 month old male patient. On 14-JAN-2016, the patient was vaccinated with a expired dose of MMR II 0.5 ml, frequency: one time, lot # J009382, expiration date 08-AUG-2015, subcutaneously for prevention. There was no concomitant medication reported. No adverse event was reported due to the administration of the expired vaccine. It was unknown if the patient would continue to receive MMR II and the outcome of the receiving an expired dose of MMR II and the outcome of the receiving an expired dose of MMR II was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the physician's assistant refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On an unknown date, the patients were vaccinated with improperly stored oral, ROTATEQ lot # K024700 with expiry date: 30-JUL-2016, (dose not reported). No concomitant medication was reported. No adverse effect reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of an unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. Since 25-NOV-2015, the patients were vaccinated with an improperly stored doses of VARIVAX (Merck) lot # L016125 expiration date: 06-MAY-2017, (dose and route were not provided). No adverse effects were reported. The temperature stability information was reported as follows: Temperature 19F; time frame: 2 hours; there was no previous temperature excursion, it was back in range and there was no call because of a "data logger". This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of PROQUAD Lot # L034930, expiry date 03-MAR-2017; Lot # K022444, expiry date 13-MAY-2016; Lot #, reported as L040415, expiry date 13-APR-2017; Lot # L030584, expiry date 10-FEB-2017; Lot # L032759, expiry date 24-FEB-2017; Lot # L004005, expiry date 05-AUG-2016 (dose and route were not reported), were given to unspecified patients on unspecified dates. It was reported that the nurse did not know which of the above lots were actually administered. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified adult patient. The patient's concurrent conditions and medical history were not provided. On 13-NOV-2015 the patient was inadvertently vaccinated with pediatric RECOMBIVAX HB lot # K018180, expiration date on: 17-SEP-2016 (route and dose were not provided) instead of an adult dose of VAQTA, (dose, route, strength, lot number and expiration date were not provided). Concomitant therapies were not provided. No adverse events were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. Since 25-NOV-2015, the patients were vaccinated with improperly stored doses of PROQUAD (rHA) lot # L019998, expiration date: 02-DEC-2016 (dose and route were not provided). No adverse effects were reported. The temperature stability information was reported as follows: Temperature: 19F; time frame: 2 hours; there was no previous temperature excursion, there were back in range and there was no call because of a "data logger". This is one of several reports from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: MEA, MU, RUB
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 21 year old female patient. Pertinent medical history and drug reactions/allergies were reported to be none. On an unspecified date in October 1992 (reported as when the patient was 13months old), the patient received a set of monovalent vaccines (the names of these vaccines and manufacturer were unspecified). Subsequently, on an unspecified date in 1995 (reported as when the patient was 4 years old), the patient received a monovalent vaccine (the name of this vaccine and manufacturer was unspecified). On 13-AUG-2013, a blood titer was drawn from the patient and it was discovered that there was a low titer for rubella antibodies (rubella antibody negative). In response to this, on 27-AUG-2013, the patient was vaccinated with M-M-R II (dose, lot# and expiration date were not reported). On 05-JAN-2016, another blood titer was drawn and it was discovered that there was a low titer for rubella antibodies (rubella antibody negative) again. The outcome of rubella antibody negative was considered to be not recovered. No causal relationship was provided between the event and vaccinations with the rubella vaccine (manufacturer unknown) and M-M-R II. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown demographics. Information about the patients' pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. On unspecified dates, since 03-AUG-2015, the patients were vaccinated with improperly stored doses of PEDVAXHIB, lot # L006545 with expiration date 16-NOV-2017 and lot # L006546 with expiration date 27-NOV-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. The PEDVAXHIB was also exposed to 68F for 19 hours. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown demographics. Information about the patients' pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. On unspecified dates, since 03-AUG-2015, the patients were vaccinated with improperly stored doses of GARDASIL, lot # J013324 with expiration date 12-FEB-2016 and lot # K007264 with expiration date 02-MAR-2017, (dose and route of administration were not provided); that were supported by prescribing information. Concomitant medication was not reported. No adverse effect were reported. The GARDASIL was also exposed to 68F for 19 hours. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, Therapeutic response unexpected
Clinical narrative: This spontaneous report was received from a physician and refers to an unspecified number of female patients of unknown age. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with doses of GARDASIL 9 (lot #, expiration date, exact doses and route of administration were not reported). It was reported that the patients were females over the age of 26 years old. The physician reported, that on unknown dates, there were fewer cases of human papilloma virus (HPV) infection after receiving the full series of GARDASIL 9. No PQC (product quality complaint) was involved. The outcome of HPV infection was unknown. The relatedness between the event and GARDASIL 9 was not reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L013827 exp. 21-APR-2017, (dose and route were not provided). The vaccines were exposed to temperature of -11.9 C during 21 Hours. Then they were back in range. It was also stated that the vaccines were not previous exposed to any other excursion. No adverse effect was reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Anaphylactic reaction, Dizziness, Excessive eye blinking, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a healthcare worker via a company representative refers to a 13 year old female patient. The patient's concurrent condition, medical history and drug reaction/allergies were not reported. On an unknown date in October 2015 the patient was vaccinated with GARDASIL 9 (first dose of 0.05 ml, once, route of administration not specified). On an unknown date October 2015 the patient felt lightheaded, had fluttering eyes and felt numbness and tingling [location unknown] "immediately after receiving her first dose of GARDASIL 9. Two weeks later on an unknown date in October 2015 approximately the patient returned to the physician's office with anaphylaxis which included "swollen lips". The reporter stated that the patient will not be receiving any additional GARDASIL 9 series of injections due to her side effects. The patient visited the physician to seek medical attention. She was given an unspecified treatment for the adverse events. It was unspecified by the reporter if any lab diagnostics were performed. The outcome of the adverse events lightheaded, had fluttering eyes, felt numbness, tingling, anaphylaxis, swollen lips was not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, Lip swelling, Paraesthesia
Clinical narrative: This spontaneous report as received from a healthcare worker via a company representative refers to a 13 year old female patient. The patient's concurrent condition, medical history and drug reaction/allergies were not reported. On an unknown date in October 2015 the patient was vaccinated with GARDASIL 9 (first dose of 0.05 ml, once, route of administration not specified). On an unknown date October 2015 the patient felt lightheaded, had fluttering eyes and felt numbness and tingling [location unknown] "immediately after receiving her first dose of GARDASIL 9. Two weeks later on an unknown date in October 2015 approximately the patient returned to the physician's office with anaphylaxis which included "swollen lips". The reporter stated that the patient will not be receiving any additional GARDASIL 9 series of injections due to her side effects. The patient visited the physician to seek medical attention. She was given an unspecified treatment for the adverse events. It was unspecified by the reporter if any lab diagnostics were performed. The outcome of the adverse events lightheaded, had fluttering eyes, felt numbness, tingling, anaphylaxis, swollen lips was not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a physician and refers to an unspecified number of female patients of unknown age. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with doses of GARDASIL 9 (lot #, expiration date, exact doses and route of administration were not reported). It was reported that the patients were females over the age of 26 years old. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown demographics. Information about the patients' pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. On unspecified dates, since 03-AUG-2015, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23, lot # L002310 with expiration date 08-JUL-2016, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. The PNEUMOVAX 23 was also exposed to 68F for 19 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. The patient's concurrent condition, medical history and concomitant medication were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (route and site of administration, lot#, expiry date were not reported). On an unknown date, the patient developed shingles in the eye region and on her face after receiving ZOSTAVAX. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not provided. Additional information is not expected, as reporter did not wish to be contacted.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from the consumer's wife, concerning her husband, a male patient of unknown age. The patient's medical history included shingles on an unspecified date. On an unknown date, the patient was vaccinated with ZOSTAVAX (Lot No., dose, frequency and route were not reported). No concomitant therapy was provided. On an unknown date, the patient presented the shingles again (herpes zoster). No Product Quality Complaint (PQC) was involved. The outcome of herpes zoster was unknown. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: HPVX
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from an unspecified reporter via an online article published and refers to a 12995 patients of unknown age and gender who reported the events via Vaccine Adverse Event Reporting System. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of quadrivalent HPV vaccine (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not reported). On unknown dates, the patients experienced unspecified adverse events that required an emergency room visits. The outcome of the events was unknown. The relatedness between the events and quadrivalent HPV vaccine (manufacturer unknown) was not reported. This is one of several reports received from the same reporter. Additional information is not expected as no contact details were provided.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Borrelia test
Clinical narrative: This spontaneous non valid social media report as received from a patient's parent via web page refers to a 14 year old female patient. The patient's relevant medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, route, lot# and expiration date were not reported). The reporter stated that the patient was in the process of getting specialized blood testing for Lyme (onset date unspecified). The reporter was looking for a good doctor for the patient. The outcome of the event was not reported. The reporter stated that had never considered GARDASIL as a possible cause of the event before but in fact the reporter did not provide the causality assessment. This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Arthralgia and fever. Ibuprofen.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 30-NOV-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (incorrect product storage) (lot # K006135 with expiration date: 29-APR-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The administered dose experienced a temperature excursion of 71 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. This is one of the many reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 30-NOV-2015 the patient was vaccinated with dose of improperly stored (Oka/Merck) VARIVAX (lot # K006135 with expiration date: 29-APR-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. This is one of the many reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown demographics. No medical histories, concurrent conditions or concomitant therapies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L005295, expiration date: 17-AUG-2016, therapy type HSA; doses and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.