chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Injection site erythema, Pain, Pruritus
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. The patient's concurrent conditions included COPD (chronic obstructive pulmonary disease). The patient's pertinent medical history or concomitant medications were not reported. On 07-JUN-2017, the patient was vaccinated with ZOSTAVAX (lot#, dose, frequency and route of administration were unspecified) for prophylaxis. On an unspecified date in June 2017, the patient experienced shortness of breath, redness at the site, itching and pain. The patient went to the physician's office, where she was advised not to worry about the vaccination. Additionally, it was reported that the patient was not hospitalized. No product quality complaint was involved. At the time of the report, the outcome of dyspnea, pain, pruritus and vaccination site erythema was unknown. The relatedness assessment between ZOSTAVAX and the aforementioned adverse events was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On 20-JUN-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, frequency and route of administration were not provided) lot # M027348 with expiration date of 27-JUL-2017, that were reconstituted with diluent MRK (injection; lot # L005461 with expiration date of 28-OCT-2017), for prophylaxis. The temperature of the ZOSTAVAX was between 15 °F and 46 °C for a time frame of 96 hours. No previous temperature excursion occurred. Data logger was not involved. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Vaccination site reaction
Clinical narrative: This spontaneous report was received from a physician via a company representative, concerning unspecified patients of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates, the patients were subcutaneously vaccinated with different lots of PNEUMOVAX 23 injection (dose, frequency, lot # and expiration date were not provided), for prophylaxis. On unspecified dates, after vaccinations, the patients had unspecified "site reactions". At the time of the report, the outcome of the events was unknown. The causality between the event and PNEUMOVAX 23 was unknown. Additional information is not expected, as no consent to contact the reporter was granted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant, and refers to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies, and concomitant medications were not reported. On unknown dates, the unspecified patients were vaccinated with improperly stored doses of VARIVAX lot # M048200 with expiration date of 07-DEC-2018 (strength, dose, and route were not reported), for prophylaxis. A digital data logger notified the temperature excursions, being of -9°C to 8°C for 34 hours, and another one of -14°C to -10°C for 20 hours and 45 minutes. No previous temperature excursions were reported. No adverse effects and no product quality complaints were reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician referring to a 13 year old female patient. The The patients medical history, concurrent conditions and concomitant medication ere not reported. The patient had an allergy to cephalexin (KEFLEX). In approximately 2005 (reported as when the patient was one year old), she was vaccinated with the first dose of VARIVAX, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). In approximately 2008 (reported as when she was four years old), the patient received the second dose of VARIVAX, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unspecified date in June 2017, the patient experienced "shingles" (herpes zoster) and she was being treated with acyclovir at the time of reporting. No laboratory tests were performed. The outcome of the event and the causal relationship between the event and VARIVAX were not reported. No product quality complaint was involved. 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 licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 20-JUN-2017, the patients were inadvertently vaccinated subcutaneously with improperly stored single doses of VARIVAX injection (lot # M044347, expiration date: 04-NOV-2018; exact doses were not reported). The doses of VARIVAX were reconstituted with a properly stored MERCK STERILE DILUENT. The reporter stated that the administered doses of VARIVAX were stored at temperature range between 15 degrees Fahrenheit (F) to 46 degrees F for 30 minutes on an unknown date. Previous temperature excursions included storage at the temperature in the range of 6 degrees F to 14 degrees F for 5 hours 49 minutes on unknown dates. Data logger was used to detect temperature excursions. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information is not expected because there was no consent to contact the reporter. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD and VARIVAX. {Additional information has been requested. / Additional information is not expected.} Sender's Comments: US-009507513-1706USA010767.
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 patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 13-JUN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot number M040138 with expiration date 28-SEP-2018, for prophylaxis (dose, frequency, route of administration, and anatomical location were not reported), which was reconstituted with a properly stored STERILE DILUENT (lot number and expiration date were not reported). No adverse events were reported. The vaccine was exposed to a temperature of 26.73 Fahrenheit for 15 hours; data logger was not involved. No previous temperature excursion was reported.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided. On 26-APR-2017, the patient was inadvertently vaccinated with an expired dose of GARDASIL lot # L040459 expiration date on 06-APR-2017 for prophylaxis. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000644.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of an unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. On 22-JUN-2017, the patient was vaccinated with an expired and improperly stored dose of ZOSTAVAX lot number: L046295, expiration date: 17-FEB-2017 (strength, dose, frequency, route of administration, and anatomical location were not provided) for prophylaxis. It was unknown the duration and the temperature at which the vaccine was maintained. There was no previous temperature excursion and the call was not because of a "data logger". No adverse effects were reported in the patient. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 22-JUN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX (dose and route of administration were not reported) (lot # K026365 and expiration date 15-MAR-2016) and a DILUENT MRK (dose and route of administration were not reported) (lot # L014261 and expiration date 21-JAN-2018) for prophylaxis. No adverse effects reported.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 lot # M043731 and expiration date of 22-JUN-2019 (strength, dose, route of administration and anatomica location were not reported) for prophylaxis. The vaccine was exposed to a temperature of 32°F to 35°F, during 15 hours. The vaccine was also exposed to a previous temperature excursion of 32°F to 35°F during 49 hours. Digital data logger was involved. No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a male patient of unknown age. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 22-JUN-2017, the patient was vaccinated with an expired VAQTA (lot # M034893, expiration date 26-MAY-2017) for prophylaxis (dose, frequency and route of administration were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Hypersomnia
Clinical narrative: This spontaneous report has been received from a physician, via a company representative concerning a female patient of unknown age. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were unknown by the reporter. On an unknown date, the patient was vaccinated with a dose of GARDASIL intramuscular injection, (lot #, expiration date, strength, dose number and dose were not provided) for prophylaxis. On an unknown date, the patient experienced fatigue and "slept for three days". It was unknown by the reporter if treatment was given for the adverse events. The physician had stopped therapy with GARDASIL and it was unknown if therapy would be resumed for the patient. No additional adverse events had been reported. At the reporting time, the outcome of hypersomnia and fatigue was unknown. The causal assessment between the events and vaccination with GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 26-JUN-2017 the patient was vaccinated with ZOSTAVAX for prophylaxis. On 26-JUN-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 25-JUN-2017, the patient was vaccinated with improperly stored dose of ZOSTAVAX lot # M042504, expiration date 30-NOV-2017 (dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 11.4 degrees Fahrenheit for 2 hours. The vaccine experienced a previous temperature excursion of 8.6 degrees Fahrenheit for 30 minutes. The reporter stated that ZOSTAVAX also experienced a second excursion and no additional patients were administered. Data logger was involved. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M001579, expiration date 05-OCT-2018 (dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. Administered doses of vaccines experienced the following temperature excursions between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 12 hours. The vaccine experienced the previous temperature excursion between -47 degrees Fahrenheit and 77 degrees Fahrenheit for 3 hours. Data logger was involved. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided. On 26-MAY-2017, the patient was inadvertently vaccinated with an expired dose of GARDASIL lot # L035105 expiration date on 14-MAY-2017 for prophylaxis. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA010259: Original Case: 1706USA010259.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt's right arm around injection site is red, swollen, and painful. Pt said the reaction started about an hour after the injection, but didn't notify the pharmacy until 3 days later. The redness and swelling is starting to wrap around her arm. Pharmacist told her to use ice and apap/ibu and called the dr.
Age: 0.83
Sex: M
Vaccine: DTAPIPV, HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient received KINRIX too soon, at 10 months. Reported by Medical Assistant after administered. Notified parent, no symptoms or signs of distress at the time of the call reported to RN.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Decreased appetite, Dysphagia, Fatigue, Haematuria
Clinical narrative: On Sunday, July 9, 2017, at 0955 hours; patient informed me he was experiencing the following; pharyngitis, arthralgia, fatigue, anorexia, dysphagia and felt as if he was febrile. He stated he believed it to be a reaction to the Hepatitis B Vaccine he received on July 5, 2017.  At 1505 hours, patient informed me he was having a friend take him to the hospital due to be unable to swallow at all. At 1820 hours; patient informed me he had been discharged from the hospital with a diagnosis of strep throat and hematuria.  He had been given an antibiotic and was told to remain off work for at least twenty-four (24) hours.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Impaired work ability, Pharyngitis, Pharyngitis streptococcal, Pyrexia
Clinical narrative: On Sunday, July 9, 2017, at 0955 hours; patient informed me he was experiencing the following; pharyngitis, arthralgia, fatigue, anorexia, dysphagia and felt as if he was febrile. He stated he believed it to be a reaction to the Hepatitis B Vaccine he received on July 5, 2017.  At 1505 hours, patient informed me he was having a friend take him to the hospital due to be unable to swallow at all. At 1820 hours; patient informed me he had been discharged from the hospital with a diagnosis of strep throat and hematuria.  He had been given an antibiotic and was told to remain off work for at least twenty-four (24) hours.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient was given immunization on 07/07/17 in right arm (IM). Patient went to E.R. last night due to arm swelling over the pass couple of days. Patient was given Doxycycline as an antibiotic at the E.R. and as a prescription. Patient said since starting Doxycycline her arm as gotten a little better. Today (07/10/17), patient picked up Rx for the Doxycycline.
Age: 10.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: NO ADVERSE event OTHER than the fact this Vaccine was given in stead of the TDaP.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Heart rate increased, Pallor, Vomiting
Clinical narrative: Lightheaded, vomiting, pale, increased HR, causes to rest; drank OJ - back to normal within 1/2 hour.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Adrenal insufficiency, Asthma, Obstructive airways disorder, Rash maculo-papular, Respiratory distress
Clinical narrative: In the first 24 hours airway swelling, respiratory distress, rash diffuse macule papular, severe exacerbation of asthma (less than 24 hrs) requiring extensive use of steroids for control of allergic exacerbation. Continued less than 50 mg prednisone 2 months over months causing adrenal insufficiency now tapering off. The event was the second reaction after or to a vaccine within 6 months prior event to FLUZONE occurred in Jan 2015. This event was to PREVNAR but was similar with rash, respiratory distress exacerbation of asthma and allergies requiring prolonged use of high dose steroid as symptoms and sign of respiratory issues occurred but needed to continue prednisone due to adrenal insufficiency or failure on attempts to withdrawal steroid with cortisol approximately 1.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site is red, swollen, itchy. Hot to touch oblong shaped. 2-3 in. in length. Seen by MD on 6/23/17, recommended ibuprofen as needed. Observe per continued improvement.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Rash erythematous
Clinical narrative: Patient reported having a red rash and burning sensation and had to visit PCP.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Received PNEUMOVAX 23 vaccine June 29. Experienced swelling and burning sensation at injection site and upper arm. Did not seek treatment and subsided after 3-4 days.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Hives on the back. Transient.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Paralysis
Clinical narrative: "Paralyzed from flu shot given at work."  Flu shot given on 10/6/2016.  Just reporting this to us on 6/20/2017.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: ENTIRE LEFT ARM SWELLING , SOUGHT URGENT CARE, PRESCRIBED BENADRYL AND ANTIBIOTICS.
Age: 53.0
Sex: F
Vaccine: TYP
Symptoms: Blood test, Eating disorder, Laboratory test, Retching, Stool analysis
Clinical narrative: 6/20/2017 12:00:00 AM - RN; Pt called stating vomiting and dry heaving 12 hours after 2nd oral typhoid. I recommend she see her PMD, stop the oral typhoid; 7/5/2017 12:00:00 AM - RN; Pt. called today to update on status. She has difficulty eating, lost 13 pounds, has had many lab tests including blood, urine and stool with her PMD.. She will be seeing an ID MD in 2 days. Dr. aware 7/10/2017 2:04:25 PM - RN; spoke to pt today. She saw ID MD on Friday. Is on antispasmotic.to help her eat. She has gained 2 pounds since Friday. No other treatment, is feeling better.
Age: 53.0
Sex: F
Vaccine: TYP
Symptoms: Urine analysis, Vomiting, Weight decreased
Clinical narrative: 6/20/2017 12:00:00 AM - RN; Pt called stating vomiting and dry heaving 12 hours after 2nd oral typhoid. I recommend she see her PMD, stop the oral typhoid; 7/5/2017 12:00:00 AM - RN; Pt. called today to update on status. She has difficulty eating, lost 13 pounds, has had many lab tests including blood, urine and stool with her PMD.. She will be seeing an ID MD in 2 days. Dr. aware 7/10/2017 2:04:25 PM - RN; spoke to pt today. She saw ID MD on Friday. Is on antispasmotic.to help her eat. She has gained 2 pounds since Friday. No other treatment, is feeling better.
Age: 9.0
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of drug administration, Pruritus, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of welts in a 9-year-old male patient who received RABAVERT. Co-suspect products included RABAVERT. Concurrent medical conditions included cat bite. Concomitant products included RABAVERT and Immunoglobulin. On 18th June 2017, the patient received the 2nd dose of RABAVERT. On 21st June 2017, the patient received the 3rd dose of RABAVERT 1 ml. On 18th June 2017, unknown after receiving RABAVERT and not applicable after receiving RABAVERT, the patient experienced drug dose administration interval too long. On 22nd June 2017, the patient experienced welts and pruritus. The patient was treated with AUGMENTIN and BENADRYL. RABAVERT was discontinued. On 26th June 2017, the outcome of the welts and pruritus were recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the welts to be related to RABAVERT. The reporter considered the pruritus to be almost certainly related to RABAVERT. Additional details were provided as follows: The case was reported by patient's mother. On 14th June 2017 at 8 PM, the patient received 1st dose of RABAVERT on left thigh with Antiglobulin. On 18th June 2017, the patient received 2nd dose of RABAVERT on right thigh which led to lengthening of vaccination schedule. On 21st June 2017 at 3 PM, the patient received 3rd dose of RABAVERT on left thigh. On 22nd June 2017, the patient developed welts all over his body and looked as if he had been dipped in boiling water. His hands were itching and the welts were on his hands, feet, thighs, a little on his chest, behind his ears and on his chin. This covered 80 to 85 percent of the body. Later, he was prescribed AUGMENTIN 750 mg and given BENADRYL and Hydrocortisone.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Eyelid oedema
Clinical narrative: Swelling around eyes few hours after BEXSERO shot given in office. Took oral BENADRYL and subsided.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Eye pain, Fatigue, Migraine, Pyrexia
Clinical narrative: Approximately 1 pm developed high fever (not measured) and severe chills. At 2:30 took 2 adult ibuprofen. At 4 pm chills decreased. 1-2:30 preferred darkness, eye pains, migraine headache which lasted until 10 pm. Residual fatigue for next 48 hrs. like the flu.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, pertinent medical histories, drug reactions or allergies were not provided. On unknown dates, the patients received doses of improperly stored VARIVAX, lot # M035688 with expiration date 10-AUG-2018, lot # M042496 with expiration date 19-OCT-2018 and lot # M049127 with expiration date 15-DEC-2018 (doses and route of administration were not reported). Administered doses of VARIVAX experienced a temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 570 minutes and an excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit, which lasted for 300 minutes. No previous temperature excursion was reported. A digital data logger was involved in recording the excursion. Administered doses of VARIVAX were reconstituted with STERILE DILUENT, also reported as "sterile water diluent" (lot # and expiration date were unknown). The STERILE DILUENT was properly stored. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 19-JUN-2017, the patient was vaccinated with an expired dose of M-M-R II injection (lot# L020188, expiry date 03-JUN-2017; exact dose, route of administration and albumin status were not reported), reconstituted with DILUENT MRK. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the second dose of improperly stored M-M-R II lot # M000768, expiration date 05-JAN-2018, for prophylaxis (route was not reported). Concomitant therapies included STERILE DILUENT lot # reported as K024994, with expiration date 12-OCT-2017. It was stated that the temperature excursion was for 67 minutes, with a temperature of 14 Celsius degrees. A digital data logger was used to control temperature. No previous temperature excursions were reported. It was also reported that the sterile diluent was properly stored. No adverse effects were reported. A product quality complaint was not involved.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. The patient's medical history and concurrent conidtions were not reported. Concomitant therapies included STERILE DILUENT. On 19-JUN-2017, the patient was vaccinated with VARIVAX lot # K010442 expiration date 22-JUL-2016 for prophylaxis. No adverse event were reported.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical assistant concerning to unspecified patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 19-JUN-2017, the patient was vaccinated with an expired dose of GARDASIL lot # M014929, the expiration date: 27-MAY-2017 (expired product administered) (dose and route were not reported) for prophylaxis. There was no concomitant medication provided. There was no adverse effects reported nor Product Quality Complaint (PQC) involved.
Sex: F
Vaccine: HPV4
Symptoms: Nervous system disorder
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative and refers to a female patient who is currently 19 years old. The patient's concurrent conditions and medical history were not reported. Approximately in 2009 (reported as "8 years ago,") the patient was vaccinated with GARDASIL intramuscularly (lot number, expiry date, dose and frequency were not reported) for prophylaxis. Information regarding concomitant therapies was not reported. The reporter stated that the patient completed the GARDASIL series. Then, since an unspecified date, the patient experienced unspecified neurological issues. No product quality complaint (PQC) was involved. At the reporting time, the outcome of nervous system disorder was reported as not recovered. The reporter did not provide a causality assessment between the event and GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On 16-JUN-2017, 2 weeks less than the 6 months minimum, the patient was vaccinated with the second dose of VAQTA, for prophylaxis, (dose, route, lot number and expiration date were not provided). No adverse effects were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with a dose of ROTATEQ orally, lot number M035456, expiration date: 01-MAY-2018 or Lot # M038208, expiration date: 04-MAY-2018 or lot M040267, expiration date 14-MAY-2018 or lot M041181, expiration date 03-MAY-2018 (strength and dose were not reported) for prophylaxis. The temperature of excursion with dose of ROTATEQ was between 47 to 77 Fahrenheit degrees for 192 hours. No previous temperature of excursion was performed. The temperature of excursions were detected by a data logger. This is one of two cases from the same reporter.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Chest pain, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist, concerning 39 year-old male patient. There were no concurrent conditions or medical history reported. The patient did not have any drug reaction or allergy, and his concomitant medications included clonazepam, lisinopril (manufacturer unknown), venlafaxine, metoprolol, oxycodone, oxymorphone, gabapentin and glipizide. On 19-JUN-2017, the patient was intramuscularly vaccinated with a dose of PNEUMOVAX23 (dose and frequency were not reported) lot # N010105 with expiration date of 15-NOV-2018, for prophylaxis (reported as "prevent pneumonia"). On 20-JUN-2017, the patient returned to the pharmacist complaining that his arm was "swollen and the injection site was very warm to touch". The pharmacist mentioned that "upon inspection, the injection site was very warm to touch, swollen, the skin was tight and the patient complained of pain from the back side of his shoulder around his chest". The pharmacist advised the patient to take his temperature, apply ice at the injection site and to take MOTRIN for the pain; also, if his conditions did not improve or worsened he needs to consult medical treatment. No laboratory diagnostics or studies were performed to the patient. At the time of the report, the outcome of the aforementioned events was unknown. The causality between the events and PNEUMOVAX23 was unknown. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Skin tightness
Clinical narrative: This spontaneous report was received from a pharmacist, concerning 39 year-old male patient. There were no concurrent conditions or medical history reported. The patient did not have any drug reaction or allergy, and his concomitant medications included clonazepam, lisinopril (manufacturer unknown), venlafaxine, metoprolol, oxycodone, oxymorphone, gabapentin and glipizide. On 19-JUN-2017, the patient was intramuscularly vaccinated with a dose of PNEUMOVAX23 (dose and frequency were not reported) lot # N010105 with expiration date of 15-NOV-2018, for prophylaxis (reported as "prevent pneumonia"). On 20-JUN-2017, the patient returned to the pharmacist complaining that his arm was "swollen and the injection site was very warm to touch". The pharmacist mentioned that "upon inspection, the injection site was very warm to touch, swollen, the skin was tight and the patient complained of pain from the back side of his shoulder around his chest". The pharmacist advised the patient to take his temperature, apply ice at the injection site and to take MOTRIN for the pain; also, if his conditions did not improve or worsened he needs to consult medical treatment. No laboratory diagnostics or studies were performed to the patient. At the time of the report, the outcome of the aforementioned events was unknown. The causality between the events and PNEUMOVAX23 was unknown. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an approximately 72 year old female patient. No information was provided regarding the patient's concurrent conditions or concomitant medications. The patient was not sure whether she received a dose of ZOSTAVAX while previously living in a nursing home. The patient stated that she had received "vaccines" on unspecified dates. However, the pharmacist stated that there was no history of vaccines in the patient's records. On 20-JUN-2017, the pharmacist administered a dose of PNEUMOVAX23 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unspecified date, the patient also received ZOSTAVAX for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported. No product quality complaint was filed.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. On 20-JUN-2017 the patient was vaccinated with PROQUAD for prophylaxis. Other suspect therapies included VARIVAX. On 20-JUN-2017, 1 day after onset of therapy the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event. The outcome of inappropriate schedule of drug administration and no adverse event is unknown. The reporter considered no adverse event to be not related to PROQUAD and VARIVAX. The reporter considered inappropriate schedule of drug administration to be not related to VARIVAX and PROQUAD.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 13 year old female patient. On an unknown date the patient was vaccinated with GARDASIL for prophylaxis. Other suspect therapies included GARDASIL 9. On an unknown date the patient experienced interchange of vaccine products and no adverse event. The outcome of no adverse event is unknown. The reporter considered interchange of vaccine products to be not related to GARDASIL 9 and GARDASIL. The reporter considered no adverse event to be not related to GARDASIL and GARDASIL 9. {Additional information has been requested. / Additional information is not expected.}
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; Unspecified patient was administered an expired dose of MMR II; This spontaneous report was received from an office manager referring to an unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 09-JUN-2017, the patient was vaccinated with an expired dose of M-M-R II, (rHa, lot # L019989, expiry date 01-JUN-2017) for prophylaxis. Other suspect therapies included STERILE DILUENT. No adverse effects were reported. The outcome of expired product administered and no adverse event was unknown. Additional information is not expected as no consent to obtain follow-up information was provided.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local swelling and redness on site of injection. Pharmacist recommended ice pack and MOTRIN. Symptoms worsen next day, swelling continued on elbow. Went to MD, MD prescribed KEFLEX 500 mg TID for 7 days. Talked patient on 7-1-17, recovering fine.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse (reported as licensed vocational nurse (LVN)), and refers to two patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD, lot number M043307 with expiration date 24-APR-2018 for prophylaxis (dose, frequency, route of administration, and anatomical location were not reported), which was reconstituted with properly stored STERILE DILUENT, lot number reported as N000383 with expiration date 28-JUN-2019. No adverse events were reported. The vaccine doses were exposed to a temperature of 7.6 degrees Celsius for 4 hours and 20 minutes; the digital data logger was involved. No previous temperature excursion was reported.
Age: 0.17
Sex: U
Vaccine: HEP, HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a 2 month old patient.    On 19-JUN-2017 the patient was vaccinated with VAQTA lot # M047658 for prophylaxis. Other suspect therapies included RECOMBIVAX HB. On 19-JUN-2017, 1 day after onset of therapy the patient experienced wrong drug administered. On an unknown date the patient experienced no adverse event. The outcome of wrong drug administered and no adverse event is unknown. The reporter considered wrong drug administered to be not related to VAQTA and RECOMBIVAX HB. The reporter considered no adverse event to be not related RECOMBIVAX HB and VAQTA. {Additional information has been requested. / Additional information is not expected.}
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and allergies were not reported. On 20-JUN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot number M046004 with expiration date 18-NOV-2018, for prophylaxis (dose, frequency, route of administration, and anatomical location were not reported), which was reconstituted with properly stored STERILE DILUENT, lot number M044950 with expiration date 30-MAY-2019. No adverse events were reported. The vaccine was exposed to a temperature of 6 to 14 degree Fahrenheit for 180 minutes; the digital data logger was involved. No previous temperature excursion was reported. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1707USA000673: US-009507513-1707USA000674.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 22-AUG-2007 the patient was vaccinated with VAQTA dose 2 for prophylaxis. On 22-AUG-2007, 5 months 27 days after onset of therapy the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event. The outcome of inappropriate schedule of drug administration and no adverse event is unknown. The reporter considered inappropriate schedule of drug administration and no adverse event to be not related to VAQTA.     {Additional information has been requested.}
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product packaging quantity issue
Clinical narrative: This spontaneous report was received from a medical assistant via a company representative and refers to an unspecified number of patients of an unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. On an unspecified date, the patients were vaccinated with a dose of ZOSTAVAX subcutaneously (strength, dose, frequency, anatomical location, lot number, and expiration date were not provided) which was reconstituted with a sterile diluent (Manufacturer unknown) for prophylaxis; however, the reporter mentioned that when drawing up and reconstitution of the ZOSTAVAX, less that the recommended dosage for administration was detected. No adverse effects were reported. There was a product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a online article via company representative regarding to unspecified number of female patients of unknown age. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown dates, the patients were vaccinated with GARDASIL, (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. It was reported that on unspecified date, the patients had adverse events. Additionally it stated that the pharmaceutical companies which made GARDASIL, as well as the Department of Health and Human Services which hold patents and earns profits from GARDASIL said that they were all coincidence also that the mainstream media denied that these events were even happened. The relatedness between the event and therapy with GARDASIL was not reported. This is one of several reports from the same source. Additional information is not expected as follow up information cannot be obtained.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. 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 the improperly stored dose of PNEUMOVAX23 (lot # N003993 and expiration date 20-OCT-2018; dose and route of administration were not reported) for prophylaxis. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 72 degrees Fahrenheit for 18 days. Data logger was not involved. There were no previous excursions reported.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from  a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with a dose of GARDASIL 9 injection, lot # M041990, expiration date: 28-JUN-2019 (strength, route and dose were not reported) for prophylaxis. The temperature of excursion with dose of GARDASIL 9 was between 47 to 77 Fahrenheit degrees for 192 hours. No previous temperature of excursion was performed. The temperature of excursions were detected by a data logger. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1706USA009345.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and allergies were not reported. On 20-JUN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot number M046004 with expiration date 18-NOV-2018, for prophylaxis (dose, frequency, route of administration, and anatomical location were not reported), which was reconstituted with properly stored STERILE DILUENT, lot number M044950 with expiration date 30-MAY-2019. No adverse events were reported. The vaccine was exposed to a temperature of 6 to 14 degree Fahrenheit for 180 minutes; the digital data logger was involved. No previous temperature excursion was reported. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1707USA000674: US-009507513-1706USA010264.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and allergies were not reported. On 21-JUN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot number M046004 with expiration date 18-NOV-2018, for prophylaxis (dose, frequency, route of administration, and anatomical location were not reported), which was reconstituted with properly stored STERILE DILUENT, lot number M044950 with expiration date 30-MAY-2019. No adverse events were reported.  The vaccine was exposed to a temperature of 6 to 14 degree Fahrenheit for 60 minutes; the digital data logger was involved. A previous temperature excursion was of 6 to 14 degree Fahrenheit for 180 minutes. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1706USA010264: US-009507513-1707USA000673.
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Rash macular
Clinical narrative: This is a spontaneous report from a contactable consumer (parent). This consumer reported that a male patient (son) received the TRUMENBA via an unspecified route of administration on 23Jun2017 at single dose for immunization. The patient medical history and concomitant medication were not reported. The parent reported that a rash appeared two days before (01Jul2017) - 8 days after the injection- but the parent didn't make the possible connection until evening the day before. The rash had changed dramatically and it occurred to the parent that the location was where the vaccine was given. It could still be a complete coincidence and have nothing to do with the vaccine but it was parent's understanding that the parent supposed to report it. On 01Jul2017, the rash was the normal skin tone and consisted of large soft bumps in the area about the size of a 50 cent piece. The day before the area was larger and uniformly red. On the reporting day the area was more of a blotchy paler red. The outcome of events was unknown.