chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.26
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pyrexia, Rash, Vomiting
Clinical narrative: Information has been received from a physician via a company representative referring to a 15 month old female patient. Concurrent condition and medical history of the patient were not reported. On 13-MAY-2016 the patient was vaccinated with one dose of VARIVAX (lot # L025206, expiration date: 07-JUL-2017 (dose and route were unspecified). On the same day, the patient experienced fever, vomiting, blisters and a rash for an unspecified reason. The patient did not seek medical attention. No treatment was given for the events, and no lab diagnostics studies was performed. The outcome of the events was reported as recovered/resolved on an unspecified date in May 2016. Additional information has been requested. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker referring to an unspecified number of patients of unknown ages and genders. Information regarding medical history or concurrent conditions was not informed. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (which had the lot # L048459, expiration date 22-FEB-2018, M003659, expiration date 20-SEP-2017) (dose, route and anatomical site of vaccination were not provided). Information regarding concomitant medication was not reported. No adverse effects were reported. There was not product quality complaint involved. This is one of several cases from the same reporter. 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 health care worker referring to an unspecified number of patients of unknown ages and genders. Information regarding medical history or concurrent conditions were not informed. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB (which had the lot # reported as M006709, expiration date 05-DEC-2018, lot # L042258, expiration date 18-AUG-2018, lot # L014428 expiration date 12-MAR-2018, lot # L038502, expiration date 16-AUG-2018) (dose, route and anatomical site of vaccination were not provided. Information regarding concomitant medication was not reported. No adverse effects were reported. And there was not product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant, regarding an unspecified number of patients of unknown gender and age. On unspecified dates the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # L017138), expiration date 13-AUG-2016), dose and route were not provided. No adverse effects were reported. It was reported that the vaccines were exposed to 7F for 12 hours, and there was a past excursion at 36F for another 12 hours. This was recorded as a result of a digital data logger. This is one of the two reports from the same reporter. (see MARRS 1606USA003558). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with unspecified improperly stores doses of ROTATEQ Oral liquid, orally, which had a lot # of L010844, and an expiration date of 16-NOV-2016 (concentration, dose, and anatomical place of vaccination were not provided). Which were exposed to a temperature of 32.7 F for 31 hours. There were no previous excursion and a data logger was involved. Information regarding concomitant therapies was not reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unknown dates, the patient received the first and second doses of GARDASIL injection, (lot numbers, doses, routes and anatomical sites of injection were not reported). After that, on 25-MAY-2016, the patient was vaccinated with GARDASIL 9 injection, (lot number, dose, route and anatomical site of injection were not reported). Concomitant therapies were not provided. No adverse effect was reported. No product quality complain (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker referring to an unspecified number of patients of unknown ages and genders. Information regarding medical history or concurrent conditions was not informed. On an unknown dare, the patients were vaccinated with improperly stored doses of ROTATEQ (which had the lot # M002252, expiration date 18-FEB-2017) (dose, route, and anatomical site of vaccination were not provided). Information regarding concomitant medication was not reported. No adverse effects were reported. There was not product quality complaint involved. This is one of several cases from the same reporter. 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 health care worker referring to an unspecified number of patients of unknown ages and genders. Information regarding medical history or concurrent conditions was not informed. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II (which had the lot # of L020189, expiration date 03-JUN-2017, L023385 expiration date 25-JUN-2017) (dose, route and anatomical site of vaccination were not provided). Information regarding concomitant medication was not reported. No adverse effects were reported. There was not product quality complaint involved. This is on of several cases from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Fainted 10 mins after getting GARDASIL 9. Had pt. lay down for 30 mins given cold soda.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a nurse referring to a 33 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. The patient had an unknown vaccination or chicken pox history and showed low immunity to varicella. On 12-MAY-2016 the patient was vaccinated with a dose of VARIVAX (lot # K021486, 03-NOV-2016, dose unknown, subcutaneous). On 23-MAY-2016, the patient developed a varicella like rash on the back of her left arm where she was vaccinated. The patient saw an unspecified primary care physician. No lab diagnostics studies were performed. The patient had not recovered from the varicella like rash at the time of reporting. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Swelling, redness, warm to touch and pain when moving it. (L) arm. Cold compress, BENADRYL PRN itching, Ibuprofen PRN pain.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Insomnia, Pain in extremity
Clinical narrative: Patient's arm was sore following injection and then had a hard time sleeping due to pain that night. Pain has not gone away after 2 weeks, and has trouble lifting left arm. There was no redness/warmth the day after the injection and left arm appeared the same as right.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Fatigue, Injection site erythema, Pyrexia
Clinical narrative: Fever T102.6, redness at injection site, chills, fatigue.
Age: 0.68
Sex: M
Vaccine: PNC13
Symptoms: Body temperature increased
Clinical narrative: First ever temperature started around 1pm and was over 103 degrees by 3am on 06/18/2014.
Age: 10.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Arthralgia, Chills, Joint swelling, Pain in extremity, Peripheral coldness
Clinical narrative: Initial unsolicited report received from a nurse on 26 May 2016. This case involves a 11-years-male patient who was vaccinated with a first dose of YFVAX (batch number UI270AA, expiry on date 26 October 2017, route and site of administration was not reported) and first dose of TYPHIM VI (batch number L1072-1, expiry date 17 February 2017, route and site of administration was not reported) on 11 May 2016. Illness at time of vaccination was reported as none and Pre-existing physician diagnosed allergies, birth defects, medical conditions was no known allergy. Concomitant medications were not reported. On 13 May 2016, two days following vaccination, patient developed migratory rash/hives all over the body, joint pain, fever, swelling in hands and feet. Patient required emergency room or doctor visit. It was reported that patient had a low serum protein level. The patient received corrective treatment with prednisone. The patient was not recovered from events. List of documents held by sender: none.
Age: 10.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Peripheral swelling, Protein total decreased, Proteinuria, Pyrexia, Rash pruritic
Clinical narrative: Initial unsolicited report received from a nurse on 26 May 2016. This case involves a 11-years-male patient who was vaccinated with a first dose of YFVAX (batch number UI270AA, expiry on date 26 October 2017, route and site of administration was not reported) and first dose of TYPHIM VI (batch number L1072-1, expiry date 17 February 2017, route and site of administration was not reported) on 11 May 2016. Illness at time of vaccination was reported as none and Pre-existing physician diagnosed allergies, birth defects, medical conditions was no known allergy. Concomitant medications were not reported. On 13 May 2016, two days following vaccination, patient developed migratory rash/hives all over the body, joint pain, fever, swelling in hands and feet. Patient required emergency room or doctor visit. It was reported that patient had a low serum protein level. The patient received corrective treatment with prednisone. The patient was not recovered from events. List of documents held by sender: none.
Age: 10.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Serum sickness, Skin discolouration, Swelling face
Clinical narrative: Initial unsolicited report received from a nurse on 26 May 2016. This case involves a 11-years-male patient who was vaccinated with a first dose of YFVAX (batch number UI270AA, expiry on date 26 October 2017, route and site of administration was not reported) and first dose of TYPHIM VI (batch number L1072-1, expiry date 17 February 2017, route and site of administration was not reported) on 11 May 2016. Illness at time of vaccination was reported as none and Pre-existing physician diagnosed allergies, birth defects, medical conditions was no known allergy. Concomitant medications were not reported. On 13 May 2016, two days following vaccination, patient developed migratory rash/hives all over the body, joint pain, fever, swelling in hands and feet. Patient required emergency room or doctor visit. It was reported that patient had a low serum protein level. The patient received corrective treatment with prednisone. The patient was not recovered from events. List of documents held by sender: none.
Age: 10.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Arthralgia, Peripheral swelling, Protein total decreased, Pyrexia, Rash generalised
Clinical narrative: Initial unsolicited report received from a nurse on 26 May 2016. This case involves a 11-years-male patient who was vaccinated with a first dose of YFVAX (batch number UI270AA, expiry on date 26 October 2017, route and site of administration was not reported) and first dose of TYPHIM VI (batch number L1072-1, expiry date 17 February 2017, route and site of administration was not reported) on 11 May 2016. Illness at time of vaccination was reported as none and Pre-existing physician diagnosed allergies, birth defects, medical conditions was no known allergy. Concomitant medications were not reported. On 13 May 2016, two days following vaccination, patient developed migratory rash/hives all over the body, joint pain, fever, swelling in hands and feet. Patient required emergency room or doctor visit. It was reported that patient had a low serum protein level. The patient received corrective treatment with prednisone. The patient was not recovered from events. List of documents held by sender: none.
Age: 10.0
Sex: M
Vaccine: TYP, YF, TYP, YF
Symptoms: Urticaria
Clinical narrative: Initial unsolicited report received from a nurse on 26 May 2016. This case involves a 11-years-male patient who was vaccinated with a first dose of YFVAX (batch number UI270AA, expiry on date 26 October 2017, route and site of administration was not reported) and first dose of TYPHIM VI (batch number L1072-1, expiry date 17 February 2017, route and site of administration was not reported) on 11 May 2016. Illness at time of vaccination was reported as none and Pre-existing physician diagnosed allergies, birth defects, medical conditions was no known allergy. Concomitant medications were not reported. On 13 May 2016, two days following vaccination, patient developed migratory rash/hives all over the body, joint pain, fever, swelling in hands and feet. Patient required emergency room or doctor visit. It was reported that patient had a low serum protein level. The patient received corrective treatment with prednisone. The patient was not recovered from events. List of documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Headache, Lethargy, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, nausea, arm pain, malaise.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Malaise, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever, nausea, arm pain, malaise.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injected limb mobility decreased, Injection site injury, Injection site pain, Periarthritis
Clinical narrative: Upper arm soreness in left arm as expected with flu vaccine began shortly after injection, but did not subside. Pain/soreness continued without lessening for over one year. In January 2016, pain rapidly got much worse and spread to shoulder, resulting in inability to do much of anything with that arm followed by increasingly limited range of motion. Upon return home from trip, visited doctor in March 2016.  Doctor prescribed physical therapy.  Physical therapist identified pain as caused by combination of adhesive capsulitis combined with bursitis, which he noted he had not seen present similarly in 35 years of practice, and believed fit the profile of a flu vaccine injection injury. After 25 days of therapy and recommended daily exercises pain was still significant; health provider did steroid injection (triamcinolone acetonide 40mg) in bursa; pain was reduced significantly after a few days. Therapy course concluded, though some pain and limitations in range of motion remains as of June 13, 2016.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Reason for PCP office visit on 6/7/16:  The symptoms began 1 day ago and generally lasts 1 day as being moderate occur randomly are acute and have worsened.  Pt received vaccines on 6/6/16, that night started having a fever 101, and pain in left thigh with a small area of redness where she received shots, mom thought it was normal side effects from shots but pain has become worse and redness has increased along with swelling.  Has been giving her Tylenol for fever.  Eating and drinking normally.  Assessment:  Cellulitis.  Plan:  Warm compresses to left upper thigh three times a day for 20 min, Ibuprofen for pain or fever.  Take medication as directed, start tonight (cephalexin 250/5, 10 ml BID x 10 days).  Return Thursday to have checked, if redness spreads past red (body maker) line, high fever, increased pain, need to go to ER or return to office sooner. I talked w/ mom after office visit, she noticed fever (not measured/per touch (99.2 at this OV)) and L thigh swelling at 8 pm yesterday (6th).  I measured the red area laterally 11 cm X 12.3 cm longitudinally. I called mom to see how pt's L thigh is doing (13th).  She said it is completely normal today.  Still taking ABX.  Did go to ER the night of 6/7 because the redness extended beyond the drawn outline at the OV; but ER said it looks good.  No concerns at this time.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: No adverse event experienced by patient.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 17-MAY-2016, the patient was vaccinated with the first dose of RECOMBIVAXS HB (dose, route of administration, lot # and expiration date not reported). On 26-MAY-2015, the patient received another dose of RECOMBIVAX HB (lot # L035881, expiration date 26-JUN-2017 (dose and route of administration were not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an adult patient of unknown exact age and gender. There was no information about the patient's concurrent, concomitant therapies or medical history provided. On 02-MAR-2016, the patient was inadvertently vaccinated with RECOMBIVAX HB (lot# L045117, expiration date 06-OCT-2018; dose, anatomical location were not reported) intramuscularly. On 22-MAY-2016, the patient was again inadvertently vaccinated with RECOMBIVAX HB (lot# L045117, expiration date 06-OCT-2018; dose, anatomical location were not reported) intramuscularly. This was outside the labeled recommendations in the prescribing information. No adverse events were reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician via a company representative referring to a female patient of unknown age. Information about concurrent condition, medical history and concomitant medication was unknown. On 31-MAY-2016 the patient was vaccinated with a dose of PNEUMOVAX 23 (batch#/lot  # L035686, expiration date February 2017, 1 injection, dose# unknown, subcutaneous). On the same day the patient experienced cellulitis and the patient was seen at Urgent Care and treated with antibiotics on an unspecified date after that. The outcome of the event was unknown. Upon internal review, the event cellulitis was considered to be medically significant. Additional information is not expected since there is not consent to contact physician.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of 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 improperly stored VARIVAX (lot # K02319, expiration date 28-APR-2017; route and dose were not reported). The vaccines were exposed to 33 F for 3 hours and 49 F for 50 minutes without previous excursion. The issue was due to data logger. No symptoms were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Chills, Feeling abnormal, Headache, Influenza like illness
Clinical narrative: Patient is a 33-year-old who presents to the office today with complaints of fever, chills, feeling like she has the flu and severe abdominal pain. She was seen in the office yesterday and received T dap vaccination. States she woke up this morning and felt horrible, has a severe headache, nausea, fever, chills and severe abdominal pain. Patient is visibly shaking.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: Patient is a 33-year-old who presents to the office today with complaints of fever, chills, feeling like she has the flu and severe abdominal pain. She was seen in the office yesterday and received T dap vaccination. States she woke up this morning and felt horrible, has a severe headache, nausea, fever, chills and severe abdominal pain. Patient is visibly shaking.
Sex: M
Vaccine: PPV
Symptoms: Vision blurred
Clinical narrative: This spontaneous report as received from a pharmacist via Pfizer, refers to a male patient of unknown age. Concurrent conditions and medical history of the patient were not provided. On an unreported date, the patient was vaccinated with PNEUMOVAX 23 (dose, site of administration, route, dose# and lot# not reported). Concomitant medication was not mentioned by the pharmacist. On an unknown date the patient experienced blurred vision as a reaction to PNEUMOVAX 23. The outcome of vision blurred was unknown. Causality statement was not provided by the reporter. No product quality complaint was filed. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a nurse practitioner via a company representative referring to two 20 year old female patients. Information regarding the patients' current condition, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with GARDASIL (dose, route, lot # and expiration date were unknown). On unknown dates the patients each developed an unspecified type of HPV. Outcome of the events was unknown. Additional information is not expected since we have no consent to contact the nurse practitioner.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse provided that in May 2016, she had a temperature excursion (to 34.4F for 8 hours and 24 minutes) with VAQTA (lot #L017757 with an expiration date 08-APR-2018). On unknown dates in 2016, the patients were administered the improperly stored doses of VAQTA (dose and route were not reported). On an unknown date in 2016, the vaccines has a second excursion to 28.9F for 8 hours cycling every 20 minutes. No vaccines were administered since the second excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles post vaccine, Rash, Vaccination failure
Clinical narrative: This literature marketed report was received from the authors of a published article, and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medication was reported. On unknown dates, the patient was vaccinated with three doses of MMR (manufacturer unknown) (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided). On an unknown date between 28-DEC-2014 and 08-FEB-2015, the patient experienced measles with rash (vaccination failure). It was unspecified if the patient was exposed to measles in one or both of the two theme parks, if there was secondary exposure to measles or the source of measles exposure was unknown. The outcome of the event was not reported. The authors considered the event of measles outbreak despite of 3 doses of measles-containing vaccine to be related to MMR (manufacturer unknown). This is one of several cases received from the same literature (cross-referenced cases MARRS # 1606USA004609 and 1606USA005685). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist via a field representative referring to an adult patient of unknown age and gender. On 14-FEB-2016 the patient was vaccinated with the first dose of RECOMBIVAX HB (strength, lot/exp., dosage and frequency unspecified), followed by her second dose of RECOMBIVAX HB (lot# reported as L030609, exp.26-JUN-2017; strength, dosage and frequency unspecified). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles post vaccine, Rash, Vaccination failure
Clinical narrative: This literature marketed report was received from the authors of a published article, and refers to 7 patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medication was reported. On unknown dates, the patients were vaccinated with two doses of MMR vaccine (manufacturer unknown) (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided). On unknown dates between 28-DEC-2014 and 08-FEB-2015, the patients experienced measles with rash. It was unspecified if the patients were exposed to measles in one or both of the two theme parks, if there was secondary exposure to measles or the source of measles exposure was unknown. The outcome of the event was not reported. The authors considered the event of measles outbreak despite two doses of measles-containing vaccine to be related to MMR vaccine (manufacturer unknown). This is one of several cases received from the same literature (cross-referenced cases MARRS # 1606USA004609 and 1606USA005686). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles post vaccine, Rash, Vaccination failure
Clinical narrative: This literature marketed report was received from the authors of a published article and refers to 5 patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medication as reported. On unknown dates, the patients were vaccinated with one dose of MMR (manufacturer unknown) (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided). On unknown dates between 28-DEC-2014 and 08-FEB-2015, the patients experienced measles with rash (vaccination failure). It was unspecified if the patients were exposed to measles in one or both of the two theme parks, if there was secondary exposure to measles or the source of measles exposure was unknown. The outcome of the event was not reported. The authors considered the event of measles outbreak despite of one dose of measles-containing vaccine to be related to MMR (manufacturer unknown). This is one of several cases received from the same literature (cross-referenced cases MARRS # 1606USA005685 and 1606USA005686). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse provided that in May 2016, she had a temperature excursion (to 34.4F for 8 hours and 24 minutes), with RECOMBIVAX HB (lot# L038499 with expiration date 26-JUN-2017). On unknown dates in 2016, the patients were administered the improperly stored doses of RECOMBIVAX HB (dose and route were not reported). On an unknown date in 2016, the vaccines has a second excursion to 28.9F for 8 hours cycling every 20 minutes. No vaccines were administered since the second excursion. This is on of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. The nurse provided that in May 2016, she had a temperature excursion (to 34.4F for 8 hours and 24 minutes) with GARDASIL 9 (lot # L025737 with expiration date 28-JUL-2017). On unknown dates in 2016, the patients were administered the improperly stored doses of GARDASIL 9 (dose and route not reported). On an unknown date in 2016, the vaccines had a second excursion to 28.9F for 8 hours cycling every 20 minutes. No vaccines were administered since the second excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. On 09-JUN-2016 the patient was vaccinated with an expired dose of VARIVAX (lot # K007974 with expiration date of 03-JUN-2016, subcutaneous; dosage and frequency unspecified). No known adverse event. The outcome of expired product administered and no adverse effects was reported. Additional information has been reported.
Sex: F
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a female patient of unknown age referring to herself. The current condition, medical history and concomitant therapy were unknown. On unknown dates the patient was vaccinated with two doses of GARDASIL 9 (lot#, dose and route not reported). On 09-JUN-2016, the patient received the third dose in the series. The patient stated that the dose she received on 09-JUN-2016 might have been GARDASIL (lot#, dose and route not reported) (interchange of vaccine products). No adverse effects were reported. Additional information is not expected since no consent to contact.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: This spontaneous report was received from an external source (reported as an executive) via company representative referring to a 50 year old female patient. The patient's concurrent conditions and medical history were not provided. On 02-JUN-2016, the patient was vaccinated with ZOSTAVAX (Lot # L046893, expiration date was not reported) dose reported as "19400 PFU", subcutaneous injection. There was not concomitant medication reported. Approximately in 04-JUN-2016 (also reported as "within two days") the patient experienced full blown chickenpox on her trunk. The patient sought for medical attention visiting the physician's office. At time of the report the outcome of varicella was unknown. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 01 June 2016. This case involves 74-year-old female patient who was vaccinated with a dose of TENIVAC (batch number and site of administration not reported) in right deltoid on 29 May 2016 after a boating accident. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. The patient had no known allergy. Reporter was unsure about previous vaccination with TENIVAC vaccine. The patient had not received any vaccine as concomitant medications. On 29 May 2016, when the vaccine was administered it hurt going in and afterward and the shot looked sort of high. On 01 June 2016, three days following vaccination, patient could not lift his arm. The patient required emergency room/doctor visit. Laboratory data was reported as none. The patient received warm soaks as corrective treatment. The patient was not recovered from events. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: HPVX, MNQ, TDAP
Symptoms: Dizziness, Eye movement disorder, Fall, Muscle tightness, Nausea
Clinical narrative: Initial unsolicited report received from other non-healthcare professional (medical assistant) on 03 June 2016. This case involves 11-year-old male patient who was vaccinated with a first dose of ADACEL (batch number- U5278AA, expiry date- 25 February 2018) intramuscularly in right deltoid, first dose of MENACTRA (batch number- U5180AA, expiry date- 22 January 2017) intramuscularly in right deltoid and also received first dose of HPV (batch number- L016429, manufacturer- Merck) intramuscularly in right deltoid on 01 June 2016. Illness at time of vaccination was reported as unknown. Pre-existing physician diagnosed allergies, birth defects, medical conditions included no known allergy. Concomitant medications were not reported. On 02 June 2016, one day following the vaccination, the patient had experienced 3 mini seizures vs syncope episodes (according to ER record) and the patient was warm, nauseated and lightheaded and fell to the ground, the patient's mother reported that patient's eyes rolled up into head and arms and legs tightened up and were shaking. On 02 June 2016 in the evening, one day following the vaccination, patient vomited 3 times. On 02 June 2016 at 2:44 pm, the patient was seen at emergency room. Laboratory data and corrective treatment were not reported. On an unspecified date, the patient was recovered from events. Upon internal review the case was considered as serious because of important medical event mini seizures. List of documents held by sender: none. Sender's Comments: Seizures may occur after administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This case is not sufficiently documented. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Age: 11.0
Sex: M
Vaccine: HPVX, MNQ, TDAP
Symptoms: Seizure, Skin warm, Syncope, Tremor, Vomiting
Clinical narrative: Initial unsolicited report received from other non-healthcare professional (medical assistant) on 03 June 2016. This case involves 11-year-old male patient who was vaccinated with a first dose of ADACEL (batch number- U5278AA, expiry date- 25 February 2018) intramuscularly in right deltoid, first dose of MENACTRA (batch number- U5180AA, expiry date- 22 January 2017) intramuscularly in right deltoid and also received first dose of HPV (batch number- L016429, manufacturer- Merck) intramuscularly in right deltoid on 01 June 2016. Illness at time of vaccination was reported as unknown. Pre-existing physician diagnosed allergies, birth defects, medical conditions included no known allergy. Concomitant medications were not reported. On 02 June 2016, one day following the vaccination, the patient had experienced 3 mini seizures vs syncope episodes (according to ER record) and the patient was warm, nauseated and lightheaded and fell to the ground, the patient's mother reported that patient's eyes rolled up into head and arms and legs tightened up and were shaking. On 02 June 2016 in the evening, one day following the vaccination, patient vomited 3 times. On 02 June 2016 at 2:44 pm, the patient was seen at emergency room. Laboratory data and corrective treatment were not reported. On an unspecified date, the patient was recovered from events. Upon internal review the case was considered as serious because of important medical event mini seizures. List of documents held by sender: none. Sender's Comments: Seizures may occur after administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This case is not sufficiently documented. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Anaphylactic reaction, Vaccination complication
Clinical narrative: Initial unsolicited report received from a pharmacist on 07 June 2016. This case involves a female patient (age not reported) who received a dose of Flu Vaccine (batch number, expiry date, route and site of administration: not reported) on an unspecified date. Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced "anaphylactic" reaction to the flu vaccine. Laboratory data was not reported. Corrective treatment was not reported. Outcome of the events was reported as unknown. Upon internal review, the company decided to consider the event serious because of important medical event anaphylactic reaction to a flu vaccine. List of documents held by sender: none. Sender's Comments: This is a poorly documented case of anaphylactic reaction after INFLUENZA VACCINE. Further information regarding dates of vaccine administration and the reported events, investigation results and etiological work up are needed for the complete assessment of the case. Based on the data provided, the role of vaccine cannot be assessed.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Initial unsolicited report received from a pharmacist on 07 June 2016. This case involves a female patient (age not reported) who received a dose of Flu Vaccine (batch number, expiry date, route and site of administration: not reported) on an unspecified date. Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced "anaphylactic" reaction to the flu vaccine. Laboratory data was not reported. Corrective treatment was not reported. Outcome of the events was reported as unknown. Upon internal review, the company decided to consider the event serious because of important medical event anaphylactic reaction to a flu vaccine. List of documents held by sender: none. Sender's Comments: This is a poorly documented case of anaphylactic reaction after INFLUENZA VACCINE. Further information regarding dates of vaccine administration and the reported events, investigation results and etiological work up are needed for the complete assessment of the case. Based on the data provided, the role of vaccine cannot be assessed.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of 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 improperly stored ROTATEQ (lot# L033693, expiration date 31-MAY-2017; Lot# L029617, expiration date 19-MAY-2017; Lot# M004890, expiration date 10-NOV-2017; dose was not reported) orally. The vaccines were exposed to 33 F for 3 hours and 49 F for 50 minutes without previous excursion. The issue was due to datealogger. No symptoms were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of 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 improperly stored PEDVAXHIB (lot # L051122, expiration date 12-OCT-2018; lot # M006709, expiration date 06-DEC-2018; route and dose were not reported). The vaccines were exposed to 33 F for 3 hours and 49 F for 50 minutes without previous excursion. The issue was due to data logger. No symptoms were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: MMR
Symptoms: Hypersensitivity, Hypertension, Prostatic disorder, Rhinorrhoea, Seasonal allergy
Clinical narrative: Allergic reactions to air borne substances. Symptoms: runny nose, hay-fever. Increasing over the years... controlled with Benadryl... which ended up causing high blood pressure and prostate problems... which required blood pressure medication and prostate medication.
Age: 0.23
Sex: F
Vaccine: MEN
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant regarding unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of M-M-R II (route and dose were unknown). No adverse event was reported. The information of administered vaccine was below: Lot# L012482 with expiration date: 10-APR-2017 was administered on 21-JAN-2016, 27-JAN-2016, 01-FEB-2016, 08-FEB-2016, 11-FEB-2016, 13-APR-2016,  22-APR-2016. The information of temperature excursion and time frame was below: On 07-JAN-2016, it was stored in 49 degrees F for 24 hours. On 23-FEB-2016, it was stored in 34 degrees F for 24 hours. From 14-APR-2016 to 18-APR-2016, it was stored in 48 degrees F for 95 hours. On  22-APR-2016, it was stored in 47 degrees F for 24 hours. Lot# K024825 with expiration date: 02-DEC-2016 was administered on 12-JAN-2016 and the temperature excursion and time frame was 49 degrees F for 24 hours on 07-JAN-2016. Lot # L015280 with expiration date 30-APR-2017 was administered on 08-JAN-2016, 05-FEB-2016, 24-FEB-2016, 15-MAR-2016, 23-MAR-2106. The information of temperature excursion and time frame was 49 degrees F for 24 hours on 07-JAN-2016 and 34 degrees F for 24 hours on 23-FEB-2016. Lot# K026366 with expiration date: 15-DEC-2106 was administered on 26-JAN-20106, 05-FEB-2016, 12-FEB-2101, 18-FEB-2016, 07-MAR-2016, 21-MAR-2106. The information of temperature excursion and time frame was 49 degrees F for 24 hours on 07-JAN-2016 and 34 degrees F for 24 hours on 23-FEB-2016. Lot# L007217 with expiration date: 03-APR-2017 was administered on 07-MAR-2016. The information of temperature excursion and time frame was 49 degrees F for 24 hours on 07-JAN-2016 and 34 degrees F for 24 hours on 23-FEB-2016. Lot# L033589 with expiration date: 02-SEP-2017 was administered on 28-MAR-2016, 04-APR-2016, 08-APR-2016, 06-APR-2016, 13-APR-2016, 21-APR-2016, 22-APR-2016. The information of temperature excursion and time frame was below: On 23-FEB-2016, it was stored in 34 degrees F for 24 hours. From 14-APR-2016 to 18-APR-2016, it was stored in  48 degrees F for 95 hours. On 22-APR-2016, it was stored in 47 degrees F for 24 hours. From 13-MAY-2016 to 24-MAY-2016, it was stored in 33 degrees F for 264 hours. Lot# L039612 with expiration date: 07-OCT-2017 was administered on 25-APR-2016, 26-APR-2016, 27-APR-2016, 18-MAY-2016. The information of temperature excursion and time frame was below: From 14-APR-2016 to 18-APR-2016, it was stored in 48 degrees F for 95 hours. On 22-APR-2016, it was stored in 47 degrees F for 24 hours. From 13-MAY-2016 to 24-MAY-2016, it was stored in 33 degrees F for 264 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of 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 improperly stored RECOMBIVAX HB (lot # M003661, expiration date 15-SEP-2017; route and dose were not reported). The vaccines were exposed to 33 F for 3 hours and 49 F for 50 minutes without previous excursion. The issue was due to date logger. No symptoms were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Dry skin, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 31-MAY-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly in the arm (unspecified), lot # L035686, expiration date 16-FEB-2017 (dose was not provided). On an unspecified date in 2016, the patient experienced a reaction described as: injection site arm was red and swollen, tender to touch, with red streak center, pink and dry (diagnosed as symptoms of cellulitis). The nurse reported that the patient sought medical attention on 02-JUN-2016. The patient was prescribed antibiotics of KEFLEX 500 mg, every 6 hours for treatment by a physician. The patient was also instructed to go to an unspecified emergency room if symptoms worsened at the time of the visit. The nurse reported follow up with the patient on 03-JUN-2016 by an unknown provider and the patient stated that redness was improved and the patient was feeling better. The nurse stated that the patient did not seek further medical attention as of 10-JUN-2016 (reported as today). The patient did not have lab diagnostic studies performed. The outcome of the events was considered as recovering/resolving at the time of the report. The relatedness between the events and PNEUMOVAX 23 was not reported. Upon internal review, the event of cellulitis was considered to be medically significant. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Headache, Immediate post-injection reaction, Injection site bruising, Injection site cellulitis
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's coexisting conditions included rheumatoid arthritis with an unspecified onset. No other information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 06-JUN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot # L035686, expiration date 16-FEB-2017 (dose and anatomical location were not provided). On approximately 06-JUN-2016 (reported as immediately after receiving the PNEUMOVAX 23, the patient experienced a reaction described as: swelling, muscle pain, headache, neck ache, injection site swollen to size of orange (diagnosed as symptoms of cellulitis). The nurse reported that the patient sought medical attention by calling nurse practitioner office on 09-JUN-2016 but was not seen by the nurse practitioner until 10-JUN-2016 (also reported as today). The treatment note was not completed at the time of the call (reported as the patient was given the treatment). During infusion of REMICADE for rheumatoid arthritis on an unspecified date in June 2016, the unspecified staff member noticed that the patient had a hard area which was bruised and tender where the PNEUMOVAX 23 was administered. The patient did not have lab diagnostic studies performed. The outcome of the events was not reported. The relatedness between the events and PNEUMOVAX 23 was not reported. Upon internal review, the event of cellulitis was considered to be medically significant. This is one of two reports received from the same reporter. Additional information has been requested.