chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site infection, Mobility decreased, Peripheral swelling, Skin warm
Clinical narrative: Infection at site of injection. Arm was swollen and hot to touch. Caused limited mobility pt received indirect attention.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain, swelling, hardness at site. Patient stated lasted 3-4 days. Took BENADRYL. Had same vaccination (different year) 10/7/16.
Age: 62.0
Sex: F
Vaccine: FLUR4
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site swelling, Pain in extremity
Clinical narrative: Per patient, arm is sore, injection site is swollen and bruised, bruising down arm to the elbow, and unable to raise arm over head.
Age: 17.0
Sex: M
Vaccine: HPV4, MENB, MNQ
Symptoms: Diarrhoea, Dizziness, Induration, Nausea, Peripheral swelling
Clinical narrative: Hard and swollen Lt. arm, nauseous, fever, dizzy and diarrhea.
Age: 17.0
Sex: M
Vaccine: HPV4, MENB, MNQ
Symptoms: Pyrexia
Clinical narrative: Hard and swollen Lt. arm, nauseous, fever, dizzy and diarrhea.
Age: 47.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site warmth, Pain, Pain in extremity
Clinical narrative: Sore arm to a point where lifting the arm was painful, large 2+ inch red very warm circle where the pneumonia vaccine was given. Pain continued for about 3 days.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Skin erosion
Clinical narrative: Injection site red and painful. Looking at the area it was toward the back of the left upper arm. A dime sized red/raw wound. No discharge, pus, or itchiness. Counseled patient on how to take care of the area and follow up on 10/30/2017.
Age: 5.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event
Clinical narrative: None listed.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; an unspecified number of unspecified patients were administered doses of VARIVAX which were improperly stored.; Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent(manufacturer unknown).  On 01-SEP-2017, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency and route were unknown, lot # M049127, expiration date:15-DEC-2018, lot # N010107, expiration date:28-MAR-2019) for prophylaxis(Incorrect product storage).   Administered vaccine experienced the temperature excursion of -14 celsius degree to -10 celsius degree (-14.2 celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint(PQC) was involved.    This is one of several reports from the same reporter.  All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful.  Follow up information has been received from an other reporter concerning a 12 month old patient. On 08-SEP-2017, the patient vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency and route were unknown, lot # N010107, expiration date:28-MAR-2019) for prophylaxis(Incorrect product storage).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1709USA002098:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; an unspecified number of unspecified patients were administered doses of VARIVAX which were improperly stored.; Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent(manufacturer unknown).  On 01-SEP-2017, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency and route were unknown, lot # M049127, expiration date:15-DEC-2018, lot # N010107, expiration date:28-MAR-2019) for prophylaxis(Incorrect product storage).   Administered vaccine experienced the temperature excursion of -14 celsius degree to -10 celsius degree (-14.2 celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint(PQC) was involved.    This is one of several reports from the same reporter.  All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful.  Follow up information has been received from an other reporter concerning a 12 month old patient. On 05-SEP-2017, the patient vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency and route were unknown, lot # N010107, expiration date:28-MAR-2019) for prophylaxis(Incorrect product storage).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1709USA002098:
Age: 1.5
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; an unspecified number of unspecified patients were administered doses of VARIVAX which were improperly stored.; Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent(manufacturer unknown).  On 01-SEP-2017, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency and route were unknown, lot # M049127, expiration date:15-DEC-2018, lot # N010107, expiration date:28-MAR-2019) for prophylaxis(Incorrect product storage).   Administered vaccine experienced the temperature excursion of -14 celsius degree to -10 celsius degree (-14.2 celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint(PQC) was involved.    This is one of several reports from the same reporter.  All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful.  Follow up information has been received from an other reporter concerning a 18 month old patient. On 12-SEP-2017, the patient vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018) for prophylaxis(Incorrect product storage).  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-1709USA002098:
Age: 21.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity
Clinical narrative: Vaccine was given too high in the shoulder. The normal amount of vaccine pain was present for the next few days. On 10/2/17 the pain became very bad. Went to Dr. on 10/12/17 for exam and they prescribed Pred. Arm was slightly improved on the medicine but once off the meds, it became worse again.
Age: 21.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Drug administered at inappropriate site, Pain, X-ray
Clinical narrative: Vaccine was given too high in the shoulder. The normal amount of vaccine pain was present for the next few days. On 10/2/17 the pain became very bad. Went to Dr. on 10/12/17 for exam and they prescribed Pred. Arm was slightly improved on the medicine but once off the meds, it became worse again.
Age: 19.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Computerised tomogram abdomen, Full blood count, Haematuria, Petechiae, Platelet count decreased
Clinical narrative: GARDASIL on 9/20/17, on 9/24/17-pt developed petechiae and had blood in his urine-continued to increase, pt developed a rash and had increased bleeding on 9/29/17 and was admitted to hospital and was diagnosed with ITP, blood platelets were 7. Remained in hospital until 10/11/17-pt is having transfusions of platelets every few days, on high dose steroids and no improv. as of 10/27/17.
Age: 19.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Thrombocytopenia
Clinical narrative: GARDASIL on 9/20/17, on 9/24/17-pt developed petechiae and had blood in his urine-continued to increase, pt developed a rash and had increased bleeding on 9/29/17 and was admitted to hospital and was diagnosed with ITP, blood platelets were 7. Remained in hospital until 10/11/17-pt is having transfusions of platelets every few days, on high dose steroids and no improv. as of 10/27/17.
Age: 19.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Biopsy bone marrow normal, Blood urine present, Computerised tomogram abdomen normal, Computerised tomogram head normal, Full blood count normal
Clinical narrative: GARDASIL on 9/20/17, on 9/24/17-pt developed petechiae and had blood in his urine-continued to increase, pt developed a rash and had increased bleeding on 9/29/17 and was admitted to hospital and was diagnosed with ITP, blood platelets were 7. Remained in hospital until 10/11/17-pt is having transfusions of platelets every few days, on high dose steroids and no improv. as of 10/27/17.
Age: 19.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Haemorrhage, Immune thrombocytopenic purpura, Laboratory test normal, Petechiae, Platelet count decreased
Clinical narrative: GARDASIL on 9/20/17, on 9/24/17-pt developed petechiae and had blood in his urine-continued to increase, pt developed a rash and had increased bleeding on 9/29/17 and was admitted to hospital and was diagnosed with ITP, blood platelets were 7. Remained in hospital until 10/11/17-pt is having transfusions of platelets every few days, on high dose steroids and no improv. as of 10/27/17.
Age: 19.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Platelet transfusion, Rash, Ultrasound abdomen normal, Ultrasound skull normal
Clinical narrative: GARDASIL on 9/20/17, on 9/24/17-pt developed petechiae and had blood in his urine-continued to increase, pt developed a rash and had increased bleeding on 9/29/17 and was admitted to hospital and was diagnosed with ITP, blood platelets were 7. Remained in hospital until 10/11/17-pt is having transfusions of platelets every few days, on high dose steroids and no improv. as of 10/27/17.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions included: multiple myeloma. Concomitant medications were not reported. On 04-OCT-2017 the patient was vaccinated with VARIVAX lot # N017700, expiration date: 09-JUN-2019, strength and route was not reported), together with an unspecified sterile diluent (lot# and date of expiration was unspecified). No adverse event was reported.
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Neuropathy peripheral
Clinical narrative: Initial unsolicited case received from a nurse on 16 Oct 2017. This case involves 56-year-old female patient who was vaccinated with one dose of FLUZONE ID (Batch number: UT5902AA, Expiry date: 30 Jun 2018) via intradermal route in right arm on 05 Oct 2017. Patient medical history and concomitant medications were not reported. On 07 Oct 2017, two days after the vaccination, patient developed neuropathy of left thumb. The patient tried chiropractor with no relief. Relevant lab tests and other corrective treatment were not reported. Outcome of the event was unknown. Upon internal review the company decided to consider the case as serious, due to important medical event neuropathy of left thumb. List of documents held by sender: none. Sender's Comments: The patient experienced neuropathy of left thumb post vaccination with FLUZONE ID. Time to onset was compatible. No information regarding patient's medical history or tolerance to previous vaccination was reported. Patient could have experienced the event due to an alternate etiology that needs to be investigated. At this time due to lack of information no conclusive decision could be made regarding the role of the vaccine.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, IPV, PNC13, RV1, DTAPHEPBIP, PNC13, RV5
Symptoms: Fontanelle bulging, Swelling, Ultrasound skull abnormal
Clinical narrative: Developed bulging fontanelle, transient increase in ICP (and presumed CSF).
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, IPV, PNC13, RV1, DTAPHEPBIP, PNC13, RV5
Symptoms: Fontanelle bulging, Intracranial pressure increased, Ultrasound skull
Clinical narrative: Developed bulging fontanelle, transient increase in ICP (and presumed CSF).
Age: 25.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Pain
Clinical narrative: I remember the pharmacist leaning over the counter to administer the shot in my left arm, which was laying on the counter. I remember the angle of the injection seemed awkward, and I remember the injection being given lower in my arm than usual. The injection itself felt different, and was a little more painful than flu shots tend to be. Immediately after the injection, the injection area was tender and felt bruised and achey. This tender, bruised and achey feeling continued in my left arm 1 month after the injection. At that point I realized that something about the injection wasn't right.
Age: 25.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injection site bruising, Injection site pain
Clinical narrative: I remember the pharmacist leaning over the counter to administer the shot in my left arm, which was laying on the counter. I remember the angle of the injection seemed awkward, and I remember the injection being given lower in my arm than usual. The injection itself felt different, and was a little more painful than flu shots tend to be. Immediately after the injection, the injection area was tender and felt bruised and achey. This tender, bruised and achey feeling continued in my left arm 1 month after the injection. At that point I realized that something about the injection wasn't right.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain
Clinical narrative: The vaccine was given very high on the point of the shoulder. The muscle was not pinched and lifted as normally is done. It was a very painful injection. Arm was painful for a day or two as usual after vaccines, but on 10/2/17, I began to experience marked soreness, stiffness and pain that limited movement of the arm and prevented me from sleeping at night and performing my job duties comfortably. Visited Dr. who x-rayed shoulder and did a physical exam, he put me on Medrol pack which helped for 3 days but the pain returned upon completion of the medication.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Drug administered at inappropriate site, Impaired work ability, Injection site pain, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: The vaccine was given very high on the point of the shoulder. The muscle was not pinched and lifted as normally is done. It was a very painful injection. Arm was painful for a day or two as usual after vaccines, but on 10/2/17, I began to experience marked soreness, stiffness and pain that limited movement of the arm and prevented me from sleeping at night and performing my job duties comfortably. Visited Dr. who x-rayed shoulder and did a physical exam, he put me on Medrol pack which helped for 3 days but the pain returned upon completion of the medication.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Sleep disorder, X-ray limb
Clinical narrative: The vaccine was given very high on the point of the shoulder. The muscle was not pinched and lifted as normally is done. It was a very painful injection. Arm was painful for a day or two as usual after vaccines, but on 10/2/17, I began to experience marked soreness, stiffness and pain that limited movement of the arm and prevented me from sleeping at night and performing my job duties comfortably. Visited Dr. who x-rayed shoulder and did a physical exam, he put me on Medrol pack which helped for 3 days but the pain returned upon completion of the medication.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Injection site pruritus, Laboratory test, Pruritus generalised, Rash erythematous
Clinical narrative: Note: Unsure about the flu vaccine type, but the nurse did mention that it was four strains. Rash on areas throughout body (reddish). Persistent Itchiness on areas throughout body. Itchiness more pronounced on same arm as the vaccine given (upper to middle part of arm). Initially, rash appeared on same arm as the. Elevated blood pressure (159/79). Had been consistently in 120 or below range.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Rash generalised
Clinical narrative: Note: Unsure about the flu vaccine type, but the nurse did mention that it was four strains. Rash on areas throughout body (reddish). Persistent Itchiness on areas throughout body. Itchiness more pronounced on same arm as the vaccine given (upper to middle part of arm). Initially, rash appeared on same arm as the. Elevated blood pressure (159/79). Had been consistently in 120 or below range.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Dyskinesia, Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling
Clinical narrative: Pt states that he was given the shot and it hurt like it normally does but this particular time he also had irritation at the site in the form of redness and swelling a few hours after getting the vaccine. Pt went on to say that a couple of days went by and he noticed some pain in the left jaw as well as an inability to open his mouth past a certain point. This went for a couples of days and then subsided with no other symptoms. Pt denies any other symptoms, being sick, SOB or recently being treated for an illness around the time, so just assumed it was due to the vaccine. Pt did not report this until just yesterday because he had been temporarily assigned to another location immediately after getting the vaccination, then once his symptoms went away, he didn't think it was a big deal and forgot about it.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Pain in jaw
Clinical narrative: Pt states that he was given the shot and it hurt like it normally does but this particular time he also had irritation at the site in the form of redness and swelling a few hours after getting the vaccine. Pt went on to say that a couple of days went by and he noticed some pain in the left jaw as well as an inability to open his mouth past a certain point. This went for a couples of days and then subsided with no other symptoms. Pt denies any other symptoms, being sick, SOB or recently being treated for an illness around the time, so just assumed it was due to the vaccine. Pt did not report this until just yesterday because he had been temporarily assigned to another location immediately after getting the vaccination, then once his symptoms went away, he didn't think it was a big deal and forgot about it.
Age: 28.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Fu-like symptoms including muscle aches, fever, headache, within hours of vaccination.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Pain, Swelling
Clinical narrative: Swelling, pain for 2 days. Applying ice, MOTRIN.
Age: 45.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Headache, Nasal congestion, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Pt reports runny/stuffy nose, sore throat, headache and general weakness.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site rash
Clinical narrative: Rash 4x5 cm upper left thigh.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, DTAPIPVHIB, FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: PENTACEL was given and noted that was outdated, after checking with state health, was advised to repeat- no adverse reactions at this time.
Age: 75.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Exposure via skin contact, Injection site extravasation, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75 year old male patient. On 21-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # M041086 dose 1 in the right arm for prophylaxis. Concomitant therapies included FLUZONE. On 21-AUG-2017 the patient experienced accidental exposure to product and underdose. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a unspecified patients of unknown age and gender. On an unknown date, the patient was vaccinated with improperly stored doses of ZOSTAVAX (dose, route of administration, lot # N021170, expiration date: 27-OCT-2018) reconstituted with improperly stored diluent. Data logger was involved, conditions of previous excursion were unknown by reporter. Was call because of. No adverse effects were reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Ear pain, Headache, Herpes zoster, Pain of skin
Clinical narrative: Initial and follow up information was received from a pharmacist concerning to a 69 year old female patient with rheumatoid arthritis. No allergies reported. On 25-SEP-2017 (also reported as "a couple of days ago"), the patient was vaccinated with a dose of ZOSTAVAX (Lot No. M037655, exp. date 29-NOV-2017) subcutaneous for prophylaxis. Secondary suspect included sterile diluent (manufacturer unknown) (Lot number and expiration date not reported). Concomitant therapies included prednisone (manufacturer unknown) and PLAQUENIL. On 01-OCT-2017, the patient returned to the pharmacy describing "pain in her ear, radiating to her scalp and head". The patient made an appointment to be examined by an unspecified physician. On 02-OCT-2017, the physician diagnosed the patient with shingles. No laboratory tests were performed. The patient did not received treatment. At the time of the report, the patient had not recovered from shingles. No death nor life threatening were reported. The relationship between shingles and therapy with ZOSTAVAX was not reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions or concomitant medication. On unknown dates, the patient was vaccinated with the first and second dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported) in first series, according to the recommended schedule. The patient did not received the third dose of GARDASIL 9. Because of this, the nurse re-started the vaccination at appropriate interval. On unknown dates, the patient was vaccinated with the first and second dose of GARDASIL 9 in a second series, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 08-AUG-2017, the patient was vaccinated with an expired third dose of GARDASIL 9 in a second series, for prophylaxis, lot # M014929 and expiration date 27-MAY-2017. No adverse events were reported.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a 81 year old female patient. None medical history, concomitant therapy and drug reactions or allergies were reported. On 05-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 intramuscularly (strength, dose, frequency and dose number were not reported), lot number N012840, expiration date 20-JAN-2019, for immunisation. The patient called to the physician's office on 06-OCT-2017 and inform that on the same date, the injection site was painful to touch, she was unable to lift arm and lightheadedness; but there was no redness or swelling. The patient was instructed to take MOTRIN or ALEVE, to put ice on the injection site and to contact the physician's office if there was not improvement. It was also reported that the patient made an appointment to see the physician 09-OCT-2017. Lab diagnostics or studies were not performed. The outcome of vaccination site joint movement impairment, injection site pain and dizziness was reported as not resolved. The causality assessment between PNEUMOVAX 23 and the aforementioned events was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a currently 79 year old female patient. Information regarding the patient's medical history, concurrent conditions or concomitant medications was unknown. On an unspecified date in 2009, the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, route of administration, lot number and expiration date were unknown by the reporter). On an unknown date, the patient developed shingles. Furthermore, the patient sought medical attention and contacted the doctor. At the time of the report, the outcome of herpes zoster was unknown. Additionally, the reporter did not provide causality assessment between the event and vaccination with ZOSTAVAX. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1710USA004491.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: This spontaneous report was received from a podiatrist physician referring to his wife, a 59 year old female patient. The patient had none pertinent medical history, drug reactions or allergies and had none concomitant medications. On 08-OCT-2017 the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) vial, subcutaneously in the in the posterior area of her left arm (dose, lot number and expiration date were not provided) for prevention of shingles and was reconstituted with sterile diluent (MRK). On 08-OCT-2017, "a few hours" after receiving the vaccination, the patient began experiencing "a well defined area of swelling approximately 7 cm in diameter at the injection site, as well as erythema, itchiness, hives, and warmth at, as well as surrounding the injection site". The reporter stated that, the patient began taking BENADRYL as treatment for the events and continued to take it at this time, the reporter also stated that, none laboratory diagnostics studies were performed and that "she had not needed to seek medical attention at this time." It was reported that, the swelling seemed to be enlarging but at a slow rate, therefore, at the reporting time the patient had not recovered from swelling. The outcome of the patient for erythema, itchiness, hives, and warmth surrounding the injection site injection was unknown and  the causality assessment between ZOSTAVAX and the sterile diluent (MRK) with the events was not reported.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Immediate post-injection reaction, Lethargy, Limb discomfort
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a 15 year old male patient. The patient's historical drugs included amoxicillin. The patient's concurrent conditions included allergy to amoxicillin. On 13-JUN-2017, the patient was vaccinated with a dose of GARDASIL 9 per intramuscular administration, lot # M04471 with expiration date 19-JUL-2019, to prevent Human Papillomavirus Infection (HPV). It was stated that immediately after receiving the injection, the patient felt light headed. The next day, on 14-JUN-2017, the patient felt lethargic and his arms and legs felt heavy. It was stated the patient contacted his physician and an unspecified treatment was given for the adverse events. Additionally, the patient did not received the second dose of GARDASIL 9 as indicated. At the time of reporting the outcome of the events was reported as recovered (no date reported). The causality assessment between dizziness, lethargy, and limb discomfort with GARDASIL 9 was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant via a company representative referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 10-OCT-2017, the patient was vaccinated with a properly stored, but expired dose of ZOSTAVAX lot number M032141 and expiration date of 02-OCT-2017 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No adverse reaction were reported.
Sex: M
Vaccine: PPV
Symptoms: Blood test, Stool analysis, White blood cell count increased
Clinical narrative: This spontaneous report was received from a pharmacist referring to a currently 87 year old male patient with unspecified breathing issues. The patient's concomitant therapies included an unspecified Parkinson medications. No information was provided regarding the patient's medical history. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 lot number N019348 and expiration date of 08-FEB-2019 for prophylaxis (dose and route of administration were not reported). On an unknown date, the patient had a white blood cell count drawn for an unspecified reason after receiving PNEUMOVAX 23 and the result of the laboratory showed an increased white blood count (unspecified amount). There were also performed stool test and blood test and no results were provided. The outcome of white blood cell count increased was reported as resolved. Additionally, the reporter did not provide causality assessment between the event and therapy with PNEUMOVAX 23.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 09-OCT-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose and frequency not provided) lot # N015476, expiration date 18-MAY-2019 for prophylaxis.  Other suspect therapies included sterile diluent (MERCK). The doses of VARIVAX were exposed to a temperature excursion of 19° Fahrenheit (°F) during a time frame of 2 hours and 15 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported.
Age: 41.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report has received from a registered nurse referring to a 41 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 10-OCT-2017, the patient was vaccinated with a pediatric dose of VAQTA second dose (strength, route of administration were not provided) lot # M033611, expiration date 02-MAR-2018, for prophylaxis. No adverse reactions reported.
Sex: F
Vaccine: HPVX
Symptoms: Exposure during pregnancy, Interchange of vaccine products
Clinical narrative: This spontaneous prospective pregnancy report was received from a consumer and referred to a female pregnant patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, frequency, route of administration, lot# and expiration date were not reported) or GARDASIL (dose, frequency, route of administration, lot# and expiration date were not reported). The reporter stated that it was "the number to report human papilloma virus (HPV) and pregnancy". The date of last menstrual period (LMP) and estimated date of delivery (EDD) was unknown. The outcome of exposure during pregnancy and interchange of vaccine products was unknown. The pregnancy outcome was unknown as there was no possibility to contact the reporter. The relatedness between the events and GARDASIL 9 and GARDASIL was not reported.
Age: 0.75
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse via company representative and refers to a 9-month-old patient of an unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, when the patient was 9 months old, the patient was vaccinated with the first dose of ROTATEQ orally (dose, lot# and expiration date were not reported). The patient received the second dose of ROTATEQ on an unknown date, when the patient was 11 months old. No adverse effects were reported. The action taken with ROTATEQ was not reported. The relatedness between the event and ROTATEQ was not reported.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 61-year-old female patient. The patient's medical history included shingles and anxiety. The patient's concurrent conditions included chronic pain. The patient's concomitant therapies included hydrocodone. The patient did not have any drug reactions and allergies. On 12-OCT-2017, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously in right deltoid region, lot# M042849 and expiration date: 18-JAN-2018 (dose was not reported), reconstituted with sterile diluent (lot# and expiration date were not reported). In October 2017 (reported as "on an unspecified date after receiving ZOSTAVAX"), the patient noticed a slight bump along with pain, swelling and redness at injection site. The patient stated that pain "felt like a pinched nerve" but denied any numbness or tingling. The patient stated that pain radiates from injection site up to shoulder level. The reporter was unaware if the patient sought medical attention or if any treatment was provided. The outcome of the events was reported as not recovered. The relatedness between the events, ZOSTAVAX and sterile diluent was not reported.
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Skin discolouration
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a male patient of unknown age. The reporter did not provide any information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On an unknown date, the patient was vaccinated with the second dose (in a 2-dose regimen) of GARDASIL 9 (exact dose, lot # and expiration date were not reported) intramuscularly for prophylaxis. Other suspect therapies included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid vaccine, administered on the same day and in the same arm as GARDASIL 9. On an unknown date, the patient developed skin discoloration on the insertion arm. He sought medical attention by visiting the physician's office, but it was not reported if any treatment was given for the event. The outcome of the skin discoloration was not reported. The causality assessment between the event and GARDASIL 9 was not provided.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 68 years old female patient. The patient's medical history and concomitant therapies were not reported. The patient's concurrent conditions included drug reactions/allergies for Sulfa and ENTEX. On 09-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N022703, expiration date: 27-FEB-2019, 0.5 ml, intramuscularly in the right arm for prophylaxis. In the afternoon or evening on 09-OCT-2017, the patient experienced swelling and redness, from her bicep down to her elbow on the right arm. The patient sought for medical attention and was seen in the office on 11-OCT-2017 due to the reaction. On the same date, KEFLEX was prescribed by the doctor as a treatment for cellulitis. The doctor thought that there was some cellulitis going on. The reporter stated that they had another patient with a similar reaction to PNEUMOVAX 23 and requested a lot check for PNEUMOVAX 23 lot # N022703. The outcome of the event was unknown. Relatedness between the event and PNEUMOVAX 23 was not reported. Upon internal review, the event of cellulitis was considered to be medically significant. This is one of two cases from the same reporter (MARRS# 1710USA009576). Sender's Comments: US-009507513-1710USA009576.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Bacterial test positive, Blood test normal, Borrelia test negative, Cardiac function test normal, Cardiac stress test normal
Clinical narrative: This spontaneous report was received from a registered nurse referring to her husband, a 60 year old male patient. The patient had no relevant medical history, concurrent conditions or drug reactions or allergies. Concomitant therapies included omeprazole and losartan (manufacturer unknown). In August 2017 the patient was vaccinated with ZOSTAVAX 19400 plaque forming units (PFU) for prophylaxis (route, dose, units and lot number were not reported). On an unspecified day of 2017, 10 days after onset therapy, the patient experienced numbness and tingling in his right arm, right flank, and right foot. It was also reported that the patient felt weird. On an unspecified day of 2017, the patient was seen at the emergency room and tested negative for Lyme disease and tested positive for anaplasmosis which was treated with intravenous steroids and oral prednisone (manufacturer unknown) for an unspecified amount of time. The full course of treatment was taken and then discontinued. The primary reporter stated that two weeks after the emergency room visit, the patient was treated with doxycycline for two weeks to treat the diagnosis of anaplasmosis and then, on an unspecified date, was tested negative for anaplasmosis. The patient had a "full cardiac workup and stress test", magnetic resonance imaging (MRI), and unspecified "bloodwork" that came back negative for cardiac or other diagnosis. At the time of this report the patient was on muscle relaxants and gabapentin. The outcome of hemiparaesthesia, feeling abnormal, human anaplasmosis and hypoaesthesia was reported as not recovered. Causality assessment was not provided. Upon internal review, hemiparaesthesia was determined to be medically significant.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Human anaplasmosis, Hypoaesthesia, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: This spontaneous report was received from a registered nurse referring to her husband, a 60 year old male patient. The patient had no relevant medical history, concurrent conditions or drug reactions or allergies. Concomitant therapies included omeprazole and losartan (manufacturer unknown). In August 2017 the patient was vaccinated with ZOSTAVAX 19400 plaque forming units (PFU) for prophylaxis (route, dose, units and lot number were not reported). On an unspecified day of 2017, 10 days after onset therapy, the patient experienced numbness and tingling in his right arm, right flank, and right foot. It was also reported that the patient felt weird. On an unspecified day of 2017, the patient was seen at the emergency room and tested negative for Lyme disease and tested positive for anaplasmosis which was treated with intravenous steroids and oral prednisone (manufacturer unknown) for an unspecified amount of time. The full course of treatment was taken and then discontinued. The primary reporter stated that two weeks after the emergency room visit, the patient was treated with doxycycline for two weeks to treat the diagnosis of anaplasmosis and then, on an unspecified date, was tested negative for anaplasmosis. The patient had a "full cardiac workup and stress test", magnetic resonance imaging (MRI), and unspecified "bloodwork" that came back negative for cardiac or other diagnosis. At the time of this report the patient was on muscle relaxants and gabapentin. The outcome of hemiparaesthesia, feeling abnormal, human anaplasmosis and hypoaesthesia was reported as not recovered. Causality assessment was not provided. Upon internal review, hemiparaesthesia was determined to be medically significant.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 4 year old patient. On 08-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 13-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N016089, expiration date: 22-NOV-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 15-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N016089, expiration date: 22-NOV-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 20-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N016089, expiration date: 22-NOV-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 03-OCT-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N016089, expiration date: 22-NOV-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.