chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: FLU4, HEP, HEPA, MMR, TYP
Symptoms: Lip swelling, Paraesthesia oral, Peripheral swelling, Rash
Clinical narrative: Vaccines received 9/13/16 pm. Rash was present morning of 9/14/16. Rash worse morning of 9/15/16 and 9/16/2016. Hands swollen, lips swollen, slight tingling of lips.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to multiple unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored VAQTA (lot # M021124, expiry date: 02-FEB-2018). No adverse effects were reported. This is one of the three reports received from the same reporter. 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 nurse practitioner refers to multiple unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L039638, expiry rate: 23-AUG-2017 or lot # M007124, expiry date: 05-OCT-2017). No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in October 2015, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque-Forming Units (lot #, dose and route were not provided) and then the patient was inadvertently administered a second dose of ZOSTAVAX 19400 Plaque-Forming Units (lot # M013377, expiration date: 25-MAY-2017; dose and route were not provided) on 12-SEP-2016. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to multiple unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018). No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Peripheral swelling, Rash
Clinical narrative: This spontaneous report was received from a registered nurse regarding an 18 year old female patient. Information on the medical history and concurrent conditions of the patient were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # M011117, expiry date 07-DEC-2016, (dose#, units, route and anatomical location were not reported). Concomitant medication were not reported. On an unknown date, mother of the patient reported that the patient had "some swelling of her arm and a rash for approximately two days after the GARDASIL 9. Outcome of peripheral swelling and rash is unknown. There were no additional side effects reported. No additional information available. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Vaccine administered on 9//16, and patient reports a rash developed on 9/13/16 on arms and legs. She does not have a PCP and chose not to be seen by an MD.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 01-JUL-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # M001200, dose, route of administration and expiration date was not reported). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 24-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # M001200, dose, route of administration and expiration date was not reported). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-AUG-2016, the patient was vaccinated with a dose of improperly stored M-M-R II (lot # L029266; strength, dose, route and site of administration were unspecified). This one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-AUG-2016, the patient was vaccinated with a dose of improperly stored M-M-R II (lot # L026553; strength, dose, route and site of administration were unspecified). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 21-JUN-2016, the patient was vaccinated with a dose of improperly stored M-M-R II (lot # L026553; strength, dose, route and site of administration were unspecified). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 10-JUN-2016, the patient was vaccinated with a dose of improperly stored M-M-R II (lot # L026553; strength, dose, route and site of administration were unspecified). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 08-JUL-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # M001200, dose, route of administration and expiration date was not reported). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 19-AUG-2016, the patient was vaccinated with improperly stored dose of M-M-R II lot # L029266, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 19-JUL-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # M001200, dose, route of administration and expiration date was not reported). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 14-AUG-2016, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # L049744, expiration date 12-OCT-2017, dose and route were not reported). No adverse reactions were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 02-AUG-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # M010478 with expiry date on 01-SEP-2017, therapy type, dose and route of administration were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 17-AUG-2016, the patient was vaccinated with unknown doses of VARIVAX and KINRIX (route, lot # and expiry date were not reported for both vaccines). On 22-AUG-2016, the patient to another office and was vaccinated with an unknown dose of M-M-R II (route, lot # and expiry date were not provided). No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 03-JUN-2016, the patient was vaccinated with improperly stored M-M-R II (lot # L003855 and expiration date 05-FEB-2017; lot L026553 and expiration date 16-JUL-2017, albumin status therapy type, dose and route of administration were not reported) and VARIVAX (lot # L039092 and expiration date 06-OCT-2017; lot # L043622 and expiration date 03-NOV-2017; lot # M004326 and expiration date 25-JAN-2018, dose and route of administration were not reported). On 06-JUN-2016, the patient was vaccinated with improperly stored VAQTA (lot # M011116 and expiration date 17-JUN-2017; lot # K008333 and expiration date 10-MAR-2017, dose and route of administration were not reported) and GARDASIL 9 (lot # L045711 and expiration date 08-MAY-2017; lot number M004116 and expiration date 12-OCT-2017; lot number L011846 and expiration date 16-JUN-2017, dose and route of administration were not reported). On 27-JUN-2016, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # M006708 and expiration date 02-JUN-2018; lot # L033343 and expiration date 13-SEP-2017, dose and route of administration were not reported). The maximum temperature of excursion of M-M-R II, VAQTA, GARDASIL 9, RECOMBIVAX HB (lot # L033343 and expiration date 13-SEP-2017) was 22.7 Celsius degrees with the frame of 3 hours and 48 minutes and the minimum temperature of excursion was 0.2 Celsius degrees with the time frame of 31 hours and 1 minute. The maximum temperature of excursion of VARIVAX was minus 5.2 Celsius degrees with the time frame of 50 hours and 17 minutes. The maximum temperature of excursion of RECOMBIVAX HB (lot # M006708 and expiration date 02-JUN-2018) was 22.7 Celsius degrees with the time frame of 3 hours and 48 minutes and minimum temperature of excursion was 0.2 Celsius degrees with the time frame of 7 hours and 36 minutes. There were no known adverse effects. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 31-MAY-2016, the patient was vaccinated with improperly stored M-M-R II  (lot # L003855 and expiration date 05-FEB-2017; lot # L026553 and expiration date 16-JUl-2017, albumin status therapy type, dose and route of administration were not reported), VAQTA (lot # M011116 and expiration date 17-JUN-2017; lot # K008333 and expiration date 10-MAR-2017, dose and route of administration were not reported) and VARIVAX (lot # L039092 and expiration date 06-OCT-2017; lot # L043622 and expiration date 03-NOV-2017; lot # M004326 and expiration date 25-JAN-2018, dose and route of administration were not reported). The maximum temperature of excursion of M-M-R II and VAQTA was 22.7 Celsius degrees with the time frame of 3 hours and 48 minutes and the minimum temperature of excursion was 0.2 Celsius degrees with the time frame of 3 hours and 48 minutes and the minimum temperature of excursion was 0.2 Celsius degrees with the time frame of 31 hours and 1 minute. The maximum temperature of excursion of VARIVAX was minus 5.2 Celsius degrees with the time frame of 50 hours and 17 minutes. There were no known adverse effects. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 08-JUL-2016, the patient was vaccinated with an improperly stored doses of M-M-R II (lot # M001200, dose, route of administration and expiration date was not reported). This is of several reports received from the same source. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Erythema, Rash macular
Clinical narrative: 3:14pm-Tdap, MMR given per pt. request. Observed for 15 min. Pt's s/s of reaction. 3:40 Pt scratching scalp. Assessed upper thorax red blotchy areas appearing around neck also right upper c area no airway problems. BENADRYL 25mg given po, swallowed OK. 3:54 Pt left under own power, laughing and talking with daughter accompanied by mother.
Age: 40.0
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event, pt was give Peds dose of DTAP .5ml - pt was to receive TDAP .5ml
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient had developed a red, warm area from site of injection to elbow. No pain. No pruritus. Patient went to urgent care and was told that it was a histaminergic reaction and instructed to ice it and watch for worsening symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Fever, redness, swelling at injection site. Only at site of KINRIX injection (DTaP/IPV).
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative and refers to a 18 year old male patient. The patient's concurrent conditions, pertinent medical history and drug reactions or allergies were unknown. The patient's concomitant therapies included TRUMENBA and MENACTRA. Approximately on 03-AUG-2016 (reported as "approximately 6 weeks ago") the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency, route, lot number and expiration date were unknown). The reporter stated that the patient experienced dizziness approximately on 04-AUG-2016 (reported as "24 hours after receiving the first dose of GARDASIL 9") It was also reported that the patient recovered approximately on 18-AUG-2016, as her symptoms lasted approximately for two weeks. The patient sought medical attention by speaking to the nurse practitioner. The reporter stated that the patient received an unspecified treatment for the event. It was unknown if the patient had laboratory diagnostic studies performed. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling of arm after injection, swollen for about 1 wk before resolving. (right arm where pneumovax was given).
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ, TD
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out unconscious about 3 minutes after getting vaccines. Dr. and staff went to check on the patient. Took blood pressure. Patient stayed in room to recover. He become conscious about 2 minutes after passing out.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Dyspnoea
Clinical narrative: Mother called unit = 1 hr. after shots stating child is having "breathing problems"-instructed to go to ER.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse reporting to a multiple unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose and route were not reported). 5 lots: #M000760, the expiration date: 06-JAN-2018, time out of range: 2,760 hours, lot # L000455, the expiration date: 06-JAN-2017, time out range: 1,640 hours, lot #M019641, the expiration date: 20-APR-2018, time out of range: 720 hours or lot #M010482, the expiration date: 01-MAR-2018, time out of range: 888 hours or lot # M019643 the expiration date: 20-APR-2018, Time out of range: 576 hours. The temperature was 21 degree F. There was no previous temperature excursion. The call was no due to data logger and no adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 2 patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 08-SEP-2016, the patients were vaccinated with a dose of improperly stored PROQUAD (incorrect product storage), lot number L032760, expiration date 24-FEB-2017, (dose, route and anatomical location were not reported). There was no concomitant medication reported. No adverse reactions were reported. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a phlebotomist regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 30-AUG-2016 the patient was inadvertently vaccinated with PNEUMOVAX 23, intramuscular injection, in the left arm, lot # L003188/expiration date - 06-JUL-2016. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist regarding 2 patients of unknown demographics. There was no information about concurrent condition and historical medication. On 22-AUG-2016, the 2 patients were vaccinated with improperly stored GARDASIL 9, Intramuscular (incorrect product storage). No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 22 year old female patient. Patient's medical history, concurrent conditions and drug reactions/allergies were not reported. The patient received her first dose of VAQTA on 21-NOV-2011. On 14-JUL-2016, the patient was vaccinated with a pediatric dose of VAQTA as her second dose, (lot #, expiration date, dose and route of administration were not reported). Patient's concomitant medication was not provided. No adverse symptoms were reported. A product quality complaint was not involved. Additional information is not expected because the reporter did not want to be contacted.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Swelling
Clinical narrative: 9-13-16 Redness/swelling started. 9-14-16 Redness, swelling, bruising. 9-15-16 Redness and swelling progressed down arm swelling in shoulder area. 9-16-16 Swelling/redness subsided.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, PNC13
Symptoms: Injection site erythema, Injection site reaction, Pallor
Clinical narrative: (R) thigh 3x4 cm erythematous, blanching, non-tender area. No sign of abscess or infection. No streaking. Gait WNL.
Age: 71.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Body temperature increased, Chills, Injected limb mobility decreased, Injection site swelling, Muscle spasms
Clinical narrative: Swelling at injection site, achy arm with difficulty in movement, woke up with chest spasms and chills, elevated temperature (99 degrees F) pt took APAP and has applied ice with some relief.
Age: 71.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Pain in extremity
Clinical narrative: Swelling at injection site, achy arm with difficulty in movement, woke up with chest spasms and chills, elevated temperature (99 degrees F) pt took APAP and has applied ice with some relief.
Age: 6.0
Sex: M
Vaccine: FLUC4
Symptoms: Cough, Cyanosis, Eye swelling, Wheezing
Clinical narrative: After leaving Dr., mom said child began coughing/wheezing, eyes swelling and lips purple. Stopped at UC/ER where they gave steroid and albuterol Tx's.
Age: 70.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Injection site pain, Oedema, Peripheral swelling
Clinical narrative: Patients right arm swelled markedly, edema from shoulder down to forearm. It was not red and not painful to the touch but injection site was painful.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Loss of consciousness, Nausea
Clinical narrative: On 9/14/16 patient had received BEXSERO left deltoid immediately after she passed out since vaccine given she also has had dizziness nausea, HA's and severe pain left arm.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: On 9/14/16 patient had received BEXSERO left deltoid immediately after she passed out since vaccine given she also has had dizziness nausea, HA's and severe pain left arm.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Neck pain
Clinical narrative: The next morning patient had pain on backside of Right knee. It was worse then in afternoon, it started to pain in Left backside of neck. For few days it felt that way. After 1 week knee pain is getting better but still neck pain is there. Patient is using ALEVE for the pain.
Age: 76.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Injection site pain
Clinical narrative: Patient reported pain at injection site following vaccine admin. Completed flu visit with PCP. Advised to use NSAIDS, ice, mild exercise.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Presyncope, Seizure
Clinical narrative: Patient received FLUZONE HD at 9AM on 9/9/16. On 9/16/16 at 10pm he came in to let us know that on that evening he had a seizure and a couple of hours later a vasovagal episode. He will be following-up with his physician.
Age: 64.0
Sex: U
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash below injection site and rash on opposite arm by wrist. Took BENADRYL. Rash clearing up. No additional problems.
Sex: F
Vaccine: FLU3
Symptoms: Asthma
Clinical narrative: Case PHEH2016US023152, is an initial spontaneous case received from a consumer on 12 Sep 2016. This report refers to an elderly female patient of unknown age. Medical history included heart disease and lung disease. Current conditions included allergies (unspecified). Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) at an unknown dose intramuscularly on an unknown date. It was reported that, a list of allergies stated the patient developed asthma after taking FLUVIRIN. The outcome of event was unknown. The seriousness and causality of the event was not reported. The seriousness assessment of asthma (medically significant) was upgraded based on information available in the source document. The case is lost to follow up at initial.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Tremor
Clinical narrative: 1st reported on 9-7-2016- phone call to pharmacy. Diarrhea for 3 days with some shaking in the hands (EPR) slowly recovered by weeks end 9-11-16. Still has some shakiness as of 9/16/16.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative, Biopsy bone marrow normal, Blood immunoglobulin G normal, Blood immunoglobulin M decreased, CD4 lymphocytes decreased
Clinical narrative: Information has been received from the authors in a published literature article, regarding a 41-year-old male patient who presented a clinic for an evaluation of recurrent sinus infections (for the past 30 years), septic thrombophlebitis of the right internal jugular vein and multiple periodontal abscesses. He reported having had 4 episodes of bacterial sinusitis in the last year requiring extended course of antibiotics, 2 episodes of hand, foot and mouth disease and 1 hospitalization for pneumonia. Laboratory evaluation revealed low IgG, normal IgG, CD3 and CD4 lymphopenia and nonprotective pneumococcal titers following immunization with PNEUMOVAX 23 (route, dosage and lot number unknown). The patient complained of headaches, episodic dyspnea, right sided facial pressure, postnasal drip and nasal congestion. He denied having fever or chills, chest tightness, cough, wheezes or skin rashes. A physical examination including his vital signs and spirometry were normal. Significant findings included low IgM, a poor pneumococcal polysaccharide antibody response to 1 of 23 serotypes after PNEUMOVAX 23, 5 of 14 serotypes after PREVNAR vaccination and low numbers of CD3+ and CD4+ T cells. White blood cell count: 4.3 10000/micro-l Lymphocyte count: 0.79 1000/micro-l. Bone marrow biopsy was negative for malignancy. Because of a poor post vaccination polysaccharide antibody response, intravenous immunoglobulin (IVIG) replacement therapy was initiated. Due to debilitating headaches following the IVIG infusions, the patient was transitioned to subcutaneous gamma globulin. With subcutaneous immunoglobulin replacement, he reported a significant improvement in the frequency of infections. Initial immunological work-up demonstrated a low IgM level with low-to-normal IgG and IgA levels. The patient has been followed with subsequent lab studies to ensure these values continue to remain in the normal range. It was unknown if the patient recovered from his poor pneumococcal polysaccharide antibody response. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Discomfort, Dyspnoea, Headache, Immunoglobulin therapy, Lymphocyte count abnormal
Clinical narrative: Information has been received from the authors in a published literature article, regarding a 41-year-old male patient who presented a clinic for an evaluation of recurrent sinus infections (for the past 30 years), septic thrombophlebitis of the right internal jugular vein and multiple periodontal abscesses. He reported having had 4 episodes of bacterial sinusitis in the last year requiring extended course of antibiotics, 2 episodes of hand, foot and mouth disease and 1 hospitalization for pneumonia. Laboratory evaluation revealed low IgG, normal IgG, CD3 and CD4 lymphopenia and nonprotective pneumococcal titers following immunization with PNEUMOVAX 23 (route, dosage and lot number unknown). The patient complained of headaches, episodic dyspnea, right sided facial pressure, postnasal drip and nasal congestion. He denied having fever or chills, chest tightness, cough, wheezes or skin rashes. A physical examination including his vital signs and spirometry were normal. Significant findings included low IgM, a poor pneumococcal polysaccharide antibody response to 1 of 23 serotypes after PNEUMOVAX 23, 5 of 14 serotypes after PREVNAR vaccination and low numbers of CD3+ and CD4+ T cells. White blood cell count: 4.3 10000/micro-l Lymphocyte count: 0.79 1000/micro-l. Bone marrow biopsy was negative for malignancy. Because of a poor post vaccination polysaccharide antibody response, intravenous immunoglobulin (IVIG) replacement therapy was initiated. Due to debilitating headaches following the IVIG infusions, the patient was transitioned to subcutaneous gamma globulin. With subcutaneous immunoglobulin replacement, he reported a significant improvement in the frequency of infections. Initial immunological work-up demonstrated a low IgM level with low-to-normal IgG and IgA levels. The patient has been followed with subsequent lab studies to ensure these values continue to remain in the normal range. It was unknown if the patient recovered from his poor pneumococcal polysaccharide antibody response. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Lymphopenia, Nasal congestion, Spirometry normal, T-lymphocyte count decreased, Upper-airway cough syndrome
Clinical narrative: Information has been received from the authors in a published literature article, regarding a 41-year-old male patient who presented a clinic for an evaluation of recurrent sinus infections (for the past 30 years), septic thrombophlebitis of the right internal jugular vein and multiple periodontal abscesses. He reported having had 4 episodes of bacterial sinusitis in the last year requiring extended course of antibiotics, 2 episodes of hand, foot and mouth disease and 1 hospitalization for pneumonia. Laboratory evaluation revealed low IgG, normal IgG, CD3 and CD4 lymphopenia and nonprotective pneumococcal titers following immunization with PNEUMOVAX 23 (route, dosage and lot number unknown). The patient complained of headaches, episodic dyspnea, right sided facial pressure, postnasal drip and nasal congestion. He denied having fever or chills, chest tightness, cough, wheezes or skin rashes. A physical examination including his vital signs and spirometry were normal. Significant findings included low IgM, a poor pneumococcal polysaccharide antibody response to 1 of 23 serotypes after PNEUMOVAX 23, 5 of 14 serotypes after PREVNAR vaccination and low numbers of CD3+ and CD4+ T cells. White blood cell count: 4.3 10000/micro-l Lymphocyte count: 0.79 1000/micro-l. Bone marrow biopsy was negative for malignancy. Because of a poor post vaccination polysaccharide antibody response, intravenous immunoglobulin (IVIG) replacement therapy was initiated. Due to debilitating headaches following the IVIG infusions, the patient was transitioned to subcutaneous gamma globulin. With subcutaneous immunoglobulin replacement, he reported a significant improvement in the frequency of infections. Initial immunological work-up demonstrated a low IgM level with low-to-normal IgG and IgA levels. The patient has been followed with subsequent lab studies to ensure these values continue to remain in the normal range. It was unknown if the patient recovered from his poor pneumococcal polysaccharide antibody response. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: White blood cell count decreased
Clinical narrative: Information has been received from the authors in a published literature article, regarding a 41-year-old male patient who presented a clinic for an evaluation of recurrent sinus infections (for the past 30 years), septic thrombophlebitis of the right internal jugular vein and multiple periodontal abscesses. He reported having had 4 episodes of bacterial sinusitis in the last year requiring extended course of antibiotics, 2 episodes of hand, foot and mouth disease and 1 hospitalization for pneumonia. Laboratory evaluation revealed low IgG, normal IgG, CD3 and CD4 lymphopenia and nonprotective pneumococcal titers following immunization with PNEUMOVAX 23 (route, dosage and lot number unknown). The patient complained of headaches, episodic dyspnea, right sided facial pressure, postnasal drip and nasal congestion. He denied having fever or chills, chest tightness, cough, wheezes or skin rashes. A physical examination including his vital signs and spirometry were normal. Significant findings included low IgM, a poor pneumococcal polysaccharide antibody response to 1 of 23 serotypes after PNEUMOVAX 23, 5 of 14 serotypes after PREVNAR vaccination and low numbers of CD3+ and CD4+ T cells. White blood cell count: 4.3 10000/micro-l Lymphocyte count: 0.79 1000/micro-l. Bone marrow biopsy was negative for malignancy. Because of a poor post vaccination polysaccharide antibody response, intravenous immunoglobulin (IVIG) replacement therapy was initiated. Due to debilitating headaches following the IVIG infusions, the patient was transitioned to subcutaneous gamma globulin. With subcutaneous immunoglobulin replacement, he reported a significant improvement in the frequency of infections. Initial immunological work-up demonstrated a low IgM level with low-to-normal IgG and IgA levels. The patient has been followed with subsequent lab studies to ensure these values continue to remain in the normal range. It was unknown if the patient recovered from his poor pneumococcal polysaccharide antibody response. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medial assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 15-JUL-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # M001200, dose, route of administration and expiration date was not reported). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
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. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 29-AUG-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L019297, expiration date 18-AUG-2017, 0.5 ml (route of administration was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 25 degrees Fahrenheit for 7 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 07-JUL-2016, the patient was vaccinated with an improperly stored dose of (wistar ra 27-3) M-M-R II (lot # M001200, dose, route of administration and expiration date was not reported). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 19-AUG-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II lot # L029266, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 06-JUL-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # M001200, dose, route of administration and expiration date was not reported). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-JUN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M001152 (dose, expiration date and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patients concurrent conditions, medical history and concomitant medications were not reported. On 03-JUN-2016, the patient was vaccinated with improperly stored (wistar ra 27-3) M-M-R II (lot # L003855 and expiration date 05-FEB-2017; lot # L026553 and expiration date 16-JUL-2017, albumin status therapy type, dose and route of administration were not reported) and (Oka/Merck) VARIVAX (lot # L039092 and expiration date 06-OCT-2017; lot # L043622 and expiration date 03-NOV-2017; lot # M004326 and expiration date 25-JAN-2018, dose and route of administration were not reported). The maximum temperature of excursion of (wistar ra 27-3) M-M-R II was 22.7 Celsius degrees with the time frame of 3 hours and 48 minutes and the minimum temperature of excursion was 0.2 Celsius degrees with the time frame of 31 hours and 1 minute. The maximum temperature of excursion of (Oka/Merck) VARIVAX was minus 5.2 Celsius degrees with the time frame of 50 hours and 17 minutes. There were no known adverse effects. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified patient of unknown demographics. On an unknown date, the patient was vaccinated with an expired dose of ROTATEQ (strength, lot#, dosage unspecified) via oral route. The patient sought medical attention. No product quality complaint was involved. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-JUN-2016, the patient was vaccinated with a dose of improperly stored M-M-R II (lot # L026553; strength, dose, route and site of administration were unspecified). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 11-JUL-2016, the patient was vaccinated with a dose of improperly stored (wistar ra 27-3) M-M-R II (lot # L026553; strength, dose, route and site of administration were unspecified). This is one of several reports received 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 as received from a medical assistant refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored M-M-R II lot # K024825 expiry date: 02-DEC-2016, 0.5 ml, subcutaneously. No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored VARIVAX (lot # L013824, expiry date: 21-APR-2017), which was stored at temperature -13.7 degree centigrade for a time frame of 56 hours. There was no previous temperature excursion reported. The call was not due to data logger. No adverse effects reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 25-AUG-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # L019835, the expiration date: 23-MAR-2017, 0.5 ml, intramuscularly. Temperature: 9.8 degrees C Time frame: 1 hour 22 minutes, Data logger: Yes. There was no prior excursions. No adverse effects were reported. There was no concomitant medication provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and the expiration date were not reported). There was no concomitant medication provided. On an unknown date after receiving ZOSTAVAX, the patient developed an unspecified rash on an unspecified location of their body. The pharmacist was interested in Varicella Zoster Virus Identification Program(VZV) Analysis by PCR (Polymerase Chain Reaction) and wanted to send viral isolates. The outcome of rash was unknown at the time of reporting. Relatedness between the therapy with ZOSTAVAX and the event was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-JUN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M001152 (dose, expiration date and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Pruritus, Urticaria
Clinical narrative: INFLAMMATION, ITCHING, HIVES ALONG VARIOUS PARTS OF LEFT ARM (ARM IN WHICH FLU SHOT WAS RECEIVED); TOOK ZYRTEC, BUT DID NOT HELP. WENT TO AN CLINIC FOR STEROID SHOT & BEGAN COURSE OF PREDNISONE THEREAFTER.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Arthralgia, Asthenia, Blood glucose, Blood iron, Blood test
Clinical narrative: Symptoms include severe headaches, fatigue, muscle pain, joint pain, numbness in feet, eye pain, chest pain, night sweats, loss of appetite, weakness, sensitivity to touch. Several tests have been run. Blood work, urine tests, EKG, EEG, CT scan, xrays. Symptoms have persisted for 3 weeks without relief or diagnosis.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Borrelia test, Chest pain, Computerised tomogram head, Decreased appetite, Electrocardiogram
Clinical narrative: Symptoms include severe headaches, fatigue, muscle pain, joint pain, numbness in feet, eye pain, chest pain, night sweats, loss of appetite, weakness, sensitivity to touch. Several tests have been run. Blood work, urine tests, EKG, EEG, CT scan, xrays. Symptoms have persisted for 3 weeks without relief or diagnosis.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Electroencephalogram, Eye pain, Fatigue, Full blood count, Headache
Clinical narrative: Symptoms include severe headaches, fatigue, muscle pain, joint pain, numbness in feet, eye pain, chest pain, night sweats, loss of appetite, weakness, sensitivity to touch. Several tests have been run. Blood work, urine tests, EKG, EEG, CT scan, xrays. Symptoms have persisted for 3 weeks without relief or diagnosis.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Hyperaesthesia, Hypoaesthesia, Myalgia, Night sweats, Thyroid function test
Clinical narrative: Symptoms include severe headaches, fatigue, muscle pain, joint pain, numbness in feet, eye pain, chest pain, night sweats, loss of appetite, weakness, sensitivity to touch. Several tests have been run. Blood work, urine tests, EKG, EEG, CT scan, xrays. Symptoms have persisted for 3 weeks without relief or diagnosis.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Pruritus
Clinical narrative: A quick onset of a burning itch under the breast area and extending to my back with redness.  Lasted for approximately one half hour and then subsided.  I did put on anti-itch crème but it did not help.
Age: 89.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Erythema, Injection site erythema, Injection site warmth, Skin warm
Clinical narrative: Patient reported that her whole ARM (where injection was given) was red and bit hot to touch.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: ERYTHEMA, MILD TO MODERATE SWELLING, WARMTH AND TENDERNESS.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Rash, arm injection was given (right) swollen from elbow to shoulder.