chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Injection site urticaria, Laryngeal oedema, Lip swelling, Swelling face, Swollen tongue
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a 19-year-old male patient who received BEXSERO (batch number 166801A, expiry date 31st May 2017). On 13th March 2017, the patient received the 2nd dose of BEXSERO (intramuscular) .5 ml. On 13th March 2017, less than a day after receiving BEXSERO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling. The patient was treated with prednisone. On an unknown date, the outcome of the anaphylactic reaction, injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling were unknown. It was unknown if the reporter considered the anaphylactic reaction, injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on the left deltoid. On 13th March 2017, in the evening, the patient began to have a reaction which began initially as hives, then progressed to an anaphylactic reaction. The patient had swelling of the tongue, lips, eyes and face. The patient also had swelling, hardness, and hives at the injection site. On the same date, the patient was seen in the emergency room, treated with Prednisone, and discharged. Follow up information (targeted follow up questionnaire) was received from a nurse on 12th April 2017: The patient demographics details were updated. The patient had received 2 doses of BEXSERO before the hypersensitivity reaction occurred. The VAERS details were updated. On 13th March 2017, less than a day after vaccination, the patient also experienced laryngeal edema and urticaria. The events were resolved after 48 hours. The patient went to the emergency department for management. The details of diagnostics test and full drug history were not provided. It was unknown if the reporter considered the laryngeal edema and urticaria to be related to BEXSERO.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Erythema, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Local reaction at injection site including redness, swollen, hot to touch, and hard lump.  Symptoms resolved in 1 week. Patch on back that was red, blistering, and itching and three "pok" spots on the face that resolved in 3 days. Mild fever and body aches for a few days. No medical treatment needed for symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash macular, Swelling face, Varicella
Clinical narrative: Local reaction at injection site including redness, swollen, hot to touch, and hard lump.  Symptoms resolved in 1 week. Patch on back that was red, blistering, and itching and three "pok" spots on the face that resolved in 3 days. Mild fever and body aches for a few days. No medical treatment needed for symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Local reaction at injection site including redness, swollen, hot to touch, and hard lump.  Symptoms resolved in 1 week. Patch on back that was red, blistering, and itching and three "pok" spots on the face that resolved in 3 days. Mild fever and body aches for a few days. No medical treatment needed for symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Local reaction, Pain, Pruritus
Clinical narrative: Local reaction at injection site including redness, swollen, hot to touch, and hard lump.  Symptoms resolved in 1 week. Patch on back that was red, blistering, and itching and three "pok" spots on the face that resolved in 3 days. Mild fever and body aches for a few days. No medical treatment needed for symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash pustular
Clinical narrative: Local reaction at injection site including redness, swollen, hot to touch, and hard lump.  Symptoms resolved in 1 week. Patch on back that was red, blistering, and itching and three "pok" spots on the face that resolved in 3 days. Mild fever and body aches for a few days. No medical treatment needed for symptoms.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Pyrexia
Clinical narrative: Unresponsive, kind of seemed out of it, fever of 104.1 F, taken to ER, Rectal temp. 102 F, did blood labs, result was high WBC's. given antibiotics, children's tylenol, and fluids, received chest x-ray, urinalysis, ultrasound, blood culture, urine culture, Nasal Flu and virus test, All tests came back negative.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Blood culture negative, Chest X-ray normal, Culture urine negative, Feeling abnormal, Influenza virus test negative
Clinical narrative: Unresponsive, kind of seemed out of it, fever of 104.1 F, taken to ER, Rectal temp. 102 F, did blood labs, result was high WBC's. given antibiotics, children's tylenol, and fluids, received chest x-ray, urinalysis, ultrasound, blood culture, urine culture, Nasal Flu and virus test, All tests came back negative.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Pyrexia, Ultrasound scan normal, Unresponsive to stimuli, Urine analysis normal, Viral test negative
Clinical narrative: Unresponsive, kind of seemed out of it, fever of 104.1 F, taken to ER, Rectal temp. 102 F, did blood labs, result was high WBC's. given antibiotics, children's tylenol, and fluids, received chest x-ray, urinalysis, ultrasound, blood culture, urine culture, Nasal Flu and virus test, All tests came back negative.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: White blood cell count increased
Clinical narrative: Unresponsive, kind of seemed out of it, fever of 104.1 F, taken to ER, Rectal temp. 102 F, did blood labs, result was high WBC's. given antibiotics, children's tylenol, and fluids, received chest x-ray, urinalysis, ultrasound, blood culture, urine culture, Nasal Flu and virus test, All tests came back negative.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning to multiple unspecified patients of unknown demographics. The patients' concurrent conditions, medical history, drug reactions/allergies, and concomitant therapies were not provided. On unspecified dates in 2017, the patients were vaccinated with improperly stored doses of VARIVAX for prophylaxis (the lot #, expiration date, dose, route, and strength were not provided). The storage conditions were reported as follows: temperature range. 6° F to 14° F; reportedly, the nurse did not think the overall average temperature was between -58°F to 5°F, the time frame was 48 days (02-FEB-2017 through 20-MAR-2017), with not previous temperature excursion. Data logger was involved. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning to an unspecified patient of unknown demographics. The patient's medical history, drug reactions/allergies and concomitant therapies were not reported. In March 2017 reported as the last week, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were not reported); however, the patient was HIV positive or on antiretroviral therapy (contraindicated product administered). No adverse effects were reported. Additional information is not expected because there was no consent to contact the physician.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Pyrexia
Clinical narrative: This spontaneous report was received from a female patient of an unknown age reporting on herself. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. On 20-MAR-2017, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (strength, anatomical location, dose, frequency, lot number, and expiration date were not provided) for prophylaxis reported as prevention of shingles. On the same date, within hours of receiving the vaccine, the patient experienced chills and fever. Additionally, the patient stated that at one point her temperature reached 102 degrees. The patient did not seek medical attention, and she did not receive any treatment. At the time of reporting, the patient had not recovered from the adverse events, reported as "I still do not feel right today". The causal relationship between the therapy with ZOSTAVAX and the adverse events was not reported. Additional information is not expected as there was no information to contact the physician.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.    On 22-JUL-2013, the patient was vaccinated with a dose of GARDASIL Lot # H021346, intramuscularly (dose and expiration date were not reported) for prophylaxis. Then, on 11-AUG-2016, outside of the prescribing information, the patient received GARDASIL 9 Lot #L043214 with an expiry date of 30-AUG-2017, intramuscularly (dose not reported) and on 06-DEC-2016, received GARDASIL 9 Lot # M031557 (dose not reported) with an expiry date of 06-APR-2019, intramuscularly (dose not reported) both for prophylaxis, as the second and third dose respectively. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Information has been received from a pharmacist concerning an elderly female patient. The patient's medical history was not reported and previous dose(s) of pneumococcal vaccine (manufacturer not provided by reporter) was administered on an unspecified date. The patient's concomitant medications were unknown. On an unknown date, the patient came in requesting a shot of ZOSTAVAX (dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis, when coming in for the last pneumococcal vaccine (manufacturer not provided by reporter). The pharmacist reports that after administering ZOSTAVAX, he discovered that the patient had already received ZOSTAVAX in 2011. It was unknown if the patient experienced any adverse reactions to the ZOSTAVAX dose provided by the pharmacist. Relevant laboratory data was unknown. As of 22-MAR-2017, it was unknown if the patient continued to receive ZOSTAVAX and the outcome of the second ZOSTAVAX dose provided by the pharmacist was unknown. Additional information has been requested.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of an unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. On 23-MAR-2017, the patient was vaccinated with a dose of RECOMBIVAX HB (strength, dose, frequency, route of administration, anatomical location, lot number, and expiration date were not provided) for prophylaxis. Additionally, on the same date, the patient was also vaccinated with a dose of PEDIARIX (strength, dose, frequency, route of administration, anatomical location, lot number, and expiration date were not provided) for prophylaxis. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Information has been received from a nurse practitioner via Poison and Drug Center (manufacturer control # US17-013052) concerning a 51 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy information was unknown.    On an unknown date, the patient was vaccinated with PROQUAD (lot#, expiration date, strength, dose, frequency and route were not reported) and sterile diluent (STERILE DILUENT) (lot#, expiration date, strength, dose, frequency and route were not reported) for prophylaxis (inappropriate age at vaccine administration). The reporter was unknown if the patient had had any adverse reactions form this administered vaccine or if any treatments were provided and at the report time, the reporter was unknown if the patient continued on suspect therapies. 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 a patient of unknown age and gender. No concurrent conditions, historical conditions or concomitant medications were reported. On 22-MAR-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L037356, expiration date 28-SEP-2017, albumin status, dose and route of administration not provided) for prophylaxis. The dose was exposed to a tenperature of 67F for 68 hours. Data logger was not involved. There was no prior temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA009301:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of VARIVAX with Lot # reported as M039318 with an expiration date of 20-SEP-2018, lot # M034586 with an expiration date of 27-JUL-2018 and lot # 7/27/18 with an expiration date of 7-SEP-2018 (strength, dose and route of administration were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccines were exposed to temperature of - 14 centigrade degrees (°C) to - 10 °C for a time frame of 1 hour and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA008784:
Age: 26.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Incorrect route of drug administration
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 26 year old male patient, who is a pharmacy student. The patient's concurrent conditions included neuropathy peripheral, intervertebral disc disorder and some others not reported. The patient had none drug reactions/allergies. Concomitant therapies included diphenhydramine hydrochloride (BENADRYL), montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC), gabapentin, tramadol hydrochloride and melatonin. Approximately in 1996 (reported as at an unspecified time in 1996 and 1997), the patient was vaccinated with VARIVAX (dose, route, lot # and expiration date were not reported) for prophylaxis. Approximately on 27-MAR-2017 (reported as about a week ago), the patient had varicella titers drawn and the titers showed lack of immunity to varicella (antibody test negative). The patient sought medical attention by visiting the office. On 03-APR-2017, the patient received a dose of VARIVAX (dose not reported) (lot # M002064 and expiration date 12-JAN-2018) in response to the low titers. The patient was inadvertently vaccinated by intramuscular route. The outcome of the event antibody test negative was unknown. It was reported that the patient was doing fine at the time of this report. The causality between the event and VARIVAX was not reported. 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 pharmacist, concerning an unknown number of patients of an unknown gender and age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (dose, frequency and route were not reported) lot # L040053 with expiration date of 10-MAY-2017. The temperature of the PNEUMOVAX23 was 14 °C for a time frame of 3 hours; no previous temperature excursion was reported. No side effects were reported and no product quality complaint (PQC) was involved. Data logger was involved. This is one of two reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1704USA004545:
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Antibody test negative, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report has been received from a Medical Assistant, concerning a female patient (reported as around twenty years of age). The patient's medical history, concurrent conditions and concomitant medication were not provided. On an unknown date in her childhood, the patient was vaccinated with VARIVAX; (dose, route of administration, lot and expiration date were not provided) for prophylaxis. Other suspect therapies included M-M-R II  (dose, route of administration, lot and expiration date were not provided) for prophylaxis; both vaccines were reconstituted usiag a sterile diluent (MANUFACTURER UNKNOWN). The reporter stated that on unknown date, the patient had lab studies for infertility treatment, that showed negative titers for MMR and Varicella (antibody test negative). The outcome of negative titers for MMR and Varicella, and infertility were unknown. The causal relationship between the events and the suspect therapies was unknown. Product quality control was not involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning an unknown number of patients of an unknown gender and age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II (dose, frequency and route were not reported) lot # M035935 with expiration date of 09-AUG-2017. The M-M-R II was reconstituted with properly stored diluent MRK (lot: M041413 with expiration date of 27-MAY-2019). The temperature of the M-M-R II was 14 °C for a time frame of 3 hours; no previous temperature excursion was reported. No side effects were reported and no product quality complaint (PQC) was involved. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-0095007513-1704USA001740:
Age: 15.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received on 10-APR-2017 from a medical assistant who was reporting on a 15 year old female patient. No medical history or concomitant medications were reported. The medical assistant reported that on 06-APR-2017, the patient received a dose of PROQUAD (lot: M033209, expiration: 20-MAR-2018)(dose and site not reported). No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 13-month-old patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On 12-APR-2017, the patient was vaccinated with an expired dose of M-M-R II injection (albumin status: recombinant human albumin rHA), lot # L012479 with an expiry date 10-APR-2017, subcutaneously, together with non-expired sterile diluent (DILUENT MRK). No adverse experience had been reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 5 year old female patient. The patient's concomitant medications and drug reactions/allergies were reported as none. The patient's pertinent medical history included asthma. On 20-MAR-2017, the patient was vaccinated with a dose of PROQUAD, subcutaneously (lot # M015699 with expiration date of 26-SEP-2017; dose and anatomical location were not provided), for prophylaxis. It was reported that the patient returned to the office on 22-MAR-2017 with rash, redness and swelling at the injection site that started on an unknown date in March 2017 after vaccination with PROQUAD. Therefore, the patient was diagnosed with cellulitis and treated with an unspecified dose of trimethoprim (+) sulfamethoxazole (BACTRIM). However, lab diagnostics were not performed. No product quality complaint was involved. At the time of reporting, the patient had not recovered from the cellulitis. The causal relationship between the event and the PROQUAD was not reported. Upon internal review, the event of cellulitis was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On 17-APR-2017, the patient was vaccinated with an expired dose of GARDASIL injection (strength, dose, and lot number were not reported) (expiration date: 08-APR-2017) for prophylaxis. It was reported that the vaccine was supported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of ZOSTAVAX with Lot # reported as M039453 and expiration date of 19-DEC-2017 (strength, dose and route of administration were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccines were exposed to temperature of - 14 Centigrade degrees (°C) to - 10 °C for a time frame of 1 hour and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000656.
Sex: U
Vaccine: MMR
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. No concurrent conditions, historical conditions or concomitant medications were reported. On 27-MAR-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L037356, expiration date 28-SEP-2017, albumin status, dose and route of administration not provided) for prophylaxis. The dose was exposed to a temperature of 67F for 68 hours. Data logger was not involved. There was no prior temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000290.
Sex: M
Vaccine: PNC13
Symptoms: Malaise, Meningitis pneumococcal, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 62-year-old male patient received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation. Relevant medical history included surgical splenic. Concomitant medications included two unspecified medicines. The patient experienced pneumococcal meningitis and pneumonia on an unspecified date. The reporter mentioned that 1 week after vaccination the patient was in the hospital for at least two days with pneumococcal meningitis. He was really sick for 1-2 days. He had pneumonia too. The events were recovering. Sender's Comments: The reported events pneumococcal meningitis and pneumonia are most likely due to patient underlying medical conditions.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness, itching at site of injection.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the administrator referring to an unspecified patient (age and gender unknown). No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on an unspecified date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# M032649 with unknown expiration date) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine dose was exposed to a temperature excursion of 48 Fahrenheit degrees for 30 minutes; no digital data logger was involved or previous temperature excursions. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA000587.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored VAQTA lot # M036459 with expiration date of 28-OCT-2017 and lot # M036459 with expiration date of 18-JAN-2018 (doses, route of administration and anatomical location were not provided). No adverse effects were reported. Administered doses of vaccine underwent a temperature excursion of 48.7 degrees Fahrenheit (F) for 13 hours which was detected by a data logger. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA009410: US-009507513-1704USA009408: US-009507513-1704USA009409.
Sex: M
Vaccine: MMR
Symptoms: Abdominal discomfort, Arthralgia, Blood thyroid stimulating hormone, Full blood count, Impaired work ability
Clinical narrative: This spontaneous report was received from a nurse and refers to a 47-year-old male patient with diabetes mellitus and with no drug reactions or allergies. On 28-MAR-2017, the patient was vaccinated with M-M-R II (rHA) (dose and route of administration were not provided) lot # M029919, expiration date: 13-JUN-2018. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) lot#M034194, expiration date: 25-FEB-2019. Concomitant medication included an unspecified antihypertensive drug. On 03-APR-2017, the patient sought medical attention at the hospital, because he had developed a rash on both legs, both arms, his torso and his back. The nurse described the rash on his back appearing like "one big welt". The patient also experienced abdominal discomfort and joint pain. The nurse considered this a significant disability for the patient as he had to miss work for an unspecified amount of time. An unspecified treatment was given for the reported adverse events. On 04-APR-2017, the patient had lab diagnostics performed, including complete blood count, comprehensive metabolic panel, thyroid stimulating hormone and hepatic panel (reported as "hepati"), but results were not provided. The outcome of the adverse event was reported as not recovered. The causality between M-M-R II and the adverse events was not provided. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Liver function test, Metabolic function test, Rash, Urticaria
Clinical narrative: This spontaneous report was received from a nurse and refers to a 47-year-old male patient with diabetes mellitus and with no drug reactions or allergies. On 28-MAR-2017, the patient was vaccinated with M-M-R II (rHA) (dose and route of administration were not provided) lot # M029919, expiration date: 13-JUN-2018. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) lot#M034194, expiration date: 25-FEB-2019. Concomitant medication included an unspecified antihypertensive drug. On 03-APR-2017, the patient sought medical attention at the hospital, because he had developed a rash on both legs, both arms, his torso and his back. The nurse described the rash on his back appearing like "one big welt". The patient also experienced abdominal discomfort and joint pain. The nurse considered this a significant disability for the patient as he had to miss work for an unspecified amount of time. An unspecified treatment was given for the reported adverse events. On 04-APR-2017, the patient had lab diagnostics performed, including complete blood count, comprehensive metabolic panel, thyroid stimulating hormone and hepatic panel (reported as "hepati"), but results were not provided. The outcome of the adverse event was reported as not recovered. The causality between M-M-R II and the adverse events was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored M-M-R II lot # M007279 with expiration date of 09-FEB-2018 and lot # M034857 with expiration date of 27-JUL-2018 (doses, route of administration and anatomical location were not provided) reconstituted with properly stored diluent MRK (lot # and expiration date were unknown). No adverse effects were reported. Administered doses of vaccine underwent the temperature excursion of 48.7 degrees Fahrenheit (F) for 13 hours which was detected by a data logger. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA009409: US-009507513-1704USA009410: US-009507513-1704USA002131.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # M043424 with expiration date of 06-JUN-2018, lot # M029681 with expiration date of 22-JAN-2018 and lot # M039060 with expiration date of 22-MAY-2018 (doses, route of administration and anatomical location were not provided). No adverse effects were reported. Administered doses of vaccine underwent the temperature excursion of 48.7 degrees Fahrenheit (F) for 13 hours which was detected by a data logger. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA002131: US-009507513-1704USA009410: US-009507513-1704USA009408.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # M032649 with expiration date of 11-NOV-2018, lot # M044031 with expiration date of 21-FEB-2019 and lot # M039642 with expiration date of 03-JUL-2019 (doses, route of administration, anatomical location and thimerosal status were not provided). No adverse effects were reported. Administered doses of vaccine underwent a temperature excursion of 48.7 degrees Fahrenheit (F) for 13 hours which was detected by a data logger. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA009409: US-009507513-1704USA002131: US-009507513-1704USA009408.
Age: 21.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Seizure
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable other HCP reported for a 21-year-old male patient of an unspecified race who received the second dose of TRUMENBA (lot N11903, exp.date 01Jul2017, NDC number: 000050100010) via intramuscular route in the left deltoid on 15Oct2016 09:03 at 0.5ml single dose for immunization and the second dose of influenza vaccine (manufacturer Sanofi Pasteur, lot UI690AB, exp.date 30Jun2017, NDC number: 49281041650) as seasonal flu protection via intramuscular route in the right deltoid at 0.5ml single dose on 15Oct2016. Medical history included seizure disorder, seasonal allergies, brain surgery, mass on the brain, this has a date of 12Aug2015 but unsure of initial diagnosis date. Later clarified it was at least 2012. Concomitant medication included KEPPRA for seizure disorder at 3000 mg, daily, CLARITIN for seasonal allergies at 10 mg, as needed and vitamin B6 per Vitamin supplementation since 18Aug2016 at 100 mg, 1x/day all ongoing. The patient had received the first dose of TRUMENBA (Lot Number/Expiry Date: N16808 01Jul2017) via intramuscular route in the left deltoid on 19Aug2016 and the first dose of influenza vaccine in 2013. In the morning of 16Oct2016 the patient experienced seizure. The outcome of the event was reported as recovered. Patient was seen in the ER in response to the seizure, on 16Oct2016 and he was not admitted. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Abasia, Anxiety, Balance disorder, Dehydration, Dizziness
Clinical narrative: On August 9th, I received the tdap vaccine at University in order to fulfill the health requirements to attend school there part-time. I collapsed after having the shot, which the nurses told me was a vasovagal response, and not to worry. I was dizzy the rest of the evening, and the next day did not feel well, but went to work, assuming the symptoms were due to the shot and would pass. That week I began to experience severe fatigue, severe nausea, a feeling of wanting to jump out of my skin, hot flashes running from my neck into my shoulders, anxiety, low grade fever, inability to walk, dehydration, trouble breathing, debilitating headaches, dizziness, a feeling of being off balance, severe muscle weakness, rapid heart rate, and fullness in my ears that would not clear. This lasted over 2 years.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Dyspnoea, Ear discomfort, Fatigue, Feeling abnormal, Headache
Clinical narrative: On August 9th, I received the tdap vaccine at University in order to fulfill the health requirements to attend school there part-time. I collapsed after having the shot, which the nurses told me was a vasovagal response, and not to worry. I was dizzy the rest of the evening, and the next day did not feel well, but went to work, assuming the symptoms were due to the shot and would pass. That week I began to experience severe fatigue, severe nausea, a feeling of wanting to jump out of my skin, hot flashes running from my neck into my shoulders, anxiety, low grade fever, inability to walk, dehydration, trouble breathing, debilitating headaches, dizziness, a feeling of being off balance, severe muscle weakness, rapid heart rate, and fullness in my ears that would not clear. This lasted over 2 years.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Heart rate increased, Hot flush, Malaise, Muscular weakness, Nausea
Clinical narrative: On August 9th, I received the tdap vaccine at University in order to fulfill the health requirements to attend school there part-time. I collapsed after having the shot, which the nurses told me was a vasovagal response, and not to worry. I was dizzy the rest of the evening, and the next day did not feel well, but went to work, assuming the symptoms were due to the shot and would pass. That week I began to experience severe fatigue, severe nausea, a feeling of wanting to jump out of my skin, hot flashes running from my neck into my shoulders, anxiety, low grade fever, inability to walk, dehydration, trouble breathing, debilitating headaches, dizziness, a feeling of being off balance, severe muscle weakness, rapid heart rate, and fullness in my ears that would not clear. This lasted over 2 years.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Presyncope, Pyrexia, Syncope
Clinical narrative: On August 9th, I received the tdap vaccine at University in order to fulfill the health requirements to attend school there part-time. I collapsed after having the shot, which the nurses told me was a vasovagal response, and not to worry. I was dizzy the rest of the evening, and the next day did not feel well, but went to work, assuming the symptoms were due to the shot and would pass. That week I began to experience severe fatigue, severe nausea, a feeling of wanting to jump out of my skin, hot flashes running from my neck into my shoulders, anxiety, low grade fever, inability to walk, dehydration, trouble breathing, debilitating headaches, dizziness, a feeling of being off balance, severe muscle weakness, rapid heart rate, and fullness in my ears that would not clear. This lasted over 2 years.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Redness to Right Deltoid area to elbow.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Burning sensation, Erythema, Fatigue, Pruritus
Clinical narrative: On evening of 4-14-17 she states she started having fatigue and joint pain. On 4-18-17 patient describes a rash starting. Per D.O. visit on 4-19-17-Abdomen with 2 well defined somewhat annular areas of erythema with slightly raised areas. No central pore. Pruritic and "burns."  2x5 cm and 3 cm diam. Take over the counter pain medications as needed. Follow up on 4-26-17.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: On evening of 4-14-17 she states she started having fatigue and joint pain. On 4-18-17 patient describes a rash starting. Per D.O. visit on 4-19-17-Abdomen with 2 well defined somewhat annular areas of erythema with slightly raised areas. No central pore. Pruritic and "burns."  2x5 cm and 3 cm diam. Take over the counter pain medications as needed. Follow up on 4-26-17.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Anal incontinence, Enuresis, Urinary incontinence
Clinical narrative: Night time bedwetting began after vaccine given. Urine and bowel incontinence occurred after vaccination was given.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Chest discomfort, Chills, Fatigue, Malaise, Myalgia
Clinical narrative: Called the doctors office when I became sick and talked to a nurse.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Called the doctors office when I became sick and talked to a nurse.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This is a spontaneous case received from a medical assistant reporting on a 50-year-old female who received a dose of ZOSTAVAX on 05-Apr-2017 (lot # M041669, exp. 09-Jan-2018). The primary reporter reported that the physician 'confirmed shingles' after the ZOSTAVAX was administered. Onset of confirmed shingles was 10-APR-2017. Unspecified treatment was given to the patient on an unspecified date. There were no labs or diagnostics performed. At the time of the report the patient was not recovered. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia, Mucous stools
Clinical narrative: This spontaneous report as received from a Medical Assistant via Company Representative refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions or allergies were not reported. On 07-FEB-2017, the patient was vaccinated with ROTATEQ orally as prophylaxis (lot number and expiration date were not reported). On an unspecified date in 2017, the patient developed bloody mucous in her stool. The patient sought medical attention. It was unknown if the treatment was given. The outcome of the event was not reported. No product quality complaint was involved in this case. No further information was available. The causality between the event and ROTATEQ was not reported.  Upon internal review, the event was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (exact dose, route of administration, lot # and expiry date were not reported). The dose was exposed to the temperature between 47 and 77 degrees Fahrenheit for 9 minutes. Previous temperature excursions included exposure to the temperature between 47 and 77 degrees Fahrenheit for 40 hours and 22 minutes. The highest temperature the dose ever reached during those two excursions was reported as 49.6 degrees Fahrenheit. Digital data logger was involved. The reporter noticed the excursions on 14-APR-2017 (reported as "today"). No adverse symptoms were reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Anxiety, Immediate post-injection reaction, Muscle spasms
Clinical narrative: Immediate Lumbar Muscle Spasms x 15 minutes.  Relieved with massage, and heat. Oxygen administered at 2L/min via nasal cannula to alleviate anxiety of situation.  NO SOB, NO Rash, NO medications given to reverse event.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Anxiety, Cardiac function test normal, Chest pain, Electrocardiogram normal, Immediate post-injection reaction
Clinical narrative: Immediate Chest pain, Lumbar muscle spasms, Anxiety.  O2, Benadryl and Ativan administered. Transported to ER.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Muscle spasms
Clinical narrative: Immediate Chest pain, Lumbar muscle spasms, Anxiety.  O2, Benadryl and Ativan administered. Transported to ER.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative and refers to a female patient of an unknown age with no pertinent medical history, concurrent conditions, and drug reactions or allergies. As concomitant therapies, the patient was taking CYMBALTA, WELLBUTRIN, and AMBIEN. Approximately in 14-DEC-2016 reported as "on an unspecified date in December 2016", the patient was vaccinated with a dose of ZOSTAVAX dose and frequency reported as "one dose / once", route reported as "injection" (strength, anatomical location, lot number, and expiration date were not provided), to prevent shingles. Subsequently, about a week later on 21-DEC-2016, the patient experienced a rash on her back. It was reported that the patient sought medical attention but it was unspecified, and as a result she was placed on treatment with VALTREX, and consequently, on an unknown date, the rash resolved. It was unknown if laboratory diagnostic studies were performed. The causal relationship between the therapy with ZOSTAVAX and the event of rash was not provided. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013227.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with a dose of RECOMBIVAX HB for prophylaxis (dose, route, lot/batch # and expiration date were not reported) reconstituted with diluent MRK (STERILE DILUENT) (dose, lot/batch # and expiration date were not reported). It was reported that, on multiple unknown dates, the patients "had low titers when tested" to RECOMBIVAX HB (hepatitis b antibody negative), tested byan unspecified titer test. The primary reporter reported that an unspecified amount of the patients were treated byre-vaccinating with a dose of RECOMBIVAX HB (dose, route, lot/batch # and expiration date were not reported) reconstituted with diluent MRK (STERILE DILUENT) (dose, lot/batch # and expiration date were not reported). The outcome of hepatitis b antibodynegative was not reported. The causality between hepatitis b antibody negative and RECOMBIVAX HB was not reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA009678: