chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Loss of personal independence in daily activities, Musculoskeletal pain, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old male patient. The patient's concurrent conditions, and medical history were not reported. On 04-JUL-2017, the patient was vaccinated with ZOSTAVAX (dosing details unknown) from lot # M041511, expiry date: 08-JAN-2018 for prevention of shingles. Other suspect therapies included sterile diluent (dosing details unknown) used for reconstitution of vaccine. Concomitant therapies included clonidine, potassium (unspecified), allopurinol, phentermine, lorazepam, diltiazem, labetalol, finasteride (manufacturer unknown) and furosemide (manufacturer unknown). On an unknown date in 2017, the patient developed pain in most of his joints and he experienced "limitations in mobility". The patient was treated with TYLENOL for pain. No laboratory tests were performed. The pharmacist further stated that the patient had reported of worsening in pain for past two days and he advised him to take ibuprofen to treat the increase in pain. The patient visited an unspecified physician however the physician "did not seem to be overly concerned" about the events. The outcome of arthralgia, and mobility decreased was reported as not recovered. Causality assessment was not provided by the reporter. Product quality complaint was not involved.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old male patient. The patient's concurrent conditions, and medical history were not reported. On 04-JUL-2017, the patient was vaccinated with ZOSTAVAX (dosing details unknown) from lot # M041511, expiry date: 08-JAN-2018 for prevention of shingles. Other suspect therapies included sterile diluent (dosing details unknown) used for reconstitution of vaccine. Concomitant therapies included clonidine, potassium (unspecified), allopurinol, phentermine, lorazepam, diltiazem, labetalol, finasteride (manufacturer unknown) and furosemide (manufacturer unknown). On an unknown date in 2017, the patient developed pain in most of his joints and he experienced "limitations in mobility". The patient was treated with TYLENOL for pain. No laboratory tests were performed. The pharmacist further stated that the patient had reported of worsening in pain for past two days and he advised him to take ibuprofen to treat the increase in pain. The patient visited an unspecified physician however the physician "did not seem to be overly concerned" about the events. The outcome of arthralgia, and mobility decreased was reported as not recovered. Causality assessment was not provided by the reporter. Product quality complaint was not involved.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacy intern referring to a patient of unknown age and gender. There was no information about medical history or concurrent condition. On 31-JUL-2017, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # M015926, expiration date 28-JUN-2017) (dose and route unknown), which was reconstituted with non-expired sterile diluent (manufacturer unknown) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMRV, VARCEL, VARZOS
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age. On an unknown date, the patient might have been vaccinated with either VARIVAX (lot # M045205, exp. date: 11-NOV-2018 or lot#N014366, exp. date: 05-SEP-2019 or lot#M033211, exp. date: 13-JUL-2018), or ZOSTAVAX (lot# M041511, exp. date 08-JAN-2018) or PROQUAD (recombinant human albumin (rHA)) (lot#N010866, exp. date 01-OCT-2018). Concomitant therapies included sterile diluent (STERILE DILUENT). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information about concomitant medication and medical history was not provided. On 11-AUG-2017, the patient was inadvertently received an expired dose (unspecified in series) of M-M-R II (expiration date 16-JUL-2017; dose, route and lot # were not reported) for prophylaxis. No adverse events were reported.
Sex: F
Vaccine: HPV4
Symptoms: Ovarian cyst
Clinical narrative: This spontaneous report was received from a  medical assistant via a field representative, referring to two separate unspecified female patient (both medical assistant's daughters) of unknown age. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were unknown. On unknown dates, the patients were vaccinated three doses of with GARDASIL (lot#, expiration date, concentration, dose, route and frequency were unknown) for prophylaxis. On unknown dates, the patients both developed ovarian cysts. The patients both received some sort of medical treatment for the ovarian cysts. The outcome of ovarian cyst was unknown. The causality between event and GARDASIL was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to 2 unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of improperly stored VARIVAX (lot/batch#M034582 (invalid), expiration date 27-JUL-2018) (strength and route of administration were not reported) for prophylaxis. Sterile diluent was used. The vaccine was exposed to "6 degree Fahrenheit to 14 degree Fahrenheit" for 25 minutes.There was no previous temperature excursion. No adverse effects reported. Digital data logger was involved. There was no product quality complaint(PQC) involved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a nurse referring to multiple unspecified patients. The patients' medical history, concurrent condition and concomitant therapy were not reported. On multiple unspecified dates, the multiple unspecified patients received doses of improperly stored ROTATEQ (lot#M038207, expiration date 02-MAY-2018) (dose, frequency and route were not reported). The vaccine was exposed to temperature excursion of 47 F to 77 F for 3 hours and 47 minutes and the data logger was involved. There was no previous temperature excursion. No adverse effects reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA000098:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple patients of unknown ages and genders. On an unknown dates in 2017 (reported as since 12-JUL-2017), the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M042322 expiration date 21-FEB-2018 and lot # N002913 expiration date 23-FEB-2018 for prophylaxis. The temperature excursion lasted 15 minutes. No adverse effects reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010530: US-009507513-1708USA010529: US-009507513-1708USA010532: US-009507513-1708USA010531.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 04-AUG-2017, the patient was vaccinated with improperly stored PROQUAD lot # N010867, expiration date: 01-OCT-2018 for prophylaxis. Concomitant therapies included sterile diluent. No adverse event was reported. Digital Data Logger was involved. The improperly stored PROQUAD experienced temperature excursion within temperature range from 36 Fahrenheit degrees to 46 Fahrenheit degrees for 21 days. There was no previous temperature excursion.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple patients of unknown ages and genders. On an unknown dates in 2017 (reported as since 12-JUL-2017), the patients were vaccinated with improperly stored doses of M-M-R II lot # M008588 expiration date 13-JUN-2018, lot# M008588 expiration date 16-FEB-2018 for prophylaxis. The temperature excursion lasted 15 minutes. Concomitant therapies included sterile diluent. No adverse effects reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010530: US-009507513-1708USA010515: US-009507513-1708USA010532: US-009507513-1708USA010531.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple patients of unknown ages and genders. On an unknown dates in 2017 (reported as since 12-JUL-2017), the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # N001007 expiration date 19-SEP-2018 for prophylaxis. The temperature excursion lasted 15 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010515: US-009507513-1708USA010529: US-009507513-1708USA010532: US-009507513-1708USA010531.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple patients of unknown agea and genders. On an unknown dates in 2017 (reported as since 12-JUL-2017), the patients were vaccinated with improperly stored doses of ROTATEQ lot # M042171 expiration date 19-SEP-2018 for prophylaxis. The temperature excursion lasted 15 minutes. No adverse effects were reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1708USA010530: US-009507513-1708USA010529: US-009507513-1708USA010532: US-009507513-1708USA010515:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a multiple patients of unknown ages and genders. On an unspecified dates in 2017 (reported as since 12-JUL-2017), the patient were vaccinated with improperly stored doses of VAQTA lot # M042322 expiration date 21-FEB-2018, lot # N002913 expiration date 23-FEB-2019 for prophylaxis. The temperature excursion lasted 15 minutes. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1708USA010530: US-009507513-1708USA010529: US-009507513-1708USA010515: US-009507513-1708USA010531.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients (names and other demographics unknown). On an unknown date, the patients received an unknown number of doses of M-M-R II (Lot. M022408 Exp. date 02-MAY-2018 and Lot. M025607 expiration (Exp.) date 18-MAY-2017; dose and route not reported) following temperature excursions of 54.12 F for 33 min and 55.25 degree Fahrenheit (F) for 37 minutes. Data logger was involved. There was no previous temperature excursion. No adverse events were reported in any patients. This is one of both reports received from the same reporter. Sender's Comments: US-009507513-1708USA013183.
Sex: F
Vaccine: PPV
Symptoms: Sudden death
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age with tolerances to ACE inhibitors and tree nut allergies. The pharmacist noted the patient did take other medications but did not provide a list. On 21-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 (dose and frequency was not provided), lot # N001007 with expiration date 19-SEP-2018 for prophylaxis. On 22-AUG-2017, the patient died suddenly with possible toxic shock syndrome. Autopsy was unknown. The causal relationship between PNEUMOVAX 23 and the death was not provided. Upon internal review, death was determined to be medically significant. Reported Cause(s) of Death: possible toxic shock syndrome.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # N004564, expiry date 22-OCT-2018) (dose and route not reported) for prophylaxis. The vaccine was exposed to temperature of 47 degrees Fahrenheit to 77 degrees Fahrenheit (49.1 Fahrenheit) for 1 hour and 45 minutes. No previous temperature excursion was reported. The call was not because of a data logger. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1709USA000688: US-009507513-1709USA000689.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse prescriber via company representative refers to a 73 year old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, (route: intramuscular) for active immunization for the prevention of pneumococcal disease. On an unknown date, the patient experienced redness and swelling around the injection site for PNEUMOVAX 23. The patient sought medical attention for the events. The outcome of the events was reported as recovered on unknown dates. The causality of the events was unknown.
Sex: U
Vaccine: HPV9
Symptoms: Mental status changes, Paranoia
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 for prophylaxis. On an unknown date the patient experienced paranoia and mental status changes. The outcome of paranoia and mental status changes is unknown.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with drug hypersensitivity and drug hypersensitivity. On 23-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # N009167 for prophylaxis. Other suspect therapies included sterile diluent. On 24-AUG-2017, 2 days after onset of therapy the patient experienced injection site erythema and injection site warmth. The outcome of injection site erythema and injection site warmth was reported as not recovered/not resolved.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's medical history was not reported. On 23-AUG-2017, the patient was vaccinated with an expired dose of M-M-R II, (rHA) (Strength, dose, frequency and anatomical location were not reported) of lot # L030162 with an expiry date of 11-AUG-2017, subcutaneously for prophylaxis. The M-M-R II was reconstituted with a sterile diluent of lot # L042473 with an expiry date of 23-AUG-2017. There were no adverse effects reported. There was no product quality complaint involved. Lot number, L042473 has been verified to be a valid lot number for sterile diluent. The therapy type of the lot number, L030162 is recombinant human albumin (rHA).
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age with medication dilution. On 07-AUG-2017 the patient was vaccinated with M-M-R II for prophylaxis. Other suspect therapies included sodium chloride (manufacturer unknown). On an unknown date the patient experienced product preparation error and no adverse event. For sodium chloride (manufacturer unknown), the lot number is not available and the serial number is not available.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose, Fall, Hyperhidrosis, Loss of consciousness, Seizure
Clinical narrative: Information has been received from a medical assistant reporting on an 18 year old male patient. The patient had not current conditions, medical history or concomitant medication. On 27-JUL-2017, the patient was vaccinated with GARDASIL 9 for prophylaxis lot # reported as N010497 and expiry date 15-JAN-2020 (dose and route of administration were not reported). On 27-JUL-2017, after the vaccine was administered, the patient walked into the waiting room and sat down, then passed out and fell from chair onto the floor. The patient was unconscious and unresponsive for approximately 10 seconds. Then the patient had a mini-seizure and he was very sweaty. The reporter indicated that that patient's vital signs and blood sugar were assessed (conflicting information, also reported as "no lab diagnostics or studies were performed"). The patient declined transport to a hospital.  No treatment was given for the adverse events. On 27-JUL-2017, while the patient was still in the office the patient recovered from the adverse events loss of consciousness, hyperhidrosis and seizure, and was able to leave on his own. The causal relationship between the event and therapy with GARDASIL 9 was not reported. It was reported the case # 00565267 with additional AE regarding to the same product, and the case was created with MARSS#1708USA012553. The medical assistant considered the event loss of consciousness to be serious for the following reason: life threatening. Upon internal review the events loss of consciousness, and seizure were considered to be medically significant. This is one of two case from the same reporter.; Sender's Comments: US-009507513-1708USA012553:
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Unresponsive to stimuli
Clinical narrative: Information has been received from a medical assistant reporting on an 18 year old male patient. The patient had not current conditions, medical history or concomitant medication. On 27-JUL-2017, the patient was vaccinated with GARDASIL 9 for prophylaxis lot # reported as N010497 and expiry date 15-JAN-2020 (dose and route of administration were not reported). On 27-JUL-2017, after the vaccine was administered, the patient walked into the waiting room and sat down, then passed out and fell from chair onto the floor. The patient was unconscious and unresponsive for approximately 10 seconds. Then the patient had a mini-seizure and he was very sweaty. The reporter indicated that that patient's vital signs and blood sugar were assessed (conflicting information, also reported as "no lab diagnostics or studies were performed"). The patient declined transport to a hospital.  No treatment was given for the adverse events. On 27-JUL-2017, while the patient was still in the office the patient recovered from the adverse events loss of consciousness, hyperhidrosis and seizure, and was able to leave on his own. The causal relationship between the event and therapy with GARDASIL 9 was not reported. It was reported the case # 00565267 with additional AE regarding to the same product, and the case was created with MARSS#1708USA012553. The medical assistant considered the event loss of consciousness to be serious for the following reason: life threatening. Upon internal review the events loss of consciousness, and seizure were considered to be medically significant. This is one of two case from the same reporter.; Sender's Comments: US-009507513-1708USA012553:
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 pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. There were no concomitant medications reported. The pharmacist reported that, on an unknown date in 2013 the patient was vaccinated with one dose of GARDASIL for prophylaxis (route, indication, lot/batch# were not reported). On 31-JUL-2017, the patient was administered one dose of GARDASIL 9 (route, indication, lot/batch# were not reported) for prophyalxis (interchange of vaccine products and inappropriate schedule of drug administration). No adverse events reported. There was no product quality complaint involved.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old male patient. The patient's pertinent medical history, drug reactions and allergies were unknown. The patient's concurrent condition included chronic obstructive pulmonary disease (COPD). There were no concomitant medications reported. On 26-JAN-2016, when the patient was 60 year old, the patient was vaccinated with first dose of PNEUMOVAX 23 (lot # L035686, expiry date 16-FEB-2017) (dosing regimen and frequency unknown) for prophylaxis. On 28-AUG-2017, at 62 years of age the patient again received the second dose of PNEUMOVAX 23 (lot M018766, expiry date: 15-OCT-2017) (extra dose administered) (inappropriate schedule of drug administration). The patient received a second dose of vaccine since the patient had initially reported that he had never received a dose of PNEUMOVAX 23 before. No adverse events were reported. There was no product quality complaint reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. The patients' concurrent conditions and medical history were not reported. On 28-AUG-2017, the patients were vaccinated with improperly stored doses of PROQUAD injection, (dose unknown) subcutaneously from lot # M037011; expiry date: 21-FEB-2018 for prophylaxis (incorrect product storage). The vaccine was reconstituted with properly stored sterile diluent. The vaccine was exposed to a temperature excursion of 6 degree Fahrenheit (F) to 14 degree F for 10 minutes and from 15 degree F to 46 degree F (31 F) for 3 hours and 15 minutes. There was no previous excursion. This report was because of data logger. No adverse effects were reported. Product quality complaint was not involved. This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA013464: Original Case : 1708USA012645.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with an expired dose of M-M-R II lot # L032182 and expiration date 25-AUG-2017 for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Arrhythmia, Injection site mass, Injection site swelling, Pain
Clinical narrative: Information has been received from a physician via a company representative referring to a female patient of unknown age.  The patient's concurrent conditions, concomitant medication and medical history were not provided. "Last Friday", on 25-AUG-2017, the patient was vaccinated with one dose of ZOSTAVAX (route, lot# and expiry date were unspecified) for shingles prevention.  Then over the weekend (in August 2017) the patient started experiencing "pain, swelling and arrhythmia." It was reported that the patient's swelling consisted of a "20 cm by 15 cm lump" that had appeared around the injection site of her arm. The patient had a follow up visit with the physician the following Monday (28-AUG-2017) as a result of the adverse events. No product quality compliant (PQC) involved. The outcome of the events was unknown. Upon internal review, arrhythmia was determined to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients (names and other demographics unknown). On unknown date, the patients received an unknown number of doses of ROTATEQ (Lot M032643 expiration (Exp.) date 04-MAR-2018; dose and route not reported) following temperature excursions of 54.12 degree Fahrenheit (F) for 33 minutes and 55.25 F for 37 minutes. Data logger was involved. There was no previous temperature excursion. No adverse events were reported in any patients. This is one of both reports received from the same reporter. Sender's Comments: US-009507513-1708USA010856.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose, route of administration, lot# and expiration date were not provided). No adverse effects were reported. Temperature and time frame: 32 degrees Fahrenheit to 35 degrees Fahrenheit for 67 minutes and 47 degrees Fahrenheit to 77 degrees Fahrenheit for 139 minutes. Previous temperature excursion?: No. Was call because of a "data logger"?: Yes. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1709USA000878: US-009507513-1709USA000879: US-009507513-1709USA000880.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to an elderly male patient of unknown age. In August 2017, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. In August 2017, the patient experienced injection site pruritus and injection site erythema. The outcome of injection site pruritus and injection site erythema was reported as recovered/resolved.; Sender's Comments:  US-009507513-1708USA013584:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. The patients' concurrent conditions and medical history were not reported. On 25-AUG-2017, the patients were vaccinated with improperly stored VARIVAX injection, (dose and route unknown) from lot # N001527; expiry date: 13-JAN-2019 for prophylaxis (incorrect product storage). Concomitant therapies included properly stored sterile diluent for reconstitution. The vaccine was exposed to a temperature range of 6 degree Fahrenheit (F) to 14 degree F for 10 minutes and from 15 degree F to 46 degree F (31 F) for 3 hours and 15 minutes. There was no previous excursion. This report was because of data logger. No adverse effects were reported. Product quality complaint was not involved. This is one of the two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA012645: Original Case : 1708USA012645.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a other health professional refers to a 4 month old female patient with prophylaxis. On 17-AUG-2017 the patient was vaccinated with LIQUID PEDVAXHIB, .5 ml, intramuscular for prophylaxis. Other suspect therapies included PEDIARIX, PREVNAR 13 and ROTARIX.  On AUG-2017, 20 min after onset of therapy the patient experienced urticaria. The outcome of urticaria was reported as recovered/resolved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M045546, expiration 12-JUN-2018, oral, for prophylaxis. No adverse effects reported. Sender's Comments: US-009507513-1707USA004891.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a nurse referring to multiple unspecified patients. The patients' medical history, concurrent condition and concomitant therapy were not reported. On multiple unspecified dates, the multiple unspecified patients received doses of improperly stored PEDVAXHIB) (lot#N000237, expiration date 25-OCT-2019) (dose, frequency and route were not reported). The vaccine was exposed to temperature excursion of 47 degree Fahrenheit (F) to 77 F for 3 hours and 47 minutes and the data logger was involved. There was no previous temperature excursion. No adverse effects reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA010267.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX, 1 DF (reported as "vaccine dose") lot# reported as N011475 with an expiration date 08-AUG-2019 for prophylaxis (route of administration and anatomical location were not reported). On an unknown date, the patient experienced injection site pain, injection site swelling and injection site erythema. The outcome of injection site pain, injection site swelling and injection site erythema is unknown. Lot number N011475 is an invalid lot number for ZOSTAVAX.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneous injection (exact dose, lot # and expiration date were not reported), for prophylaxis. On an unknown date, three days after vaccination, the patient experienced injection site erythema, injection site pruritus and injection site warmth. The outcome of injection site erythema, injection site pruritus and injection site warmth was no reported. The causality assessment between the events and ZOSTAVAX was not provided.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site joint pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a other health professional refers to a 34 year old female patient. The patient's medical history included nausea and fatigue. On 28-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 lot # N013521 for prophylaxis. On 29-AUG-2017, 2 days after onset of therapy the patient experienced injection site joint pain, pyrexia, injection site erythema, injection site swelling and chills. The outcome of injection site joint pain, pyrexia, injection site erythema, injection site swelling and chills was reported as not recovered/not resolved.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Bronchitis, Chest pain, Decreased appetite, Dyspnoea
Clinical narrative: This spontaneous report as received from a 73 year old female patient refers to herself. The patient's medical history included pneumonia. The patient had no drug allergies. Concomitant therapies included losartan (manufacturer unknown), carvedilol, aspirin (manufacturer unknown), furosemide (manufacturer unknown), potassium chloride (KLOR-CON), spironolactone and atorvastatin. On 02-FEB-2017, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot # not reported) for prevention of pneumonia. "About two weeks" after the vaccination, on approximately 16-FEB-2017, the patient developed bronchitis. Because the patient had taken an over the counter medication guaifenesin (MUCINEX), the patient recovered from the bronchitis on an unspecified date in 2017. On unspecified dates after recovering from bronchitis in approximately 2017, the patient felt like she "couldn't breath", had "chest pains that felt like heart failure", "loss of appetite", "woke up from hunger pains", and "had been sleeping only 3-4 hours each night". The patient saw her family physician for the adverse experiences; however, the physician "did not help (her) symptoms". On 14-AUG-2017, the patient developed swollen legs. The patient's cardiologist recommended that the patient had an echocardiogram performed. On 30-AUG-2017, the echocardiogram was performed and it showed that the patient had "edema" (the onset date of "edema" was unknown, estimated as in approximately 2017). Except bronchitis, the outcome of other events was reported as not recovered. Causality assessment was not provided. Upon internal review, chest pains that felt like heart failure and "edema" on echocardiogram were considered to be medically significant.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Echocardiogram abnormal, Insomnia, Oedema, Peripheral swelling
Clinical narrative: This spontaneous report as received from a 73 year old female patient refers to herself. The patient's medical history included pneumonia. The patient had no drug allergies. Concomitant therapies included losartan (manufacturer unknown), carvedilol, aspirin (manufacturer unknown), furosemide (manufacturer unknown), potassium chloride (KLOR-CON), spironolactone and atorvastatin. On 02-FEB-2017, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot # not reported) for prevention of pneumonia. "About two weeks" after the vaccination, on approximately 16-FEB-2017, the patient developed bronchitis. Because the patient had taken an over the counter medication guaifenesin (MUCINEX), the patient recovered from the bronchitis on an unspecified date in 2017. On unspecified dates after recovering from bronchitis in approximately 2017, the patient felt like she "couldn't breath", had "chest pains that felt like heart failure", "loss of appetite", "woke up from hunger pains", and "had been sleeping only 3-4 hours each night". The patient saw her family physician for the adverse experiences; however, the physician "did not help (her) symptoms". On 14-AUG-2017, the patient developed swollen legs. The patient's cardiologist recommended that the patient had an echocardiogram performed. On 30-AUG-2017, the echocardiogram was performed and it showed that the patient had "edema" (the onset date of "edema" was unknown, estimated as in approximately 2017). Except bronchitis, the outcome of other events was reported as not recovered. Causality assessment was not provided. Upon internal review, chest pains that felt like heart failure and "edema" on echocardiogram were considered to be medically significant.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On unknown dates, these patients were vaccinated with improperly stored doses of VARIVAX (lot # N002204 and expiry date 19-JAN-2019) or PROQUAD (lot #N010247 and expiry date 25-SEP-2018) for prophylaxis (strength, dosing details, anatomical location were unknown). The vaccines were reconstituted with sterile diluent (lot number and expiry date unspecified). The vaccines were exposed to the temperature of 6 degree Fahrenheit to 14 degree Fahrenheit, for 15 hours. Previous temperature excursion included, exposure to 6 degree Fahrenheit to 14 degree Fahrenheit, for 179 hours. A data logger was involved. No adverse effects reported. No PQC present.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored GARDASIL 9 (lot #M042853, expiry date: 17-FEB-2019; lot # N004798, expiry date: 31-OCT-2019) (dosing regimen and frequency unknown) which was reconstituted with properly stored sterile diluent (STERILE DILUENT) for prophylaxis (incorrect product storage). No adverse effects were reported. The temperature excursion was 9 degree C to 25 degree C for 1 hour 35 minutes. The temperature excursion was detected by digital data logger. No previous temperature excursions were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000705:US-009507513-1709USA000706: US-009507513-1709USA000707: US-009507513-1709USA000708: US-009507513-1709USA000709:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # N004564, expiry date 22-OCT-2018) (dose and route not reported) for prophylaxis. The vaccine was exposed to temperature of 47 degrees Fahrenheit to 77 degrees Fahrenheit (49.1 Fahrenheit) for 1 hour and 45 minutes. No previous temperature excursion was reported. The call was not because of a data logger. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA011699: US-009507513-1709USA000689.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # N004564, expiry date 22-OCT-2018) (dose and route not reported) for prophylaxis. The vaccine was exposed to temperature of 47 degrees Fahrenheit to 77 degrees Fahrenheit (49.1 Fahrenheit) for 1 hour and 45 minutes. No previous temperature excursion was reported. The call was not because of a data logger. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1709USA000688: US-009507513-1708USA011699.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Patient's pertinent medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored VAQTA (lot # N008823, expiry date: 26-MAY-2018; lot # N005274, expiry date: 13-APR-2018) (dosing regimen and frequency unknown) which was reconstituted with properly stored sterile diluent for prophylaxis. No adverse effects were reported. The temperature excursion was 9 degree C to 25 degree C for 1 hour 35 minutes. The temperature excursion was detected by digital data logger. No previous temperature excursions were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000706: US-009507513-1709USA000707: US-009507513-1709USA000708: US-009507513-1709USA000709: US-009507513-1709USA000667.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Patient's pertinent medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored VARIVAX (lot # N012487, expiry date: 20-APR-2019) (dosing regimen and frequency unknown) which was reconstituted with properly stored sterile diluent for prophylaxis (incorrect product storage). No adverse effects were reported. The temperature excursion was -9 degree C to 8 degree C for 1 hour 25 minutes and -14 degree C to -10 degree C for 1 hour 49 minutes. The temperature excursion was detected by digital data logger. No previous temperature excursions were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000705: US-009507513-1709USA000707: US-009507513-1709USA000708: US-009507513-1709USA000709: US-009507513-1709USA000667.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Patient's pertinent medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (lot # N002202, expiry date: 04-NOV-2019; lot # N006321, expiry date: 08-NOV-2019) (dosing regimen and frequency unknown) which was reconstituted with properly stored sterile diluent for prophylaxis. No adverse effects were reported. The temperature excursion was 9 degree C to 25 degree C for 1 hour 35 minutes. The temperature excursion was detected by digital data logger. No previous temperature excursions were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000667: US-009507513-1709USA000705: US-009507513-1709USA000706: US-009507513-1709USA000708: US-009507513-1709USA000709.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Patient's pertinent medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored M-M-R II (lot # M045392, expiry date: 14-NOV-2018) (dosing regimen and frequency unknown) which was reconstituted with properly stored sterile diluent for prophylaxis. No adverse effects were reported. The temperature excursion was 9 degree C to 25 degree C for 1 hour 35 minutes. The temperature excursion was detected by digital data logger. No previous temperature excursions were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000705: US-009507513-1709USA000706: US-009507513-1709USA000707: US-009507513-1709USA000709: US-009507513-1709USA000667.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (albumin status, dose number, exact dose, route of administration, lot # and expiration date were not reported), for prophylaxis. No known adverse effects were reported. The administered doses of M-M-R II experienced multiple temperature excursions over unspecified time periods. The reporter did not know if digital data logger was involved to capture the temperature excursions. Previous temperature excursions were also reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000918: US-009507513-1709USA000920: US-009507513-1709USA000917: US-009507513-1709USA000919.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. On 30-AUG-2017, the patients were vaccinated with improperly stored PROQUAD (lot # and expiration date were not reported), that was mixed with a properly stored sterile diluent (STERILE DILUENT). Administered doses of vaccines underwent a temperature excursion of 3.6 degrees Celsius, which lasted for 23 hours. There was no previous temperature excursion. A digital data logger was involved in recording the excursion. No adverse effects were reported. Product quality complaint was not involved. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA000928:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored VAQTA (dose, route of administration, lot# and expiration date were not provided). No adverse effects were reported. Temperature and time frame: 32 degrees Fahrenheit to 35 degrees Fahrenheit for 67 minutes and 47 degrees Fahrenheit to 77 degrees Fahrenheit for 139 minutes. Previous temperature excursion?: No. Was call because of a "data logger"?: Yes. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA013411: US-009507513-1709USA000879: US-009507513-1709USA000880.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (orally, dose, lot# and expiration date were not provided). No adverse effects were reported. Temperature and time frame: 32 degrees Fahrenheit to 35 degrees Fahrenheit for 67 minutes and 47 degrees Fahrenheit to 77 degrees Fahrenheit for 139 minutes. Previous temperature excursion?: No. Was call because of a "data logger"?: Yes. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA013411.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (dose, route of administration, lot# and expiration date were not provided). No adverse effects were reported. Temperature and time frame: 32 degrees Fahrenheit to 35 degrees Fahrenheit for 67 minutes and 47 degrees Fahrenheit to 77 degrees Fahrenheit for 139 minutes. Previous temperature excursion?: No. Was call because of a "data logger"?: Yes. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA013411:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose number, exact dose, route of administration, lot # and expiration date were not reported), for prophylaxis. No known adverse effects were reported. The administered doses of GARDASIL 9 experienced multiple temperature excursions over unspecified time periods. The reporter did not know if digital data logger was involved to capture the temperature excursions. Previous temperature excursions were also reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000808.