chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: PNC13, FLU3, PNC13
Symptoms: Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). This is a spontaneous report from a contactable pharmacist. A 67-year-old female patient received PREVNAR 13 (Lot # N16562, Expiry date 01Oct2017, NDC # 00005197102) via an unspecified route of administration at 0.5 ml, single at left arm on 08Nov2016 for immunisation. Medical history included ongoing hypertension, ongoing cardiac failure. The patient's concomitant medications were not reported. On 08Nov2016 the patient experienced soreness in the injected arm and she was having trouble lifting it and had trouble sleeping on it because her arm was constantly sore, with outcome of not recovered. Pharmacist said that the pain was still persisting, but the pain can be intermittent now. No relevant tests to report. Pharmacist stated that he/she did not know how if the patient's symptoms are related to the PREVNAR 13 or not. Pharmacist said that the patient is competent and the patient is correlating the pain in her arm to the PREVNAR 13. The Pharmacist said that she just doesn't know how to answer the causality questions. Pharmacist said that she was not at the pharmacy when the patient received the injection. The Pharmacist wanted to know what to tell the patient to do regarding how to alleviate the discomfort.
Age: 67.0
Sex: F
Vaccine: PNC13, FLU3, PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). This is a spontaneous report from a contactable pharmacist. A 67-year-old female patient received PREVNAR 13 (Lot # N16562, Expiry date 01Oct2017, NDC # 00005197102) via an unspecified route of administration at 0.5 ml, single at left arm on 08Nov2016 for immunisation. Medical history included ongoing hypertension, ongoing cardiac failure. The patient's concomitant medications were not reported. On 08Nov2016 the patient experienced soreness in the injected arm and she was having trouble lifting it and had trouble sleeping on it because her arm was constantly sore, with outcome of not recovered. Pharmacist said that the pain was still persisting, but the pain can be intermittent now. No relevant tests to report. Pharmacist stated that he/she did not know how if the patient's symptoms are related to the PREVNAR 13 or not. Pharmacist said that the patient is competent and the patient is correlating the pain in her arm to the PREVNAR 13. The Pharmacist said that she just doesn't know how to answer the causality questions. Pharmacist said that she was not at the pharmacy when the patient received the injection. The Pharmacist wanted to know what to tell the patient to do regarding how to alleviate the discomfort.
Age: 1.08
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Fever, redness around injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 25-FEB-2017, the patient received an expired dose of ZOSTAVAX vial 19400 plaque forming units (PFU) (lot # L046293 with expiration date 17-FEB-2017, 0.65 ml, once, subcutaneous (SQ)) for prophylaxis. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: Information was received from Pfizer, Inc. [2017070652] as part of a business agreement on 03-MAR-2017. Information was received originally from a registered nurse regarding a female patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX23 (lot number, expiration, dose and route not reported) for prophylaxis.  On an unknown date the patient experienced drug allergy to PNEUMOVAX23. The outcome of drug hypersensitivity is unknown. Additional information is not expected because information was received from the business partner.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: Information has been received from Pfizer, Inc. (Manufacturer # 2017070827) via a health care provider regarding a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date the patient was vaccinated with PNEUMOVAX23, (route, lot# and expiration date unknown), for prophylaxis.  It was noted on the patient's current medication list that she had an allergy to PNEUMOVAX23.  The outcome of the event was not provided.  Additional information is not expected.
Sex: U
Vaccine: HPVX
Symptoms: Vaccination complication
Clinical narrative: This solicited report was received from a mother referring to unspecified number of her children, of unknown age and gender, as a part of a market research. There was no information about the patients' concomitant medications, concurrent conditions and medical history reported. On an unknown dates, the patients were vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (dose, route of administration, lot# and expiry date were not reported). On an unknown dates, the patients had bad reaction to the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown), therefore their mother reported that her children did not need the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown). The outcome of the event was unknown. The reporter considered the event to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(manufacturer unknown). 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 medical assistant and refers to unspecified patients of unknown demographics. No information regarding the patients' medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On an unknown dates in February 2017 the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot numbers M022085, expiration date: 09-OCT-2017 and M038359, expiration date: 13-MAY-2018 (doses, routes and sites of administrations were not reported). The PNEUMOVAX 23 doses were stored in the temperature of 35 Fahrenheit for 9 days. No other temperature excursions were reported. No adverse events were reported. Additional information has been requested. Sender's Comments: US-009507513-1703USA006308: US-009507513-1703USA006309: US-009507513-1703USA006310.
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 unspecified patients of unknown demographics. No information regarding the patients' medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On an unknown dates in approximately February 2017 (reported as "since the beginning of February") the patients were vaccinated with improperly stored doses of GARDASIL 9 lot numbers M031557, expiration date: 07-APR-2019 and M013636, expiration date: 15-FEB-2018 (doses, routes and sites of administrations were not reported). The GARDASIL 9 doses were stored in the temperature of 35 Fahrenheit for 9 days. No other temperature excursions were reported. No adverse events were reported. Additional information has been requested. Sender's Comments: US-009507513-1703USA006301: US-009507513-1703USA006309: US-009507513-1703USA006310.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown demographics. No information regarding the patients' medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On an unknown dates in approximately February 2017 (reported as "since the beginning of February") the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot number M031650, expiration date: 16-MAR-2018 (doses were not reported). The ROTATEQ doses were stored in the temperature of 35 Fahrenheit for 9 days. No other temperature excursions were reported. No adverse events were reported. Additional information has been requested.; Sender's Comments: US-009507513-1703USA006301: US-009507513-1703USA006308: US-009507513-1703USA006310:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in March 2017 (reported as "starting on or after 06-MAR-2017"), the patients were vaccinated with doses of M-M-R II, lot # M004899, expiry date: 27-JAN-2018, for prophylaxis (dose number and route of administration were unknown), which were improperly stored at 11.4 degrees Celsius (C) for 1 hour 10 minutes. A data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA012132: US-009507513-1703USA012133:
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Paraesthesia, Rash erythematous
Clinical narrative: This spontaneous report was received from a currently 75 year old female patient, reporting on herself. The patient did not have pertinent medical history, drug reactions or allergies. On an unknown date, the patient was vaccinated with ZOSTAVAX (dosage information, lot number and expiration date were not informed), single 0.65 mL, subcutaneously, for prevention of shingles. Concomitant medication included unspecified diabetic medication, unspecified cholesterol and high blood pressure medication. On an unknown date the patient, reported pain in her back and a "red, bumby rash" on right arm from elbow to hand. The patient also reported "tingly feeling" in right hand. On an unknown date, she was diagnosed with shingles, after receiving  ZOSTAVAX. It was also informed that the patient received an unspecified treatment for the adverse events. And she sought medical attention at an office visit. At the time of reporting, the outcome of herpes zoster and back pain was reported as not recovered. The causality assessment between herpes zoster and back pain and therapy with ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to an unknown number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates since 14-MAR-2017, the patients were vaccinated with improperly stored VAQTA, lot number M027879, expiration date 24-JAN-2018, and lot number M047658, expiration date 28-OCT-2017, (dose, dose number, route and anatomical location were not reported), for prophylaxis.  The vaccines experienced a temperature excursion between 47 to 77 Fahrenheit Degrees during 30 minutes and previously on an unknown date, during 1 hour between the same temperatures. Digital data logger was involved. No adverse effects were reported. Product quality complain was not involved. No other suspect or concomitant therapies were reported. Additionally, the reporter stated that the "Outcome: all supported". This is one of several reports from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1703USA012120: US-009507513-1703USA012118: US-009507513-1703USA012119:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a multiple patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored PROQUAD, lot number M031568, expiration date 24-DEC-2017, (dose, dose number, route and anatomical location were not reported), for prophylaxis. The vaccines experienced a temperature excursion between 6 to 14 Fahrenheit Degrees ("6 Fahrenheit Degrees was the actual highest temperature of exposure"), during 30 minutes of time frame. No previous temperature excursions and no digital data logger was involved. No adverse effect were reported and no product quality complain was involved. Additionally, there was also reported that only "2 doses administered". No other suspect or concomitant therapies were reported. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA012141.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to an unknown number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates since 14-MAR-2017, the patients were vaccinated with improperly stored GARDASIL 9, lot number M036059, expiration date 03-JUN-2019, (dose, dose number, route and anatomical location were not reported), for prophylaxis. The vaccines experienced a temperature excursion between 47 to 77 Fahrenheit Degrees during 30 minutes and previously on an unknown date, during 1 hour between the same temperatures. Digital data logger was involved. No adverse effects were reported. Product quality complain was not involved. No other suspect or concomitant therapies were reported. Additionally, the reporter stated that the "Outcome: all supported". This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA012119: US-009507513-1703USA012119: US-009507513-1703USA011942.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to an unknown number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates since 14-MAR-2017, the patients were vaccinated with improperly stored PNEUMOVAX23 lot number M043424, expiration date 06-JUN-2018, (dose, dose number, route and anatomical location were not reported), for prophylaxis.  The vaccines experienced a temperature excursion between 47 to 77 Fahrenheit Degrees during 30 minutes and previously on an unknown date, during 1 hour between the same temperatures. Digital data logger was involved. No adverse effects were reported. Product quality complain was not involved. No other suspect or concomitant therapies were reported. Additionally, the reporter stated that the "Outcome: all supported". This is one of several reports from the same reporter. Additional information has been requested; Sender's Comments: US-009507513-1703USA011942: US-009507513-1703USA012120: US-009507513-1703USA012118:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to an unknown number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates since 14-MAR-2017, the patients were vaccinated with improperly stored ROTATEQ, lot number as reported M038847, expiration date 27-APR-2018, (dose, dose number, route and anatomical location were not reported), for prophylaxis.  The vaccines experienced a temperature excursion between 47 to 77 Fahrenheit Degrees during 30 minutes and previously on an unknown date, during 1 hour between the same temperatures. Digital data logger was involved. No adverse effects were reported. Product quality complain was not involved. No other suspect or concomitant therapies were reported. Additionally, the reporter stated that the "Outcome: all supported". This is one of several reports from the same reporter. Additional information has been requested; Sender's Comments: US-009507513-1703USA012119: US-009507513-1703USA011942: US-009507513-1703USA012118:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in March 2017 (reported as "starting on or after 06-MAR-2017"), the patients were vaccinated with doses of PNEUMOVAX 23, lot # M037669, expiry date: 09-MAY-2018, for prophylaxis (dose number and route of administration were unknown), which were improperly stored at 11.4 degrees Celsius (C) for 1 hour 10 minutes. A data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA012133: US-009507513-1703USA011911.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in March 2017 (reported as "starting on or after 06-MAR-2017"), the patients were vaccinated with doses of ROTATEQ, orally, lot # M019707, expiry date: 25-OCT-2017, for prophylaxis (dose number was unknown), which were improperly stored at 11.4 degrees Celsius (C) for 1 hour 10 minutes. A data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA012132: US-009507513-1703USA011911:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a multiple patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX lot number M037642, expiration date 01-SEP-2018, (dose, dose number, route and anatomical location were not reported), for prophylaxis. The vaccines experienced a temperature excursion between 6 to 14 Fahrenheit Degrees ("6 Fahrenheit Degrees was the actual highest temperature of exposure"), during 30 minutes of time frame. No previous temperature excursions and no digital data logger was involved. No adverse effect were reported and no product quality complain was involved. No other suspect or concomitant therapies were reported. Additionally,  there was also reported that only "9 doses administered". This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA012014:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a pharmacist, referring to a female patient of unknown age. The patients' medical history, concurrent conditions and concomitant therapies were not reported. In January 2017, the patient were vaccinated with a dose of ZOSTAVAX (strength, dose, anatomical location, administration route, lot number and expiration date were not reported) for immunization. On unspecified date in January 2017 after vaccination, the patient experienced a rash around injection site and also developed 5 or 6 bumps around injection site. The reporting pharmacist recommended using hydrocortisone (manufacturer unknown) cream for the rash and when she followed up with the patient, the patient reported that rash was resolved with the treatment in January 2017. It was reported that the patient did not seek medical attention. The patient returned to the pharmacy approximately one month later (in February 2017) and reported that her symptoms had completely resolved. The causality between the vaccination with ZOSTAVAX and the events was unknown. No product quality complaint (PQC) was involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA000245.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-MAR-2017, the patient was vaccinated with a improperly stored dose of VARIVAX lot # M023382 with an expiration date 11-MAY-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of VARIVAX experienced the temperature excursion of 7 degrees Fahrenheit, reported also as  from 6 degrees Fahrenheit to 14 degrees Fahrenheit (from -14 degrees Celsius to -10 degrees Celsius) for 30 minutes. A digital data logger was involved. There was no previous temperature excursion. This is one of several reports received from this reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA007869: , US-009507513-1703USA012358:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-FEB-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M022402 with an expiration date 01-NOV-2017 or lot# M035690 with an expiration date 06-FEB-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). No adverse effect were reported. Administered doses of PROQUAD experienced the temperature excursion of 7 degrees Fahrenheit, reported also as from 6 degrees Fahrenheit to 14 degrees Fahrenheit (and as from -14 degrees Celsius to -10 degrees Celsius) for 30 minutes. A digital data logger was involved. There were no previous excursions reported. Product quality compliant (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA012359: US-009507513-1703USA012358.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 15-MAR-2017, the patient was vaccinated with an improperly stored dose of M-M-R II injection, subcutaneously, lot # reported as M006104, expiration date 01-AUG-2017 (dose was not reported), which was reconstituted with properly stored diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 2 hours. Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from emergency medical technician and refers to a unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date between 13-OCT-2016 and 31-OCT-2016, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M015735, expiration date: 30-MAR-2018 and lot #M025870, expiration date: 24-MAY-2018) (dose, route and anatomical location were not reported) and properly stored sterile water diluent (manufacturer unknown) (route, anatomical location, lot# and expiration date were not reported). No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 90 minutes. There was no previous excursion reported. The call was because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA012491:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age or gender. There was no information about the patient's concurrent conditions, medical history or concomitant medications. On an unknown date, the patients were vaccinated with GARDASIL 9 (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis. The reporter stated that the patients could receive the second or the third doses of the vaccine on an unspecified date at intervals not in accordance with the dosing schedule detailed in the prescribed information. No adverse effects were reported in any patients. Additional information is not expected because there was no consent to contact the reporter.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Skin lesion
Clinical narrative: This spontaneous report was received from a pharmacist, who also happens to be the patient's daughter, via a company representative, and refers to her mother a female patient (age unknown). The reporter indicated that, the patient was administered with pneumococcal 13v conj vaccine previously (date unknown) and she had no reaction for that. The patient's concurrent conditions or concomitant therapies were not provided. On an unspecified date, the patient received a dose of injectable PNEUMOVAX23 for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported). On an unspecified date, the patient developed unspecified cellulitis after receiving the injection. The reporter indicated that she advised the patient to go back and showed the lesion to her physician, but the patient refused. No treatment was given for the event, and it was unknown whether laboratory diagnostics studies were performed. It was reported that the cellulitis lasted approximately 5 days and the patient recovered from it on an unspecified date. The relationship between the event and PNEUMOVAX23 was not provided. Upon internal review, the event cellulitis was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age or gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. From an unspecified date, the patient had an unknown condition (adverse event) that required a prescription of cyclosporine. At the time of reporting the outcome for the adverse event was not provided. The reporter considered the adverse event to be not related to ZOSTAVAX. Additional information is not expected because there was no consent to contact the reporter.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies, or concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of RECOMBIVAX HB (strength, dose, and route were not reported) lot number M041373; expiration date 18-NOV-2018, for prophylaxis. According to the reporter, RECOMBIVAX HB dose was exposed to the following temperature excursion: 1 hour and 13 minutes at -2.7 degrees Celsius (C). No adverse effects were reported. A digital data logger was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an adult patient of unspecified age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown date, the adult patient was vaccinated with a dose of PROQUAD injection (dose, route of administration, lot# and expiration date were not provided). Additional information has been requested.
Sex: U
Vaccine: HEPA, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse referring to multiple unspecified patients who on multiple unknown dates were vaccinated with improperly stored ROTATEQ (batch number M025576, expiration date 07-NOV-2017), orally or VAQTA (batch number M027897, expiration date 24-JAN-2018)  intramuscularly, both of them for prophylaxis. It was reported that the storage temperature was between 0°C and 1°C. The timeframe was unknown by the reporter and there was not previous temperature excursion. The improper storage was recognized due to a data logger. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a two unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided.  On 10-MAR-2017, the patients were vaccinated with PROQUAD injection lot # M022402 with an expiration date 01-NOV-2017 and lot# M035690 with an expiration date 06-FEB-2018 for prophylaxis (doses and route of administration were not reported). There was no adverse effect reported. Administered doses of PROQUAD experienced the temperature excursion of 7 degree Fahrenheit, reported also as from 6 degrees Fahrenheit to 14 degrees Fahrenheit (and also as -14 degrees Celsius to -10 degrees Celsus) for 30 minutes. A digital data logger was involved. There was no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA012359: US-009507513-1703USA007869:
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 65-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-FEB-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX23 injection (intramuscularly, lot # L040178 with expiration date 18-AUG-2017; dose was not reported). The vaccine was exposed to the temperature between 8 and 25 degrees Celsius for 26 hours. Previous temperature excursions included the temperature between 8 and 25 degrees Celsius for 14 hours 10 minutes and the temperature between 0 and 2 degrees Celsius for 24 hours. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. No additional information is available. Additional information is not expected as all scheduled correspondence has been received.; Sender's Comments: US-009507513-1703USA012482: US-009507513-1701USA014175:
Age: 72.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse and refers to a 72-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (intramuscularly, lot # L040178 with expiration date 18-AUG-2017; dose was not reported). The vaccine was exposed to the temperature between 8 and 25 degrees Celsius for 26 hours. Previous temperature excursions included the temperature between 8 and 25 degrees Celsius for 14 hours 10 minutes and the temperature between 0 and 2 degrees Celsius for 24 hours. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. No additional information is available. Additional information is not expected as all scheduled correspondence has been received. Sender's Comments: US-009507513-1701USA014175: US-009507513-1703USA012481.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Chest pain, Continuous positive airway pressure, Hyperhidrosis, Immunodeficiency
Clinical narrative: This spontaneous report was received from a 53 year old male patient referring to himself. He had no pertinent medical history and no drug reactions/allergies. He was taking no concomitant medications.  On 18-NOV-2014, the patient received PNEUMOVAX23 intramuscularly in the left deltoid for "routine vaccination" (lot number not provided). Within 24 hours of receiving the vaccine, his arms started swelling up and became sore. The following morning, on 19-NOV-2014, the patient developed a 103 fever, had the sweats, became extremely weak-where his wife was taking care of him, and hel felt like his lungs were on fire. The patient reported he had these symptoms for seven months, with fevers consistently between 100F and 103F. Afterwards, the patient's lungs were damaged to the point that he will have to be on a continuous positive airway pressure (CPAP) machine. He immune system is compromised and in fact he had a staph infection on an unspecified date. The patient was seen by his physician and had unspecified lab tests. He was not hospitalized. The patient stated he can no longer work and felt like he "almost died" because of the PNEUMOVAX23.  The patient stated his present status was "slowly recovering". The patient requested Merck assistance with the vaccine compensation fund. He does not want to sue Merck, but needs help getting an exception from the fund due to the "extreme nature of his side effects". The patient stated he went through the court system and was "even told by a judge to keep pursuing this". However, his attorney declined to help him pursue this further due to an unspecified reason. The patient felt the events his arms started swelling up and became sore, fever, sweats, became extremely weak, felt like his lungs were on fire/lungs were damaged to the point that now he will have to be on a CPAP machine, immune system is compromised and staph infection were disabling and life threatening. Upon internal review, immune system is compromised and staph infection were considered medically significant. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Impaired work ability, Laboratory test, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a 53 year old male patient referring to himself. He had no pertinent medical history and no drug reactions/allergies. He was taking no concomitant medications.  On 18-NOV-2014, the patient received PNEUMOVAX23 intramuscularly in the left deltoid for "routine vaccination" (lot number not provided). Within 24 hours of receiving the vaccine, his arms started swelling up and became sore. The following morning, on 19-NOV-2014, the patient developed a 103 fever, had the sweats, became extremely weak-where his wife was taking care of him, and hel felt like his lungs were on fire. The patient reported he had these symptoms for seven months, with fevers consistently between 100F and 103F. Afterwards, the patient's lungs were damaged to the point that he will have to be on a continuous positive airway pressure (CPAP) machine. He immune system is compromised and in fact he had a staph infection on an unspecified date. The patient was seen by his physician and had unspecified lab tests. He was not hospitalized. The patient stated he can no longer work and felt like he "almost died" because of the PNEUMOVAX23.  The patient stated his present status was "slowly recovering". The patient requested Merck assistance with the vaccine compensation fund. He does not want to sue Merck, but needs help getting an exception from the fund due to the "extreme nature of his side effects". The patient stated he went through the court system and was "even told by a judge to keep pursuing this". However, his attorney declined to help him pursue this further due to an unspecified reason. The patient felt the events his arms started swelling up and became sore, fever, sweats, became extremely weak, felt like his lungs were on fire/lungs were damaged to the point that now he will have to be on a CPAP machine, immune system is compromised and staph infection were disabling and life threatening. Upon internal review, immune system is compromised and staph infection were considered medically significant. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Staphylococcal infection, Traumatic lung injury
Clinical narrative: This spontaneous report was received from a 53 year old male patient referring to himself. He had no pertinent medical history and no drug reactions/allergies. He was taking no concomitant medications.  On 18-NOV-2014, the patient received PNEUMOVAX23 intramuscularly in the left deltoid for "routine vaccination" (lot number not provided). Within 24 hours of receiving the vaccine, his arms started swelling up and became sore. The following morning, on 19-NOV-2014, the patient developed a 103 fever, had the sweats, became extremely weak-where his wife was taking care of him, and hel felt like his lungs were on fire. The patient reported he had these symptoms for seven months, with fevers consistently between 100F and 103F. Afterwards, the patient's lungs were damaged to the point that he will have to be on a continuous positive airway pressure (CPAP) machine. He immune system is compromised and in fact he had a staph infection on an unspecified date. The patient was seen by his physician and had unspecified lab tests. He was not hospitalized. The patient stated he can no longer work and felt like he "almost died" because of the PNEUMOVAX23.  The patient stated his present status was "slowly recovering". The patient requested Merck assistance with the vaccine compensation fund. He does not want to sue Merck, but needs help getting an exception from the fund due to the "extreme nature of his side effects". The patient stated he went through the court system and was "even told by a judge to keep pursuing this". However, his attorney declined to help him pursue this further due to an unspecified reason. The patient felt the events his arms started swelling up and became sore, fever, sweats, became extremely weak, felt like his lungs were on fire/lungs were damaged to the point that now he will have to be on a CPAP machine, immune system is compromised and staph infection were disabling and life threatening. Upon internal review, immune system is compromised and staph infection were considered medically significant. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from emergency medical technician and refers to a unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date between 13-OCT-2016 and 31-OCT-2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot # M022402, expiration date: 01-NOV-2017) (dose, route and anatomical location were not reported) and properly stored sterile water diluent (manufacturer unknown) (route, anatomical location, lot# and expiration date were not reported). No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 90 minutes. There was no previous excursion reported. The call was because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA007917:
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: SWELLING, REDNESS, ITCHING A/NEAR INJECTION SITE.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient has redness and swelling to RA on injections site given by patient pharmacy.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Generalised erythema, Local swelling, Musculoskeletal stiffness, Pain
Clinical narrative: 7/7/16 TDAP administered. 7/8/16 Redness all over body. 7/9 - severe pain 10/10 - stiff left side of body - swollen left side neck.
Sex: F
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information had been received on 07-MAR-2017 from a nurse who reported that a female patient received the first dose of VARIVAX (dosage not reported, unknown lot/expiry date) on 06-MAR-2002, at the age of 11 months, 22 days, sooner than the indicated minimum of 12 months. Nurse reported that the second dose of VARIVAX (dosage not reported, unknown lot/expiry date) was received on 10-MAY-2007. No adverse effects reported. No additional information provided.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 23-FEB-2017, the patient was vaccinated with an improperly store dose of VARIVAX, subcutaneously, lot number M038225 with expiration date 07-SEP-2018 (dose and anatomical location were not reported). The vaccine was exposed to temperatures between 6 F (Fahrenheit) (-14 C (Celsius)) to 14F (-10C) during 6 hours. There was no previous temperature excursion. Data logger was filled. No adverse effects were noted for the patient. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA012499: US-009507513-1703USA012499:
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 13-MAR-2017 from a registered nurse regarding a female patient (age not provided). Medical history, concurrent conditions and concomitant medications were not reported. On 13-MAR-2017 the nurse reported the patient was administered a dose of ROTATEQ (lot number and dose not provided) which was improperly stored. No adverse effects were reported. Temperature 46-77 degrees Fahrenheit for 2.5 hours. There was no previous temperature excursion. Call was made because of a "data logger". Outcome was reported as "supported". No further information was provided. Additional information has been requested.
Sex: F
Vaccine: FLUX, HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from registered nurse and refers to a female patient of unknown age. No information regarding the patient's medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On 12-SEP-2016, the patient was vaccinated with a first dose of GARDASIL 9 (dose route of administration, lot number and expiration date were not reported). On 17-NOV-2016, the patient was supposed to receive her second dose of GARDASIL 9, however according to the chart documentation she received an unspecified influenza vaccine (reported as "flu shot") (dose, route of administration, lot number and expiration date were not reported). The nurse reported that the patient stated she received the second dose of GARDASIL 9. On 09-MAR-2017, the patient received another dose of GARDASIL 9 lot number: M04373, expiration date: 22-JUN-2019 (dose and route of administration were not reported). The reporting nurse was not sure if this was the second or third dose, since there had been a confusion which of the vaccines the patient received on 17-NOV-2017. No adverse events were reported. Product Quality Complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to two patients of unspecified gender and age. No information regarding the patients' concurrent conditions, medical history or concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (dose, formulation, route of administration and anatomical location were not provided, lot # M024680, expiration date 18-MAY-2018), for prophylaxis. The VARIVAX was reconstituted with properly stored diluent (lot number and expiration date were unknown). No adverse effects were reported. The VARIVAX was improperly stored for 1 hour in a temperature range between: 6 Fahrenheit degree (F) and 14 F (-14 Celsius degree (C) to -10 C) on an unspecified date. There has been previous temperature excursions and the cumulative time of improper storage was 5 hours in a temperature range of 6 F to 14 F (-14 C to -10 C). No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient might have been vaccinated with improperly stored VAQTA injection, lot # M027879, expiration date: 24-JAN-2018, lot# M047658, expiration date: 28-OCT-2017 (dose and route of administration were not reported). Temperature excursion ranged from 47 to 77 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. Digital data logger was used. No adverse effect was reported. No product quality complaint was involved. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA012509: US-009507513-1703USA012508: