chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a multiple unknown  patients of unknown age and gender. No pertinent medical history, drug reactions/Allergies and concomitant medications were reported. On an multiple unknown dates, the patients were vaccinated with improperly stored (incorrect product storage) doses of ROTATEQ (lot #M004726 and expiry date 19-OCT-2017) (dosing regimen was unknown by the reporter), orally for prophylaxis. The vaccine was exposed to temperature of 0.2 degree Celsius for 4 hours and 51 minutes. No previous temperature excursion was reported. The call was  due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was filed. Follow up information has been received from an office manager (OM) on 13-DEC-2016. The OM stated that she would research it and fax in the patient identifiers and dates of vaccination. This is one of several reports received from the same reporter. Additional information has been requested. Reporter and narrative was updated. Sender's Comments: US-009507513-1611USA000480: US-009507513-1611USA000483: MERCK 1611USA000375:Mfr number.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a multiple unknown patients of unknown age and gender. No pertinent medical history, drug reactions/Allergies and concomitant medications were reported. On an multiple unknown dates, the patients were vaccinated with improperly stored (incorrect product storage) doses of VAQTA (lot #M027879 and expiry date 24-JAN-2018) (dosing regimen was unknown by the reporter) for prophylaxis. The vaccine was exposed to temperature of 0.2 degree Celsius for 4 hours and 51 minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was filed. Follow up information has been received from an office manager (OM) on 13-DEC-2016. The OM stated that she would research it and fax in the patient identifiers and dates of vaccination. This is one of several reports received from the same reporter. Additional information has been requested. Reporter and narrative were updated. Sender's Comments: US-009507513-1611USA000375: MERCK 1611USA000480:Mfr number.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a multiple unknown  patients of unknown age and gender. No pertinent medical history, drug reactions/Allergies and concomitant medications were reported. On an multiple unknown dates, the patients were vaccinated with improperly stored (incorrect product storage) doses of RECOMBIVAX HB (lot #M018625 and expiry date 11-AUG-2018) (dosing regimen was unknown by the reporter) for prophylaxis. The vaccine was exposed to temperature of 0.2 degree Celsius for 4 hours and 51 minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was filed. Follow up information has been received from an office manager (OM) on 13-DEC-2016. The OM stated that she would research it and fax in the patient identifiers and dates of vaccination. This is one of several reports received from the same reporter. Additional information has been requested. Reporter and narrative were updated. Sender's Comments: US-009507513-1611USA000480: US-009507513-1611USA000375: MERCK 1611USA000483:Mfr number.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 51.3 F for 30,75 hours and in 59.4 F for 4,5 hours) doses of VAQTA (lot # M027879, expiration date 24-JAN-2018; dose and route of administration were not reported) for prophylaxis. No adverse effect and no previous excursion were reported. The call was made because of the data logger. This is one of several reports received from the same reporter. Follow up information has been received on 13-DEC-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative updated. Sender's Comments: US-009507513-1611USA001105: US-009507513-1611USA001104: US-009507513-1610USA011275: US-009507513-1611USA001103: MERCK 1611USA001102:Mfr number.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 51.3 F for 30,75 hours and in 59.4 F for 4,5 hours) doses of RECOMBIVAX HB (lot # M020926, expiration date 11-AUG-2018; dose and route of administration were not reported) for prophylaxis. No adverse effect and no previous excursion were reported. The call was made because of the data logger. This is one of several reports received from the same reporter. Follow up information has been received on 13-DEC-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative updated. Sender's Comments: US-009507513-1611USA001105: US-009507513-1610USA011275: US-009507513-1611USA001102: US-009507513-1611USA001103: MERCK 1611USA001104:Mfr number.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 51.3 F for 30,75 hours and in 59.4 F for 4,5 hours) doses of ROTATEQ (orally, lot # M006111 with expiration date 18-NOV-2017 or lot # M019707 with expiration date 25-OCT-2017; dose was not reported) for prophylaxis. No adverse effect and no previous excursion were reported. The call was made because of the data logger. This is one of several reports received from the same reporter. Follow up information has been received on 13-DEC-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative updated. Sender's Comments: US-009507513-1610USA011275: US-009507513-1611USA001104: US-009507513-1611USA001102: US-009507513-1611USA001103: MERCK 1611USA001105:Mfr number.
Sex: F
Vaccine: HPV4
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient (reporter's daughter) of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL injection (dose, route of administration, lot# and expiration date were not provided). In approximately 2012 (reported as "3 to 4 years ago"), the patient experienced an injection site reaction as "hot to the touch" after vaccination with GARDASIL. The injection site reaction lasted for one week and on unspecified date the patient recovered from the event. The relatedness between the adverse event and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 28-NOV-2016, the patient was inadvertently administered an expired dose of VARIVAX (lot # K021937, expiration date 10-NOV-2016, dose and route not reported) for prophylaxis. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to a multiple unknown patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, during an unspecified two week period, the patients were vaccinated with improperly stored GARDASIL (lot # K011325, expiry date: 08-APR-2017 and K011562, expiry date: 08-APR-2017) (doses and route of administration were not reported). No concomitant therapy was reported. Temperature excursion was 32 degree of Fahrenheit through 7 days during 2 weeks period. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA006826.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 30-NOV-2016, the patient was vaccinated with an expired dose of ZOSTAVAX 19400 PFU (Lot number L028281 and expiration date 28-OCT-2016) administration route reported as intramuscular (dose and strength were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Breast mass
Clinical narrative: Information has been received from a nurse referring to a currently 17 year old male patient with penicillin allergy. The patient had no pertinent medical history. He did not take concomitant medication. On 22-JAN-2013, the patient was vaccinated with GARDASIL (lot# H019088, expiration date 26-JUN-2015) (strength and dose were not reported) intramuscularly for prophylaxis. On an unspecified date after 22-JAN-2013, the patient was diagnosed by an unspecified physician with "multiple lumps in his breast". The reporter did not know if treatment was given. The outcome of the event was unknown. The causality between GARDASIL and the event was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Drug administration error, No adverse event
Clinical narrative: This spontaneous report received from a physician via nurse referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The physician reported to the nurse that he/she had a difficult time removing a ROTATEQ 1 DS X 10 TUBES 00006404741 2 ml oral solution cap and punctured the tube with a needle then snipped the top off with scissors and proceeded to give the oral solution to the patient. No adverse effect reported. It is unspecified what dose in the series this was. Additional information is not possible as the permission to contact physician was not available.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 05-DEC-2016 the patient received an expired dose of M-M-R II (lot # K020188, therapy type rHA, expiration date 22-OCT-2016) 0.5 ml subcutaneously for prophylaxis. The nurse reported the vaccine was reconstituted with Sterile Diluent (lot # M023896, expiration date 18-JAN-2018). There were no prior temperature excursions with the vaccine. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients. On multiple unspecified dates the patients were vaccinated for prophylaxis with GARDASIL 9 (lot # L014415, expiration date 25-JUL-2017; L024993, expiration date 17-OCT-2017), which was improperly stored at 61.03 F for 3 hours 38 minutes.  The temperatures were not logged with a data logger and there were no previous excursions. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA006817: US-009507513-1612USA006815: US-009507513-1612USA006816.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly doses of M-M-R II (rHA, lot # M011666, expiration date 08-MAR-2018; dose and route unknown) for prophylaxis, which was exposed to temperature excursion of 33.2 degrees Fahrenheit(F) for 12 hours and 43 minutes and 54.3 F for 1 hour and 23 minutes. Data logger was involved. There was no previous temperature excursion. No adverse effect had been reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA004258: US-009507513-1612USA004371.
Sex: U
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with ROTATEQ (dose, lot# and expiration date unknown) orally for prophylaxis. On an unknown date after the vaccination, the patient experienced intussusception. The patient had sought for medical attention (type unknown). The outcome of intussusception was unknown. Upon internal review, intussusception was determined to be medically significant. Additional information is not expected because there was no consent for further contact.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site nodule, Injection site pain, Injection site swelling, Panniculitis
Clinical narrative: This spontaneous report was received from a physician referring to a 12 year old female patient. The patient had no concomitant medications, no pertinent medical history and no drug reactions/allergies. On 10-NOV-2016, the patient was vaccinated with a dose of GARDASIL 9 (lot # M030380, expired date on 01-FEB-2019, concentration, dose and frequency were unknown) intramuscularly as "standard" therapy. On 04-DEC-2016, the patient had panniculitis with tender swollen nodule at injection site. The patient was instructed to take non-steroidal anti-inflammatory medications for 3 weeks. There was no lab diagnostics studies performed. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse referred to a unspecified patients. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that an unspecified number of improperly stored doses of ROTATEQ (lot number: M026315; expiry date: 26-JAN-2018, lot number: M016238; expiry date: 07-DEC-2017, lot number: M006111; expiry date: 18-NOV-2017, lot number: M025565; expiry date: 06-NOV-2017, lot number: M019707; expiry date: 25-OCT-2017, lot number: M019706; expiry date: 24-OCT-2017) was administered to an unspecified number of unspecified patients. The vaccines were stored at 32 F for 13 cumulative hours. No adverse effects reported. This is one of the two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA001393:
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner refers to a female patient of an unknown age. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date in 2000, the patient was vaccinated with first dose of VARIVAX, (lot number, expiry date and dose not reported) for prophylaxis. On 12-DEC-2016, the patient was vaccinated with second dose of VARIVAX, (lot number, expiry date and dose not reported) for prophylaxis (inappropriate schedule of vaccine administration). No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was inadvertently administered with a dose of PEDVAXHIB (lot # L051124, expiry date: 14-OCT-2018) (route: intramuscular) that had been improperly stored on an unknown date. The vaccine was stored at a temperature of 9.8C, for 15 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. The outcome of the events was unknown. Additional information is not expected as reporter did not give consent to contact.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: Information has been received from a pharmacist referring to a 47 year old male patient with diabetes mellitus. There were no drug reactions/allergies. In the evening on 11-DEC-2016 the patient was vaccinated with PNEUMOVAX 23 lot # M037669 (expiration date 09-MAY-2018), intramuscularly for prophylaxis. Concomitant therapies included LIPITOR and METAGLIP. The patient contacted the pharmacy and reported that on 12-DEC-2016 at 10:00 am, he experienced numb arm and hurting arm when he moved it. No treatment was given for the events. There were no lab diagnostics studies. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients. On multiple unspecified dates the patients were vaccinated for prophylaxis with RECOMBIVAX HB (Lot # L039660, expiration date 04-FEB-2018), which was improperly stored at 61.03 F for 3 hours 38 minutes. The temperatures were not logged with a data logger and there were no previous excursions. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA006816: US-009507513-1612USA006817: US-009507513-1612USA004271.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients. On multiple unspecified dates the patients were vaccinated for prophylaxis with ROTATEQ (lot # L035510, expiration date 13-MAY-2017), which was improperly stored at 61.03 F for 3 hours 38 minutes. The temperatures were not logged with a data logger and there were no previous excursions. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA004271: US-009507513-1612USA006817: US-009507513-1612USA006815.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients. On multiple unspecified dates the patients were vaccinated for prophylaxis with VAQTA (lot # L023936, expiration date 15-MAR-2017), which was improperly stored at 61.03 F for 3 hours 38 minutes.  The temperatures were not logged with a data logger and there were no previous excursions. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1612USA006816:US-009507513-1612USA004271:US-009507513-1612USA006815:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurses and refers to a multiple unknown patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, during an unspecified two week period, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot number: M022086, expiry date: 09-OCT-2017) (dose and route of administration were not reported). No concomitant therapy was reported. Temperature excursion was 32 degree of Fahrenheit through 7 days during 2 weeks period. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA000292.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative.  A patient of unspecified age, ethnicity and gender started to receive PREVENAR 13 and influenza vaccine (MANUFACTURER UNKNOWN), both via unspecified routes of administration, on unknown dates at a single doses for immunization. The patient's medical history and concomitant medications were not reported.  On an unknown date, after receiving pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and influenza vaccine, the patient experienced rash. The clinical outcome of the event, rash, was unknown.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Initial unsolicited report received from a consumer on 30 Nov 2016. This case involves a five years old female patient who was vaccinated with a dose of Fluzone QIV (batch number-UI724AA, expiry date- 30-Jun-2017; dose in series- unknown) via intramuscular route in left deltoid on 21 Nov 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. The patient was previously vaccinated with at least three doses of Fluzone QIV. The patient had similar vaccination site reaction with previous vaccination of Flu vaccine on 2015. Any other vaccinations within 4 weeks of vaccination was reported as none. The patient concomitant medications were not reported. On 21 Nov 2016, at night following the vaccination, the patient developed red, swollen, itchy and hard lump (3 inch by 3 inch) at injection site. On the next night area enlarged and on 23 Nov 2016, hard lump increased to 5 inch by 5 inch and painful at injection site. On 30 Nov 2016, area around injection site is still red but is no longer swollen and hard lump has disappeared. Laboratory investigations were not reported. The patient corrective treatment were Benadryl and Tylenol. The patient outcome was not reported. List of documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Initial unsolicited report received from a consumer on 30 Nov 2016. This case involves a five years old female patient who was vaccinated with a dose of Fluzone QIV (batch number-UI724AA, expiry date- 30-Jun-2017; dose in series- unknown) via intramuscular route in left deltoid on 21 Nov 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. The patient was previously vaccinated with at least three doses of Fluzone QIV. The patient had similar vaccination site reaction with previous vaccination of Flu vaccine on 2015. Any other vaccinations within 4 weeks of vaccination was reported as none. The patient concomitant medications were not reported. On 21 Nov 2016, at night following the vaccination, the patient developed red, swollen, itchy and hard lump (3 inch by 3 inch) at injection site. On the next night area enlarged and on 23 Nov 2016, hard lump increased to 5 inch by 5 inch and painful at injection site. On 30 Nov 2016, area around injection site is still red but is no longer swollen and hard lump has disappeared. Laboratory investigations were not reported. The patient corrective treatment were Benadryl and Tylenol. The patient outcome was not reported. List of documents held by sender: none.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Confusional state, Pain, Palpitations
Clinical narrative: Initial unsolicited report received from a company representative on 03 December 2016. This case involves a 74-years-old female patient who was vaccinated with a dose of FLUZONE HD (batch number-UI728AB, expiration date-03 June 2017) via intramuscular route of administration in left deltoid (dose and dose in series and dose was not reported) on 15 November 2016. Illness at time of vaccination was reported as none and patient had allergies to actinal, quinolone, red dye and patient had medical history of asthma, Gastro esophageal Reflux Disease (GERD) (Reported as GURD). Concomitant medications were not reported. On 15 November 2016, same day by the evening following the vaccination, the patient had experienced rigor, aches, confusion, and palpitations. Relevant laboratory data was reported as none. Corrective treatment was not reported. On an unspecified date (within 24 hours) patient was recovered from the events. List of documents held by sender: none.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Non pustule raised rash to shoulders, chest, back and neck with minimal itching. Has used Aloe Vera lotion to ease rash. Denies changes to soaps, detergents, deodorants or other environmental factors. Also denies taking medications at the present time. Patient was given (2) doses of the pediatric Hepatitis B vaccine with lot #2474H from Glaxo Smith Kline in the Right Deltoid.
Age: 35.0
Sex: U
Vaccine: FLU4, TDAP
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Right arm very painful, decreased range of motion. Left arm very painful, decreased range of motion.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Bacterial infection, Herpes simplex, Immediate post-injection reaction, Immune system disorder
Clinical narrative: Prior to the flu shot I was in excellent health with no medical concerns. Following the flu shot I had excessive decrease in energy levels and immunity. Due to the decline in immunity I was constantly sick with mild bacterial and viral infections such as a mild cold, persistent mild UTI's, and also contracted strep. These illnesses persisted for many months. In late September I had a mild UTI that developed into an aggressive double kidney infection which hospitalized me for 1 day requiring IV antibiotics and fluids. Immediately following this incident the next week I contracted the flu (for the first time in 15 years). Immediately following the flu I contracted a severe herpes type 1 infection extending from half of my upper left lip all the way up to my nose. These series of serious infections started late September and extended over a 5 week period to the end of October. These events have never occurred in my life, prior to the flu vaccine I was very rarely sick and always had great energy and immunity. It took up until July 2016 to finally start gaining back my energy levels (which are still diminished today). These series of events have cost me my health and wellness, a decreased quality of life, and financial strains due to the hospitalization, ER visit, and Urgent care visit.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Kidney infection, Malaise, Nasopharyngitis, Quality of life decreased
Clinical narrative: Prior to the flu shot I was in excellent health with no medical concerns. Following the flu shot I had excessive decrease in energy levels and immunity. Due to the decline in immunity I was constantly sick with mild bacterial and viral infections such as a mild cold, persistent mild UTI's, and also contracted strep. These illnesses persisted for many months. In late September I had a mild UTI that developed into an aggressive double kidney infection which hospitalized me for 1 day requiring IV antibiotics and fluids. Immediately following this incident the next week I contracted the flu (for the first time in 15 years). Immediately following the flu I contracted a severe herpes type 1 infection extending from half of my upper left lip all the way up to my nose. These series of serious infections started late September and extended over a 5 week period to the end of October. These events have never occurred in my life, prior to the flu vaccine I was very rarely sick and always had great energy and immunity. It took up until July 2016 to finally start gaining back my energy levels (which are still diminished today). These series of events have cost me my health and wellness, a decreased quality of life, and financial strains due to the hospitalization, ER visit, and Urgent care visit.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Streptococcal infection, Urinary tract infection, Urine analysis, Viral infection
Clinical narrative: Prior to the flu shot I was in excellent health with no medical concerns. Following the flu shot I had excessive decrease in energy levels and immunity. Due to the decline in immunity I was constantly sick with mild bacterial and viral infections such as a mild cold, persistent mild UTI's, and also contracted strep. These illnesses persisted for many months. In late September I had a mild UTI that developed into an aggressive double kidney infection which hospitalized me for 1 day requiring IV antibiotics and fluids. Immediately following this incident the next week I contracted the flu (for the first time in 15 years). Immediately following the flu I contracted a severe herpes type 1 infection extending from half of my upper left lip all the way up to my nose. These series of serious infections started late September and extended over a 5 week period to the end of October. These events have never occurred in my life, prior to the flu vaccine I was very rarely sick and always had great energy and immunity. It took up until July 2016 to finally start gaining back my energy levels (which are still diminished today). These series of events have cost me my health and wellness, a decreased quality of life, and financial strains due to the hospitalization, ER visit, and Urgent care visit.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reaction/allergies or concomitant information were not reported. On 03-OCT-2016, the patients were vaccinated with improperly stored doses of PROQUAD lot # L046509 and expiration date of 17-MAY-2017 (albumin status therapy type, strength, dose and route of administration were not provided). No adverse reactions were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Follow up information has been received on 29-NOV-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA001898: US-009507513-1610USA003836: MERCK 1610USA003835: Mfr number.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reaction/allergies or concomitant information were not reported. On 03-OCT-2016, the patients were vaccinated with doses of improperly stored VARIVAX lot # L032391, expiration date: 26-AUG-2017 (strength, dose and route of administration were not provided). No adverse events were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Follow-up information has been received on 29-NOV-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA001898: US-009507513-1610USA003835: MERCK 1610USA003836:Mfr number.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacy intern referring to two unspecified patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On 12-OCT-2016, the patients were administered doses of PNEUMOVAX 23 syringes (lot number M020521 with expiration date 17-NOV-2017; dose was unknown) intramuscularly for pneumonia vaccination. On an unspecified date in October 2016, after administration, the patients experienced "redness, and swelling from the shoulder to the elbow on the arm, where PNEUMOVAX 23 was administered". Both patients also experienced the area being "hot to touch". No treatment was given for the events. These symptoms lasted for an unspecified amount of time, and the current status of the unspecified patients was unknown. The pharmacy intern requested a lot check for this lot of PNEUMOVAX 23. The causal relationship between the events and PNEUMOVAX 23 was unknown. An investigation into the manufacture of lot M020521 was completed and confirmed that all in-process quality checks were satisfactory. The results indicated that the lot was manufactured in accordance with manufacturing site standard operating procedures. The lot was confirmed to have met the requirements for market release. Following medical review of the AE report and the Quality investigation, there were no identified concerns related to quality within the results of the investigation. Additional information has been requested. Sender's Comments: MERCK 1610USA008156:Mfr number.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Discomfort, Injection site erythema, Injection site paraesthesia, Injection site swelling
Clinical narrative: Information has been received on 23-NOV-2016 from a pharmacist via an employee referring to an 83 year old male patient. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 15-NOV-2016 the patient was vaccinated with PNEUMOVAX 23, (lot number and expiration not reported) unknown route for prophylaxis. On 15-NOV-2016 the patient developed swelling and redness on his injection arm from his armpit to his wrist. The patient reported feeling like his injection arm was "flappy" or "asleep." The patient reported experiencing tingling in his injection arm and feeling very uncomfortable. The pharmacist states that there is a slight chance that he was bitten by a bug around the same time he received PNEUMOVAX 23. The pharmacist emphasized that the patient's swelling and redness was on the inside of his arm or the anterior aspect of the injection arm. The pharmacist didn't specify whether or not the patient was ever vaccinated with a pneumococcal vaccine before 15-NOV-2016. The patient did seek treatment by consulting with the pharmacist. No additional information was provided. The outcome of tingling in his injection arm, feeling very uncomfortable and swelling and redness on his injection arm was reported as recovering/resolving. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, HPV9, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. The patient was vaccinated with improperly stored GARDASIL 9 (lot# M017983, expiration date: 30-MAY-2018), RECOMBIVAX HB)(lot# M020926, expiration date: 11-AUG-2018), ROTATEQ orally (lot# M019707, expiration date: 25-OCT-2017) or VAQTA (lot# M030598, expiration date: 13-OCT-2017) on multiple unspecified dates. No adverse effects were reported. Temperature excursion details: Data logger was involved. Temperature: 30.30 F. Time frame: 15 Minutes. Previous temperature excursion: 32 F for 2 hours. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Cold sweat, Computerised tomogram, Full blood count, Musculoskeletal pain, Pallor
Clinical narrative: This spontaneous report was received from the patient's wife and refers to a 79 year old male patient. The patient's pertinent medical history included rheumatoid arthritis, cardiovascular disease, ulcers and absence seizures (reported to be controlled). He was allergic to HUMIRA (also reported as HUMERA; the patient had also unspecified side effects from it) and valacyclovir hydrochloride. On 14-NOV-2016, the patient was vaccinated with a dose of ZOSTAVAX injection (lot #, expiration date, site, dose and route of administration were not reported) for prevention of shingles. Concomitant therapies included ENBREL (also reported as EMBREL), VYTORIN, quinapril hydrochloride, phenytoin sodium, hydrochlorothiazide (also reported as HCTZ DIARTIC), metoprolol succinate, NEXIUM (also reported as NIXIUM), fexofenadine hydrochloride, potassium chloride, methotrexate (manufacturer unknown), vitamin D (unspecified) and sulfasalazine. On 20-NOV-2016, the patient started experiencing severe rheumatoid pain between blades, he broke into a cold sweat and became very pale. According to the reporter, the patient might have developed a reaction to ZOSTAVAX because he was on ENBREL. The effects were so severe that paramedics had to be called to take the patient to the emergency room. He was not admitted, but received an unspecified treatment for the events, had complete blood work and a full computerized tomography (CAT) scan performed (results were not reported). Subsequently, on the same day, the patient was released. The outcome of the events was reported as not recovered. The relatedness between rheumatoid pain, reaction to ZOSTAVAX, cold sweat, pallor and ZOSTAVAX was not reported. Upon internal review, the event of rheumatoid pain was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were unknown. On an unknown date, the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous) for prevention of shingles. On an unknown date, unspecified time post vaccination, the patient developed shingles. The outcome of the event was unknown. The causality was not provided. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to 15 year old patient of unknown gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 28-SEP-2016, the patient was vaccinated with improperly stored doses of GARDASIL from lot# L035105 with expiry date 14-MAY-2017 or lot # L043213 with expiry date date 28-AUG-2017 for prophylaxis (dose, vaccination site, route unspecified). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of three reports received from the same reporter. Additional information is not expected since no further information was available. Sender's Comments: US-009507513-1610USA009528: US-009507513-1610USA005486.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry mouth, Herpes zoster, Musculoskeletal disorder, Pruritus, Tinnitus
Clinical narrative: Severe case of shingles. Itchy legs symptom shortly after vaccine was administered. In addition to shingles not completely healing I have noticed additional symptoms. Tinnitus, Itchy legs, dry mouth and partial loss of use of my right arm which indicates I may have developed a mild case of Ramsay-Hunt-syndrome.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Got vertigo.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site inflammation, Pain
Clinical narrative: Red inflamed area around site of injection and achy feeling.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema multiforme, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever, erythema multiform and swelling and erythema spreading around injection site. Influenza 0.5 ml once.
Age: 41.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: Was given MMR/Varicella Proquad instead of regular MMR.
Age: 29.0
Sex: F
Vaccine: YF
Symptoms: Tremor
Clinical narrative: The ADE began on day 10 after the immunization and is still ongoing at this present time; total duration for symptoms was about 5 months. It is a fine tremor, non-disruptive to ADLs.  It is exacerbated by caffeine and the intensity is alleviated with rest. No treatment received, as it should be self-limited. No fever at onset or throughout the duration. Tremor is the only symptom.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Emotional distress, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient started with subjective fever and chills and was inconsolable despite mom giving TYLENOL in the evening after receiving the flu vaccine. Yesterday he refused to put pressure on his foot. Mom says he feels "warmer" than usual but not as high as the first night. Still not wanting to walk on it today but will walk some. She says the leg is swollen and red from the thigh down to his knee. Giving ADVIL. Other siblings have been fine with no reaction. Specifically no breathing problems. No history of egg allergy.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Skin warm, Weight bearing difficulty
Clinical narrative: Patient started with subjective fever and chills and was inconsolable despite mom giving TYLENOL in the evening after receiving the flu vaccine. Yesterday he refused to put pressure on his foot. Mom says he feels "warmer" than usual but not as high as the first night. Still not wanting to walk on it today but will walk some. She says the leg is swollen and red from the thigh down to his knee. Giving ADVIL. Other siblings have been fine with no reaction. Specifically no breathing problems. No history of egg allergy.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Malaise, Mobility decreased, Muscular weakness
Clinical narrative: Patient called to report adverse reaction the day after vaccine administration. Patient stated injection site redness and swelling as well as a fever and malaise. She said those symptoms progressed to weakness and pain in her arm at approximately 1 hours after vaccine. All continued the day after her vaccine, with some improvement in pain. Patient described pain as "almost unbearable" at approximately one hour after vaccination and that she could "barley move her arm by evening".
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient called to report adverse reaction the day after vaccine administration. Patient stated injection site redness and swelling as well as a fever and malaise. She said those symptoms progressed to weakness and pain in her arm at approximately 1 hours after vaccine. All continued the day after her vaccine, with some improvement in pain. Patient described pain as "almost unbearable" at approximately one hour after vaccination and that she could "barley move her arm by evening".
Age: 5.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: CLIENT WAS GIVEN ADULT DOSE HEP B INSTEAD OF CHILD DOSE HEP B. NO ADVERSE REACTION NOTED.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unknown number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection lot # M007762 with expiration date 07-DEC-2018 and lot # M014927 with expiration date 18-FEB-2019 (dose and route of administration were not reported). No adverse effects were reported. There was no product quality complaint involved. Administered doses of vaccines were exposed to the temperature excursion of 11.8 degrees Celsius for a time frame of 1 hour 3 minutes on an unspecified date.  A digital data logger was involved. There was a previous excursion of 10.2 Celsius for a time frame of 1 hour 3 minutes involved (date unknown). This is one of several reports received from the same reporter. Follow up information has been received on 21-NOV-2016. All telephone attempts to obtain follow-up information had been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA000210: US-009507513-1610USA004153: MERCK 1610USA004154:Mfr number.
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Viral infection
Clinical narrative: This spontaneous report was received via social media from a consumer and refers to a female patient of unknown age. The patient's concurrent condition included a viral infection (reported as "dormant virus similar to Lyme disease"). No information regarding the patient's drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced progression of the viral infection (reported as "the vaccine actually woke it up"). Action taken with the therapy, the outcome of the event and the relatedness between the event and the GARDASIL were not reported. Additional information is not expected as no contact details were provided.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an adult female patient (exact age was not reported). There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 16-AUG-2016, the patient was vaccinated with the first dose of RECOMBIVAX HB 10/1.0 mcg/ml injection (lot #, expiration date, site, dose and route of administration were not reported). The second dose of RECOMBIVAX HB 10/1.0 mcg/ml injection was administered on 29-NOV-2016 (lot #, expiration date, site, dose and route of administration were not reported). No adverse effects were reported. Additional information is not expected as there was no consent to contact the reporter.