chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a nurse prescriber via a company representative, who referred to a female patient of an unknown age. No information regarding the patients pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-MAY-2017, the patient was administered ZOSTAVAX subcutaneously (formulation, dose, anatomical location, lot# and expiration date were not reported) for prevention of herpes zoster (shingles). On 19-MAY-2017, the patient reported to the nurse prescriber that she experienced an unspecified injection site reaction to ZOSTAVAX. The patient sought medical attention by visiting the nurse prescriber's office on 22-MAY-2017 (reported as today) to be examined. No product quality complaint (PQC) was involved. The outcome of the unspecified injection site reaction was unknown. The relatedness between the event and ZOSTAVAX was reported as related. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Injection site reaction, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: This spontaneous report was received from a registered nurse, via a company representative, referring to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 intramuscularly, vaccine to prevent human papilloma virus (HPV) (strength, dose, frequency, lot/batch # and expiration date were not reported). On an unknown date, reported as " two weeks after receiving a GARDASIL 9 injection", the patient experienced an injection site reaction. It was reported that her arm was swollen, sore, and tender. It was reported that the patient contacted the nurse, however, not treatment was given, no intervention for preventing serious criteria was performed, no significant disability or incapacity occurred, no hospitalization was needed and no life threatening happened. The patient recovered form peripheral swelling, injection site reaction, tenderness and pain in extremity, on an unknown date. The causality between peripheral swelling, injection site reaction, tenderness and pain in extremity with GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine site coordinator and 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 GARDASIL 9 lot # M034437 with an expiration date of 03-FEB-2019 (doses, route of administration and anatomical location were not reported). Administered doses of vaccine underwent a temperature excursion of -1 degree Celsius or colder -0.5 degree Celsius for 2 hours and 30 minutes which was detected by a data logger. There was previous excursion between 0 degree Celsius to 1 degree Celsius for 4 hours reported. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Rash vesicular
Clinical narrative: Information was received on 26-MAY-2017 from a lawyer regarding a female patient of unknown age. he patient was inoculated with ZOSTAVAX (dose, site, lot and expiration not reported) on or about 03-AUG-2009, at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-NOV-2014, the patient was treated by a physician at a hospital for a vesicular outbreak that was diagnosed as severe shingles. On or about 01-DEC-2014, the patient was treated again for ongoing and worsening symptoms by a physician who affirmed the diagnosis of shingles. On or about 29-DEC-2014, the patient required further treatment by the physician and  was diagnosed with the condition of shingles and chronic nerve pain. The patient was prescribed valacyclovir (manufacturer unknown), hydrocodone, acetaminophen (NORCO), and oxycodone, acetaminophen (PERCOCET) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information had been received on 26-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 27-APR-2010 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-MAR-2010 (conflicting information as this precedes date of vaccination), patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. Patient was further diagnosed with post herpetic neuralgia, a secondary condition to shingles that involves residual and chronic nerve pain. Patient was prescribed gabapentin for management of her symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 26-MAY-2017 from a lawyer and a female patient of unknown age regarding a case in litigation. The patient was inoculated with ZOSTAVAX (dose. route, lot number and expiration date were not reported) on or about 25-FEB-2009 as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-JUN-2016, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed valacyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. 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 medical assistant and refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot # M033907 with expiration date at 20-JUL-2018 and lot # M038856 with expiration date at 14-SEP-2018; for prophylaxis; dose, route of administration and anatomical location were not reported), which were reconstituted with properly stored sterile diluent (STERILE DILUENT) (strength, dose, lot # and expiration date were not reported). The administered doses of vaccine experienced multiple temperature excursions. From21-MAR-2017 to 14-APR-2017, the doses of VARIVAX with lot numbers: M033907 and M038856 were exposed to a temperature in the range between 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (F) for 3 hours and 27 minutes in total. On 29-MAR-2017, took place the longest (24 min) temperature excursion. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected since all scheduled correspondence was received.; Sender's Comments: US-009507513-1705USA015599: US-009507513-1705USA015600: US-009507513-1705USA000770: US-009507513-1705USA015602: US-009507513-1705USA015597: US-009507513-1705USA015598:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (recombinant human albumin, rHA) injection (lot # M039904 with expiration date at 26-SEP-2018 and lot # M029918 with expiration date at 13-JUN-2018; for prophylaxis; dose, route of administration and anatomical location were not reported), which were reconstituted with properly stored sterile diluent (strength, dose, lot # and expiration date were not reported). The administered doses of vaccine experienced multiple temperature excursions. From 21-MAR-2017 to 14-APR-2017, the doses of M-M-R II with lot numbers: M039904 and M029918 were exposed to a temperature in the range between 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (F) for 3 hours and 27 minutes in total. On 29-MAR-2017, took place the longest (24 min) temperature excursion. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected since all scheduled correspondence was received. Sender's Comments: US-009507513-1705USA015599: US-009507513-1705USA015600: US-009507513-1705USA015601: US-009507513-1705USA000770: US-009507513-1705USA015597: US-009507513-1705USA015598.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 15-MAY-2017, the patient was vaccinated with PROQUAD lot # M044018, expiration date: 01-MAY-2018 that might have underwent temperature excursions of -14 to -10 degrees Celsius for 1 hour and -9 to 8 degrees Celsius for 2 hours reconstituted in sterile diluent. No adverse experience was reported. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA008370.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Gave Hep A 19+ to 18 year old.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal discomfort, Blood test, Cardiac stress test, Cardiac telemetry, Chest pain
Clinical narrative: Chest pain, nausea, light-headed, vomiting, loss appetite 911 call to work site - Emergency Dept. 4 1/2 hrs. Inpatient admit - total 2 days [ED - Telemetry]. Blood draws Cx7, EKG x 3, x-ray, stress test, continue - loss appetite - Abd discomfort, fatigue.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Dizziness, Electrocardiogram normal, Fatigue, Haematocrit abnormal
Clinical narrative: Chest pain, nausea, light-headed, vomiting, loss appetite 911 call to work site - Emergency Dept. 4 1/2 hrs. Inpatient admit - total 2 days [ED - Telemetry]. Blood draws Cx7, EKG x 3, x-ray, stress test, continue - loss appetite - Abd discomfort, fatigue.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Haemoglobin, Haemoglobin abnormal, Monocyte count abnormal, Nausea, Platelet disorder
Clinical narrative: Chest pain, nausea, light-headed, vomiting, loss appetite 911 call to work site - Emergency Dept. 4 1/2 hrs. Inpatient admit - total 2 days [ED - Telemetry]. Blood draws Cx7, EKG x 3, x-ray, stress test, continue - loss appetite - Abd discomfort, fatigue.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Troponin normal, Vomiting, X-ray
Clinical narrative: Chest pain, nausea, light-headed, vomiting, loss appetite 911 call to work site - Emergency Dept. 4 1/2 hrs. Inpatient admit - total 2 days [ED - Telemetry]. Blood draws Cx7, EKG x 3, x-ray, stress test, continue - loss appetite - Abd discomfort, fatigue.
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Bone pain, Injection site erythema, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Mild to moderate bone and joint pain lasting throughout following day. Swelling, redness in shoulder of injection. Muscle stiffness. Symptoms mildly improved with 600mg ibuprofen.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: This spontaneous case, initially received on 05-Dec-2016, was reported by a health professional and concerns a(n) female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported. Route of administration: Not Reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date after vaccine, the patient experienced Guillain Barre Syndrome (Medically Significant, outcome: Not Reported).
Age: 39.0
Sex: M
Vaccine: MMR
Symptoms: Drug dose omission, Mumps antibody test negative, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a 60 year old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 24-JAN-1996, the patient was vaccinated with the first dose reported as " only one dose" of M-M-R II, HSA diluted in sterile diluent for pre-employment vaccination (prophylaxis) (the lot #, expiration date, route, strength and the dose were not provided). On 12-MAY-2017, due to a local measles outbreak, the patient had a titers test which was negative for mumps, but was positive for measles and rubella. The reporter nurse did not know why the patient only received 1 dose of the vaccine. However, the patient was healthy, and had not experienced any other adverse effects. There was no product quality complaint (PQC) involved. The outcome of the event and the causal relationship between the events and the vaccine were unknown. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA009249: Original Case: 1705USA008462.
Sex: U
Vaccine: PPV
Symptoms: Product name confusion, Wrong drug administered
Clinical narrative: This spontaneous report was received from a laboratory technician, concerning a 2 month-old patient of an unknown gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On 19-MAY-2017, the patient was intramuscularly vaccinated with a dose of PNEUMOVAX 23 injection (strength, dose and frequency were not reported) lot # M036728 with expiration date of 20-MAY-2018, for prophylaxis; rather than receiving PREVNAR 13 due to a product confusion. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: No adverse event, Wrong patient received medication
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a male patient of unknown age. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On an unspecified date in November 2015, the patient was vaccinated with the first dose of VARIVAX for prophylaxis (dose, frequency, route lot number and expiration date were not provided) and the first dose of M-M-R II (dose, frequency, route lot number and expiration date were not provided). 23-MAY-2017, the patient was in the nurse practitioner's office and was not scheduled to receive any vaccines, however, the office staff inadvertently administered the second dose of VARIVAX (lot # M041513) for prophylaxis (dose, frequency, route and expiration date were not provided) and the second dose of M-M-R II (lot #M037096) therapy type (HSA) (dose, frequency, route and expiration date were not provided). Other suspect therapies included sterile diluent (manufacturer unknown). No adverse effects were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Sex: M
Vaccine: MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a male patient of unknown age. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On an unspecified date in November 2015, the patient was vaccinated with the first dose of VARIVAX for prophylaxis (dose, frequency, route lot number and expiration date were not provided) and the first dose of M-M-R II (dose, frequency, route lot number and expiration date were not provided). 23-MAY-2017, the patient was in the nurse practitioner's office and was not scheduled to receive any vaccines, however, the office staff inadvertently administered the second dose of VARIVAX (lot # M041513) for prophylaxis (dose, frequency, route and expiration date were not provided) and the second dose of M-M-R II (lot #M037096) therapy type (HSA) (dose, frequency, route and expiration date were not provided). Other suspect therapies included sterile diluent (manufacturer unknown). No adverse effects were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: No adverse event, Wrong patient received medication
Clinical narrative: Patient received 12 month (MMR, Varicella and Hepatitis A) inadvertently at his 2.5yo visit. Spoke with Merck (MMR/Varicella)-no action required/okay minimal interval. Spoke with GSK no action required.
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient received 12 month (MMR, Varicella and Hepatitis A) inadvertently at his 2.5yo visit. Spoke with Merck (MMR/Varicella)-no action required/okay minimal interval. Spoke with GSK no action required.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 1 year old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 08-MAY-2017, the patient was vaccinated with an improperly stored dose of M-M-R II, lot number M039904, (dose, dose number, albumin status, injection site, route of administration and expiration date were not provided) for prophylaxis. The vaccine underwent a temperature excursion of 48 degrees Fahrenheit for 30 minutes. It was also stated that the dose of vaccine was reconstituted with properly stored sterile diluent injection. There was no Digital Data Logger involved. No adverse effects were reported. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA001660: US-009507513-1704USA000587.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 1 year old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 03-MAY-2017, the patient was vaccinated with an improperly stored dose of M-M-R II, lot number M039904, (dose, dose number, albumin status, injection site, route of administration and expiration date were not provided) for prophylaxis. The vaccine underwent a temperature excursion of 48 degrees Fahrenheit for 30 minutes. It was also stated that the dose of vaccine was reconstituted with properly stored sterile diluent injection. There was no Digital Data Logger involved. No adverse effects were reported. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA001660: US-009507513-1704USA000587.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to two patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX for prophylaxis, lot # M024680 with expiration date of 18-MAY-2018 (dose, route, anatomical location and frequency were not reported). No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of -12 degrees Celsius for 1 hour and 15 minutes. Previous temperature excursion was reported as -12 degrees Celsius for 1 hour and 15 minutes. The call was because of a "data logger". Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information had been received on 26-MAY-2017 from a lawyer regarding a case in litigation. The patient's medical history, concurrent conditions and concomitant medication were not provided. It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX (dose, route, site of administration, lot # and expiration date were not provided) on or about 05-FEB-2009 at a clinic, as recommended for routine adult health maintenance for the prevention of shingles. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 12-MAR-2015, the patient was treated at clinic for a vesicular outbreak that was diagnosed as severe shingles. On or about 24-MAY-2016 the female patient was further diagnosed with post herpetic neuralgia, a secondary condition to shingles that involves residual and chronic nerve pain. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information had been received on 26-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 05-JUN-2015 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. Throughout February 2016, patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. Patient was prescribed antivirals but continued to feel residual pain at the site of the outbreak. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: YF
Symptoms: Dizziness, Injection site erythema, Injection site induration, Injection site pruritus, Pyrexia
Clinical narrative: Initial unsolicited report received from a pharmacist on 20-May-2017. This case involves 18-year-old female patient who was vaccinated with a dose of YF-VAX (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 18-May-2017. The patient's medical history including illness at time of vaccination and the pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. The concomitant medications were reported as vaccination with a dose of Vivotif (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was also reported that Vivotif have not lot number since was not administered at reporter's facility. On 18-May-2017, same day following the vaccination, the patient had experienced red, itchy and hard area at injection site. On 20-May-2017, two days following the vaccination, the patient had experienced fever and dizziness. The lab data and corrective treatment were not reported. The outcome of all the events were unknown. List of documents held by sender: none.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Abnormal behaviour, Anaemia, Full blood count abnormal, Lethargy, Pyrexia
Clinical narrative: Rash on legs, fever 103.5, lethargic and not acting normal.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash on legs, fever 103.5, lethargic and not acting normal.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Significant swelling and redness of leg in which DTAP was given. Area of swelling was the lateral aspect of the leg, from hip to knee. Swelling and redness persisted for 4 days.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Area was painful and then in morning noted to have redness and warmth. This cont to worse through the weekend until it extended to elbow. Started taking BENADRYL, today there is improvement.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: The Medical Assistant went to give the vaccine and the child kicked  and only half the vaccine was given.  The MA states she cleaned the needle with an alcohol wipe and cleansed the child's skin with a fresh alcohol wipe and injected the rest of the vaccine.
Sex: M
Vaccine: HEPA
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of a 72 year old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. In APR-2017 (reported as approximately 10 days ago) the patient was vaccinated with VAQTA (lot number and expiration not reported) via left arm. In May 2017, the patient experienced ""muscle aches and pain" in left arm at the site where he had received VAQTA. No further information was provided. The outcome of muscle aches and pain at the site he received vaccine is unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Periarthritis
Clinical narrative: Information was received from a pharmacist via a company representative concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The pharmacist reported that the patient came into the pharmacy to pick up an unspecified prescription and stated that in early May 2017 (reported as "within the last week"), she was vaccinated with the PNEUMOVAX 23 (lot number, dosage, and route of administration not provided) during an office appointment with her physician, for the prevention of pneumonia. It was reported that the patient was now experiencing a "frozen shoulder which she finds difficulty in moving" (exact onset date not provided). It was unknown if the patient contacted her doctor's office. The pharmacist reported that it "looks like it was administered at the top of her arm and not in the muscle." The outcome of the events is unknown. No further information was provided. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received from a registered nurse concerning a 16 year old patient of unknown gender. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was administered one dose of PROQUAD (lot # M021428, expiration date 29-OCT-2017) (route of administration not provided), reconstituted with sterile diluent (MSD) (lot number and expiration date unknown) at 16 years of age, which is outside the prescribing information. No adverse effects reported. No further information provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information was received from a medical assistant concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 16-MAY-2017, the patient inadvertently received a second dose of ZOSTAVAX (lot #M024700, expiration date 18-JUL-2017) (route of administration not provided), reconstituted with sterile diluent (MSD), after receiving the first dose of ZOSTAVAX in July 2016. No adverse effects reported. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date in April 2017, the patients were vaccinated with improperly stored doses of M-M-R II lot # M035935 with expiration date: 09-AUG-2018, as prophylaxis (Strength, dose and route were not reported), which experienced a temperature excursion of 12.7 Celsius degrees for 2 hours and 15 minutes. There were no previous temperature excursions reported. Data logger was involved. No symptoms were reported. The patients' concomitant therapies included properly stored sterile diluent (manufacturer unknown). This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA006461: US-009507513-1705USA014915.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information had been received on 26-MAY-2017 from a lawyer regarding a case in litigation. The patient's medical history, concurrent conditions and concomitant medication were not provided. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX (dose, route, site of administration, lot # and expiration date were not provided) on or about 03-MAR-2014 at a health care facility, as recommended for routine adult health maintenance for the prevention of shingles. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 13-SEP-2016, the male patient was treated in the emergency department (ED) of a health care system for a vesicular outbreak that was diagnosed as severe shingles. On or about 22-SEP-2016 the male patient was treated by a certified nurse practitioner, at the Hospital for ongoing and worsening symptoms of shingles outbreaks. The male patient was prescribed valcyclovir (as reported) for management of his painful symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Erythema, Fatigue, Joint range of motion decreased, Myalgia
Clinical narrative: Initial unsolicited report received from a consumer on 22-May-2017. This case involves 44 year-old female patient who was vaccinated with dose of ADACEL (Batch number, expiration date, dose, dose in series, were not reported) intramuscularly in right deltoid on 12-May-2017. Medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was allergic to iodine. No Illness at the time of vaccination. Any other vaccinations within four weeks of vaccinations were not reported. On 12-May-2017, four to five hours following vaccination patient developed throat swelling, hives widespread over the body which were red, itchy and blotchy, right arm became very sore and she had difficulty with ROM. On an unknown date following vaccination patient nausea, diarrhea, and she feels exhausted. Patient still had soreness in the right arm, the muscle is tender to touch, hives are coming and going and are red, itchy and blotchy. On 12-May-2017, patient required emergency room and doctor visit. Laboratory investigations were not reported. Corrective treatment included BENADRYL, CORTIZONE, PREDNISONE and antibiotics. Outcome of all the events were not recovered. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain in extremity, Pharyngeal oedema, Pruritus, Rash macular
Clinical narrative: Initial unsolicited report received from a consumer on 22-May-2017. This case involves 44 year-old female patient who was vaccinated with dose of ADACEL (Batch number, expiration date, dose, dose in series, were not reported) intramuscularly in right deltoid on 12-May-2017. Medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was allergic to iodine. No Illness at the time of vaccination. Any other vaccinations within four weeks of vaccinations were not reported. On 12-May-2017, four to five hours following vaccination patient developed throat swelling, hives widespread over the body which were red, itchy and blotchy, right arm became very sore and she had difficulty with ROM. On an unknown date following vaccination patient nausea, diarrhea, and she feels exhausted. Patient still had soreness in the right arm, the muscle is tender to touch, hives are coming and going and are red, itchy and blotchy. On 12-May-2017, patient required emergency room and doctor visit. Laboratory investigations were not reported. Corrective treatment included BENADRYL, CORTIZONE, PREDNISONE and antibiotics. Outcome of all the events were not recovered. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Initial unsolicited report received from a consumer on 22-May-2017. This case involves 44 year-old female patient who was vaccinated with dose of ADACEL (Batch number, expiration date, dose, dose in series, were not reported) intramuscularly in right deltoid on 12-May-2017. Medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was allergic to iodine. No Illness at the time of vaccination. Any other vaccinations within four weeks of vaccinations were not reported. On 12-May-2017, four to five hours following vaccination patient developed throat swelling, hives widespread over the body which were red, itchy and blotchy, right arm became very sore and she had difficulty with ROM. On an unknown date following vaccination patient nausea, diarrhea, and she feels exhausted. Patient still had soreness in the right arm, the muscle is tender to touch, hives are coming and going and are red, itchy and blotchy. On 12-May-2017, patient required emergency room and doctor visit. Laboratory investigations were not reported. Corrective treatment included BENADRYL, CORTIZONE, PREDNISONE and antibiotics. Outcome of all the events were not recovered. Documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: Persistent 8x4 inch bruise around area of the injection site. Seen by PCP on 5/31/2017 to report.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Immediate post-injection reaction, Skin reaction, Urticaria
Clinical narrative: Immediate skin reaction; erythema with hives on shoulder and arm.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: Redness at injection site. Swelling to the area. Pain. Swelling in the lymph nodes.
Age: 1.33
Sex: M
Vaccine: DTAP, MMR
Symptoms: Eye movement disorder
Clinical narrative: Had unusual movements of both eyes: at times both eyes moving downwards or upwards together at the same time; at times one eye is looking straight and the other eye turns in. Each episode lasting 5 to 10 seconds. For the first 24 hours--> happened 10 times; then in the following 2 days--> happened 6 times in a day.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Pts mother calling ER stating that she "is worried patient is having an  allergic reaction to the PNEUMOVAX injection he got on Friday." Pts arm is sore, swollen, painful to move per mother, pt able to raise both arms above head, temp 100.4 at this time, mother has been alternating tylenol and ibuprofen, highest temp 104 yesterday. This author placed caller on hold to look up chart, two identifiers used, and caller hung up, plans to see health aide tomorrow.
Age: 7.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Decreased eye contact, Disturbance in attention, Hallucination, visual, Muscle twitching, Speech disorder
Clinical narrative: Father reports several hours after receiving vaccines, child began having uncontrolled twitching to extremities intermittently over several hours in addition to comprehensible but speech unrelated to topic of discussion, altered attention, lack of eye contact and hallucination of white hallway. Symptoms reportedly continued through morning and mid-day after vaccines. No loss of consciousness noted. Symptoms resolved by afternoon of following day.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Fatigue, Headache, Injection site pain
Clinical narrative: Pain at injection site started night of injection (5/30/2017) but fatigue, tightness in chest, and headache occurred the following day approximately 24 hours after administration.
Age: 1.33
Sex: M
Vaccine: DTAP, MMR
Symptoms: Audiogram, Cochlea implant, Deafness neurosensory, Hearing aid user, Otoscopy
Clinical narrative: Severe-to-profound sensorineural hearing loss-right ear cochlear implant and left ear hearing aid.
Age: 1.33
Sex: M
Vaccine: DTAP, MMR
Symptoms: Tympanometry
Clinical narrative: Severe-to-profound sensorineural hearing loss-right ear cochlear implant and left ear hearing aid.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Feeling cold, Haematemesis, Musculoskeletal stiffness, Myalgia
Clinical narrative: Within approximately 1 1/2 hrs of injection had 1 hr of extreme coldness and shivering before falling asleep. Next am muscles seemed stiff and sore. No temp recorded - next night woke up with bloody emesis x 4. Fine after that.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Crying, Injection site warmth, Pyrexia, Tremor
Clinical narrative: Patient states she developed a warm feeling over injection site traveling to her left neck. She started crying, shivering and shaking uncontrollably in bilateral upper and lower extremities. She had no fever at this time but developed a fever soon after.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Arthralgia, Bone pain, Myalgia, Pain, Pyrexia
Clinical narrative: Fever, joint aches, muscle aches. I was paged by mom today at 1230 hrs on this weekend Saturday, d/t low grade fever and whole body aches in patient today that made him leave graduation early. Mom was asking if these symptoms were anything to worry about. I told her the low grade fever was within normal limits for yesterday's MENACTRA and Tdap boosters but the body aches were not. Update: Though bone/joint and muscle aches have been described in post-marketing reports, which I found after I got off the phone w/mom, so see below: I called mom back at 1318 hrs: she had spoken w/patient who confirmed no friends or school reports of Influenza the last 10 days of school. Therefore, I retracted my earlier advice to send him to the Immediate Care for a flu test. Instead, I recommended ALEVE three times daily today then two times daily w/meals for 2-3 more days and phone a progress report on Tues, 5/30. If symptoms resolve within 48 hrs more, I'll call it in to the VAERS as likely an adverse RX to MENACTRA since onset myalgias w/low grade fever within 24 hrs of booster.
Age: 76.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Muscle disorder, Pain
Clinical narrative: Muscle distress in left arm and shoulder, down to wrist. Achy all over my body.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Inappropriate age vaccine given. Client 2 yrs. Received FLUZONE 0.5 ml instead of FLUZONE 0.25ml. No adverse effects noted.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Pyrexia, Skin lesion, Varicella post vaccine
Clinical narrative: Given VZV vaccine 5/24/17. Pt with varicella 5 days later (fever and lesions).
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Gave inj in (L) Deltoid. Pt/Mom left office approximately 10 mins after inj. Front desk employee came back stating Pt. fainted in elevator. She was given water and PEDIALYTE. Physician stayed with pt/Mom until she was feeling better. BP checked. Also, Pt. hadn't eaten since 10:00a that day.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Deltoid area swelling with pain.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: 2 x 3" painful rash on inside Left arm. Injection site was (R) arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Local reaction, Rash erythematous
Clinical narrative: Minimal local reaction 2.5 erythematous patch on R thigh.
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient behind on vaccines was reviewing his sisters vaccine to see how mom like to give the vaccines. I thought I was back in his chart and gave him MMR and Varicella and he wasn't due yet for them. Called health dept and informed them. Lady there said that he should be ok. May have fever in 2-3 wks but will need to be revaccinated. Mom called also.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Redness, itchy, welt.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Oxygen saturation decreased, Pallor
Clinical narrative: Pt stood to leave and loss consciousness, caught by nurse and lowered to floor, legs elevated. Pt regained consciousness, oriented x3, diaphoretic, pale. Admits to not having anything to eat since breakfast. Cool compress applied BP lying 112/64, HR 67, SaO2 97% RA. Moved from floor to chair in Trendelenburg BP 108/71, HR79 SaO2 97% RA, Sprite given. After 5 mins placed in sitting position BP 111/67 HR64, SaO2 98%, PulseOx Dc'd. BP standing 102/66, HR 76, Pt lightheaded returned to sitting. Reattempted standing after 5 mins BP 114/76 HR82, denies dizziness. Discharged with Boyfriend ambulatory to home with instruction to eat and f/u with PCP if problems.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mild swelling and redness (L) lat thigh Hib, MMR.
Age: 1.58
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Tdap was administered at the age of 19 months instead of Dtap.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Flushing
Clinical narrative: Immediately after receiving the 4 vaccines. Pt had a marked flushing of skin at the side of some existing eczema. This resolved over 5 min and pt was normal after. No treatment needed.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Erythema, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: My arm was red from my shoulder to my elbow and very hot. My arm was also swollen. I had a headache and was not hungry for dinner. My arm was very sore for 3 days.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: My arm was red from my shoulder to my elbow and very hot. My arm was also swollen. I had a headache and was not hungry for dinner. My arm was very sore for 3 days.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Ear infection, Erythema multiforme, Rash generalised, Urticaria
Clinical narrative: Pt. given vaccines on 5/12/17 and put on amoxicillin for ear infection, that same day, returned to office on 5/21/17 with hive like rash all over body. Returned again to office on 5/22/17 with hive like rash getting worse given Dx of Erythema Multiforme.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: 5/19/17 pt was seen at emergency dept. Dx'd with pneumonia. Prescribed LEVAQUIN x10days.
Age: 41.0
Sex: F
Vaccine: MNQ
Symptoms: Hyperhidrosis, Injection site erythema, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: Swelling mild at site of injection, day 2 afterward the site appeared a red whelp, soreness several days, a knot or hard bump at injection site - still there. Sensation of fever some days after, sweats.
Age: 41.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site reaction, Injection site swelling, Pyrexia, Urticaria
Clinical narrative: Swelling mild at site of injection, day 2 afterward the site appeared a red whelp, soreness several days, a knot or hard bump at injection site - still there. Sensation of fever some days after, sweats.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Pain, Urticaria
Clinical narrative: Hives and/or large welts (approx. 2" x 2") on my shoulder and arm pit area - 7 of them. The first appeared about 6 hours after the shot then they appeared approx. every 8 - 12 hours for the next 3 days. Very sore! I have been given 3 pneumonia shots in the past 2 1/2 years and feel this might be the reason for the reaction.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Contusion, Ear infection, Erythema multiforme, Influenza virus test positive, Otitis media acute
Clinical narrative: Pt given vaccines on 5/1/17. Pt returned on 5/10/17 and Dx with acute supportive otitis media and started amoxicillin.  Pt returned on 5/17/17 with a rash that appeared to be viral-stopped Amoxicillin. Pt returned on 5/18/17 with large bluish, eryth spots Dx with Erythema-multiform and started TAMIFLU due to a POS Flu test. Pt has been rash free since 5/22/17 reported by mom.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash erythematous, Viral rash
Clinical narrative: Pt given vaccines on 5/1/17. Pt returned on 5/10/17 and Dx with acute supportive otitis media and started amoxicillin.  Pt returned on 5/17/17 with a rash that appeared to be viral-stopped Amoxicillin. Pt returned on 5/18/17 with large bluish, eryth spots Dx with Erythema-multiform and started TAMIFLU due to a POS Flu test. Pt has been rash free since 5/22/17 reported by mom.