chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR, HEP, HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 25-APR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, 0.5 ml lot # L0026553, expiration date 16-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). Digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information had been requested.
Sex: U
Vaccine: MMR, HEP, HEP
Symptoms: Blood test, Burning sensation, Electromyogram, Hypoaesthesia, Neuropathy peripheral
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 25-APR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, 0.5 ml lot # L0026553, expiration date 16-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). Digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information had been requested.
Sex: U
Vaccine: MMR, HEP, HEP
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 25-APR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, 0.5 ml lot # L0026553, expiration date 16-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). Digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information had been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 07-JUN-2016, the patient was vaccinated with improperly stored dose of M-M-R II 0.5 ml injection, lot# L032181, expiry date: 25-AUG-2017 (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. 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 registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 05-MAY-2016, the patient was vaccinated with an improperly stored dose M-M-R II injection, 0.5 ml lot # L026553, expiration date 16-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). Digital data logger was involved. No adverse symptoms. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an immunization coordinator referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX Lot#: L012034, expiration date on 07-APR-2017, lot#: L012035, expiration date on 04-JUL-2017, lot#: L012036, expiration date on 07-APR-2017, lot#: L013063, expiration date on 14-APR-2017, lot#: L013064, expiration date on 14-APR-2017, lot#: L032395, expiration date on 26-AUG-2017, lot#: M004328, expiration date on 26-JAN-2018, lot#: K015944, expiration date on 23-SEP-2016 and lot#: L048465, expiration date on 02-DEC-2017 (strength, dose number, route of administration and anatomical location were not provided). No adverse events were reported. Administered doses of vaccines experienced the temperature excursion of 6 degrees Fahrenheit for 30 minutes. Data logger was involved. There were previous excursions reported as 13.1 degrees Fahrenheit for 3 hours 10 minutes and 7 degrees Fahrenheit for 2 hours, 50 minutes. It was reported total cumulative time out of range 6 hours 30 minutes. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an immunization coordinator referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with the improperly stored doses of PROQUAD lot#: M006106, expiration date on 01-AUG-2016 (strength, dose number, route of administration and anatomical location were not provided). No adverse events were reported. Administered doses of vaccines experienced the temperature excursion of 6 degrees Fahrenheit for 30 minutes. Data logger was involved. There were previous excursions reported as 13.1 degrees Fahrenheit for 3 hours 10 minutes and 7 degrees Fahrenheit for 2 hours, 50 minutes. It was reported total cumulative time out of range 6 hours 30 minutes. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 14-JUL-2016, the patient was vaccinated with an expired dose of ROTATEQ orally, lot # L000569, expiration date on 13-JUL-2016 (strength, dose number and anatomical location were not provided). Concomitant therapies were not provided. No adverse event reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The concurrent condition, medical history and concomitant therapy were not provided. On 12-JUL-2016 the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017, dose and route were not reported). No adverse effects were reported. The vaccines had been stored under temperature of 1 degree Celsius for 48 hours. There were no previous temperature excursion and data logger involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were unspecified. Approximately in July 2013 (reported as "3 years ago"), the patient was vaccinated with first dose of ZOSTAVAX 19400 PFU subcutaneously (dose, vaccination site, lot # not provided). On 13-JUL-2016, the patient was vaccinated with second dose of ZOSTAVAX 19400 PFU (dose, vaccination site, route lot # not provided). No adverse effects were reported. The patient sought medical attention and called pharmacy. The patient was advised after the second vaccine was given. Product quality complaint (PQC) was not involved. Additional information is not expected since there was no consent to contact the reporter.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Rash, heat, and swelling at injection site (right deltoid) and around arm, patient was treated by a physician for reaction-physician stated it looked like an allergic reactions and not an injection site reaction.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Had the shingles vaccine on 27 June and by the next day started having severe joint pain in my thumbs that still continues as of today. Had not had this pain before the vaccine at all.
Age: 1.53
Sex: M
Vaccine: HEPA
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: 3 days after vaccine, high fever and febrile seizure, V/P, VAQATA, HepA #2
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Vaccines given on Monday, July 18, 4:48pm. Next day felt "yucky". Tuesday evening arm red, painful, swollen. Wed pm LA much more swollen, red, hot, only painful when pressed on. Seen in office today, July 21, 2016, "much less red and swollen,",  per mother. Redness (L) arm measures 13.5cmx 11cm with induration
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. The patient's medical history and concurrent condition was not reported. On 16-OCT-2013 the patient was vaccinated with the first dose of GARDASIL (route, lot # and expiration date were not reported). The patient's second dose of GARDASIL (route, lot # and expiration date were not reported) was given on 26-OCT-2014, followed by her third dose of GARDASIL (lot # M014929, expiration date 27-MAY-2017, route not reported on 12-JUL-2106. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2016, 3 doses of improperly stored RECOMBIVAX HB lot# L048236 with expiration date: 31-MAR-2018 and 1 dose of improperly stored RECOMBIVAX HB lot# L044694 with expiration date: 04-FEB-2018 (dose and route of administration were not reported) were administered to the patients. Administered doses of RECOMBIVAX HB underwent temperature excursions at 49.5 Fahrenheit degrees for 1 hour. Data logger was not involved. Product quality complaint (PQC) was not involved. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2016, 2 doses of improperly stored M-M-R II lot# reported as L043703 with expiration date: 03-NOV-2017 and 1 dose of improperly stored M-M-R II lot# L032182 with expiration date: 25-AUG-2017 (dose and route of administration were not reported) were administered to the patients. Administered doses of M-M-R II underwent temperature excursions at 49.5 Fahrenheit degrees for 1 hour. Data logger was not involved. Product quality complaint (PQC) was not involved. No adverse symptoms were reported. This is one of several reports received from the same source. 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 registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 20-MAY-2016, the patient was vaccinated with improperly stored dose of M-M-R II injection, 0.5 ml lot # L026553, expiration date 16-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). Digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEP, MENB
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered medical assistant referring to a 20 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On 08-JUL-2016, the patient inadvertently administered a pediatric dose of RECOMBIVAX HB (lot # M000442 with expiry date 31-MAR-2016, intramuscular). No adverse effect was reported. 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 registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 06-MAY-2016, the patient was vaccinated with improperly stored dose of M-M-R II injection, 0.5 ml lot # L026553, expiration date 16-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). Digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2016, 2 doses of improperly stored GARDASIL 9 lot# M005714 with expiration date: 03-MAR-2017 and 1 dose of improperly stored GARDASIL 9 lot# L020015 with expiration date: 16-AUG-2017 (dose and route of administration were not reported) were administered to the patients. Administered doses of GARDASIL 9 underwent temperature excursions at 49.5 Fahrenheit degrees for 1 hour. Data logger was not involved. Product quality complaint (PQC) was not involved. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified 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 20-JUN-2016, 7 doses of improperly stored VAQTA, lot # M011116 with expiration date: 17-JUN-2017 and 1 dose of improperly stored VAQTA lot# L048456 with expiration date: 25-MAY-2017 (dose and route of administration were not reported) were administered to the patients. Administered doses of VAQTA underwent temperature excursions at 49.5 Fahrenheit degrees for 1 hour. Data logger was not involved. Product quality complaint (PQC) was not involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a 52 year old male patient reporting on himself. Medical history and concurrent conditions were not reported. In November 2014 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous. Dose, frequency, lot number and expiration date were not provided. No other suspect or concomitant therapy was reported. The patient stated that since that time he had experienced intermittent bouts of rashes on his back, legs, back of legs that appears and then disappears. The outcome of rash was unknown. The causality between the therapy with ZOSTAVAX and the event was unknown. 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 registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 03-JUN-2016, the patient was vaccinated with improperly stored doses of M-M-R II 0.5 ml injection, lot# L032181, expiry date: 25-AUG-2017 (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea, Feeling hot, Paraesthesia
Clinical narrative: Hot prickly feeling accompanied with dizziness. (initially) Experienced difficulty breathing while driving and went to ER.
Age: 27.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: Redness, tenderness, raised, itching with in 24 hours.
Age: 49.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, tenderness to injection site. Evaluated by provider 7/21 recommend ice to area, monitor for improvement, RTC, if any concerns/no improvement in 5 days.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Computerised tomogram head normal, Electrocardiogram normal, Head injury, Seizure, Syncope
Clinical narrative: After receiving vaccines listed below, 15 minutes after, Patient had syncopal episode, hit back of head on wall and had seizure activity.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: HPV injection approximately 10:30 am 7/20. 9 pm 7/20 fever, and chills; called and spoke with on-call MD, advised ibuprofen 400 mg every 608 hrs. Had intermittent HA, otherwise no localized pain. No rashes. Continue ibuprofen every 6-8 hrs.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Large local reaction, redness, swelling at injection location on right deltoid.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient states a couple of hours after receiving the PNEUMOVAX 23 vaccine, her left upper arm became painful, swollen and warm to the touch from the injection site down to her elbow.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Insomnia, Malaise, Pallor, Pyrexia
Clinical narrative: Patient could not sleep at all the first night after he received vaccine. Then the next day developed low grade fever, slept all day, was pale and generally felt sick.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Meningism, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Initial unsolicited report received from a Physician via other company (Pfizer) (Manufacturer report number 2016208994) on 17 June 2016. This case involves a 16 years old female patient who was vaccinated with a intramuscular second dose of MENACTRA (batch number M15066, expiration date 30 September 2016) in arm and intramuscular 0.5 ml single injection of TRUMENBA (batch number M37314, expiration date 17 April 2016) in left arm on 25 March 2016. The patient's medical history and concomitant medications were not reported. On 25 March 2016, same day following vaccination, patient had bad reaction, fever, stiff neck and other meningitis type symptoms and was diagnosed with a meningitis-like reaction to the immunizations. On 25 March 2016, patient went to emergency room and doctor visit. It was reported that patient had received MENACTRA at 11 or 12 year without a problem. Lab data was not reported. The patient did not receive any corrective treatment. On an unspecified date, the patient was recovered from events. Upon internal review the case was considered as serious because of important medical event: Other meningitis like symptoms. The reporter assessed the causal relationship as possible. List of documents held by sender: none. Sender's Comments: In this case, the reported symptoms are consistent with Meningitis-like reaction. The time to event onset post vaccination is not provided. Reportedly on previous exposure to the meningococcal vaccine, patient did not experience any adverse reaction. Further information regarding the evolution of symptoms, complementary investigation results including CSF findings, neuroimaging results as well as infectious serologies are needed to further assess the case. Based on available information, the role of vaccine cannot be assessed. Moreover, as two vaccines were administered concomitantly, the role of each component cannot be assessed separately.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Meningism, Musculoskeletal stiffness, Pyrexia, Vaccination complication
Clinical narrative: Initial unsolicited report received from a Physician via other company (Pfizer) (Manufacturer report number 2016208994) on 17 June 2016. This case involves a 16 years old female patient who was vaccinated with a intramuscular second dose of MENACTRA (batch number M15066, expiration date 30 September 2016) in arm and intramuscular 0.5 ml single injection of TRUMENBA (batch number M37314, expiration date 17 April 2016) in left arm on 25 March 2016. The patient's medical history and concomitant medications were not reported. On 25 March 2016, same day following vaccination, patient had bad reaction, fever, stiff neck and other meningitis type symptoms and was diagnosed with a meningitis-like reaction to the immunizations. On 25 March 2016, patient went to emergency room and doctor visit. It was reported that patient had received MENACTRA at 11 or 12 year without a problem. Lab data was not reported. The patient did not receive any corrective treatment. On an unspecified date, the patient was recovered from events. Upon internal review the case was considered as serious because of important medical event: Other meningitis like symptoms. The reporter assessed the causal relationship as possible. List of documents held by sender: none. Sender's Comments: In this case, the reported symptoms are consistent with Meningitis-like reaction. The time to event onset post vaccination is not provided. Reportedly on previous exposure to the meningococcal vaccine, patient did not experience any adverse reaction. Further information regarding the evolution of symptoms, complementary investigation results including CSF findings, neuroimaging results as well as infectious serologies are needed to further assess the case. Based on available information, the role of vaccine cannot be assessed. Moreover, as two vaccines were administered concomitantly, the role of each component cannot be assessed separately.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 79 year old female patient with multiple unspecified chronic conditions. In approximately July 2009, the patient was vaccinated with 1 dose of ZOSTAVAX (lot # and route were not provided). The patient sought medical attention by going into the physician's office on 19-MAY-2016 with a "vesicular patch in the lower lumbar area" and was diagnosed with a case of shingles. The patient was given a course of treatment with VALTREX. The physician had not heard from the patient since the office visit. No product quality complain was involved. The outcome of the event of herpes zoster was unknown. The relatedness between the event of herpes zoster and ZOSTAVAX was not reported. Follow-up information has been received from physician on 19-JUL-2016 concerning a female patient with a history of chickenpox when she was 10 years old. The reporter stated that the vaccine was administered on an unknown date in July 2009 (when the patient was 72 years old), on an unknown anatomical location on the left side and did not present rash at the injection site within 42 days of vaccination. Additionally, it was reported that, on an unknown date, the patient experienced renal insufficiency. Furthermore, on 18-MAY-2016, the patient experienced shingles and on 19-MAY-2016, when the patient sought medical attention, she had 7 lesions with a diameter of 5 centimeters (cm) located in the low lumbar spine, reported as L5; in addition, the patient presented a maximum temperature of 102 degrees (units not provided) and reported a pain of 7 in a 0-10 scale. It was reported that the treatment with VALTREX was with a low dose due to the renal failure. At the time of reporting, the outcome of the event of herpes zoster was recovered on an unknown date in 2016; moreover, the outcome of the event of renal failure was unknown. The causality between ZOSTAVAX and renal failure was not assessed. Upon internal review, the event of renal failure was considered medically significant. Additional information is not expected as all schedule correspondence was received. Reporter information, patient information, product information, event information and narrative were updated.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Herpes zoster, Pain, Rash vesicular, Renal failure
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 79 year old female patient with multiple unspecified chronic conditions. In approximately July 2009, the patient was vaccinated with 1 dose of ZOSTAVAX (lot # and route were not provided). The patient sought medical attention by going into the physician's office on 19-MAY-2016 with a "vesicular patch in the lower lumbar area" and was diagnosed with a case of shingles. The patient was given a course of treatment with VALTREX. The physician had not heard from the patient since the office visit. No product quality complain was involved. The outcome of the event of herpes zoster was unknown. The relatedness between the event of herpes zoster and ZOSTAVAX was not reported. Follow-up information has been received from physician on 19-JUL-2016 concerning a female patient with a history of chickenpox when she was 10 years old. The reporter stated that the vaccine was administered on an unknown date in July 2009 (when the patient was 72 years old), on an unknown anatomical location on the left side and did not present rash at the injection site within 42 days of vaccination. Additionally, it was reported that, on an unknown date, the patient experienced renal insufficiency. Furthermore, on 18-MAY-2016, the patient experienced shingles and on 19-MAY-2016, when the patient sought medical attention, she had 7 lesions with a diameter of 5 centimeters (cm) located in the low lumbar spine, reported as L5; in addition, the patient presented a maximum temperature of 102 degrees (units not provided) and reported a pain of 7 in a 0-10 scale. It was reported that the treatment with VALTREX was with a low dose due to the renal failure. At the time of reporting, the outcome of the event of herpes zoster was recovered on an unknown date in 2016; moreover, the outcome of the event of renal failure was unknown. The causality between ZOSTAVAX and renal failure was not assessed. Upon internal review, the event of renal failure was considered medically significant. Additional information is not expected as all schedule correspondence was received. Reporter information, patient information, product information, event information and narrative were updated.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin lesion
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 79 year old female patient with multiple unspecified chronic conditions. In approximately July 2009, the patient was vaccinated with 1 dose of ZOSTAVAX (lot # and route were not provided). The patient sought medical attention by going into the physician's office on 19-MAY-2016 with a "vesicular patch in the lower lumbar area" and was diagnosed with a case of shingles. The patient was given a course of treatment with VALTREX. The physician had not heard from the patient since the office visit. No product quality complain was involved. The outcome of the event of herpes zoster was unknown. The relatedness between the event of herpes zoster and ZOSTAVAX was not reported. Follow-up information has been received from physician on 19-JUL-2016 concerning a female patient with a history of chickenpox when she was 10 years old. The reporter stated that the vaccine was administered on an unknown date in July 2009 (when the patient was 72 years old), on an unknown anatomical location on the left side and did not present rash at the injection site within 42 days of vaccination. Additionally, it was reported that, on an unknown date, the patient experienced renal insufficiency. Furthermore, on 18-MAY-2016, the patient experienced shingles and on 19-MAY-2016, when the patient sought medical attention, she had 7 lesions with a diameter of 5 centimeters (cm) located in the low lumbar spine, reported as L5; in addition, the patient presented a maximum temperature of 102 degrees (units not provided) and reported a pain of 7 in a 0-10 scale. It was reported that the treatment with VALTREX was with a low dose due to the renal failure. At the time of reporting, the outcome of the event of herpes zoster was recovered on an unknown date in 2016; moreover, the outcome of the event of renal failure was unknown. The causality between ZOSTAVAX and renal failure was not assessed. Upon internal review, the event of renal failure was considered medically significant. Additional information is not expected as all schedule correspondence was received. Reporter information, patient information, product information, event information and narrative were updated.
Age: 53.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Information has been received from a pharmacist referring to a 53 years old female patient. The patient's had no known drug reactions/allergies. On 10-JUL-2016 the patient was admitted to a hospital because of "heart failure exacerbation". On 11-JUL-2016 the patient was administered her first and only dose of PNEUMOVAX23 (0.5 ml, lot # and expiration date not reported) subcutaneously for heart failure exacerbation. The patient also had unspecified concomitant medications. In the evening of 11-JUL-2016, the patient's arm "swelled up and was really red". The physician said the symptoms looked like cellulitis. The patient sought medical attention via speaking with physician during the phone call. No laboratory test was performed. The patient received unspecified treatment. The outcome of the event was reported as resolving. The patient might be discharged later on 15-JUL-2016 with antibiotics. Upon internal review, the event of cellulitis was considered to be medically significant. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Fatigue, Migraine, Mobility decreased, Pain
Clinical narrative: Vomiting, diarrhea, migraine, fatigue, deep pain that continues to get worse every day and arm is not functional. Have been using Tylenol, heat & ice as directed. No relief.
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: Vomiting, diarrhea, migraine, fatigue, deep pain that continues to get worse every day and arm is not functional. Have been using Tylenol, heat & ice as directed. No relief.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received via a field representative from a physician assistant referring to two patients of unknown age and gender. On unknown dates, the patients were vaccinated with GARDASIL (route, dose, strength were unknown). The two patients experienced syncope while on GARDASIL. They sought unknown medical attention. The outcome of syncope was reported as recovered. The causality was not provided. Additional information has been requested.
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 patient's concurrent conditions and medical history were not provided. On unknown dates, the patient were vaccinated with improperly stored doses of ROTATEQ (dose, route, site of administration and lot# not reported). Concomitant medication was not mentioned. The reporter further informed that the vaccine was exposed to a temperature of 47F for 20 hours. No adverse effects were reported. No further information was available. Product quality complaint was not filed. Additional information has been requested. This is one of the two reports received from the same reporter.
Sex: U
Vaccine: HIBV
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' concurrent conditions and medical  history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (of lot # L035880. expiry date: 11-AUG-2018; dose 0.5 ml, subcutaneously). Concomitant medication was not mentioned. The reporter further informed that the vaccine was exposed to a temperature of 47F for 20 hours. No adverse effects were reported. No further information was available. Product quality complaint was not filed. Additional information has been requested. This is one of the two reports received from the same reporter.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Injection site bruising
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 years old male patient. The patient's medical history and concurrent conditions were not reported. On 29-JUN-2016, the patient was vaccinated with ZOSTAVAX, subcutaneously (left bicep). On 05-JUL-2016, the patient experienced bruises on his abdomen and bruises on the left bicep at the injection site. The patient sought medical attention but no treatment was given for the events. The outcome and causality of the events were unknown. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Musculoskeletal stiffness, Pyrexia, Staphylococcal infection
Clinical narrative: Initial unsolicited report received from a Pharmacist on 14 July 2016. This case involves a 40-year-old female patient who was vaccinated with a intramuscular dose of ADACEL (batch number U5318AA, expiration date 28 April 2018, dose was not reported) in right deltoid on 08 July 2016. The patient had no illness at time of vaccination, Pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications were not reported. On 10 July 2016, two days following vaccination, patient experienced a quarter size, red area at injection site on right deltoid. On 11 July 2016, three days following vaccination, patient had red area increased and was red from elbow up to around injection site, was sore, stiff, and had fever. On an unspecified date, following vaccination patient was diagnosed with "Staph". Patient did see physician. Patient required emergency room or doctor visit. Lab data was not reported. The patient received corrective treatment with antibiotic. The patient was not recovered from red area of arm and soreness. Outcome of other events was not reported. Upon internal review the case was considered as serious because of important medical event: staph, red area increased and was now red from elbow up to and around injection site, was sore, stiff, quarter size, red area at injection site\red area increased and was now red from elbow up to and around injection site, was sore, stiff, fever. List of documents held by sender: none.; Sender's Comments: Patient had staphylococcal infection, stiffness, fever, localized pain and erythema following DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Time to onset is compatible, detail history regarding the aseptic technique, medical history, allergic history, past vaccination history and its tolerance are needed to further assess the case. Based on the available information role of vaccine cannot be ruled out.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Pain, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Entire back of arm where vaccine was administered SQ was swollen, red, warm and painful to touch. She also described significant pain/possible "nerve" pain in using the arm. She was advised to use take OTC NSAIDS and apply ice and if got worse throughout the day, go to the doctor. She took Naproxen and used ice and went to the urgent care facility around 5 pm on 7/19/16, where she was given a steroid injection and told to return if it spreads beyond the margin drawn or gets significantly worse. I followed up with her on 7/21/16 and the redness and swelling and pain had diminished but was not completely gone yet.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Entire back of arm where vaccine was administered SQ was swollen, red, warm and painful to touch. She also described significant pain/possible "nerve" pain in using the arm. She was advised to use take OTC NSAIDS and apply ice and if got worse throughout the day, go to the doctor. She took Naproxen and used ice and went to the urgent care facility around 5 pm on 7/19/16, where she was given a steroid injection and told to return if it spreads beyond the margin drawn or gets significantly worse. I followed up with her on 7/21/16 and the redness and swelling and pain had diminished but was not completely gone yet.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Asthenia, Computerised tomogram, Cranial nerve disorder, Dizziness, Dysarthria
Clinical narrative: After vaccination pt went to sit by Mom in waiting room. After about 10 min, pt reports dizziness and nausea. On physician exam, pt was orientated, weakness, cranial nerve deficits, slurred speech, and pupil dilation. Pt was transferred to the ER.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Mydriasis, Nausea
Clinical narrative: After vaccination pt went to sit by Mom in waiting room. After about 10 min, pt reports dizziness and nausea. On physician exam, pt was orientated, weakness, cranial nerve deficits, slurred speech, and pupil dilation. Pt was transferred to the ER.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Cerebrovascular accident
Clinical narrative: After vaccination pt went to sit by Mom in waiting room. After about 10 min, pt reports dizziness and nausea. On physician exam, pt was orientated, weakness, cranial nerve deficits, slurred speech, and pupil dilation. Pt was transferred to the ER.
Sex: F
Vaccine: HPV4
Symptoms: Neuromyelitis optica spectrum disorder
Clinical narrative: This spontaneous report as received from a physician via a company representative and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-AUG-2013, the patient was vaccinated with the first dose of GARDASIL (dose, route and site of administration, lot # and expiration date were not reported). On an unknown date in January 2014 (reported as 5 month after vaccination), the patient was diagnosed with neuromyelitis optica. There was no 2nd or 3rd vaccination administered. The patient sought unspecified medical attention. The outcome of neuromyelitis optica was reported as not recovered/not resolved at the time of the report. The relatedness between the event and GARDASIL was not reported by the physician, however the patient's mother believed it was because of GARDASIL since symptoms began after vaccination. Upon internal review, the event of neuromyelitis optica was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician (specialty: internal medicine) via a company representative referring to a 75 year old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown. In 2008 the patient was vaccinated with ZOSTAVAX (strength, dose, route, lot # and expiration date were not reported). On an unspecified date the patient developed a severe shingles outbreak of the neck and scalp. The patient was hospitalized at an unspecified facility on an unspecified date. The patient was subsequently discharged from the hospital and was recovering at the time of the report. Reporter's causality was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an adult female patient of unknown age. The patient's pertinent medical history and drug reactions/allergies were not reported. On 14-JUL-2016, the patient was vaccinated with one dose of improperly stored PNEUMOVAX23 (lot # L019835 with expiration date 23-MAR-2017, dose and route were not reported. No adverse effects were reported. Additional information is not expected as there was no consent to follow up.
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to an 18 year old female patient with seizures. The patient had a history of anxiety with injections. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (lot #, dose and route were not provided). Concomitant therapies included MENVEO and BEXSERO. Prior to receiving the vaccine, the patient did not eat or drink anything. On an unknown date, the patient passed out after receiving GARDASIL 9. Food and sweet tea were given and after that, the patient recovered from the event. The patient sought unspecified medical attention. The relatedness between the event and GARDASIL 9 was not reported. Upon internal review, the event of loss of consciousness was considered to be medically significant. Additional information is not expected, as the reporter refused any further contact.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cardiac pacemaker insertion, Cardiac stress test, Electrocardiogram, Tachycardia, Tilt table test
Clinical narrative: This spontaneous report as received from a father of the patient via a company representative refers to a 21 year old female patient. Concomitant medication, pertinent medical history, drug reactions and allergies were unknown. The patient was not pregnant. About five years ago, approximately in 2011, the patient was vaccinated with a dose of GARDASIL (dose, route of administration, lot # and expiration date were unknown). The patient was admitted to the hospital either 15-JUL-2016 or 16-JUL-2016, for tachycardia after receiving GARDASIL. A tilt test, an electrocardiography (EKG), and a stress test were performed, but results were not provided. The patient received a pacemaker on 18-JUL-2016. It was confirmed that the patient was vaccinated with GARDASIL and not GARDASIL 9. The outcome of tachycardia was unknown. The relationship between tachycardia and GARDASIL was not reported. The event of tachycardia was considered to be medically significant as required cardiac pacemaker insertion. Additional information has been requested.
Age: 55.0
Sex: U
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Information has been received from a pharmacist via a company representative referring to a diabetic patient of unknown age and gender. The patient's drug reactions/allergies and concomitant medication were unknown. On an unspecified date when the diabetic patient was 55 years old, the patient received a dose of PNEUMOVAX23 (lot #, expiration date, dose and route were not reported). On an unspecified date in April 2016 (reported as 3 months ago), the patient developed pneumonia. The outcome of the event was unknown. Causality was not provided. Upon internal review, pneumonia was considered to be medically significant. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Cervix carcinoma
Clinical narrative: Information has been received from a physician referring to a 24 year old female patient. The patient was not pregnant and had Ewing's sarcoma. On unknown dates (reported as "while she was a teenager") the patient was vaccinated with all three doses of GARDASIL (intramuscular; dose unknown). Concomitant therapy was not provided. On an unknown date in 2016 (reported as recently) the patient was diagnosed with cervical cancer, type 16 and was being treated. The outcome of the event was unknown. The causality was not provided. Upon internal review, cervical cancer was considered to be medically significant. Additional information has been requested.