chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Hemiparesis, Hypoaesthesia, Hypotonia, Incorrect route of drug administration, Muscular weakness
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 51 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with ZOSTAVAX, (unknown dose, strength, lot and expiration) intramuscularly in the left arm. The pharmacist reported that the patient started experiencing numbness, tingling and left sided weakness on an unspecified date, eleven hours after receiving ZOSTAVAX. The pharmacist could not confirm the route of administration however intramuscular route of administration was documented by an unknown source. The pharmacist reported that the patient was hospitalized at an "outside hospital" on an unspecified date and was transferred and hospitalized to other hospital from 14-APR-2016 to 17-APR-2016 to rule out stroke. The pharmacist reported that the patient experienced significant disability as the patient's left arm was flaccid and also stated that the patient was still "complaining of left arm weakness but is improving". The outcome of numbness, tingling, left sided weakness, and stroke was recovering. The causality was not provided by the reporter. The reporter considered the events numbness, tingling, left sided weakness and left arm was flaccid to be serious due to disability. Upon internal review, left sided weakness was determined to be medically significant. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 51 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with ZOSTAVAX, (unknown dose, strength, lot and expiration) intramuscularly in the left arm. The pharmacist reported that the patient started experiencing numbness, tingling and left sided weakness on an unspecified date, eleven hours after receiving ZOSTAVAX. The pharmacist could not confirm the route of administration however intramuscular route of administration was documented by an unknown source. The pharmacist reported that the patient was hospitalized at an "outside hospital" on an unspecified date and was transferred and hospitalized to other hospital from 14-APR-2016 to 17-APR-2016 to rule out stroke. The pharmacist reported that the patient experienced significant disability as the patient's left arm was flaccid and also stated that the patient was still "complaining of left arm weakness but is improving". The outcome of numbness, tingling, left sided weakness, and stroke was recovering. The causality was not provided by the reporter. The reporter considered the events numbness, tingling, left sided weakness and left arm was flaccid to be serious due to disability. Upon internal review, left sided weakness was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: DTAP
Symptoms: Adverse reaction
Clinical narrative: Initial unsolicited report received consumer on 25 March 2015. A patient, whose gender, medical history and concomitant medications were not reported, had received a dose of DAPTACEL (batch number, dose, cycle in series, route of administration, site of administration were not reported) on 02 March 2015. On an unspecified date, after vaccination, the patient experienced Adverse Reaction. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of event was unknown. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This case involves a 11-year-old female patient who was vaccinated with a intramuscular dose of Tdap (batch number, expiration date, dose was not reported) in left deltoid on 02 February 2016. It was reported that reporter denied Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical condition. Concomitant medications were not reported. On 02 February 2016, same day following the vaccination, the patient experienced redness at the injection site, swelling of left hand and pain in the left arm when patient felt tired. Patient required emergency room or doctor visit. Lab data was not reported. It was reported that ibuprofen was prescribed as corrective treatment. Outcome of event was reported as unknown. List of documents held by sender: none.
Age: 1.05
Sex: F
Vaccine: HEP, MMR, MNQ, VARCEL
Symptoms: Fatigue, Irritability, Pyrexia, Rash
Clinical narrative: Fevers reaching 104 degrees for three days in a row, fever subsided and then developed a rash on her forehead, face, neck, back and belly. Rash was raised small bumps.  Rash lasted approximately 24-36  hours.  Still remains extremely tired and fussy. Not at all like her normal self a week later.
Age: 22.0
Sex: F
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Right arm she has swelling the size of a baseball, the area is very red, warm to the touch, and pt reports she is experiencing severe pain.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC13, VARCEL
Symptoms: Injection site reaction, Rash, Rash macular
Clinical narrative: The child begin to break out with bright red blotches on his chest, neck, arms.  He showed no signs of being in distress.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous
Clinical narrative: Red circular rash.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Mom states patient presented with Hives localized to Right arm. No fever.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Left arm pain, limited motion in left shoulder after vaccine.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Electroencephalogram, Seizure
Clinical narrative: P/O seizures - 3 days prior to vaccination. Seizures 24 hr post vaccination.
Age: 63.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Chills, Headache, Injection site pain, Nausea, Pain
Clinical narrative: Patient complains of injection site pain, body aches especially legs, nausea, headache, fever of 100 degrees F and chills.
Age: 63.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient complains of injection site pain, body aches especially legs, nausea, headache, fever of 100 degrees F and chills.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Local reaction, Urticaria
Clinical narrative: Local reaction, patient stated it was like 1 large welt-2-3 cm area around injection site. Site was painful and burned and took a few days to go away.
Age: 1.96
Sex: M
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Nasopharyngitis
Clinical narrative: Mom called and spoke with our triage nurse to report redness and swelling at injection site, was advised to monitor and call back with worsening symptoms. Pt came in the office on 4/21/16 for cold symptoms and still had redness at the site.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-APR-2016, the patient was inadvertently vaccinated with an expired dose of M-M-R II, injection, lot # K005110, expiration date 04-APR-2016 (therapy type, strength, dose, route and site of administration were not reported). No adverse effect was reported. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an adult patient of unknown age and gender. Information about concurrent condition, medical history and concomitant therapy was not reported. On 09-FEB-2016 the patient was inadvertently vaccinated with a pediatric dose of unspecified hepatitis b vaccine (recombinant) (manufacturer unknown, dose 1, lot# reported as ZT59G, expiration date: 14-FEB-2016 and route not reported) (vaccine underdose). Then on 15-MAR-2016, the patient was vaccinated with another dose of RECOMBIVAX HB (dose 2, lot# K023310, expiration date: 15-APR-2017 and route not reported) (interchange of vaccine products). No adverse effect was reported. It was unspecified if the patient sought for medical attention. Lot number ZT59G is an invalid lot number for hepatitis b vaccine (recombinant). 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 medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On unknown dates the patients was vaccinated with improperly stored GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017, dose and route not reported). It was reported that the vaccine was improperly stored at 50 F for 2 hours and 40 minutes and 33.8 F for 1 hour and 20 minutes (totally 4 hours). Digital data logger (DDL) was used to capture this temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected because we are not allowed to contact the physician.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On unknown dates the patients was vaccinated with improperly stored PEDVAX HIB (lot # L035880, expiration date 11-AUG-2018, dose and route not reported). It was reported that the vaccine was improperly stored at 50 F for 2 hours and 40 minutes and 33.8 F for 1 hour and 20 minutes (totally 4 hours). Digital data logger (DDL) was used to capture this temperature excursion. No adverse effects reported. This is one several reports received from the same source. Additional information is not expected because we are not allowed to contact the physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On unknown dates the patients was vaccinated with improperly stored (Merck) VARIVAX (lot # L035124, expiration date 14-SEP-2017, dose and route not reported). It was reported that the vaccine was improperly stored at 15.1 F for 18 hours. Digital data logger (DDL) was used to capture this temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected because we are not allowed to contact the physician.
Sex: U
Vaccine: HPV9
Symptoms: Injection site cellulitis, Pharyngitis streptococcal
Clinical narrative: Information has been received from a physician via a company representative referring to a patient of unknown age. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patient was vaccinated with the first and second dose of GARDASIL 9 (lot#, dose and route unknown). The second dose was administered in the patient's right arm. About a month after the second dose of GARDASIL 9, the patient developed strep throat. As treatment, patient was administered a penicillin injection (unspecified manufacturer) in her right leg. The patient then developed cellulitis at the GARDASIL 9 injection site in her right arm an unspecified amount of time following the administration of the penicillin injection. The patient had a third dose of GARDASIL 9 administered on an unspecified date in her left arm, and had no additional adverse reaction. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On unknown dates the patients was vaccinated with improperly stored PROQUAD (Merck) (lot # L047305, expiration date 23-MAY-2017, dose and route not reported). It was reported that the vaccine was improperly stored at 15.1 F for 18 hours. Digital data logger (DDL) was used to capture this temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected because we are not allowed to contact the physician.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to 6 patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with ROTATEQ (lot # L035508, expiration date 12-MAY-2017, dose and dose # unknown, oral) which were improperly stored. The vaccines were stored under 48 F for 1 hour and had been back in range. The vaccines were not out of range before. No adverse event 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: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On an unknown date the patient was vaccinated with M-M-R II (lot # L020188, expiration date 03-JUN-2017, dose, dose # and route unknown) which was improperly stored. The vaccine was stored under 48 F for 1 hour and had been back in range. The vaccine was not out of range before. No adverse event reported. Thi sis 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: Information has been received from a healthcare worker referring to 4 patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with M-M-R II, (lot # L015279, expiration date 30-APR-2017, dose, dose # and route unknown) which were improperly stored. The vaccines were stored under 49 F for 1 hour and had been back in range. The vaccines were not out of range before. No adverse event 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: Information has been received from a healthcare worker referring to 12 patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provide. On unknown dates the patients were vaccinated with M-M-R II (lot # L026551, expiration date 16-JUL-2017, dose, dose # and route unknown) which were improperly stored. The vaccines were stored under 48 F for 1 hour and had been back in range. The vaccines were not out of range before. No adverse event reported. This is one of several reports from the same source. Additional l information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to 12 patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017, dose, dose# and route unknown) which were improperly stored. The vaccines were stored under 48 F for 1 hour and had been back in range. The vaccines were not out of range before. No adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to 5 patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with PEDVAX HIB (lot # L035880, expiration date 11-AUG-2018, dose, dose# and route unknown) which were improperly stored. The vaccines were stored under 48 F for 1 hour and had been back in range. The vaccines were not out of range before. No adverse event 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 was received from a healthcare worker and refers to an unspecified 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 VAQTA lot # K010577, expiration date 22-SEP-2016; lot # L045713, expiration date 14-JAN-2017; lot # L023232, expiration date 25-FEB-2017; lot # L039659, expiration date 15-MAR-2017; lot # reported as L009945, expiration date 01-JUN-2017 (dose and route of administration were not reported). The administered doses experienced temperature excursion of 32 degrees Fahrenheit for 63 days. The temperature excursion was detected by a data logger. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Rash
Clinical narrative: Localized rash with redness improved within 48 hours.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified 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 ROTATEQ (lot # L020861, expiration date 25-JAN-2017; lot # M002252, expiration date 28-FEB-2017; lot # L023870, expiration date 20-APR-2017; lot # M004885, expiration date 23-OCT-2017 (dose was not reported, orally). The administered doses experienced the temperature excursion of 32 degrees Fahrenheit for 63 days. The temperature excursion was detected by a date logger. There was no previous temperature excursion reported. No adverse effects were reported. 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 a healthcare worker and refers to an unspecified 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 was vaccinated with improperly stored doses of (Merck) VARIVAX lot # L013826, expiration date 21-APR-2017; lot # L032395, expiration date 26-AUG-2017; lot # L041207, expiration date 20-OCT-2017; lot # L041204, expiration date 20-OCT-2017; lot # L042265, expiration date 26-OCT-2017; lot # reported as L048465, expiration date 02-DEC-2017 (dose and route of administration were not reported). The administered doses experienced the temperature excursion of 8 degrees Fahrenheit for 5 days. The temperature excursion was detected by a data logger. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Increased warmth and swelling at injection site.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Hypersensitivity, Presyncope
Clinical narrative: This spontaneous report was received from a nurse via other company Pfizer regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. In 2004, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route of administration, lot # and expiration date were not reported). In 2004, the patient had an allergic reaction on PNEUMOVAX23, it was severe light headedness and presyncope. It was unknown if the patient received any treatment. The patient's outcome was unknown. The relatedness between the events and the therapy with PNEUMOVAX23 was not provided. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site erythema, Injection site oedema, Oedema
Clinical narrative: Mild edema and erythema from injection site to wrist.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Parent provided picture of indurated red area soft ball size on L deltoid on 4/22/16. Using Benadryl and cool compresses.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Petechiae
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of petechial rash in a 17-year-old female patient who received BEXSERO. On 8th April 2016, the patient received BEXSERO .5 ml. On 13th April 2016, 5 days after receiving BEXSERO, the patient experienced petechial rash. In April 2016, the patient experienced headache. On an unknown date, the outcome of the petechial rash and headache were recovering/resolving. It was unknown if the reporter considered the petechial rash and headache to be related to BEXSERO. Additional details provided were as follows: This case was reported by a other health professional, who herself was the patient's mother. The patient experienced petechial rash on her upper back which has spread to spinal column and on the same day the patient was taken to emergency room, but was not admitted. In April 2016, less than a week after vaccination, the patient also experienced slight headache. At the time of reporting, the side effects were better, but have not completely resolved.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Immediate post-injection reaction, Influenza like illness, Injection site discolouration, Injection site lymphadenopathy
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 44-year-old female patient who received BOOSTRIX (batch number 4R3MJ, expiry date 16th September 2017). Previously administered products included Diphtheria and Tetanus vaccine with an associated reaction of injection site pain (with any previously Td vaccine, the patient experienced only soreness of the injection site). Concurrent medical conditions included thyroid disorder (currently treated with an unspecified thyroid medication). On 2nd September 2015, the patient received the 1st dose of BOOSTRIX, .5 ml. On 2nd September 2015, immediately after receiving BOOSTRIX, the patient experienced fatigue (serious criteria other: serious as per reporter), fever and nausea. In September 2015, the patient experienced movement disorder, swelling and muscle pain. In October 2015, the patient experienced blood test abnormal. On an unknown date, the patient experienced influenza-like symptoms, injection site lymphadenopathy, injection site rash and injection site discoloration. On an unknown date, the outcome of the fatigue, influenza-like symptoms, blood test abnormal, muscle pain and injection site discoloration were not recovered/not resolved and the outcome of the fever, movement disorder, nausea and injection site lymphadenopathy, injection site rash, swelling, muscle pain and injection site discoloration to be related to BOOSTRIX. Additional details provided were as follows: This case was previously reported to a doctor. The caller reported that she has been experienced side effects since receiving the injection in her left deltoid. She noted she had a rash about an inch below the injection site that left a discolored skin area. She also noted flu like symptoms that lasted about 8 weeks and reduced but had not gone away completely and actually restarted at Christmas and went into February. She mentioned that most of the issues have completely resolved as they reappeared off and on. The patient also added she had been seen int he emergency room multiple times for fatigue, flu like symptoms, low grade fever, low blood count, swollen lymph nodes and swelled but none required an hospital admission. She is monitored for her thyroid by blood work and mentioned that since the injection she has had low blood counts and noted her WBC had gotten down to 2.2. The patient added that with any previous Td vaccines, she had only experienced soreness of the site. The lymph nodes that swollen were in the arm she received the injection in. She denied any other vaccinations that day or within 4 weeks time period. During the call, she also mentioned that her physical strength has not fully returned.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site rash, Movement disorder, Myalgia, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 44-year-old female patient who received BOOSTRIX (batch number 4R3MJ, expiry date 16th September 2017). Previously administered products included Diphtheria and Tetanus vaccine with an associated reaction of injection site pain (with any previously Td vaccine, the patient experienced only soreness of the injection site). Concurrent medical conditions included thyroid disorder (currently treated with an unspecified thyroid medication). On 2nd September 2015, the patient received the 1st dose of BOOSTRIX, .5 ml. On 2nd September 2015, immediately after receiving BOOSTRIX, the patient experienced fatigue (serious criteria other: serious as per reporter), fever and nausea. In September 2015, the patient experienced movement disorder, swelling and muscle pain. In October 2015, the patient experienced blood test abnormal. On an unknown date, the patient experienced influenza-like symptoms, injection site lymphadenopathy, injection site rash and injection site discoloration. On an unknown date, the outcome of the fatigue, influenza-like symptoms, blood test abnormal, muscle pain and injection site discoloration were not recovered/not resolved and the outcome of the fever, movement disorder, nausea and injection site lymphadenopathy, injection site rash, swelling, muscle pain and injection site discoloration to be related to BOOSTRIX. Additional details provided were as follows: This case was previously reported to a doctor. The caller reported that she has been experienced side effects since receiving the injection in her left deltoid. She noted she had a rash about an inch below the injection site that left a discolored skin area. She also noted flu like symptoms that lasted about 8 weeks and reduced but had not gone away completely and actually restarted at Christmas and went into February. She mentioned that most of the issues have completely resolved as they reappeared off and on. The patient also added she had been seen int he emergency room multiple times for fatigue, flu like symptoms, low grade fever, low blood count, swollen lymph nodes and swelled but none required an hospital admission. She is monitored for her thyroid by blood work and mentioned that since the injection she has had low blood counts and noted her WBC had gotten down to 2.2. The patient added that with any previous Td vaccines, she had only experienced soreness of the site. The lymph nodes that swollen were in the arm she received the injection in. She denied any other vaccinations that day or within 4 weeks time period. During the call, she also mentioned that her physical strength has not fully returned.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Swelling, White blood cell count decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 44-year-old female patient who received BOOSTRIX (batch number 4R3MJ, expiry date 16th September 2017). Previously administered products included Diphtheria and Tetanus vaccine with an associated reaction of injection site pain (with any previously Td vaccine, the patient experienced only soreness of the injection site). Concurrent medical conditions included thyroid disorder (currently treated with an unspecified thyroid medication). On 2nd September 2015, the patient received the 1st dose of BOOSTRIX, .5 ml. On 2nd September 2015, immediately after receiving BOOSTRIX, the patient experienced fatigue (serious criteria other: serious as per reporter), fever and nausea. In September 2015, the patient experienced movement disorder, swelling and muscle pain. In October 2015, the patient experienced blood test abnormal. On an unknown date, the patient experienced influenza-like symptoms, injection site lymphadenopathy, injection site rash and injection site discoloration. On an unknown date, the outcome of the fatigue, influenza-like symptoms, blood test abnormal, muscle pain and injection site discoloration were not recovered/not resolved and the outcome of the fever, movement disorder, nausea and injection site lymphadenopathy, injection site rash, swelling, muscle pain and injection site discoloration to be related to BOOSTRIX. Additional details provided were as follows: This case was previously reported to a doctor. The caller reported that she has been experienced side effects since receiving the injection in her left deltoid. She noted she had a rash about an inch below the injection site that left a discolored skin area. She also noted flu like symptoms that lasted about 8 weeks and reduced but had not gone away completely and actually restarted at Christmas and went into February. She mentioned that most of the issues have completely resolved as they reappeared off and on. The patient also added she had been seen int he emergency room multiple times for fatigue, flu like symptoms, low grade fever, low blood count, swollen lymph nodes and swelled but none required an hospital admission. She is monitored for her thyroid by blood work and mentioned that since the injection she has had low blood counts and noted her WBC had gotten down to 2.2. The patient added that with any previous Td vaccines, she had only experienced soreness of the site. The lymph nodes that swollen were in the arm she received the injection in. She denied any other vaccinations that day or within 4 weeks time period. During the call, she also mentioned that her physical strength has not fully returned.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction, Local reaction
Clinical narrative: 60x45 mm (R) upper arm appearing 24 hrs after injection of DTaP. Local reaction.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Blood pressure decreased, Cold sweat, Pallor, Syncope
Clinical narrative: Syncope, cool clammy skin, pale, drop in BP. Monitor vitals, elevate feet, transported to ER.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain in jaw
Clinical narrative: Arm red & sore to touch at injection site. Pt jaw also sore at roof of mouth. Patient given Prednisone.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-DEC-2015, the patient was vaccinated with a dose of VAQTA injection (dose, route of administration, administration site, lot # and expiry date were not specified. On 14-APR-2016, the patient was vaccinated with another dose of VAQTA (dose, route of administration, administration site, lot # and expiry date were not reported). No adverse symptoms were reported. Product quality complaint (PQC) was not involved. Additional information is not expected as there was no consent for further contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 25-MAR-2016, the patient was vaccinated with 0.5 ml dose of improperly stored (Merck) VARIVAX (which had a lot # of L040419 and an expiration date of 14-OCT-2017; however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. Another batch of (Merck) VARIVAX (which had a lot # of L043624 and an expiration date of 03-NOV-2017) had also been improperly stored but it was not reported whether it had been administered. The vaccines experienced a temperature excursion of 10 F for 2 hours and 15 minutes on 24-MAR-2016. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the 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 as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 14-APR-2016, the patient was vaccinated with 0.5 ml dose of improperly stored (Merck) VARIVAX (which had a lot # of L040419 and an expiration date of 14-OCT-2017; however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. Another batch of (Merck) VARIVAX (which had a lot # of L043624 and an expiration date of 03-NOV-2017) had also been improperly stored but it was not reported whether it had been administered. The vaccines experienced the following temperature excursions on the following dates: 10 F for 2 hours and 15 minutes on 24-MAR-2016; 12.4 F for 2 hours and 15 minutes on 26-MAR-2-16; 10.4 F for 2 hours and 15 minutes on 30-MAR-2016; 10 F for 2 hours on 03-APR-2016; and 9.3 F for 1 hour and 45 minutes on 07-APR-2016. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the 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 as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 05-APR-2016, the patient was vaccinated with 0.5 ml dose of improperly stored (Merck) VARIVAX (which had a lot # of L040419 and an expiration date of 14-OCT-2017; however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. Another batch of (Merck) VARIVAX (which had a lot # of L043624 and an expiration date of 03-NOV-2017) had also been improperly stored but it was not reported whether it had been administered. The vaccines experienced the following temperature excursions on the following dates: 10 F for 2 hours and 15 minutes on 24-MAR-2016; 12.4 F for 2 hours and 15 minutes on 26-MAR-2106; 10.4 F for 2 hours and 15 minutes on 30-MAR-2016; and 10 F for 2 hours on 03-APR-2016. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the 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 as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 13-APR-2016, the patient was vaccinated with 0.5 ml dose of improperly stored (Merck) VARIVAX (which had a lot # of L040419 and an expiration date of 14-OCT-2017; however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. Another batch of (Merck) VARIVAX (which had a lot # of L043624 and an expiration date of 03-NOV-2017) had also been improperly stored but it was not reported whether it had been administered. The vaccines experienced the following temperature excursions on the following dates: 10 F for 2 hours and 15 minutes on 24-MAR-2016; 12.4 F for 2 hours and 15 minutes on 26-MAR-2016; 10.4 F for 2 hours and 15 minutes on 30-MAR-2016; 10 F for 2 hours on 03-APR-2016; and 9.3 F for 1 hour and 45 minutes on 07-APR-2016. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the 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 as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 31-MAR-2016, the patient was vaccinated with a 0.5 ml dose of improperly stored VARIVAX (Merck) (which had a lot # of L040419 and an expiration date of 14-OCT-2014; however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. Another batch of VARIVAX (Merck) (which had a lot # of L043624 and an expiration date of 03-NOV-2017) had been improperly stored but it was not reported whether it had been administered. The vaccines experienced the following temperature excursions on the following dates: 10 F for 2 hours and 15 minutes on 24-MAR-2016; 12.4 for 2 hours and 15 minutes on 26-MAR-2016; and 10.4 F for 2 hours and 15 minutes on 30-MAR-2016. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 08-APR-2016, the patient was vaccinated with 0.5 ml dose of improperly stored (Merck) VARIVAX (which had a lot # of L040419 and an expiration date of 14-OCT-2017; however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. Another batch of (Merck) VARIVAX (which had a lot # of L043624 and an expiration date of 03-NOV-2017) had also been improperly stored but it was not reported whether it had been administered. The vaccines experienced the following temperature excursions on the following dates: 10 F for 2 hours and 15 minutes on 24-MAR-2016; 12.4 F for 2 hours and 15 minutes on 26-MAR-2016; 10.4 F for 2 hours and 15 minutes on 30-MAR-2016; 10 F for 2 hours on 03-APR-2016; and 9.3 F for 1 hour and 45 minutes on 07-APR-2016. . Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Rash
Clinical narrative: This spontaneous report was received from a 65 year old female patient, reporting on herself via Pfizer on 14-APR-2016. It was reported that the patient had no pertinent medical history. On an unspecified date in 2012, the patient was vaccinated with a dose of Zoster vaccine live (manufacturer unknown) (dose, route and lot # not provided). Concomitant therapies were not provided. On 23-MAR-2016, the patient received a dose of PREVNAR13 and just hours after the shot the patient's arm started to hurt (also reported as "she got the pain in her arm from the time she got the shot") and on 25-MAR-2016 she started to get a rash. Then the rash got worse and her arm hurts (also reported as "pain got so bad") that she had to go to the emergency room on 02-APR-2016 where she was diagnosed with shingles. The patient mentioned that she was given the antiviral drug and pain medication for shingles. She provided the name as famciclovir 500 mg tablet, three times a day and gabapentin 100 mg capsule, 1 to 4 capsules every 6 hours for shingles pain. She also was given hydrocodone/acetaminophen. There were no laboratory tests performed. At the time of reporting, the patient had not recovered from shingles. 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 Licensed vocational nurse refers to a patient of unknown age and gender. On 20-APR-2016, the patient was vaccinated with an improperly stored dose of VAQTA (lot # M003011 exp date 15-NOV-2017) (dose and route not reported). The vaccine's temperature excursion was 47.5 degrees F for 30 minutes. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding medical history, concurrent conditions, drug reactions or allergies were reported. On 19-APR-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (with the lot # L029480 and expiration date of 16-MAR-2016 (dose, dose number, route and anatomical location were not provided. Concomitant therapies were not reported. No adverse effects reported. 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 Licensed vocational nurse refers to a patient of unknown age and gender. On 20-SPR-2016, the patient was vaccinated with an improperly stored dose of VAQTA (lot # M003011 exp date 15-NOV-2017) (dose and route not reported). The vaccine's temperature excursion was 47.5 degrees F for 30 minutes. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fever up to 102. Fever. Fatigue. Aches.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Pain in extremity
Clinical narrative: Pain in arm that began immediately following administration - has continued x5 wks with  ass. & in ROM due to pain.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Lip swelling, Peripheral swelling
Clinical narrative: Night of shingles immunization developed itch rash to arm and scalp, felt like her lips and hands were swelling. Patient took Benadryl and two days later presented to urgent care with red, rash to arms and hands. Still swollen, hard/red spot to injection site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Night of shingles immunization developed itch rash to arm and scalp, felt like her lips and hands were swelling. Patient took Benadryl and two days later presented to urgent care with red, rash to arms and hands. Still swollen, hard/red spot to injection site.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Dyspnoea, Erythema, Headache, Oropharyngeal pain
Clinical narrative: I developed cough and fever (to 101 degrees) 46 hrs after the injection. I had fever for 4 nights and productive cough, headache, and sore throat. I was short of breath with walking and peak flow dropped by 30%. Symptoms lasted 1 week. Left arm swollen and red. Swelling lasted 2 wks.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Peak expiratory flow rate decreased, Peripheral swelling, Productive cough, Pyrexia
Clinical narrative: I developed cough and fever (to 101 degrees) 46 hrs after the injection. I had fever for 4 nights and productive cough, headache, and sore throat. I was short of breath with walking and peak flow dropped by 30%. Symptoms lasted 1 week. Left arm swollen and red. Swelling lasted 2 wks.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cardiac arrest, Death, Respiratory arrest, Resuscitation
Clinical narrative: Patient presented in full cardiac arrest, reportedly found down and not breathing. She was coded for > 20 minutes without success - presented to hospital 4/11/2016.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received f rom a health professional refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were unspecified. On 25-MAR-2016, the patient was vaccinated with an expired dose of ROTATEQ (lot # K013868, expiry date: 24-MAR-2016) (expired product administered). There were no known adverse events. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. The reporters stated that the patient received GARDASIL outside the recommended vaccination schedule: the patient was vaccinated with the first dose of GARDASIL injection (lot# J015378, expiry date 09-APR-2016, 0.5 ml intramuscularly) on 20-APR-2015; with the second dose of GARDASIL injection (lot# K006960, 0.5 ml intramuscularly; expiry date was not reported) on 29-MAY-2015; and with the third dose of GARDASIL injection (lot# K006960, 0.5 ml intramuscularly; expiry date was not reported) on 29-JUN-2015. There were no concomitant therapies reported. No adverse effects were reported. There were no product quality complaint involved. Additional information has been requested.