chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: This case was reported by a other health professional and described the occurrence of lymphopenia in a male patient who received SHINGRIX for prophylaxis. On 19th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced lymphopenia, fever, general body pain, general malaise, fatigue, leukocytosis, erythrocyte sedimentation rate increased, creatine kinase increased, hyponatremia and hypochloremia. On an unknown date, the outcome of the lymphopenia, fever, general body pain, general malaise, fatigue, leukocytosis, erythrocyte sedimentation rate increased, creatine kinase increased, hyponatremia and hypochloremia were unknown. It was unknown if the reporter considered the lymphopenia, fever, general body pain, general malaise, fatigue, leukocytosis, erythrocyte sedimentation rate increased, creatine kinase increased, hyponatremia and hypochloremia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in reporter's office. Few hours after receiving SHINGRIX, the patient experienced fever, though unmeasured, with body aches, general malaise and fatigue. On 24th July 2018, the patient was seen by doctor in his office with the above stated chief complaints. Subsequently, CBC (Complete blood count), BMP (Basic metabolic panel), CK (Creatine kinase) and ESR (Erythrocyte sedimentation rate) laboratory tests were ordered. The patient's laboratory tests showed leukocytosis and lymphocytopenia with elevated ESR (66) and CK (1153) and hyponatremia and hypochloremia. Lab Comments: On an unknown date the CBC, BMP, CK and ESR laboratory tests were performed which showed leukocytosis and lymphocytopenia with elevated ESR (66) and CK (1153) and hyponatremia and hypochloremia.
Sex: M
Vaccine: VARZOS
Symptoms: Delirium
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of delirium in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced delirium (serious criteria GSK medically significant). On an unknown date, the outcome of the delirium was unknown. It was unknown if the reporter considered the delirium to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that delirium in the patient after receiving the SHINGRIX.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Contusion, Decreased appetite
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 23rd July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, contusion, chills, fever, nausea, loss of energy, appetite absent and stomach discomfort. On an unknown date, the outcome of the pain in arm, contusion, chills, fever and stomach discomfort were unknown and the outcome of the nausea, loss of energy and appetite absent were recovering/resolving. It was unknown if the reporter considered the pain in arm, contusion, chills, fever, nausea, loss of energy, appetite absent and stomach discomfort to be related to SHINGRIX. Additional information was reported as follows: After vaccination with the 2nd dose of SHINGRIX, the patient experienced soreness in his arm, which was not as bad as experienced with the 1st dose, however it bruised quite a bit. Later on the day of vaccination, in the afternoon, the patient felt horrible and went to bed. He experienced chills, shivering, fever and nausea all the night. On the next day of vaccination, the patient's arm was a little sore than the first day after the vaccination. 1 day after the vaccination, the patient experienced no energy, no appetite and stomach felt awful. The patient had no energy or appetite. The patient's stomach felt awful and he stayed in the bed most of the day. One day before the date of reporting, the patient started to improve but still at the time of reporting felt a bit nauseated with a very little appetite. This case was linked with case US2018134297(1st dose), reported by the same reporter for the same patient.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Nausea, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 23rd July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, contusion, chills, fever, nausea, loss of energy, appetite absent and stomach discomfort. On an unknown date, the outcome of the pain in arm, contusion, chills, fever and stomach discomfort were unknown and the outcome of the nausea, loss of energy and appetite absent were recovering/resolving. It was unknown if the reporter considered the pain in arm, contusion, chills, fever, nausea, loss of energy, appetite absent and stomach discomfort to be related to SHINGRIX. Additional information was reported as follows: After vaccination with the 2nd dose of SHINGRIX, the patient experienced soreness in his arm, which was not as bad as experienced with the 1st dose, however it bruised quite a bit. Later on the day of vaccination, in the afternoon, the patient felt horrible and went to bed. He experienced chills, shivering, fever and nausea all the night. On the next day of vaccination, the patient's arm was a little sore than the first day after the vaccination. 1 day after the vaccination, the patient experienced no energy, no appetite and stomach felt awful. The patient had no energy or appetite. The patient's stomach felt awful and he stayed in the bed most of the day. One day before the date of reporting, the patient started to improve but still at the time of reporting felt a bit nauseated with a very little appetite. This case was linked with case US2018134297(1st dose), reported by the same reporter for the same patient.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Headache, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 23rd July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, 1 days after receiving SHINGRIX, the patient experienced headache, appetite absent and fever. On an unknown date, the outcome of the headache, appetite absent and fever were recovering/resolving. It was unknown if the reporter considered the headache, appetite absent and fever to be related to SHINGRIX. Additional details were reported as follows: This case was linked with case US2018133440, reported by the same reporter for the same patient.
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Eructation, Injection site rash, Lymphadenitis, Lymphadenopathy
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of nonspecific mesenteric lymphadenitis in a 52-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of gastric ulcer (1st dose received on 2nd March 2018 (see case US2018132467)). On 29th June 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced nonspecific mesenteric lymphadenitis, injection site rash, fever, enlargement of lymph nodes, lumbar pain, local swelling and belching. On an unknown date, the outcome of the nonspecific mesenteric lymphadenitis, enlargement of lymph nodes, lumbar pain and local swelling were unknown and the outcome of the injection site rash, fever and belching were recovered/resolved. It was unknown if the reporter considered the nonspecific mesenteric lymphadenitis, injection site rash, fever, enlargement of lymph nodes, lumbar pain, local swelling and belching to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a medical technologist who was also the patient. At the time of reporting, the patient was 52 years old. The age at vaccination was not reported, but the patient could be 51 or 52 years old. After receiving the dose of SHINGRIX, the patient had a rash at the injection site, fever for 2 days, right groin lymph nodes were swollen and enlarged. His lumbar region was swollen and painful. The patient said it felt like he had a kidney stone infection and stated that he was belching for days. The patient was diagnosed with mesenteric lymphadenitis and had to go to an urgent care facility after the dose of SHINGRIX. The patient underwent a magnetic resonance imaging (MRI). The patient's call was escalated to a vaccine specialist. The patient had agreed for any additional information and had supported documentation if necessary. This case was linked with US2018132467, reported for the same patient for 1st dose of SHINGRIX.
Sex: M
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging, Pyrexia, Swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of nonspecific mesenteric lymphadenitis in a 52-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of gastric ulcer (1st dose received on 2nd March 2018 (see case US2018132467)). On 29th June 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced nonspecific mesenteric lymphadenitis, injection site rash, fever, enlargement of lymph nodes, lumbar pain, local swelling and belching. On an unknown date, the outcome of the nonspecific mesenteric lymphadenitis, enlargement of lymph nodes, lumbar pain and local swelling were unknown and the outcome of the injection site rash, fever and belching were recovered/resolved. It was unknown if the reporter considered the nonspecific mesenteric lymphadenitis, injection site rash, fever, enlargement of lymph nodes, lumbar pain, local swelling and belching to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a medical technologist who was also the patient. At the time of reporting, the patient was 52 years old. The age at vaccination was not reported, but the patient could be 51 or 52 years old. After receiving the dose of SHINGRIX, the patient had a rash at the injection site, fever for 2 days, right groin lymph nodes were swollen and enlarged. His lumbar region was swollen and painful. The patient said it felt like he had a kidney stone infection and stated that he was belching for days. The patient was diagnosed with mesenteric lymphadenitis and had to go to an urgent care facility after the dose of SHINGRIX. The patient underwent a magnetic resonance imaging (MRI). The patient's call was escalated to a vaccine specialist. The patient had agreed for any additional information and had supported documentation if necessary. This case was linked with US2018132467, reported for the same patient for 1st dose of SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Pain, Performance status decreased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain and performance status decreased. On an unknown date, the outcome of the general body pain and performance status decreased were recovered/resolved. It was unknown if the reporter considered the general body pain and performance status decreased to be related to SHINGRIX. Additional information was reported as follows: The exact age at vaccination was not provided. However, the patient was over 50 years old. After vaccination with SHINGRIX, the patient experienced systemic pain, inability to function and bone pain for a period of three days. The pharmacist did not have any other information at the time of reporting. The reporting pharmacist had not vaccinated the patient. No address was provided, as the reporting pharmacist she was not working at the time of reporting. This case was linked with case US2018134312 (husband's case), reported by the same reporter.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 59-year-old male patient who received SHINGRIX (batch number 32PE4, expiry date 23rd January 2021) for prophylaxis. Concomitant products included SHINGRIX. On 24th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 25th July 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, fever, myalgia and headache. The patient was treated with TYLENOL. On an unknown date, the outcome of the injection site pain, fever and headache were recovered/resolved and the outcome of the myalgia was recovering/resolving. It was unknown if the reporter considered the injection site pain, fever, myalgia and headache to be related to SHINGRIX. Additional details were reported as follows: The patient was a eye doctor. The patient reported that he experienced fever, which went as high as 99.8 Degree F. The patient was taking TYLENOL to control fever. This case was link with case US2018082757, reported for the same reporter for the same patient.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of therapeutic response decreased in a 73-year-old male patient who received Hepatitis B vaccine for prophylaxis. The patient's past medical history included non-Hodgkin's lymphoma (in chest, and he had chemo and radiation that). Previously administered products included Diovan with an associated reaction of rhabdomyolysis (rhabdomyolysis also caused by statins). Concurrent medical conditions included heart disease, unspecified (from radiation treatment), cardiac pacemaker insertion, tachycardia and drug hypersensitivity (very sensitive to medications). On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. In 2008, the patient received hepatitis B vaccination. The patient's antibody titers were low so, the patient was receiving another round of vaccine. For tolerance for 1st dose and 2nd dose of Engerix B adult, refer cases US2018133497 and US2018GSK135695 respectively. Lab Comments: On an unknown date, the lab test was performed.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial information received on 29-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Child patient who received PENTACEL inadequately divided, did not receive the IPV and DTaP, while he/she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect PENTACEL lot C5464AA via unknown route. It was a case of actual medication error due to inappropriate schedule of vaccine administered. (Other relevant tests included No lab data.) Final diagnosis was PENTACEL inadequately divided, did not receive the IPV and DTaP. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for PENTACEL inadequately divided, did not receive the IPV and DTap. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever of 99.8, body aches, headache.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Sore arm (hot, swollen, pain), extreme tiredness for 2 days, chills for 2 days, body aches.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Sore arm (hot, swollen, pain), extreme tiredness for 2 days, chills for 2 days, body aches.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: HPV was given due to vaccines being entered incorrectly. 07/12/16- Given left arm. 09/15/16-Given left arm. 08/08/17-Given left Deltoid.
Sex: F
Vaccine: MMR
Symptoms: Malaise, Rash
Clinical narrative: This spontaneous report was received from a nurse and refers to a female patient of an unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date (reported as many years ago), the patient was vaccinated with M-M-R II (dose, frequency, lot# and expiration date were not reported) for prophylaxis, reconstituted with DILUENT MRK INJ (lot# and expiration date were not reported). On an unknown date, the patient experienced rash and general malaise, which lasted for a day or two and resolved without intervention. No treatment was given to treat adverse events. The relatedness between the events and M-M-R II was not reported.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Gait disturbance, Inappropriate schedule of drug administration, Limb discomfort, Pain
Clinical narrative: This spontaneous report as received from a physician via a company representative, referring to a 13 year old female patient. Information about concurrent condition, concomitant medication and medical history was not provided. On 26-JUN-2017, the patient was vaccinated with the first dose of GARDASIL 9 0.5 ml (lot# and expiration date was not reported) intramuscularly for prevention (prophylaxis). On 05-JUL-2018, the patient was vaccinated with the second dose of GARDASIL 9 0.5 ml (lot# and expiration date was not reported) intramuscularly. On an unknown date in July 2018 (reported as "very shortly after her second dose"), the patient experienced body aches, joint pain and difficulty walking securely, which was especially noticeable in her arms. It could not further clarify how the patient's arms related to the patient's difficulty walking. It was reported that the physician was going to do blood work on unknown date (also reported as her "yesterday"). The outcome of the events of pain, limb discomfort, pain in extremity, gait disturbance and arthralgia was reported as not recovered/not resolved. The reporter did not provide the causality between the events of pain, limb discomfort, pain in extremity, gait disturbance and arthralgia with GARDASIL 9.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a physician via a company representative, referring to a 13 year old female patient. Information about concurrent condition, concomitant medication and medical history was not provided. On 26-JUN-2017, the patient was vaccinated with the first dose of GARDASIL 9 0.5 ml (lot# and expiration date was not reported) intramuscularly for prevention (prophylaxis). On 05-JUL-2018, the patient was vaccinated with the second dose of GARDASIL 9 0.5 ml (lot# and expiration date was not reported) intramuscularly. On an unknown date in July 2018 (reported as "very shortly after her second dose"), the patient experienced body aches, joint pain and difficulty walking securely, which was especially noticeable in her arms. It could not further clarify how the patient's arms related to the patient's difficulty walking. It was reported that the physician was going to do blood work on unknown date (also reported as her "yesterday"). The outcome of the events of pain, limb discomfort, pain in extremity, gait disturbance and arthralgia was reported as not recovered/not resolved. The reporter did not provide the causality between the events of pain, limb discomfort, pain in extremity, gait disturbance and arthralgia with GARDASIL 9.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 6-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-JUL-2018, the patient was vaccinated with ROTATEQ, one oral dose of 2 ml, lot # N032567, expiration date: 10-MAY-2019 for prophylaxis (also reported as for rotavirus protection). No adverse effects were reported.
Age: 18.0
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 18 year old patient of an unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 injection, 1 dosage form (route of administration, lot # and expiration date were unspecified) for prophylaxis. On an unknown date, the patient experienced drug administered to patient of inappropriate age. No adverse event was reported.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning multiple patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD, lot #N010865, expiration date 01-OCT-2018, albumin status of recombinant human albumin (rHA) (strength, dose, frequency and route of administration were not reported) and with improperly stored doses of VARIVAX, lot #M000997, expiration date 07-JAN-2018 (strength, dose, frequency and route of administration were not reported) for prophylaxis. The vaccines were reconstituted with a properly stored sterile diluent (lot # and expiration date were not reported). The temperature excursion was reported as 15 °F to 46 °F (23.4°F) for a time frame of 2 hours and 57 minutes. Previous temperature excursion was reported as 6 °F to 14 °F (13.4 °F) for 2 hours. Digital data logger was involved to capture the temperature excursions. No product quality complaint (PQC) was involved. Follow-up information was received on 24-JUL-2018. Additional information has been requested. This is non-valid report due to lack of patient identifiers. Follow-up information was received on 24-JUL-2018 from the medical assistant who provided patient identifiers for the reported event. The patient was a 4-year-old male child who on 16-FEB-2018 was vaccinated with improperly stored dose of PROQUAD lot #N010865 with the expiration date of 01-OCT-2018. At the time of the excursion, the vaccine was deemed stable. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA013102: US-009507513-1808USA001953: US-009507513-1807USA012552: US-009507513-1807USA012553: US-009507513-1807USA012554: US-009507513-1807USA012555.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning multiple patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD, lot #N010865, expiration date 01-OCT-2018, albumin status of recombinant human albumin (rHA) (strength, dose, frequency and route of administration were not reported) and with improperly stored doses of VARIVAX, lot #M000997, expiration date 07-JAN-2018 (strength, dose, frequency and route of administration were not reported) for prophylaxis. The vaccines were reconstituted with a properly stored sterile diluent (lot # and expiration date were not reported). The temperature excursion was reported as 15 °F to 46 °F (23.4°F) for a time frame of 2 hours and 57 minutes. Previous temperature excursion was reported as 6 °F to 14 °F (13.4 °F) for 2 hours. Digital data logger was involved to capture the temperature excursions. No product quality complaint (PQC) was involved. Follow-up information was received on 24-JUL-2018. Additional information has been requested. This is non-valid report due to lack of patient identifiers. Follow-up information was received on 24-JUL-2018 from the medical assistant who provided patient identifiers for the reported event. The patient was a 5-year-old female child who on 28-FEB-2018 was vaccinated with improperly stored dose of PROQUAD lot #N010865 with the expiration date of 01-OCT-2018. At the time of the excursion, the vaccine was deemed stable. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA013102: US-009507513-1808USA001953: US-009507513-1807USA012551: US-009507513-1807USA012553: US-009507513-1807USA012554: US-009507513-1807USA012555.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning multiple patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD, lot #N010865, expiration date 01-OCT-2018, albumin status of recombinant human albumin (rHA) (strength, dose, frequency and route of administration were not reported) and with improperly stored doses of VARIVAX, lot #M000997, expiration date 07-JAN-2018 (strength, dose, frequency and route of administration were not reported) for prophylaxis. The vaccines were reconstituted with a properly stored sterile diluent (lot # and expiration date were not reported). The temperature excursion was reported as 15 °F to 46 °F (23.4°F) for a time frame of 2 hours and 57 minutes. Previous temperature excursion was reported as 6 °F to 14 °F (13.4 °F) for 2 hours. Digital data logger was involved to capture the temperature excursions. No product quality complaint (PQC) was involved. Follow-up information was received on 24-JUL-2018. Additional information has been requested. This is non-valid report due to lack of patient identifiers. Follow-up information was received on 24-JUL-2018 from the medical assistant who provided patient identifiers for the reported event. The patient was a 4-year-old female who on 26-JUN-2018 was vaccinated with improperly stored dose of PROQUAD lot #N010865 with the expiration date of 01-OCT-2018. At the time of the excursion, the vaccine was deemed stable. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA013102: US-009507513-1808USA001953: US-009507513-1807USA012551: US-009507513-1807USA012552: US-009507513-1807USA012553: US-009507513-1807USA012554.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Lymphadenopathy, Myalgia, Swelling
Clinical narrative: Besides flu-like symptoms (muscle and joint pain throughout my entire body), I developed a very large swelling of lymph gland in my right armpit (shot was in the right shoulder). Swelling extended to below right clavicle. This swelling was discovered about 24 hours after the shot. Swelling is still present but is shrinking. Still tender to the touch.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Besides flu-like symptoms (muscle and joint pain throughout my entire body), I developed a very large swelling of lymph gland in my right armpit (shot was in the right shoulder). Swelling extended to below right clavicle. This swelling was discovered about 24 hours after the shot. Swelling is still present but is shrinking. Still tender to the touch.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Acne, Erythema, Infection transmission via personal contact, Pruritus, Scab
Clinical narrative: Patient is a 21yo male with no significant past medical history. Patient reported to ED on 19 Jul 2018 concerned for sores on his face. Patient reports that 4-5 days ago he noticed 'pimples' on his face, which progressed to the current state. The sites are painless, and mildly pruritic. Patient denies any other localized or systemic symptoms, such as fever, fatigue, myalgias, chest pain, etc. The patient has two lesions on the right side of his face: lesion number 1 is approximately 0.5 inches below the lateral angle of his eye (malar area), and lesion number 2 is approximately 1.5 inches above the center of his eyebrow. The two lesions appear to be in different stages: lesion number 1 is flat, round, with partial crusting and an even, erythematous border, resembling a normal vaccine take after approximately 14 days. Lesion number 2 is slightly raised, round, with a pink center and even orders, has the appearance of a plaque. Neither lesion has any vesicles, pustules, or discharge. He denies any eye symptoms, no burning, redness, pain, or discharge. He denies lesions to GU area. He reports sm lesions to ankles. Appears to be a vaccinia contact transmission: patient believes he was exposed d/t handling all weapons for his job.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Skin lesion, Skin plaque, Skin ulcer
Clinical narrative: Patient is a 21yo male with no significant past medical history. Patient reported to ED on 19 Jul 2018 concerned for sores on his face. Patient reports that 4-5 days ago he noticed 'pimples' on his face, which progressed to the current state. The sites are painless, and mildly pruritic. Patient denies any other localized or systemic symptoms, such as fever, fatigue, myalgias, chest pain, etc. The patient has two lesions on the right side of his face: lesion number 1 is approximately 0.5 inches below the lateral angle of his eye (malar area), and lesion number 2 is approximately 1.5 inches above the center of his eyebrow. The two lesions appear to be in different stages: lesion number 1 is flat, round, with partial crusting and an even, erythematous border, resembling a normal vaccine take after approximately 14 days. Lesion number 2 is slightly raised, round, with a pink center and even orders, has the appearance of a plaque. Neither lesion has any vesicles, pustules, or discharge. He denies any eye symptoms, no burning, redness, pain, or discharge. He denies lesions to GU area. He reports sm lesions to ankles. Appears to be a vaccinia contact transmission: patient believes he was exposed d/t handling all weapons for his job.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Gout, Incomplete course of vaccination, Pain, X-ray limb normal
Clinical narrative: Gout, right big toe, no risk factors for gout, continues after 2 months, pain is mild, greatest in the morning. NSAID helps. Not getting 2nd round of shot, for fear that symptoms could get worse.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Burning sensation, Paraesthesia, Rash papular
Clinical narrative: Patient developed burning and tingling along left abdomen extending to low back, describes symptoms were similar to that of his shingles rash in 2014. No rash developed until 7/30 - erythematous, with few papules on LEFT low back. Patient was started on anti-viral-Valacyclovir 1000mg PO TID X 7days.
Age: 11.0
Sex: M
Vaccine: FLUX, HPV9
Symptoms: Abdominal pain, Blood test, Bone scan abnormal, Coeliac disease, Colitis ulcerative
Clinical narrative: Not sure who the flu shot was by, my son had the Vaccine for HPV and within one month started having cramping problems and bathroom issues, took him in to doctor, and she stated he constipated and needed more fiber, and we took him home, did this and added MIRALAX to help it pass. This continued all year and kept him still having tummy issues, he increased with the frequency, started missing school or be late, missing football and baseball practice, needed to be close to a bathroom, when we took him back in 12/2016 for wellness check, we let her know and she noticed he fell low on the growth chart now and no weight gain over the past year, she gave him second HPV shot and one more flu shot, requested bone scan test and blood work. Bone scan came back 12-15 months delayed and possible markers for Crohn's and celiac. We took him to Dr in January, this led to series of test. To confirm, not only did he have Celiac and Crohn's, he was inflamed beyond any child should be without being in excruciating pain, MRI showed ulcer colitis and Irritable Bowel Disease.
Age: 11.0
Sex: M
Vaccine: FLUX, HPV9
Symptoms: Colonoscopy, Constipation, Crohn's disease, Endoscopy, Gastric disorder
Clinical narrative: Not sure who the flu shot was by, my son had the Vaccine for HPV and within one month started having cramping problems and bathroom issues, took him in to doctor, and she stated he constipated and needed more fiber, and we took him home, did this and added MIRALAX to help it pass. This continued all year and kept him still having tummy issues, he increased with the frequency, started missing school or be late, missing football and baseball practice, needed to be close to a bathroom, when we took him back in 12/2016 for wellness check, we let her know and she noticed he fell low on the growth chart now and no weight gain over the past year, she gave him second HPV shot and one more flu shot, requested bone scan test and blood work. Bone scan came back 12-15 months delayed and possible markers for Crohn's and celiac. We took him to Dr in January, this led to series of test. To confirm, not only did he have Celiac and Crohn's, he was inflamed beyond any child should be without being in excruciating pain, MRI showed ulcer colitis and Irritable Bowel Disease.
Age: 11.0
Sex: M
Vaccine: FLUX, HPV9
Symptoms: Growth failure, Inflammation, Irritable bowel syndrome, Laboratory test abnormal, Loss of personal independence in daily activities
Clinical narrative: Not sure who the flu shot was by, my son had the Vaccine for HPV and within one month started having cramping problems and bathroom issues, took him in to doctor, and she stated he constipated and needed more fiber, and we took him home, did this and added MIRALAX to help it pass. This continued all year and kept him still having tummy issues, he increased with the frequency, started missing school or be late, missing football and baseball practice, needed to be close to a bathroom, when we took him back in 12/2016 for wellness check, we let her know and she noticed he fell low on the growth chart now and no weight gain over the past year, she gave him second HPV shot and one more flu shot, requested bone scan test and blood work. Bone scan came back 12-15 months delayed and possible markers for Crohn's and celiac. We took him to Dr in January, this led to series of test. To confirm, not only did he have Celiac and Crohn's, he was inflamed beyond any child should be without being in excruciating pain, MRI showed ulcer colitis and Irritable Bowel Disease.
Age: 11.0
Sex: M
Vaccine: FLUX, HPV9
Symptoms: Nuclear magnetic resonance imaging abnormal, Weight gain poor
Clinical narrative: Not sure who the flu shot was by, my son had the Vaccine for HPV and within one month started having cramping problems and bathroom issues, took him in to doctor, and she stated he constipated and needed more fiber, and we took him home, did this and added MIRALAX to help it pass. This continued all year and kept him still having tummy issues, he increased with the frequency, started missing school or be late, missing football and baseball practice, needed to be close to a bathroom, when we took him back in 12/2016 for wellness check, we let her know and she noticed he fell low on the growth chart now and no weight gain over the past year, she gave him second HPV shot and one more flu shot, requested bone scan test and blood work. Bone scan came back 12-15 months delayed and possible markers for Crohn's and celiac. We took him to Dr in January, this led to series of test. To confirm, not only did he have Celiac and Crohn's, he was inflamed beyond any child should be without being in excruciating pain, MRI showed ulcer colitis and Irritable Bowel Disease.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Body aches began that evening, continued into the next day along with a fever of 100.5 and extreme fatigue. Fever subsided the second evening. Fatigue subsided gradually over 48 hours.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Gastroenteritis viral, Vomiting
Clinical narrative: Pt developed diarrhea, vomiting, chills and he couldn't get out of bed the following day after receiving the vaccine. He felt like he had a stomach virus.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Abdominal discomfort, Diarrhoea, Irritability
Clinical narrative: Severe. Diarrhea, irritability, intestinal upset for 3.5 weeks.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Nausea, Pain, Pain in extremity
Clinical narrative: Beginning at 9 pm: alternating fever, chills; continuous  pain in arms and legs, did not sleep well- looked at the clock almost every hour. In the morning, suddenly felt nauseated and hot. Went to bathroom and lay on the cool tile floor. Nausea went away.STill aching all over. Took 2 Tylenol with a glass of milk , and within 15 mins, felt better. Was OK the rest of the day.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Poor quality sleep, Pyrexia
Clinical narrative: Beginning at 9 pm: alternating fever, chills; continuous  pain in arms and legs, did not sleep well- looked at the clock almost every hour. In the morning, suddenly felt nauseated and hot. Went to bathroom and lay on the cool tile floor. Nausea went away.STill aching all over. Took 2 Tylenol with a glass of milk , and within 15 mins, felt better. Was OK the rest of the day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Myalgia
Clinical narrative: Chills as of last night around 8 PM. This morning whole body muscle pain and chills. Unsettled stomach. Still have symptoms.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Tremor
Clinical narrative: Flu like symptoms such as shaking, chills, and fatigue. The same thing happened with the first dose.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Inappropriate schedule of drug administration, Myalgia, Vaccine positive rechallenge
Clinical narrative: Flu like symptoms such as shaking, chills, and fatigue. The same thing happened with the first dose.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Respiratory tract congestion
Clinical narrative: Right deltoid developed a tennis ball size swollen & reddened area as well as respiratory congestion on day 2. Guardian applied essential oils lavender to area for a couple days. Day 5 the area is much improved but continues with congestion.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: On 8/1 left deltoid at site of vaccine 2" X 4" area of swelling, redness heat. No fever.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 8/1 mother reported left deltoid area hot, red, swollen twice the size of the other arm.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site pruritus, Pain in extremity, Peripheral swelling
Clinical narrative: Immediate injection site pain with persistent pain and swelling in that arm with some itchiness around it as well.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Head injury, Presyncope, Syncope
Clinical narrative: Patient experienced a Vasovagal reaction while standing in the laboratory when sibling was having his blood drawn. Pt fainted and hit head on door jam and fell to the floor.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a health professional via other company letter refers to multiple patients of unknown ages and genders. On unknown dates, the patients were vaccinated with PNEUMOVAX23 (lot # N024717, expiry date: 06-APR-2019) and PREVNAR 13 (lot # T94429, expiry date: 31-MAR-2020; T94424 and expiry date: 31-MAR-2020; lot # T62565, expiry date: 28-FEB-2020) following temperature excursion at 1.29 °C for 100 minutes. The outcome of the event was unknown.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Disorientation, Fatigue, Feeling abnormal, Gait disturbance, Lethargy
Clinical narrative: Child was seen in clinic for immunizations. After being educated, mother of child agreed to TdaP, MENACTRA, and HPV vaccines. At the beginning of the visit, the child was very energetic, talkative, and active. About two minutes after receiving the vaccines, the child became lethargic, dazed, unsteady gait, in a stupor, and disoriented. The child never lost consciousness, but displayed a noticeable difference in personality after the vaccines were administered. I observed the child in clinic for approximately 45 minutes, and he never returned to his original state. He was walking and talking clearly before he left, but was quiet and reported being really tired.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Personality change, Stupor
Clinical narrative: Child was seen in clinic for immunizations. After being educated, mother of child agreed to TdaP, MENACTRA, and HPV vaccines. At the beginning of the visit, the child was very energetic, talkative, and active. About two minutes after receiving the vaccines, the child became lethargic, dazed, unsteady gait, in a stupor, and disoriented. The child never lost consciousness, but displayed a noticeable difference in personality after the vaccines were administered. I observed the child in clinic for approximately 45 minutes, and he never returned to his original state. He was walking and talking clearly before he left, but was quiet and reported being really tired.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient not able to raise arm above 90 degrees since receiving the vaccine. No numbness. Painful.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: 8/6/18 Patient went to an urgent care facility complaining of painful rash on face and scalp which began 8/3/18. Attending physician diagnosed her with shingles after completing physical exam and prescribed Valtrex and Folgard Rx.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 8/6/18 Patient went to an urgent care facility complaining of painful rash on face and scalp which began 8/3/18. Attending physician diagnosed her with shingles after completing physical exam and prescribed Valtrex and Folgard Rx.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Malaise, Rash
Clinical narrative: 8/6/18 Patient went to an urgent care facility complaining of painful rash on face and scalp which began 8/3/18. Attending physician diagnosed her with shingles after completing physical exam and prescribed Valtrex and Folgard Rx.
Age: 51.0
Sex: F
Vaccine: HEPAB, MMR, TDAP
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood creatinine normal, Blood immunoglobulin E normal, Blood urea normal
Clinical narrative: Pt. received vaccine 7/23/2018. On 7/26/2018 she stopped by clinic (in her place of employment) c/o chills and not feeling well, sore throat. Patient declined evaluation at clinic - "could not stay" Pt went home. 7/30/2018 - patient calls in to clinic not feeling well. Body aches, decreased appetite, diarrhea - anything she takes orally passes right through. Nurse asks patient to come in to clinic to see provider. Seen by provider same day - mobilliform rash, purpura, on abdomen, back, and bilateral lower extremities, edema in bilateral lower extremities. Diarrhea, dry mucous membranes. BP 125/85, T 98.7 F, HR 98.
Age: 51.0
Sex: F
Vaccine: HEPAB, MMR, TDAP
Symptoms: Chills, Decreased appetite, Diarrhoea, Full blood count normal, Granulocyte count increased
Clinical narrative: Pt. received vaccine 7/23/2018. On 7/26/2018 she stopped by clinic (in her place of employment) c/o chills and not feeling well, sore throat. Patient declined evaluation at clinic - "could not stay" Pt went home. 7/30/2018 - patient calls in to clinic not feeling well. Body aches, decreased appetite, diarrhea - anything she takes orally passes right through. Nurse asks patient to come in to clinic to see provider. Seen by provider same day - mobilliform rash, purpura, on abdomen, back, and bilateral lower extremities, edema in bilateral lower extremities. Diarrhea, dry mucous membranes. BP 125/85, T 98.7 F, HR 98.
Age: 51.0
Sex: F
Vaccine: HEPAB, MMR, TDAP
Symptoms: Malaise, Mucosal dryness, Oedema peripheral, Oropharyngeal pain, Pain
Clinical narrative: Pt. received vaccine 7/23/2018. On 7/26/2018 she stopped by clinic (in her place of employment) c/o chills and not feeling well, sore throat. Patient declined evaluation at clinic - "could not stay" Pt went home. 7/30/2018 - patient calls in to clinic not feeling well. Body aches, decreased appetite, diarrhea - anything she takes orally passes right through. Nurse asks patient to come in to clinic to see provider. Seen by provider same day - mobilliform rash, purpura, on abdomen, back, and bilateral lower extremities, edema in bilateral lower extremities. Diarrhea, dry mucous membranes. BP 125/85, T 98.7 F, HR 98.
Age: 51.0
Sex: F
Vaccine: HEPAB, MMR, TDAP
Symptoms: Purpura, Rash, Rash morbilliform, Red blood cell sedimentation rate increased, Vasculitis
Clinical narrative: Pt. received vaccine 7/23/2018. On 7/26/2018 she stopped by clinic (in her place of employment) c/o chills and not feeling well, sore throat. Patient declined evaluation at clinic - "could not stay" Pt went home. 7/30/2018 - patient calls in to clinic not feeling well. Body aches, decreased appetite, diarrhea - anything she takes orally passes right through. Nurse asks patient to come in to clinic to see provider. Seen by provider same day - mobilliform rash, purpura, on abdomen, back, and bilateral lower extremities, edema in bilateral lower extremities. Diarrhea, dry mucous membranes. BP 125/85, T 98.7 F, HR 98.