chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a physician regarding a male patient of unknown age. The patient's medical history and concurrent conditions were not provided. Approximately in 2014 (reported as approximately one year ago), the patient was vaccinated with his first dose of VARIVAX (Merck) (dose, lot number and expiration date were not provided). Concomitant medications were not provided. On an unknown date, the patient lost documentation of VARIVAX (Merck) administration and blood test was drawn to verify antibodies. Physician reported blood test result was a negative titer. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The reporter stated that on multiple unspecified dates ranging from 30-SEP-2015 through 13-OCT-2015, the patients received improperly stored doses of ROTATEQ oral liquid (lot # K011948 with expiration date 07-JUN-2016, lot# K020181 with expiration date 24-JUN-2016, lot# K024700 with expiration date 30-JUL-2016 and lot# L013190 with expiration date 16-NOV-2016; dose and frequency were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The reporter stated that on multiple unspecified dates ranging from 30-Sep-2015 through 13-OCT-2015, the patients received improperly stored doses of VAQTA injection (lot # L002717 with expiration date 02-JUN-2017, lot # L009445 with expiration date 01-JUN-2017 and lot# L018499 with expiration date 25-FEB-2017; dose, frequency and route were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The reporter stated that on multiple unspecified dates ranging from 30-SEP-2015 through 13-OCT-2015, the patients received improperly stored doses of RECOMBIVAX HB injection (lot # K021444 with expiration date 17-SEP-2016, lot# L004754 with expiration date 10-NOV-2016 and lot# L014418 with expiration date 13-APR-2017; dose, frequency and route were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not specified. On 15-OCT-2015, the patient was vaccinated with an expired dose (supported) of VARIVAX (Merck) injection, lot # J006359, expiry date 23-MAY-2015, (route of administration, dose and frequency not reported). No adverse effect reported. No product quality complaint (PQC) was involved. No further details provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The reporter stated that on multiple unspecified dates ranging from 30-SEP-2015 through 13-OCT-2015, the patients received improperly stored doses of GARDASIL 9 injection (lot # K026246 with expiration date 28-JAN-2017 and lot# L013429 with expiration date 21-JUL-2017; dose, frequency and route were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified patients of unknown age and gender. The patients pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored with GARDASIL 9 (strength, dose, frequency and route of administration were not reported) lot # L011846 with an expiry date of 16-JUN-2017, lot # L01628 with an expiry date of 30-JUL-2017 and lot # 04-MAR-2017. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The reporter stated that on multiple unspecified dates ranging from 30-SEP-2015 through 13-OCT-2015, the patients received improperly stored doses of GARDASIL injection (lot # K010215 with expiration date 15-MAY-2017, lot# K016966 with expiration date 10-MAY-2017 and lot# K023432 with expiration date 18-JUN-2016; dose, frequency and route were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 24-AUG-2015 the patient was vaccinated with a dose of improperly stored GARDASIL (lot # K007828, expiration date 02-MAR-2017)(dose, route and dose number were unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not reported. On 14-AUG-2015 the patient was vaccinated with a dose of improperly stored GARDASIL (lot # K007828, expiration date 02-MAR-2017) (dose, route and dose number were unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse referring to a 70 year old female patient. The patient was not pregnant. There were no pertinent medical history and drug reactions/allergies. On 13-OCT-2015, the patient was vaccinated with PNEUMOVAX 23 (lot # L008664, expiration date 03-NOV-2016, dose and route were unknown). Concomitant therapies included VENTOLIN HFA. Within 6 hours of the injection, the patient developed chills, and then within 48 hours of the injection, the patient developed redness, swelling and warmth at the injection site. No lab diagnostics studies were performed. The outcome of the events was unknown. The causality between the events and PNEUMOVAX 23 were not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. There was no medical history or concurrent condition reported. On unspecified dates, the patients were administered improperly stored PEDVAXHIB (lot # J010385, expiration date: 28-MAY-2016; lot # K004540, expiration date: 03-DEC-2016; lot # J015435, expiration date: 13-OCT-2016) (dosage, strength and route were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. There was no medical history or concurrent condition reported. On unspecified dates, the patients were administered improperly stored GARDASIL (lot # K005881, expiration date: 14-JAN-2017) (dosage, strength and route were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Moderate erythema at injection site, measures 4.5 inches in width, warm to touch with itching present.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from an 80 year old male consumer reporting on himself. On 29-APR-2015, the patient was vaccinated with ZOSTAVAX (lot number, dosage and route of administration not provided). On 01-OCT-2015, the patient was diagnosed with the shingles on his left thigh and upper leg. On 03-OCT-2015, the patient was seen by his physician and treated with acyclovir ointment and valacyclovir hydrochloride 1 gram tablets. The outcome of the shingles is unknown. Aditional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 27-AUG-2015, the patient was vaccinated with a first dose of GARDASIL 9 (route, dose, lot # and expiration date were not provided). On 09-OCT-2015, the patient was vaccinated with a second dose of GARDASIL 9 which was considered as an inappropriate schedule of drug administration. No adverse effect reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient reported having a red rash from her shoulder to her elbow and axilla region after receiving her pneumonia shot.
Sex: U
Vaccine: MMR
Symptoms: Attention deficit/hyperactivity disorder, Autism
Clinical narrative: This spontaneous report was received from a consumer concerning an unspecified patient (demographics unknown). The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, route and lot# not provided). On an unknown date, the patient was diagnosed with autism and attention deficit/hyperactivity disorder (ADHD). At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information is not expected, no contact details were provided.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Approx 20min after vaccination, patient developed itching local to vaccination area. Treated with 25mg Diphenhydramine.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse  (also reported as healthcare worker) refers to unspecified number of patients of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date an unspecified number of patients were vaccinated with improperly stored ROTATEQ (lot # K020181, expiration date 24-JUN-2016). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse (also reported as healthcare worker) refers to unspecified number of patients of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date an unspecified number of patients were vaccinated with improperly stored PEDVAXHIB (lot # L004740, expiration date 16-NOV-2017). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Vaccination site bruising, Vaccination site pain, Vaccination site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 63-year-old female patient who received FLULAVAL QUADRIVALENT (batch number C92E7, expiry date June 2016). On 7th October 2015, the patient received the 1st dose of FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 7th October 2015, several minutes after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site tenderness, injection site swelling, injection site warmth and injection site redness. On an unknown date, the outcome of the injection site tenderness, injection site swelling, injection site warmth and injection site redness were recovering/resolving. The reporter considered the injection site tenderness, injection site swelling, injection site warmth and injection site redness to be related to FLULAVAL QUADRIVALENT. Additional details were received as follows: The reporter stated that, shortly (within minutes) after receiving FLULAVAL QUADRIVALENT, the patient experienced slight ache and bruised sensation at vaccination site and noticed that vaccination site was swelling with warmth, redness and tenderness. The injection site area became noticeably larger and patient returned to the employee health nurse in the afternoon for follow-up treatment. At that time, a 5 by 5 cm area of warmth, redness, and tenderness was noted. The reporter stated that, the site was still noticeable and tender. No hospitalization was required and the reporter did not feel this is not life threatening. The medical doctor supervising the vaccine is aware of the situation. This case was a follow up of a previously reported case, but it was not able to found out, so this case processed as a initial report.
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 63-year-old female patient who received FLULAVAL QUADRIVALENT (batch number C92E7, expiry date June 2016). On 7th October 2015, the patient received the 1st dose of FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 7th October 2015, several minutes after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site tenderness, injection site swelling, injection site warmth and injection site redness. On an unknown date, the outcome of the injection site tenderness, injection site swelling, injection site warmth and injection site redness were recovering/resolving. The reporter considered the injection site tenderness, injection site swelling, injection site warmth and injection site redness to be related to FLULAVAL QUADRIVALENT. Additional details were received as follows: The reporter stated that, shortly (within minutes) after receiving FLULAVAL QUADRIVALENT, the patient experienced slight ache and bruised sensation at vaccination site and noticed that vaccination site was swelling with warmth, redness and tenderness. The injection site area became noticeably larger and patient returned to the employee health nurse in the afternoon for follow-up treatment. At that time, a 5 by 5 cm area of warmth, redness, and tenderness was noted. The reporter stated that, the site was still noticeable and tender. No hospitalization was required and the reporter did not feel this is not life threatening. The medical doctor supervising the vaccine is aware of the situation. This case was a follow up of a previously reported case, but it was not able to found out, so this case processed as a initial report.
Age: 24.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Chest pain, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 24-year-old male patient who received FLUARIX QUADRIVALENT (batch number A9SY5, expiry date 30th June 2016). Concomitant products included NORCO, ibuprofen and Penicillin. On 7th October 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 12th October 2015, 5 days after receiving FLUARIX QUADRIVALENT, the patient experienced rash. On 13th October 2015, the patient experienced chest pain. On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the chest pain was unknown. It was unknown if the reporter considered the rash and chest pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient had no known history of allergies to any medications. On 13th October 2015, 6 days after receiving the vaccine, the patient experienced chest pain. After the patient reported the events, the reporter advised the patient to discontinue penicillin and ibuprofen so as to rule out any reaction to those medications he might be experiencing.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Bradycardia, Electrocardiogram abnormal, Full blood count, Metabolic function test, Presyncope
Clinical narrative: This spontaneous report was received from a nurse refers to a 14 year old male patient. The patient's pertinent medical history and drug reactions/allergies were reported as none. Concomitant medications were unspecified. On 03-OCT-2015, the patient was vaccinated with the first (and only) 0.5 milliliter (ml) dose of GARDASIL 9 lot # L007560, expiry date 15-JUN-2017, intramuscularly. On 03-OCT-2015, immediately after receiving the vaccine, the patient's "eyes rolled back, he became white as a sheet, he said he was lightheaded, his pulse went down to 48 and his blood pressure increased". The medical assistant stated they had the patient lay down and applied a cold compress as treatment. The medical assistant stated "after 30 minutes" the patient was able to sit up and "eat something with sugar in it". The medical assistant stated "15 minutes after we sat him up it started again, his lips got pale and he said he felt lightheaded and dizzy again". The medical assistant stated the paramedics were called and the patient was taken to an unspecified Emergency Room. While at the unspecified Emergency Room the patient was given "fluids" and discharged "2 hours later". The medical assistant also reported that the patient received a "TB test" on 03-OCT-2015; "patient got a TB test before getting the GARDASIL 9". The medical assistant stated the physician spoke with the patient's mother yesterday, 04-OCT-2015, and "patient was feeling better but did not know if the patient was 100% recovered". The outcome of the events was recovering. Causality assessment was not provided. No product quality complaint (PQC) was involved. No further information was given. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a nurse refers to a 14 year old male patient. The patient's pertinent medical history and drug reactions/allergies were reported as none. Concomitant medications were unspecified. On 03-OCT-2015, the patient was vaccinated with the first (and only) 0.5 milliliter (ml) dose of GARDASIL 9 lot # L007560, expiry date 15-JUN-2017, intramuscularly. On 03-OCT-2015, immediately after receiving the vaccine, the patient's "eyes rolled back, he became white as a sheet, he said he was lightheaded, his pulse went down to 48 and his blood pressure increased". The medical assistant stated they had the patient lay down and applied a cold compress as treatment. The medical assistant stated "after 30 minutes" the patient was able to sit up and "eat something with sugar in it". The medical assistant stated "15 minutes after we sat him up it started again, his lips got pale and he said he felt lightheaded and dizzy again". The medical assistant stated the paramedics were called and the patient was taken to an unspecified Emergency Room. While at the unspecified Emergency Room the patient was given "fluids" and discharged "2 hours later". The medical assistant also reported that the patient received a "TB test" on 03-OCT-2015; "patient got a TB test before getting the GARDASIL 9". The medical assistant stated the physician spoke with the patient's mother yesterday, 04-OCT-2015, and "patient was feeling better but did not know if the patient was 100% recovered". The outcome of the events was recovering. Causality assessment was not provided. No product quality complaint (PQC) was involved. No further information was given. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Blood pressure increased, Dizziness, Eye movement disorder, Heart rate decreased, Immediate post-injection reaction
Clinical narrative: This spontaneous report was received from a nurse refers to a 14 year old male patient. The patient's pertinent medical history and drug reactions/allergies were reported as none. Concomitant medications were unspecified. On 03-OCT-2015, the patient was vaccinated with the first (and only) 0.5 milliliter (ml) dose of GARDASIL 9 lot # L007560, expiry date 15-JUN-2017, intramuscularly. On 03-OCT-2015, immediately after receiving the vaccine, the patient's "eyes rolled back, he became white as a sheet, he said he was lightheaded, his pulse went down to 48 and his blood pressure increased". The medical assistant stated they had the patient lay down and applied a cold compress as treatment. The medical assistant stated "after 30 minutes" the patient was able to sit up and "eat something with sugar in it". The medical assistant stated "15 minutes after we sat him up it started again, his lips got pale and he said he felt lightheaded and dizzy again". The medical assistant stated the paramedics were called and the patient was taken to an unspecified Emergency Room. While at the unspecified Emergency Room the patient was given "fluids" and discharged "2 hours later". The medical assistant also reported that the patient received a "TB test" on 03-OCT-2015; "patient got a TB test before getting the GARDASIL 9". The medical assistant stated the physician spoke with the patient's mother yesterday, 04-OCT-2015, and "patient was feeling better but did not know if the patient was 100% recovered". The outcome of the events was recovering. Causality assessment was not provided. No product quality complaint (PQC) was involved. No further information was given. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Pallor
Clinical narrative: This spontaneous report was received from a nurse refers to a 14 year old male patient. The patient's pertinent medical history and drug reactions/allergies were reported as none. Concomitant medications were unspecified. On 03-OCT-2015, the patient was vaccinated with the first (and only) 0.5 milliliter (ml) dose of GARDASIL 9 lot # L007560, expiry date 15-JUN-2017, intramuscularly. On 03-OCT-2015, immediately after receiving the vaccine, the patient's "eyes rolled back, he became white as a sheet, he said he was lightheaded, his pulse went down to 48 and his blood pressure increased". The medical assistant stated they had the patient lay down and applied a cold compress as treatment. The medical assistant stated "after 30 minutes" the patient was able to sit up and "eat something with sugar in it". The medical assistant stated "15 minutes after we sat him up it started again, his lips got pale and he said he felt lightheaded and dizzy again". The medical assistant stated the paramedics were called and the patient was taken to an unspecified Emergency Room. While at the unspecified Emergency Room the patient was given "fluids" and discharged "2 hours later". The medical assistant also reported that the patient received a "TB test" on 03-OCT-2015; "patient got a TB test before getting the GARDASIL 9". The medical assistant stated the physician spoke with the patient's mother yesterday, 04-OCT-2015, and "patient was feeling better but did not know if the patient was 100% recovered". The outcome of the events was recovering. Causality assessment was not provided. No product quality complaint (PQC) was involved. No further information was given. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Computerised tomogram head normal, Full blood count normal, Hypoaesthesia, Injection site hypoaesthesia, Injection site pain
Clinical narrative: C/o numb feeling left side of head and body ro foot.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Liver function test normal, Metabolic function test, Muscular weakness, Neurological examination, Nuclear magnetic resonance imaging brain
Clinical narrative: C/o numb feeling left side of head and body ro foot.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging spinal, Pain in extremity
Clinical narrative: C/o numb feeling left side of head and body ro foot.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal
Clinical narrative: C/o numb feeling left side of head and body ro foot.
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Headache, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 53-year-old female patient who received FLUARIX QUADRIVALENT (batch number 23J79, expiry date 14th June 2016). On 21st September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 21st September 2015, several hours after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm. On an unknown date, the patient experienced arthralgia and general body pain. The patient was treated with ALEVE and Unspecified Treatment. On an unknown date, the outcome of the pain in arm, arthralgia and general body pain were not recovered/not resolved. The reporter considered the pain in arm to be related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the arthralgia and general body pain to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: On 21st September 2015, several hours later, the patient began to experience soreness at the injection site and then pain radiated down the left arm and pain when lifting her left arm. In 2015, less than a month after vaccination, the patient then experienced pain which spread over her full body, which included pain in wrist, hips and ankle described as "felt old" and being awaken from her sleep due to pain. As treatment the patient was treated with 500mg of ALEVE twice daily and the symptoms improve but reoccur when pain medication was not being used. Reporter was unsure if adverse event report was documented previously. Reporter stated that the patient was currently seeking medical treatment. The reporter believed that, the patient went to see the orthopaedist first, but that the orthopaedic doctor told the patient to see their primary doctor first.
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Injection site pain, Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 53-year-old female patient who received FLUARIX QUADRIVALENT (batch number 23J79, expiry date 14th June 2016). On 21st September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 21st September 2015, several hours after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm. On an unknown date, the patient experienced arthralgia and general body pain. The patient was treated with ALEVE and Unspecified Treatment. On an unknown date, the outcome of the pain in arm, arthralgia and general body pain were not recovered/not resolved. The reporter considered the pain in arm to be related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the arthralgia and general body pain to be related to FLUARIX QUADRIVALENT. Additional details provided were as follows: On 21st September 2015, several hours later, the patient began to experience soreness at the injection site and then pain radiated down the left arm and pain when lifting her left arm. In 2015, less than a month after vaccination, the patient then experienced pain which spread over her full body, which included pain in wrist, hips and ankle described as "felt old" and being awaken from her sleep due to pain. As treatment the patient was treated with 500mg of ALEVE twice daily and the symptoms improve but reoccur when pain medication was not being used. Reporter was unsure if adverse event report was documented previously. Reporter stated that the patient was currently seeking medical treatment. The reporter believed that, the patient went to see the orthopaedist first, but that the orthopaedic doctor told the patient to see their primary doctor first.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Autoimmune disorder, Hyperaesthesia, Skin exfoliation, Sunburn, Vitiligo
Clinical narrative: Got an unusual sunburn on her face while at school - which burned really easily. When it peeled. Underneath was pure white skin. She was then sent to dermatology, when she was later (October 26, 2011) diagnosed with auto immune disease Vitiligo. She went through about a year or 2 of laser light therapy to get rid of it and it never got better. The doctors were baffled as to how she could get it as there is absolutely NO family history of Vitiligo. They said that it was not normal for her to get such a thing and that she didn't match any of the characteristics relating to getting this. Since then she has to stay out of the sun or she burns and blisters. She has very extra sensitive skin ever since.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Vaccination site swelling
Clinical narrative: 4cmx4cm round, raised, and red area surrounding vaccination site. Site was very warm to touch and sore. Resolved after one week.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Neck pain, Palpitations
Clinical narrative: Heart racing - pounding. Pain from shot sight up right shoulder and right side of neck.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain in shoulder radiating down arm.  Trouble moving shoulder.  Got worse over the next few days.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Myalgia, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: SORE THROAT, BODY PAIN, NASAL CONGESTION, COUGH, WITH EXPECTORATION, BODY PAIN, MYALGIA, HEADACHE.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Productive cough
Clinical narrative: SORE THROAT, BODY PAIN, NASAL CONGESTION, COUGH, WITH EXPECTORATION, BODY PAIN, MYALGIA, HEADACHE.
Age: 62.0
Sex: M
Vaccine: FLUC3
Symptoms: Pain in extremity
Clinical narrative: Pain in arm.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Area around injection site developed an inflamed, red rash that was warm to the touch.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Information has been received from a new article via an journalist in a website referring to 32 female patients of unknown age. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with doses of GARDASIL (dose, dose number, lot number, application and route were not reported). According to the research of Centers for Disease Control and Prevention, the researchers looked at problems reported to the Vaccine Adverse Events Reporting System in the 2.5 years since GARDASIL was licensed. Overall, 6.2 percent of the reported problems were considered serious. This included 32 deaths among women who received the vaccine. The exact adverse events were not reported. It was unknown if autopsy was done. The cause was death was unknown. It was reported that these types of reports could not determine whether adverse events were caused by the vaccine or just a coincidence. This is one of several reports received from the same source. Additional information is not expected since there was no contact details provided.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Anaphylactic reaction, Cough, Immediate post-injection reaction, Injection site urticaria, Skin test positive
Clinical narrative: Information has been received from a nurse referring to a 5 year old female patient with a known gelatin and tree nut allergy. The patient had no pertinent medical history. On 15-OCT-2015 an unspecified allergist had conducted a scratch test on the patient with the M-M-R II and the patient had a reaction to the scratch test. Then the allergist had made the decision to split up the full dose, 0.5mL, of the M-M-R II into 4 separate doses and the first dose of 0.05mL, was given on 15-OCT-2015 subcutaneously for MMR at the allergists office. There was no concomitant therapy. On 15-OCT-2015, immediately after receiving the vaccine, the patient experienced anaphylactic reaction with "tongue swelling, sneezing, coughing, clearing her throat, hives around the injection site and hives around her mouth." The nurse reported that the allergist had given the patient epinephrine, BENADRYL, an unspecified steroid and ZYRTEC as treatment. No test was performed for the event. The patient felt better later on that day after receiving the treatment. The causality between the events and the vaccination was not reported. Upon internal review, anaphylactic reaction was considered to be medically significant. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Sneezing, Swollen tongue, Throat irritation, Urticaria
Clinical narrative: Information has been received from a nurse referring to a 5 year old female patient with a known gelatin and tree nut allergy. The patient had no pertinent medical history. On 15-OCT-2015 an unspecified allergist had conducted a scratch test on the patient with the M-M-R II and the patient had a reaction to the scratch test. Then the allergist had made the decision to split up the full dose, 0.5mL, of the M-M-R II into 4 separate doses and the first dose of 0.05mL, was given on 15-OCT-2015 subcutaneously for MMR at the allergists office. There was no concomitant therapy. On 15-OCT-2015, immediately after receiving the vaccine, the patient experienced anaphylactic reaction with "tongue swelling, sneezing, coughing, clearing her throat, hives around the injection site and hives around her mouth." The nurse reported that the allergist had given the patient epinephrine, BENADRYL, an unspecified steroid and ZYRTEC as treatment. No test was performed for the event. The patient felt better later on that day after receiving the treatment. The causality between the events and the vaccination was not reported. Upon internal review, anaphylactic reaction was considered to be medically significant. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Patient called and stated she had cellulitis at the injection site. She was in that afternoon and given an antibiotic after being examined by PAC.
Age: 48.0
Sex: M
Vaccine: FLUC4
Symptoms: Chest pain, Fatigue, Herpes zoster, Malaise, Pain
Clinical narrative: The 2 days after the vaccine I experienced usual post symptoms- malaise and achiness.  5 days after developed nagging chest pain left side that was not relieved with ibuprofen. Also with fatigue. On 10/15/2015 disseminated distinct shingles rash on left chest with distinct severe pain.
Age: 48.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash
Clinical narrative: The 2 days after the vaccine I experienced usual post symptoms- malaise and achiness.  5 days after developed nagging chest pain left side that was not relieved with ibuprofen. Also with fatigue. On 10/15/2015 disseminated distinct shingles rash on left chest with distinct severe pain.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Culture, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient received flu vaccine on 10/10/15 at clinic. Gradually upper arm begin to swell up and redness noted. Mother works for my office since pediatrician only asked to use ice and child complained more pain she brought him in.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site induration, Klebsiella test positive
Clinical narrative: Patient developed cellulitis/? on (L) shoulder. Abscess like hard induration on shoulder. Treated with NSAIDS/Cephalexin 500mg x 3 and issue resolved. She has been examined on 10/9/15 and documented.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Insomnia, Supraventricular tachycardia, Tremor, Visual impairment
Clinical narrative: This has develpoed over time starting about 3 months after the injection. Hand tremors, SVT episodes (now on medication), insomnia, drastic change in vision.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injection site pain
Clinical narrative: Pt noted pain at injection site (which she thought was too high on her L arm) immediately after the injection.  The pain is sharp and tearing in nature and will at times radiate down to her L elbow. Pain has remained the same for 3 weeks.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity
Clinical narrative: When woke up this morning was having pain from elbow to wrist in vaccinated arm and numbness in fingers of same hand.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Cough, Pruritus, Rash erythematous, Rash generalised
Clinical narrative: Patient states started itching a few hours after receiving the shot but didn't think anything about it. Later, noticed small red bumps/blisters covering most of body and began coughing. Went to an urgent care facility and received a shot, oral medication and a Rx to take medication for several days.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling in arm within 24 hrs - Seen by MD - given prednisone, BENADRYL, ZANTAC. Redness worsened by 4th hrs, seen in ER - given KEFLEX (abx). Seen 10/19 and sxs resolving.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Meningitis, Musculoskeletal stiffness, Neck pain, Occipital neuralgia
Clinical narrative: Right sided neck pain, neck stiffness, severe pain (R) side of head and back of head. Seen by Primary Physician. Dx with Occipital Neuralgia. Referred to Neurologist. Dx with Acute Meningitis R/T Flu vaccine.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Fall
Clinical narrative: Approximately 5 min after vaccination patient felt dizzy. After approx 10 min after vac pt wanted to use restroom - as he stood up, he got dizzy and fell (parents and I caught him) as soon as he was laying down, he was conscious, had pt wait for another 20 min, gave him water.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Pt received Flu shot 10/14/15 in right arm. By 10/15/15 swelling and a lump noted with pain and itch per pt. Pt went to E.D. - MD who looked stated was a reaction even though it was 3-4 inches away from injection site. Pt. states minor limited rxn. Swelling and rash decreasing each day.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red swelling around injection site/Hot to touch.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose decreased, Immediate post-injection reaction, Loss of consciousness, Muscle contractions involuntary
Clinical narrative: Patient passed out immediately after vaccine administered. Time 1235, room temp 79; Pt was out for appx 15 sec, small upper extremity contractions exhibited. Epinephrine not needed. Pt woke up before administered. Pt complained of hunger 56 gram of glucose given.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness bilateral, Inner ear disorder, Laboratory test, Vertigo
Clinical narrative: This spontaneous report was received from a 70 year old male consumer regarding himself with allergy to codeine and none medical history. The patient's concurrent conditions were not reported. On 21-NOV-2014, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous, (anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. On 23-NOV-2014 (also reported as 23-NOV-2015), the patient suffered severe hearing lost in the right ear, then loss of hearing the left ear and also suffered from vertigo after vaccination. The patient was diagnosed with hypoactive labyrinth of the right ear. The patient sought medical attention and was hospitalized for one full day of observation, unspecified laboratory test and diagnostic tests were performed on an unspecified date. The patient received meclizine as treatment for vertigo. At the time of the report, the outcome of the severe hearing lost in the right ear, loss of hearing the left ear, suffered from vertigo and the patient was diagnosed with hypoactive labyrinth of the right ear was reported as not recovered. The relatedness between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Injection site rash, Muscle spasms
Clinical narrative: Rash around injection site approximately 6". Back spasms, diarrhea.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Erythema, Joint swelling
Clinical narrative: Flu shot around 3:30 pm 10/14/15. Around 7pm patient noticed swelling in left elbow. By morning 10/15/15, patient reports redness, swelling, and pain to the touch in left elbow.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray abnormal, Hyperglycaemia, Lung infiltration, Pyrexia
Clinical narrative: Fever day of vaccine, persisted, diabetic severe hyperglycemia, traveled out of state, hospitalized with fever, pulmonary infiltrates, 9/26/15 to 10/1/15.
Age: 38.0
Sex: F
Vaccine: DTAP, FLUX, PPV
Symptoms: Abscess, Burning sensation, Cellulitis, Erythema, Fatigue
Clinical narrative: Cellulitis and abscess of upper left arm. Severe pain, burning, aching of arm - unable to move due to pain. Arm redness and severe swelling, spread through arm. Fever, fatigue, body aches, headaches, malaise. Treatment: Clindamycin 300 mg 4x's a day for 10 days.
Age: 38.0
Sex: F
Vaccine: DTAP, FLUX, PPV
Symptoms: Headache, Malaise, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Cellulitis and abscess of upper left arm. Severe pain, burning, aching of arm - unable to move due to pain. Arm redness and severe swelling, spread through arm. Fever, fatigue, body aches, headaches, malaise. Treatment: Clindamycin 300 mg 4x's a day for 10 days.
Age: 38.0
Sex: F
Vaccine: DTAP, FLUX, PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Cellulitis and abscess of upper left arm. Severe pain, burning, aching of arm - unable to move due to pain. Arm redness and severe swelling, spread through arm. Fever, fatigue, body aches, headaches, malaise. Treatment: Clindamycin 300 mg 4x's a day for 10 days.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Significant edema/erythema of arm from elbow to shoulder including chest.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Musculoskeletal pain, Pain in extremity, Pyrexia
Clinical narrative: Developed fever of 102 after 2 days with aching arm and shoulder pain with diminished movement. No getting better even after 2 1/2 weeks.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Hyperhidrosis, Mobility decreased, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Extreme pain, unable to move arm for 2 days - limited arm function for several days with pain. Full arm functions after 7 days and still sore. Profuse sweating; decreased energy.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blood pressure increased, Crying, Dizziness, Dyspnoea, Electrocardiogram normal
Clinical narrative: Patient felt lightheaded and had shortness of breath within a minute of receiving flu vaccine. Within 2 minutes she was crying and complaining of pain in her arms, neck, spine, and hips. Her blood pressure was elevated, oxygen 100%. No changes on EKG in ambulance.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain
Clinical narrative: Patient felt lightheaded and had shortness of breath within a minute of receiving flu vaccine. Within 2 minutes she was crying and complaining of pain in her arms, neck, spine, and hips. Her blood pressure was elevated, oxygen 100%. No changes on EKG in ambulance.
Age: 40.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction: Redness, swelling and warm feeling at the injection site.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: Was administered the flu shot in the OR at around 1000, noticed a small welt and redness. Then by 1100 it was larger and warm to touch.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, White blood cells urine negative
Clinical narrative: Student developed pain, tenderness, redness, swelling 1.5 inches in diameter (flat) and warm to touch at injection site, approx. 1 hr. post injection. Pt iced area.
Age: 11.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large red, swollen, warm area on right upper arm. Dx cellulitis, antibiotics started.
Age: 11.0
Sex: F
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient walked into office on 10/17/2015 with parent.  Left upper arm extremely swollen, hard, red and hot to touch. Site painful and itchy.