chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist via field employee referring to a patient of unknown age and gender. Information about concurrent condition, medical history and concomitant therapy were not provided. On approximately 19-OCT-2016 (reported as 3 weeks ago as of 19-NOV-2016), the patient was vaccinated with a dose of ZOSTAVAX subcutaneous injection (19400 plaque forming unit, lot # and expiration date were unknown) intramuscularly which was outside of the prescribing information recommendation. On an unknown date in 2016, the patient had redness and swelling at the injection site that "looks like a bee sting". The events had lasted for "a couple of weeks". The outcome of redness and swelling at the injection site was reported as not recovered. The reporter did not provide the relatedness between ZOSTAVAX and redness and swelling at the injection site. The patient has spoken to the pharmacist and it was unknown if the patient has sought further medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a pharmacist via Poison and Drug Center refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On approximately 09-NOV-2016 (also reported as it was unclear if it was administered on 10-NOV-2016 or a day prior), the patient was vaccinated with the expired dose of PNEUMOVAX 23 (lot # L008664, expiration date 03-NOV-2016; dose and route of administration were not reported). Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, via a company representative, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9, (route of administration, lot # and expiration date were unknown), in the following series: 0, 4 and 6 months. No adverse effects were reported. Additional information is not expected, no permission for further contact was provided.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Presyncope
Clinical narrative: Pt had sig injection site RXN along w/pre-syncope SXS. Pt was given diphenhydramine 25mg and Prednisone 40mg QDx3days. SXS occurred approximately 4 hrs post injection./He declined ER tx.
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information was received on 27-OCT-2016 from a medical assistant concerning a female patient of unknown age. No medical history or concomitant medications were reported. On 27-OCT-2016 the patient received a dose of PROQUAD (lot, dose and route not reported) and a dose of VARIVAX (lot, dose and route not reported) during an office visit. No adverse effect was reported. Additional information is not expected. Reporter did not give consent to contact physician.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information was received on 28-OCT-201 from a 67 year old female patient regarding herself. Medical history/concurrent conditions included high cholesterol, high blood pressure depression and seasonal allergies. Concomitant medications included ZOLOFT, simvastatin and unspecified over the counter nasal spray. On 24-OCT-216 the patient received PNEUMOVAX 23. Later that day, the patient experienced severe pain and swelling at the injection site. The patient recovered. The reporter did not rate the causal relationship. No further AE information reported. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to an unknown number of patients of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II, lot # K024824, expiration date 02-DEC-2016, (dose number, route and anatomical location of administration were unknown). The temperature of excursion was 51 F for 30 minutes. There was no previous temperature excursion. The temperature excursion was detected by a digital data logger. No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer referring to herself a 70 year old female patient. The patient's medical history included uterine cancer, ovarian cancer, breast cancer, arthritis and psoriasis. The patient also had allergy to morphine, DEMEROL, codeine, ibuprofen, sulfa, clindamycin and penicillin. Concomitant therapies included several unspecified medications. On 14-Nov-2011, the patient was vaccinated with ZOSTAVAX (dosage scheduled, lot# and expiration date were not provided). In June 2016, the patient had an unspecified blood test but the results were not provided. On approximately 31-OCT-2016 (reported as a week ago), the patient developed shingles. It was reported that the patient sought unspecified medical attention and received an unknown treatment. At the reporting time the outcome of shingles was unknown. The causality between the event and ZOSTAVAX was unknown by the reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Condition aggravated, Migraine, Pyrexia
Clinical narrative: Information has been received from a registered nurse referring to an approximately 14 year old female patient. The patient was not pregnant. She had history of migraines and had no allergies. Concomitant medication was reported as no. On 18-JAN-2016, the patient was vaccinated with first dose of GARDASIL 9 (lot #, expiration date, dose and route were unknown). The reporter stated that the mother of the patient recently reported that the patient experienced a high fever and a migraine for 5 days after receiving the first dose of GARDASIL 9. No treatment was provided. The patient did not seek medical attention. The outcome of the events was recovered. The causality assessment was not provided. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a 13 year female patient. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 11-SEP-2015, the patient received first dose of GARDASIL 9 intramuscularly and a second dose on 10-NOV-2016. No adverse effects were reported. No product quality complaint was involved. This is one of the two reports: 1611USA009361 (Same reporter link). Additional information is not expected as there is no consent to contact the reporter.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to an 81 year old female patient. The patient's concurrent condition included asthma and hypothyroidism. The patient was allergy to penicillin. Concomitant therapies included levothyroxine sodium (manufacturer unknown), lorazepam and PROAIR. On 28-OCT-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose unknown, lot # M035104, expiration date: 06-MAY-2016) intramuscularly. On the same day, the patient called the pharmacy back to report swelling at the injection site. The patient then went to a hospital emergency room on 29-OCT-2016 because the swelling increased from the injection site down to her elbow and it was very painful. The patient was not admitted to the hospital, but discharged from the emergency department, on an unspecified date, with prescriptions for prednisone (manufacturer unknown), 60 mg for 5 days for the swelling and NORCO, 5/325 mg, 1 tablet every 6 hours as needed, for the pain. No lab was performed. The Pharmacist spoked with the patient again on 31-OCT-2016 and the patient stated the swelling and pain have subsided a little bit (recovering). The causal relationship between the events and PNEUMOVAX 23 was unknown. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates of November 2016 (reported as between 10-NOV-2016 and 16-NOV-2016), the patients were vaccinated with doses of improperly stored PROQUAD (lot # reported as M033216, expiration date 09-JAN-2018, dose and route not reported). The doses of vaccine were improperly stored at 16.9 degree Fahrenheit for 2 hours and 54 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product name confusion, Wrong drug administered
Clinical narrative: This spontaneous report as received from registered nurse refers to an adult female patient of unknown age. The nurse reported that an adult female received a dose of ENGERIX-B, 10 mcg, which is a pediatric dose; however, the confusion arose as the practitioner believed that ENERGIX-B corresponded to the same dosage guidelines as RECOMBIVAX HB, which is 10 mcg in a 1 ml dose for adults. There was no product lot number or expiration date available. RECOMBIVAX HB was chosen as the AE product as it was the product whose dosing formulation the nurse confused with the ENGERIX-B. No adverse effect reported. No additional information available. Additional information is not expected as permission to contact the physician was declined.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies or concomitant medication were not reported. In October 2016, the patient was vaccinated with PREVNAR (route, dose, lot # and expiration date were not reported). Then on 31-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 lot # M024673, expiration date: 17-NOV-2017 (route and dose were not reported) (inappropriate schedule of drug administration). No adverse event was reported. There was no product quality complaint (PQC) involved. Additional information have been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, concurrent conditions and concomitant medications were not reported. On an unknown dates, the unspecified patients were vaccinated with doses of PNEUMOVAX 23 (dose, route, lot # and expiration dates were not reported). Other suspect therapies included PREVNAR 13. It was stated that an unknown number of pharmacist were administering PNEUMOVAX 23 vaccine injections to patients less than a year from receipt of PREVNAR 13 vaccine injections. No adverse events were reported. There was not a product quality complaint involved. Additional information is not expected because the reporter refused additional contact.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Moaning, Mobility decreased, Musculoskeletal pain
Clinical narrative: Information has been received from Pfizer, Inc. (manufacturer report# 2016466823) on 27-OCT-2016. Reporter had a 62 year old female with an adverse side-effect from Pneumonia inspection from a pharmacy. Reporter was not sure of the vaccine, but it's the Streptococcal Pneumonia Vaccine given out at pharmacy to prevent pneumonia. Patient had shoulder pain, injection site pain and restricted movement of arm, but it looks like intense pain apparently. The vaccine was administered today (03-OCT-2016) and the side effect was not immediate, but it was into the evening and now at this point, at the middle of the night at 2:30 AM the patient was moaning at the middle of the night. Start date was not captured for moaning as it started in the middle of the night and date was not probed for it separately. Outcome for shoulder pain, injection site pain, restricted movement of arm and moaning was reported as ongoing and worsened. Reporter was not sure of the dose: it was just the syringe at the store. Reporter asked if there were any relief clues or things that he could know that would make the pain less or something to have or this was a common thing. Reporter provided the complete name of the product as PNEUMOVAX 23 Inj 25mcg/0.5ml PF SYR. Reporter did not have the product details with him (LOT#, NDC#, UPC# and expiration date). Other medical conditions were not reported. Reporter did not know if patient was on other medications. Reporter was unsure about any laboratory work. Additional information is expected.
Sex: U
Vaccine: PPV
Symptoms: Ill-defined disorder
Clinical narrative: Information was received on 02-NOV-2016 from a company employee who received information from a pharmacist. The pharmacist reported that an unspecified number of patients, names and demographics unknown, received a dose of PNEUMOVAX 23 and experienced "more side effects than with other vaccines, including PREVNAR 13". Details of adverse events were unknown by reporter. No other information was available. Additional information is not expected as pharmacist does not wish to be contacted.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local reaction, Pain, Swelling
Clinical narrative: Localized reaction redness, swelling, pain. Office visit 11/18/16. No treatment.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Interchange of vaccine products
Clinical narrative: Pt went to pharmacy near her college seeking 2nd Mening B vaccine. Was given TRUMENBA. Got BEXSERO as 1st dose. Pt. advised to finish series after 2-15-17 with TRUMENBA.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Abdominal pain upper, Pyrexia, Vomiting
Clinical narrative: C/O of vomiting and stomach pain and fever.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: First injection area became hard (in 24 hrs) then it became red and hot lasted for 10 days. I used cold compress.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Headache, Pyrexia, Urticaria
Clinical narrative: Hive on arm, fever, headache - 2 days after Imm. Feeling better on 11/21.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt arm swollen (size of 2 golf balls) and very red 2-3 days post vaccine. Recommended ice pack.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: "Excruciating" pain at injection site x weeks. Patient was unable to do her sport. Onset 10/5/16, No treatment. Pt did not return to office for care.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Eczema, Irritability, Rash, Vomiting
Clinical narrative: At her 2 month shots, she broke out in eczema from head to toe and had a bad rash all over stomach. She was fussy and threw up. Eczema was not gone by the 4 month visit.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MENB
Symptoms: Paraesthesia
Clinical narrative: Patient reports intermittent tingling in (R) arm since the evening of vaccination. Refer to Neurology.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Urticaria
Clinical narrative: Hives developed while eating, about 3 to 3 1/2 hrs after vaccine administered. No respiratory changes or swelling. Administration site ok. Improved with antihistamine. Pt w/ongoing intermittent hives prior to vaccine.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Local reaction, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Local reaction to Pneumococcal 23 polysaccharide vaccine given 9/27/16. Fever, chills right of vaccine and with local left upper arm pain. Left arm swelling and area 3 cm rash.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Local reaction to Pneumococcal 23 polysaccharide vaccine given 9/27/16. Fever, chills right of vaccine and with local left upper arm pain. Left arm swelling and area 3 cm rash.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Welts appeared around waist and up back. The welts itched. Noticed them the day after.
Age: 22.0
Sex: U
Vaccine: PPV
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Fever of 104 and rash at injection site within 24 hrs of injection.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia
Clinical narrative: Pt had a severe myalgia x5 wk after vaccine was given.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling at injection site, injection. Redness.
Age: 16.0
Sex: M
Vaccine: YF
Symptoms: Urticaria
Clinical narrative: (As reported by mother). Day 3 post vaccine, developed hives "all over" after working out after school. Possibly feverish. Took ADVIL and BENADRYL with easing. Day 8 hives returned. Took BENADRYL again and they eased. Mother reporting this is concerning and she is a nurse.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Varicella
Clinical narrative: Bilateral red rash to legs, itchy not painful. Dx modified varicella - treatment soap and gently lotion, hydrocortisone. Sx improved 6 days later.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Skin discolouration
Clinical narrative: Sore (L) arm, 8cm length, 9.5cm width, discolored, no nausea or fever. Only mild systematic symptoms.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Electrocardiogram normal, Myocarditis, Troponin I increased
Clinical narrative: This solicited study case was received from the investigator in a trial on 15 October 2013. A male subject (age and date of birth not reported) with no reported past medical history received an injection of smallpox ACAM2000, (lot number, route and site not reported) and an injection of Anthrax vaccine (manufacter, lot number, route and site not reported) on 20 July 2010. On 29 July 2010, the subject experienced elevated troponin 09 days after receiving an injection of smallpox vaccine. Troponin I on 27 July 2010 was 0.11 ng/mL (normal range <0.10 ng/mL) and troponin I on 11 August 2010 was <0.10 ng/mL (normal range <0.10 ng/mL). ECG on 11 August 2010 was normal. The subject had no cardiac symptoms. The subject recovered on 11 August 2010. According to the investigator, the event of elevated troponin was definitely related to the administration of ACAM2000. Relationship to investigational product according to Company: associated. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Follow-up information was received from the investigator on 30 October 2013. The subject was 23-years-old. Route of ACAM2000 was percutaneous. Other vaccine details were unknown. Onset date of elevated troponin was 27 July 2010, 07 days after receiving an injection of smallpox vaccine. No other information including final diagnosis and results of cardiac work-up were not available as the subject was lost to follow-up. Follow-up information was received on 07 January 2014 via a third party query tool search on the VAERS database. The VAERS ID reference number for this case was 510312. No additional information was provided. Documents held by sender: None. Follow up information received on 08 November 2016: The subject had itching (L) arm injection site on 24 July 2010, 04 days after receiving an injection of small pox vaccine which was ongoing at the time report. The subject had elevated troponin event on 29 July 2010, i.e. 09 days after receiving an injection of small pox vaccine (previously reported as 27 July 2010). For the drinking/smoking habits: a questionnaire of smoking and drinking habits was received. Lab test: on 27 July 2010 blood was drawn for rapid troponin I level and result was within normal limit (negative). On 27 July 2010 blood was drawn for central laboratory troponin I level and result was less than 0.11 ng/ml. Sender's Comments: Follow-up information received on 08 November 2016, does not change the previous medical assessment. Elevated troponin reported as possible myopericarditis post-vaccination with ACAM2000. Myopericarditis is a listed event in the current reference safety information for ACAM2000, however, no further assessment of this case is possible in the context of the limited information reported.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Blood test, Electromyogram, Muscle electrostimulation therapy, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report was received from a 58 years old female consumer regarding herself. No historical or concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot# unspecified) vial. Concomitant therapy included PRILOSEC. Later, on an unknown date, the patient developed shingles on her face. On 11-NOV-2015, the patient was vaccinated with the second dose of ZOSTAVAX (lot# unspecified) vial,  (extra  dose  administered). On 12-NOV-2015, the patient began to experience pain in the hip and severe pain in her foot. The patient sought medical attention. The physician gave her a few unspecified shots for pain. The patient stayed in bed for a few days with ice packs. On an unspecified date, the patient underwent magnetic resonance imaging (MRI) and the results indicated a bulging disk in her back. On an unknown date, the patient was diagnosed with foot drop for which she was given a steroid injection. On an unknown date, the patient underwent physical therapy and an electromyography (EMG) test for one leg. On an unknown date, the patient underwent x-ray. No Product Quality Complaint (PQC) was reported. The outcome of shingles on face, pain in the hip, severe pain in foot and foot drop were not reported. Causality assessment was not provided. Upon internal review, the event of foot drop was considered to be medically significant. Additional information has been requested. This an amended report. The event of foot drop was corrected to be medically significant.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Orthosis user, Pain in extremity, Peroneal nerve palsy, Sciatica, X-ray
Clinical narrative: This spontaneous report was received from a 58 years old female consumer regarding herself. No historical or concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot# unspecified) vial. Concomitant therapy included PRILOSEC. Later, on an unknown date, the patient developed shingles on her face. On 11-NOV-2015, the patient was vaccinated with the second dose of ZOSTAVAX (lot# unspecified) vial,  (extra  dose  administered). On 12-NOV-2015, the patient began to experience pain in the hip and severe pain in her foot. The patient sought medical attention. The physician gave her a few unspecified shots for pain. The patient stayed in bed for a few days with ice packs. On an unspecified date, the patient underwent magnetic resonance imaging (MRI) and the results indicated a bulging disk in her back. On an unknown date, the patient was diagnosed with foot drop for which she was given a steroid injection. On an unknown date, the patient underwent physical therapy and an electromyography (EMG) test for one leg. On an unknown date, the patient underwent x-ray. No Product Quality Complaint (PQC) was reported. The outcome of shingles on face, pain in the hip, severe pain in foot and foot drop were not reported. Causality assessment was not provided. Upon internal review, the event of foot drop was considered to be medically significant. Additional information has been requested. This an amended report. The event of foot drop was corrected to be medically significant.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Electromyogram, Extra dose administered, Herpes zoster, Intervertebral disc protrusion
Clinical narrative: This spontaneous report was received from a 58 years old female consumer regarding herself. No historical or concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot# unspecified) vial. Concomitant therapy included PRILOSEC. Later, on an unknown date, the patient developed shingles on her face. On 11-NOV-2015, the patient was vaccinated with the second dose of ZOSTAVAX (lot# unspecified) vial,  (extra  dose  administered). On 12-NOV-2015, the patient began to experience pain in the hip and severe pain in her foot. The patient sought medical attention. The physician gave her a few unspecified shots for pain. The patient stayed in bed for a few days with ice packs. On an unspecified date, the patient underwent magnetic resonance imaging (MRI) and the results indicated a bulging disk in her back. On an unknown date, the patient was diagnosed with foot drop for which she was given a steroid injection. On an unknown date, the patient underwent physical therapy and an electromyography (EMG) test for one leg. On an unknown date, the patient underwent x-ray. No Product Quality Complaint (PQC) was reported. The outcome of shingles on face, pain in the hip, severe pain in foot and foot drop were not reported. Causality assessment was not provided. Upon internal review, the event of foot drop was considered to be medically significant. Additional information has been requested. This an amended report. The event of foot drop was corrected to be medically significant.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Pain in extremity, Peroneal nerve palsy, X-ray
Clinical narrative: This spontaneous report was received from a 58 years old female consumer regarding herself. No historical or concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot# unspecified) vial. Concomitant therapy included PRILOSEC. Later, on an unknown date, the patient developed shingles on her face. On 11-NOV-2015, the patient was vaccinated with the second dose of ZOSTAVAX (lot# unspecified) vial,  (extra  dose  administered). On 12-NOV-2015, the patient began to experience pain in the hip and severe pain in her foot. The patient sought medical attention. The physician gave her a few unspecified shots for pain. The patient stayed in bed for a few days with ice packs. On an unspecified date, the patient underwent magnetic resonance imaging (MRI) and the results indicated a bulging disk in her back. On an unknown date, the patient was diagnosed with foot drop for which she was given a steroid injection. On an unknown date, the patient underwent physical therapy and an electromyography (EMG) test for one leg. On an unknown date, the patient underwent x-ray. No Product Quality Complaint (PQC) was reported. The outcome of shingles on face, pain in the hip, severe pain in foot and foot drop were not reported. Causality assessment was not provided. Upon internal review, the event of foot drop was considered to be medically significant. Additional information has been requested. This an amended report. The event of foot drop was corrected to be medically significant.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU4, PPV, FLU4, PPV
Symptoms: Pneumonia, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. While no medical history was reported, her concurrent conditions included a chronic lung disease. Notably, she had no drug reactions/ allergies. On 03-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 (which had a lot # of M006141 with an expiration date of 17-MAY-2018), intramuscularly, in the right arm, (the dose and dosage number were unknown). On the same day, she had also been vaccinated with influenza virus vaccine (unspecified) (which had a lot number of UI703AA  with an expiration date of 08-MAY-2017; the dose, dosage number, route of administration and anatomical location were unknown), as well. Additionally, her concomitant therapies included prednisone (Manufacturer unknown). Subsequently, on 04-OCT-2016, the patient developed a fever of 104 F, which lasted for three days. She did seek medical attention by going to a primary physician. Then, on 10-OCT-2016, she was admitted to an unspecified hospital. An unspecified treatment was given for the adverse event but it was unknown whether any laboratory diagnostic studies had been performed. Additionally, no product quality complaint was involved. At the time of reporting, the event was resolving itself. The patient considered the event and the subsequent hospitalization to be related to the PNEUMOVAX 23. No causal assessment with the influenza virus vaccine (unspecified) was reported. Follow up information was received on 20-NOV-2016 from the pharmacist. Patient had no illness at the time of vaccination. On 03-OCT-2016, patient was vaccinated with the first dose of FLUZONE on her right arm. PNEUMOVAX 23 received was, also the first dose. Vaccine administration details were updated. On 05-OCT-2016, the patient experienced pneumonia 'contraction' due to which she was hospitalized for 11 days. On an unknown date in 2016, the patient recovered from pneumonia. Causality assessment was not provided. The reporter considered pneumonia to be serious as it caused hospitalization. Upon internal review, pneumonia was considered to be medically significant. Additional information has been requested. Product details, event and narrative updated.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU4, PPV, FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. While no medical history was reported, her concurrent conditions included a chronic lung disease. Notably, she had no drug reactions/ allergies. On 03-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 (which had a lot # of M006141 with an expiration date of 17-MAY-2018), intramuscularly, in the right arm, (the dose and dosage number were unknown). On the same day, she had also been vaccinated with influenza virus vaccine (unspecified) (which had a lot number of UI703AA  with an expiration date of 08-MAY-2017; the dose, dosage number, route of administration and anatomical location were unknown), as well. Additionally, her concomitant therapies included prednisone (Manufacturer unknown). Subsequently, on 04-OCT-2016, the patient developed a fever of 104 F, which lasted for three days. She did seek medical attention by going to a primary physician. Then, on 10-OCT-2016, she was admitted to an unspecified hospital. An unspecified treatment was given for the adverse event but it was unknown whether any laboratory diagnostic studies had been performed. Additionally, no product quality complaint was involved. At the time of reporting, the event was resolving itself. The patient considered the event and the subsequent hospitalization to be related to the PNEUMOVAX 23. No causal assessment with the influenza virus vaccine (unspecified) was reported. Follow up information was received on 20-NOV-2016 from the pharmacist. Patient had no illness at the time of vaccination. On 03-OCT-2016, patient was vaccinated with the first dose of FLUZONE on her right arm. PNEUMOVAX 23 received was, also the first dose. Vaccine administration details were updated. On 05-OCT-2016, the patient experienced pneumonia 'contraction' due to which she was hospitalized for 11 days. On an unknown date in 2016, the patient recovered from pneumonia. Causality assessment was not provided. The reporter considered pneumonia to be serious as it caused hospitalization. Upon internal review, pneumonia was considered to be medically significant. Additional information has been requested. Product details, event and narrative updated.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Bacterial test positive, Injection site reaction, Rash vesicular, Staphylococcus test positive
Clinical narrative: Diffuse vesicular rash with some group plaques on his Rt shoulder, bilateral hands and forearms, and bilateral feet and lower legs.
Age: 0.58
Sex: F
Vaccine: DTAP, FLUX, HIBV, RVX
Symptoms: Cyanosis, Electroencephalogram abnormal, Eye movement disorder, Febrile convulsion, Foaming at mouth
Clinical narrative: Patient who was a healthy child from what we were aware of had received her regular 6 month vaccinations at 7 months which included the flu shot. Around 1:30 am 11/15/2016 first seizure occurred. She blanked out and started foaming at the mouth. Called emergency to which nothing was really done and was sent back home. 11/15/2016 at 8am another seizure occurred this time she was in a blank state and face and lips turned purple/blue. Called emergency again to where her eyes began to rol back while in ambulance. They took an anal temperature and had a 102 fever. They gave her Motrin and tylonal and had her go to her primary doctor the same day. Her doctor requested an eeg and was told that she had abnormal results. She was put on keppra 100 mg but was taken off and put on another type of medication that is a  suppository. Was told she had febrile seizure.
Age: 0.58
Sex: F
Vaccine: DTAP, FLUX, HIBV, RVX
Symptoms: Lip discolouration, Loss of consciousness, Pyrexia, Seizure, Skin discolouration
Clinical narrative: Patient who was a healthy child from what we were aware of had received her regular 6 month vaccinations at 7 months which included the flu shot. Around 1:30 am 11/15/2016 first seizure occurred. She blanked out and started foaming at the mouth. Called emergency to which nothing was really done and was sent back home. 11/15/2016 at 8am another seizure occurred this time she was in a blank state and face and lips turned purple/blue. Called emergency again to where her eyes began to rol back while in ambulance. They took an anal temperature and had a 102 fever. They gave her Motrin and tylonal and had her go to her primary doctor the same day. Her doctor requested an eeg and was told that she had abnormal results. She was put on keppra 100 mg but was taken off and put on another type of medication that is a  suppository. Was told she had febrile seizure.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Wife came down with the shingles 7 days after husband had shingles vaccination (VZV).
Age: 44.0
Sex: M
Vaccine: FLUX
Symptoms: Biopsy, Blister, Full blood count, Urticaria
Clinical narrative: Hives on legs, arms and back. Blisters on both hands.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death
Clinical narrative: Received report from family friend that patient passed away on 11-21-16, unknown cause of death.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis
Clinical narrative: Initial unsolicited report received from a health care professional on 08 Nov 2016. This case involves 59-year-old female patient who was vaccinated with a dose of FLUZONE QIV (batch number: UI711AB and expiry date: 30 Jun 2017 dose and dose deries were not reported) via intramuscular route in left deltoid on Nov-2016 (unspecified date). Patient's illness at time of vaccination and the pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Other vaccinations within 4 weeks of vaccination and other concomitant medications were not reported. On Nov-2016 (unspecified date), post vaccination, patient had developed cellulitis at the injection site. The patient's laboratory data was reported as none. Corrective treatment includes antibiotics and steroids and symptoms are improving. On an unspecified date, the patient was recovered from the event. List of documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a physician via Pfizer (under the reference number: 2016499114) on 09 Nov 2016. This case involves a 61-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiration date, route, dose not reported) on an unspecified date. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and concomitant medications were not provided. On an unspecified date, following the vaccination, the patient experienced allergy to influenza virus vaccine inactivated. Lab data and corrective treatment was not reported. The patient's event outcome was not reported. List of documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Hypersensitivity
Clinical narrative: Initial unsolicited report received from a physician via Pfizer (under the reference number: 2016499114) on 09 Nov 2016. This case involves a 61-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiration date, route, dose not reported) on an unspecified date. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and concomitant medications were not provided. On an unspecified date, following the vaccination, the patient experienced allergy to influenza virus vaccine inactivated. Lab data and corrective treatment was not reported. The patient's event outcome was not reported. List of documents held by sender: none.
Age: 5.0
Sex: U
Vaccine: FLU4
Symptoms: Body temperature increased, Influenza, Vaccination failure
Clinical narrative: Initial unsolicited report received from nurse on 09 November 2016. This case involves a 5-year-old patient (gender not reported) who was vaccinated with a dose of FLUZONE Quadrivalent (batch number, dose, expiration date, site and route of administration was not reported) on an unspecified date. (Reported as 05th or 6th October) The patient's medical history and concomitant medication were not reported. On 11 August 2016, following vaccination patient diagnosed with Influenza B. On an unspecified date following vaccination (had been month since immunization) patient had temperature of 103 degree Celsius. It was a case of vaccination failure. Lab data and corrective treatment were not reported. Outcome of event temperature of 103 degrees Celsius was not recovered and outcome of other event was not reported. Upon internal review the case was considered as serious because of important medical event: Influenza B and vaccination failure. List of documents held by sender: none. Sender's Comments: As with any other vaccine, INFLUENZA QUADRIVAL A-B VACCINE vaccination may not protect 100% of susceptible individuals. Aspects such as patient's immune status at the time of vaccination might interfere with the immune response to the vaccine. However patient's immune status, medical history, concomitant medication etc. is require to further assess this case.
Sex: M
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) (under the reference number: 2016151044) on 10 Nov 2016. This case involves a male patient (age unknown) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiration date, route, dose not reported) on an unspecified date. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not provided. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced allergies to tetanus vaccine, tetanus toxoids. Lab data and corrective treatment was not reported. The patient's event outcome was not reported. List of documents held by sender: none.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Erythema, Hypoaesthesia, Paraesthesia, Pruritus
Clinical narrative: Initial unsolicited report received from physicians on 10 November 2016. This case involves a 39-years-old female patient who was vaccinated with a dose of  FLUZONE QIV (batch number- UI690AA, expiration date-30 June 2017) (dose in series, dose and site of administration was not reported) via intramuscular route on 11 October 2016 at 8:00 am. Illness at time of vaccination: none and Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify): sesame seed allergy and food. Hypersensitivities. Concomitant medications were not reported. On 11 October 2016, same day (in the afternoon) following the vaccination, the patient had experienced widespread hives and rash over the body, Shortness of breath, numbness and tingling in her arm. Patient required ER visit. Relevant laboratory data was not reported. The patient received epinephrine as corrective treatment. On an unspecified date the patient was recovered from the events. List of documents held by sender: none/yes
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Rash generalised, Swelling, Urticaria
Clinical narrative: Initial unsolicited report received from physicians on 10 November 2016. This case involves a 39-years-old female patient who was vaccinated with a dose of  FLUZONE QIV (batch number- UI690AA, expiration date-30 June 2017) (dose in series, dose and site of administration was not reported) via intramuscular route on 11 October 2016 at 8:00 am. Illness at time of vaccination: none and Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify): sesame seed allergy and food. Hypersensitivities. Concomitant medications were not reported. On 11 October 2016, same day (in the afternoon) following the vaccination, the patient had experienced widespread hives and rash over the body, Shortness of breath, numbness and tingling in her arm. Patient required ER visit. Relevant laboratory data was not reported. The patient received epinephrine as corrective treatment. On an unspecified date the patient was recovered from the events. List of documents held by sender: none/yes
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Carpal tunnel syndrome, Joint swelling, Paraesthesia
Clinical narrative: Initial unsolicited report received from a healthcare professional on 11-Nov-2016. This case involves a 25-year old female patient who was vaccinated with a dose of INFLUENZA VACCINE (Influenza Vaccine) (manufacturer: unknown, batch number, expiry date, dose, dose in series were not reported) via intramuscular route in right deltoid on 10-Nov-2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) includes allergy to Zantac. It was also reported that patient had no illness at the time of vaccination. Concomitant medications was reported as Lexapro for depression. On 11-Nov-2016, one day following the vaccination, patient woke up with swelling in right wrist and tingling in the fingers of the right hand and after evaluation carpal tunnel syndrome was reported. Patient required emergency room (ER)/ doctor visit. Laboratory investigations was performed which confirmed the carpal tunnel testing was positive. Corrective treatment was not reported. The outcome of event was reported as not recovered. List of documents held by sender: none.
Age: 41.0
Sex: F
Vaccine: FLU4, MMR, TDAP
Symptoms: Arthralgia, Discomfort, Impaired work ability, Muscle spasms, Myalgia
Clinical narrative: Initial unsolicited report received from a physician on 11 November 2016. This case involves a 41-years-old female patient who was vaccinated with first a 0.5 ml dose FLUZONE QIV (Batch number-UI678AA, expiratory date-30 June 2017) in left deltoid; first dose of ADACEL (Batch number-U5489AA, expiratory date-17 November 2018) in left deltoid and first dose of MEASLES, MUMPS AND RUBELLA VACCINE (MMR) (Batch number-M008589) (expiratory date and dose was not reported) in right deltoid (Route of administration was not reported for all vaccines) on 22 October 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as none. Concomitant medications were not reported. On 29 October 2016, seven days following the vaccination, the patient had experienced pain in finger joints and thighs and also pain in muscles of her back and shoulders. It was reported as on 10 November 2016 notified that the patient still has muscle pain, muscle cramps, and was unable to work or lift anything. Patent was required ER visit. Relevant laboratory data was reported as none. It was reported as the doctor was prescribed anti-inflammatory to patient for discomfort. The outcome of events was reported as unknown. List of documents held by sender: none.
Age: 41.0
Sex: F
Vaccine: FLU4, MMR, TDAP
Symptoms: Pain in extremity
Clinical narrative: Initial unsolicited report received from a physician on 11 November 2016. This case involves a 41-years-old female patient who was vaccinated with first a 0.5 ml dose FLUZONE QIV (Batch number-UI678AA, expiratory date-30 June 2017) in left deltoid; first dose of ADACEL (Batch number-U5489AA, expiratory date-17 November 2018) in left deltoid and first dose of MEASLES, MUMPS AND RUBELLA VACCINE (MMR) (Batch number-M008589) (expiratory date and dose was not reported) in right deltoid (Route of administration was not reported for all vaccines) on 22 October 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as none. Concomitant medications were not reported. On 29 October 2016, seven days following the vaccination, the patient had experienced pain in finger joints and thighs and also pain in muscles of her back and shoulders. It was reported as on 10 November 2016 notified that the patient still has muscle pain, muscle cramps, and was unable to work or lift anything. Patent was required ER visit. Relevant laboratory data was reported as none. It was reported as the doctor was prescribed anti-inflammatory to patient for discomfort. The outcome of events was reported as unknown. List of documents held by sender: none.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dysphonia, Fatigue, Headache, Pain
Clinical narrative: Coughing low fever, headache, body achy, hoarseness, tired, sinus drainage.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Paranasal sinus hypersecretion, Pyrexia
Clinical narrative: Coughing low fever, headache, body achy, hoarseness, tired, sinus drainage.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Erythema, Fatigue, Pain, Pruritus
Clinical narrative: Associated symptoms include fatigue, weakness, Left arm redness, pain, itching. Treatment of Prednisone dose pack, Zyrtec for itching, referral to Ashtma and immunology return to clinic for worsening or unresolved symptoms.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Symptoms: soreness, red, swollen, hot to touch, & itchy.  Also, given "safety net" Rx for prednisone & instructed on appropriate Benadryl dosing.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Pt received a dose in (L) arm - area was increased in redness and swollen. Erythema went from neck to elbow. TX for cellulitis.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Nerve injury
Clinical narrative: Patient reported nerve damage in arm that vaccine was given.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Burning sensation, Erythema, Pain
Clinical narrative: Patient was administered Hepatitis A and Menactra shot on the right deltoid by M.A. Patient developed severe pain, burning inside and mild erythema after Menactra administration. Patient was given Tylenol 650 mg and ice was applied. Patient started feeling much better after 30 minutes and erythema disappeared.