chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Chest pain, Dyspnoea, Musculoskeletal pain, Peripheral swelling
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional (consumer) on 12-Oct-2018, concerning a female patient of an unspecified age. The patient was allergic to formaldehyde. On an unspecified date in 2014, the patient was administered Influenza vaccine (dose, route of administration, anatomical location, batch number, manufacturer, trade name and expiry date: not reported). On the same day, within 30 minutes of vaccination, the patient developed swelling in arm, shortness of breath and chest pain that radiated to her shoulder. On an unspecified date, the patient went to a walk-in clinic where she was given some unspecified medications. The patient was not having any breathing problems when she was released from the clinic. On an unspecified date, the patient had recovered from the event shortness of breath. At the time of this report, the outcome of other events was not reported. The reporter considered the events as related to suspect vaccine. Follow up received by other non-health professional on 31-Oct-2018: The outcome of the event shortness of breath was updated from not reported to recovered. It was reported that the patient did not give her age or date of birth, after that she was seen in the clinic and they gave her medications. When the patient was released, she was not having any breathing problems. The narrative was amended accordingly. Non-significant follow up received from other non-health professional on 16-Nov-2018: No new information received. Hence, no changes were made in the narrative.
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: This spontaneous case, initially received from pharmacist on 10-Oct-2018, concerns a 70-year-old, elderly male patient. The patient had no historical condition. The patient did not receive any concomitant medication. On 10-Oct-2018, the patient was administered with FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 250794 and expiry date: 30-Apr-2019]. On the same day, the pharmacist thought that he was administering PNEUMOVAX and instead gave another dose of FLUAD (TIV) (dose: 0.5 ml route of administration: intramuscular, anatomical location: right deltoid, batch number: 250794 and expiry date: 30-Apr-2019). The reporter wanted to know if there was any information or studies where the patient received more than the recommended dose. The patient had not experienced any adverse event. The reporter assessed the case as non-serious. Non-significant follow-up received from the pharmacist on 30-Oct-2018: It was reported that the patient had not experienced any adverse event after vaccination. The reported also confirmed the vaccination date to be 10-Oct-2018. Narrative was amended accordingly.
Sex: F
Vaccine: FLUA3
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This is a spontaneous case, initially received from other healthcare professional (pharmacist) on 25-Oct-2018, concerning an elderly, female patient of unspecified age. On 15-Sep-2018, the patient received the co-suspect vaccine: FLUZONE (dose, route of administration, anatomical location, batch number and expiry date; not reported). Later, it was reported that, the pharmacist was not sure whether the patient had received FLUZONE or Pneumonia on 15-Sep-2018 but was investigating on the same at the time of the report. On 25-Oct-2018, the patient was administered FLUAD (TIV) (dose: 0.5 ml, batch number: 250795, expiry date: 30-Apr-2019, route of administration and anatomical location: not reported). No adverse reactions were reported after the vaccine administration. The reporter assessed the case as non-serious.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site urticaria, Pain, Pyrexia
Clinical narrative: This spontaneous case, initially received on 12-Oct-2018, reported by other non-healthcare professional, concerns a 44-year-old, adult female patient. The patient's current condition included metal sensitivities. On an unspecified date in Oct-2017 (reported as late Oct-2017), the patient was administered Influenza vaccine (dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported). Within 24 hours of vaccination, the patient experienced red welts (reported as about 3x1) at the site of injection for 1-3 weeks. On an unspecified date after vaccination, the patient also experienced fever and aching all over, for a couple of weeks, as a reaction to the vaccine. According to the patient's primary care physician (PCP), the reactions were either due to the mercury or the sorbitol contained in the vaccine and the reporter thought that it was due to the preservatives in the multi dose vial (MDV). At the time of this report, the patient had recovered from injection site redness and welts. The outcome of the events fever and generalised aching was not reported. This case was cross-linked to the case 201804492 due to the same reporter. Follow-up received from other non-health professional on 02-Nov-2018: The patient's age (44 years) and current condition 'metal sensitivity' was added. Vaccination date "Oct-2017" was added. The events 'injection site erythema' and 'injection site urticaria' was added. Narrative and case comment was amended accordingly.
Age: 83.0
Sex: M
Vaccine: FLUA3
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received from a pharmacist on 31-Oct-2018, concerns an 83-year-old, elderly male patient. On an unspecified date in the past, the patient had received unspecified flu vaccine for an unknown indication. On an unspecified date, the patient had received a high dose of FLUAD (TIV) [dose, route administration, anatomical location, batch number and expiry date: not reported] (explicitly coded as overdose). It was reported that the patient received 2 doses of FLUAD (TIV) in the same season (explicitly coded as inappropriate schedule of vaccine administered). No adverse events were reported after administration of the vaccine.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Chills, Cold sweat, Musculoskeletal stiffness
Clinical narrative: This spontaneous case, initially received from a pharmacist on 31-Oct-2018, concerns a 65-year-old, elderly female patient. On 13-Oct-2018, the patient was administered FLUAD TIV [dose: 0.5 ml, route of administration; intramuscular, anatomical location: deltoid, batch number and expiry date: not reported]. On the same day after vaccination, the patient experienced chills and cold sweats which lasted for about 2 minutes. The next morning (14-Oct-2018), the patient woke up with stiffness in her fingers/hands and was hard to bend her fingers. On an unspecified date in Oct-2018 (reported as lasted 1 week), the patient had recovered from the event fingers stiffness. The reporter assessed the case as non-serious.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Rash erythematous
Clinical narrative: This spontaneous case, initially received from other health professional (pharmacist) via pharmaceutical manufacturer (Merck) on 16-Oct-2018, concerns a 69-year-old, elderly, female patient. The patient had allergy to aspirin, penicillin, codeine, sulfa drugs and iodinated contrast agents. On 04-Oct-2018, the patient was administered Influenza vaccine (anatomical location: right arm, route of administration: intramuscular, dose, batch number, trade name, manufacturer and expiry date: not reported) and the co-suspect included PNEUMOVAX 23 (route of administration: intramuscular, anatomical location: left arm, batch number: R006465, expiry date: 24-Oct-2018 and dose: not reported). On 05-Oct-2018, the patient stayed at home from work. On 07-Oct-2018, 3 days after vaccination, the patient reported to the pharmacy, showing the pictures of her left arm. The pharmacist reported that, the picture showed, a red raised rash 3 inches away from the injection site covering the elbow and bicep. On an unspecified date, the patient used BENADRYL CREAM. On 07-Oct-2018, when the patient returned to the pharmacy, the pharmacist reported that, the left arm looked normal and no rash remained. At the time of the report, the patient had recovered from the event red raised rash and the outcome of the event inability to work was not reported.
Age: 54.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from a pharmacist on 29-Oct-2018 concerns a 54-year-old, adult, female patient. The patient had no relevant medical history. The patient's concomitant medications were reported to be unknown. On 24-Oct-2018, the patient under age of 65 years was accidentally administered FLUAD TIV [dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number: 250798, expiry date: 31-May-2019] (explicitly coded as inappropriate age at vaccine administration). No adverse event was reported. The reporter assessed the event as non-serious. This case (201805054) was cross-linked to the source case: 201805049 reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous case, initially received from other health professional (pharmacist) on 10-Oct-2018, concerns a 71-year-old, elderly, female patient. On 31-Aug-2018, the patient was administered FLUZONE HD (dose, route of administration, anatomical location, batch number, expiry date: not reported). On 10-Oct-2018, the patient was administered FLUAD (TIV) (both vaccine received in the same year) [route of administration: intramuscular, anatomical location: left deltoid, dose: 0.5 ml, batch number: 250795 and expiry date: 30-Apr-2019] (explicitly coded as inappropriate schedule of vaccine administered). It was reported that, no adverse events were reported after vaccination. The reporter assessed the case as non-serious.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: This spontaneous case, initially received from the pharmacist on 21-Sep-2018, concerns a 71-year-old, elderly, female patient. The patient's concomitant medication included prednisone for an unknown indication. On 21-Sep-2018, the patient was administered incomplete dose of FLUAD (TIV) (dose: 0.25 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250793, expiry date: 30-Apr-2019), as the needle was wrongly attached to Luer Lock (explicitly coded as under dose and needle issue). No adverse event was reported after administration. The reporter assessed this case as non-serious. Non-significant follow up received from the reporter on 25-Oct-2018: No new information received. Hence, no changes were made in narrative.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Condition aggravated, Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: This spontaneous case, initially received from a pharmacist on 04-Oct-2018, concerns a 32-year-old, adult female patient. On an unspecified date in Oct-2017, the patient was administered INN flu vaccine seasonal for an unknown indication and was tolerated with the product. On 03-Oct-2018, the patient was administered Influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). On the same day, at 8 pm, 6-7 hours after vaccination, the patient experienced a local reaction of a large area of itching (approximately 3 inches in diameter, almost looked like hives), swelling and warmth at the injection site. It was reported that the area progressively increased in size and worsened over time (condition aggravated). The patient was treated with BENADRYL on an unspecified date in Oct-2018 (reported as last night) and the reaction subsided a bit but still had a little swelling and itching. On an unspecified date Oct-2018, the patient was recovering from the event injection site warmth and not recovered from the events injection site itching, injection site swelling, and condition aggravated. The reporter assessed this case as non-serious and the events related to the suspect vaccine.
Age: 63.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from a pharmacist on 29-Oct-2018 concerns 63-year-old, adult, female patient. The patient's current condition included diabetes. The patient's concomitant medications were reported to be unknown. On 24-Oct-2018, the patient under age of 65 years was accidentally administered FLUAD (TIV) [dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number: 250798, expiry date: 31-May-2019] (explicitly coded as inappropriate age at vaccine administration). No adverse event was reported. The reporter assessed the event as non-serious.
Age: 64.0
Sex: M
Vaccine: FLUA3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from a pharmacist on 10-Oct-2018, concerns a 64-year-old, adult male patient. The patient's current conditions included high blood pressure and chronic obstructive pulmonary disease (COPD) (reported as medical history). The patient's concomitant medications were not available. On 10-Oct-2018, the patient (under age of 65 years) was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250794 and expiry date: 30-Apr-2019] (explicitly coded as inappropriate age at vaccine administration). It was reported that the patient did not experience any adverse effects after vaccination. The reporter assessed this case as non-serious. This case 201804383 was cross-linked with the case 201804384 due to the same reporter. Non-significant follow up received from pharmacist on 30-Oct-2018: The reporter confirmed that the patient did not experience any adverse effects after vaccination. There was no further information available regarding the concomitant medications and case.
Age: 43.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from pharmacist on 15-Oct-2018, concerns a 43-year-old, adult, male patient. The patient's current condition included hypertension. The patient's concomitant medication included amlodipine for an unknown indication. On 15-Oct-2018, the patient (under age of 65 years) was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250793, expiry date: 30-Apr-2019] (explicitly coded as inappropriate age at vaccine administration). At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious. Non-significant follow up received from the pharmacist on 15-Nov-2018: The reporter confirmed that the patient did not experience any adverse event post-vaccination. No changes were made in narrative.
Sex: F
Vaccine: FLUA3
Symptoms: Asthenia, Dizziness, Feeling abnormal, Headache, Immediate post-injection reaction
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 15-Oct-2018, concerns an elderly female patient, older than 65-year-old. The patient's historical drug included flu vaccine for an unknown indication. The patient's current conditions included a rare spine disease, metastasized paraganglioma. The patient did not receive any concomitant medications. On 12-Oct-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, anatomical site: left arm, route of administration, batch number and expiry date: not reported]. It was reported that the patient wanted a regular influenza vaccine with 4 strains, and she was given FLUAD instead by the pharmacist (coded as wrong vaccine administered). On the same day, almost immediately after vaccination, the patient developed a hard, 3-inch knot in her left arm, where the vaccine was administered. The patient walked home afterwards, and immediately noticed that she was incredibly weak" in her legs as she walked home, something she had never experienced before. When the patient got home, she laid down and she stated that she felt worse and continued to experience weakness, but also dizziness, a headache, and nausea. At the time of this report, the patient was recovering from the event immediate post injection reaction and injection site induration. The outcome of the other events (dizziness, feeling abnormal, muscular weakness, nausea and headache) were not reported. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUA3
Symptoms: Injection site induration, Injection site nodule, Muscular weakness, Nausea, Wrong product administered
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 15-Oct-2018, concerns an elderly female patient, older than 65-year-old. The patient's historical drug included flu vaccine for an unknown indication. The patient's current conditions included a rare spine disease, metastasized paraganglioma. The patient did not receive any concomitant medications. On 12-Oct-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, anatomical site: left arm, route of administration, batch number and expiry date: not reported]. It was reported that the patient wanted a regular influenza vaccine with 4 strains, and she was given FLUAD instead by the pharmacist (coded as wrong vaccine administered). On the same day, almost immediately after vaccination, the patient developed a hard, 3-inch knot in her left arm, where the vaccine was administered. The patient walked home afterwards, and immediately noticed that she was incredibly weak" in her legs as she walked home, something she had never experienced before. When the patient got home, she laid down and she stated that she felt worse and continued to experience weakness, but also dizziness, a headache, and nausea. At the time of this report, the patient was recovering from the event immediate post injection reaction and injection site induration. The outcome of the other events (dizziness, feeling abnormal, muscular weakness, nausea and headache) were not reported. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUA3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 19-Oct-2018, concerns a female patient of unspecified age (under 65 years as reported). On an unspecified date (couple of weeks ago as reported), the patient (under 65 years of age) was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250798 and expiry date: 31-May-2018] (explicitly coded as inappropriate age at vaccine administration). At the time of this report, no adverse events were reported after the vaccine administration. The reporter assessed the case as non-serious. This case was linked to 201804741 due to same reporter. Significant follow-up received from the reporter on 20-Nov-2018: The batch number: 250798 and expiry date: 31-May-2018 were added. It was confirmed that, patient had not experienced any adverse events after the vaccination. The narrative was amended accordingly.
Age: 60.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from a pharmacist on 29-Oct-2018 concerns a 60-year-old, adult, male patient. The patient's current condition included blood pressure (reported as medical history) and concomitant medications included Eplerenone, BENICAR, QUESTRAN, CLAVATIN (as reported), CIALIS (reported as sialis). On 03-Sep-2018, the patient under age of 65 years was accidentally administered FLUAD (TIV) [dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number: 250788, expiry date: not reported] (explicitly coded as inappropriate age at vaccine administration). At this time of the report, no adverse event was reported. The reporter assessed the case as non-serious.
Age: 80.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site extravasation, Underdose
Clinical narrative: This is a spontaneous case, initially received on 16-Oct-2018, reported by other health professional (pharmacist), concerning an 80-year-old, elderly, male patient. The patient's medical history was not available at the time of the report. The patient had a prior history of medicine squirting back out of his arm after vaccination. The patient didn't receive any concomitant medications. On 15-Oct-2018, the patient was administered FLUAD TIV (dose: reported as 5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250783 and expiry date: 30-Apr-2019). The vaccine squirted out of his arm after vaccination (explicitly coded as injection site extravasation) and hence partial dose was administered (explicitly coded as underdose). It was reported that, the patient would be revaccinated. At the time of the report, the outcome of the event injection site extravasation was not reported. The reporter assessed the case as non-serious.
Age: 51.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from a pharmacist on 29-Oct-2018 concerns a 51-year-old, adult female patient. The patient had no relevant medical history. The patient's concomitant medications were reported to be unknown. On 24-Oct-2018, the patient under age of 65 years was accidentally administered FLUAD (TIV) [dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number: 250800, expiry date: 31-May-2019] (explicitly coded as inappropriate age at vaccine administration). No adverse event was reported. The reporter assessed the event as non-serious. This case (201805055) was cross-linked to the source case: 201805049 reported by the same reporter.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Incorrect route of product administration, Muscle disorder, Pain, Pain in extremity, Tenderness
Clinical narrative: This spontaneous case initially received from other non-health care professional on 18-Oct-2018, concerning a 74-year-old, elderly, female patient. The patient had no relevant medical history. The patient's concomitant medications included Vitamins, Baby aspirin and fish oil. On 11-Oct-2018, the patient was administered with FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). It was reported that, the patient received vaccine higher in the arm (shot in the wrong arm) and felt that it was not given correctly and was given too high (explicitly coded as incorrect route of drug administration). On 11-Oct-2018, on the same day after vaccination, the patient experienced soreness and pain in the arm. On an unspecified date in Oct-2018, the patient experienced that muscle was flapping inside the arm and tender inside the arms. The patient also felt like clicking when she moved the arm back and fourth. The patient experienced that, it was worse in the mornings when she wakes up and not as severe in the night. It was not constant, as she was aware of it in the day but not all the time. The patient did not administer any treatment measure associated with the event. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 64.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received on 10-Oct-2018, reported by a pharmacist, concerns a 64-year-old adult female patient. The patient's current conditions included high blood pressure and hyperthyroidism. On 10-Oct-2018, the patient (under the age of 65 years) was administered suspect vaccine FLUAD (TIV) [dose: 0.5 ml (frequency: unknown), route of administration: intramuscular, anatomical location: deltoid, batch number: 250794, expiry date: 30-Apr-2019] (considered as inappropriate age at vaccine administration). It was reported that the patient did not experience any adverse effects. The reporter assessed this case as non-serious. Non-significant follow up received from pharmacist on 30-Oct-2018: The Investigator confirmed that the patient did not experience any adverse effects after vaccination. There was no further information available regarding the concomitant medications and case.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Needle issue, Product quality issue, Underdose
Clinical narrative: This spontaneous case, initial and follow-up received from a pharmacist on 17-Oct-2018 (combinedly processed) concerns a 68-year-old, elderly, female patient. The patient did not have any medical history. The patient did not receive any concomitant medications. On 17-Oct-2018, the patient was administered partial dose of FLUAD (TIV) (dose: partial dose, route of administration: intramuscular, anatomical location: deltoid, batch number: 250804 and expiry date: 30-Jun-2019] as the vaccine leaked out from the side of the needle (explicitly coded as needle leak and incomplete dose administered). This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding product technical complaint (PTC) reference number was 1034494. It was reported that, there were no signs of damage on the needle and syringe. The needle appeared to be tightly attached and a different needle was not tried. 25gx1 needle was used. The shot out from the side of the needle not the syringe. At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious.
Age: 54.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from a pharmacist 29-Oct-2018 concerns a 54-year-old, adult, female patient. The patient had no relevant medical history. The patient's concomitant medications were unknown. On 24-Oct-2018, the patient (under age of 65 years) was administered FLUAD (TIV) [dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number: 250798, expiry date: 31-May-2019] (explicitly coded as inappropriate age at vaccine administration). No adverse event was reported. The reporter assessed the event as non-serious. This case (201805056) was cross-linked to the source case number: 201805049 due to the same reporter.
Age: 74.0
Sex: M
Vaccine: FLUA3
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous case, initially received from a pharmacist on 19-Oct-2018, concerns a 74-year-old, elderly, male patient. On 28-Sep-2018, the patient was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250804 and expiry date: 30-Jun-2019]. On 18-Oct-2018, in the same season, the patient was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250799 (reported as 257099) and expiry date: 31-May-2019]. No adverse events were reported after administration of the vaccine. On an unspecified date, the patient made an emergency room visit. The reporter assessed this case as non-serious. This case was considered as lost to follow up as the reporter did not provide consent for follow-up.
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: This spontaneous case, initially received from a pharmacist on 22-Oct-2018, concerns a 73-year-old, elderly male patient. On an 20-Oct-2018, the patient was administered with partial dose of FLUAD (TIV) [dose: reported as less than 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250793 and expiry date: 30-Apr-2019] (explicitly coded as incomplete dose administered). It was reported that during the vaccination, about 5 drops of vaccine leaked on the patient's arm (coded as syringe leak and exposure via skin contact). The patient doesn't feel like he was vaccinated and wants to be revaccinated. Only one syringe was defective. On 22-Oct-2018, the patient was revaccinated the FLUAD (TIV) [batch number: 250793, expiry date: 30-Apr-2019, dose, route of administration, anatomical location: not reported] (explicitly coded as drug administration error). The patient didn't experience any adverse event after vaccination. The PTC (product technical complaint) reference number for batch number (250793) was 1034504. The reporter assessed the case as non-serious. Follow-up report received from the pharmacist on 21-Nov-2018: The reporter confirmed that the patient was revaccinated on 22-Oct-2018 and the patient did not experience any adverse events after vaccination. Added new adverse event (drug administration error). The narrative was amended accordingly.
Age: 60.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case initially received from other non-health professional on 08-Oct-2018, concerning a 60-year-old, adult female patient. The patient's current condition included hypertension, high cholesterol, gastroesophageal reflux, artificial menopause, hyperlipidemia, allergic rhinitis, indigestion, difficult in swallowing, asthma, tension headache and non-alcoholic fat liver disease. The patient's concomitant medications included ZIAC, CELEBREX, AZOR, PRILOSEC, ADVAIR and PROVENTIL. On 08-Oct-2018, the patient (under age of 65) was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252230, expiry date: 30-Jun-2019] (explicitly coded as inappropriate age at vaccine administration). No adverse events were reported after the vaccine administration. The reporter assessed this case as non-serious.
Age: 94.0
Sex: F
Vaccine: FLUA3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received from pharmacist on 05-Oct-2018, concerns a 94-year-old, elderly female patient. The patient did not have any medical history and did not take any medications at the time of vaccination. On 05-Oct-2018, the patient was administered expired FLUAD (TIV) [dose: 0.5 ml, anatomical location: deltoid, batch number: 179303, expiry date: 30-Jun-2018, route of administration: intramuscular] (explicitly coded as expired vaccine used). At the time of this report, no adverse event was reported. The reporter assessed this case as non-serious. This case: 201804321 was linked to case: 201804319 due to the same reporter.
Age: 59.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received on 29-Oct-2018 from a pharmacist concerns 59-year-old, adult, male patient. The patient had no relevant medical history. The patient's concomitant medications were unknown. On 24-Oct-2018, the patient (under age of 65 years) was administered FLUAD TIV [dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number: 250798, expiry date: 31-May-2019] (explicitly coded as inappropriate age at vaccine administration). No adverse event or adverse reaction was reported. The reporter assessed the event as non-serious. This case: 201805050 was linked to the source case: 201805049 due to the same reporter.
Age: 50.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from a pharmacist on 29-Oct-2018 concerns 50-year-old, adult, male patient. The patient's current condition included diabetes. The patient's concomitant medications were reported to be unknown. On 24-Oct-2018, the patient under age of 65 years was accidentally administered FLUAD (TIV) [dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number: 250800, expiry date: 31-May-2019] (explicitly coded as inappropriate age at vaccine administration). No adverse event was reported. The reporter assessed the event as non-serious. This case (201805057) was cross-linked to the source case: 201805049 reported by the same reporter.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Malaise, Pain
Clinical narrative: This spontaneous case initially received from other non-health professional on 02-Nov-2018, concerning a 46-year-old, adult, female patient. The patient's historical medication included influenza vaccine during last year (as reported) and did not experienced any adverse reaction. The patient's concomitant medications included: RUBRACA for malignant neoplasm of unspecified ovary, cyclobenzaprine, COLACE, NEXIUM, Acyclovir, venlafaxine and Aspirin. On an unspecified date, the patient was administered Influenza vaccine [dose, route of administration, anatomical location, batch number, frequency, expiry date, trade name and manufacturer: not reported]. On an unspecified date, within three hours of administration of flu shot, the patient experienced chills and aches all over the body. The patient went to bed because she was not feeling well. The patient stated that she woke up fine the next morning. The patient questioned that the reaction was due to a concomitant drug RUBRACA in her system. The patient asserted that she was not taking RUBRACA for very long prior to the flu shot. At the time of report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous case, initially received on 16-Oct-2018, from other health professional (pharmacist) via pharmaceutical manufacturer (Merck). Concerns an elderly, male patient of unspecified age. On an unspecified date, the patient was administered FLUAD (TIV) (dose, route of administration, batch number and expiry date: not reported). The patient was also administered PNEUMOVAX 23 (dose: 1, frequency: once, batch number: N032092, expiry date: 12-Dec-2019 and anatomical location: not reported). On an unspecified day after vaccination, the patient experienced redness and swelling at injection site that went from shoulder to elbow, the skin at the injection site was painful to touch. It was reported that, the patient felt flu like symptoms under the weather. At the time of the report, the patient had recovered from the events (persisted for 3 to 4 days). The reporter assessed the case as non-serious.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Cardiac stress test, Chest pain, Myocardial necrosis marker increased
Clinical narrative: At around 5pm, I experienced severe pain in in chest.  I was taken to Hospital, where I was in severe pain for 3 hours before being treated.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, VARCEL, PNC13, VARCEL, HEPA, PNC13
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a registered nurse, via a company representative, concerning 12-month-old female patient. No information was provided regarding her medical history and concomitant medications. The patient did not have any illnesses at the time of vaccination. On 23-MAY-2018, the 12-month-old female patient was vaccinated with the first dose of VARIVAX lot #N031003, an expiration date: 11-MAR-2019, subcutaneously in the left thigh (strength and dose were not reported) for prophylaxis. On the same day, she was also vaccinated with the fourth dose of PREVNAR 13 lot# 794427, intramuscularly in the right thigh (strength, dose and an expiration date were nor reported) for prophylaxis. On 02-JUN-2018, the patient experienced redness and swelling increasingly worse to the injection site (also reported as in the left thigh), visited physician's office and was diagnosed with cellulitis. The patient received the treatment with cephalexin 250 mg/5ml, twice a day (bid) for 10 days. The patient recovered on an unknown date in 2018. At the time of the report the causality assessment between cellulitis and VARIVAX was not reported. Upon internal review the event cellulitis was considered to be medically significant. This is one of the three reports from the same reporter.; Sender's Comments: US-009507513-1806USA002315: US-009507513-1812USA011790:
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, VARCEL, PNC13, VARCEL, HEPA, PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered nurse, via a company representative, concerning 12-month-old female patient. No information was provided regarding her medical history and concomitant medications. The patient did not have any illnesses at the time of vaccination. On 23-MAY-2018, the 12-month-old female patient was vaccinated with the first dose of VARIVAX lot #N031003, an expiration date: 11-MAR-2019, subcutaneously in the left thigh (strength and dose were not reported) for prophylaxis. On the same day, she was also vaccinated with the fourth dose of PREVNAR 13 lot# 794427, intramuscularly in the right thigh (strength, dose and an expiration date were nor reported) for prophylaxis. On 02-JUN-2018, the patient experienced redness and swelling increasingly worse to the injection site (also reported as in the left thigh), visited physician's office and was diagnosed with cellulitis. The patient received the treatment with cephalexin 250 mg/5ml, twice a day (bid) for 10 days. The patient recovered on an unknown date in 2018. At the time of the report the causality assessment between cellulitis and VARIVAX was not reported. Upon internal review the event cellulitis was considered to be medically significant. This is one of the three reports from the same reporter.; Sender's Comments: US-009507513-1806USA002315: US-009507513-1812USA011790:
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, VARCEL, PNC13, VARCEL, HEPA, PNC13
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a registered nurse concerning 12-month-old female patient. The patient's medical history and concomitant medications were not reported. She did not have any illnesses at the time of vaccination. On 23-MAY-2018, the 12-month-old female patient was vaccinated with the first dose of VAQTA lot # N023953 with an expiration date on 05-NOV-2018, intramuscularly in the left thigh for prophylaxis. On the same day, she was also vaccinated with the fourth dose of PREVNAR 13, lot# 794427, intramuscularly in the right thigh (dose and an expiration date were nor reported) for prophylaxis. On 02-JUN-2018, the patient experienced redness and swelling increasingly worse to the injection site in the left thigh, visited physician's office and was diagnosed with cellulitis. The patient received the treatment with cephalexin 250 mg/5ml, twice a day (bid) for 10 days. The patient recovered on an unknown date in 2018. The relatedness between the cellulitis and VAQTA was not reported. Upon internal review the event cellulitis was considered to be medically significant. This is one of the three reports from the same reporter.; Sender's Comments:  US-009507513-1806USA002315: US-009507513-1812USA011677:
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, VARCEL, PNC13, VARCEL, HEPA, PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered nurse concerning 12-month-old female patient. The patient's medical history and concomitant medications were not reported. She did not have any illnesses at the time of vaccination. On 23-MAY-2018, the 12-month-old female patient was vaccinated with the first dose of VAQTA lot # N023953 with an expiration date on 05-NOV-2018, intramuscularly in the left thigh for prophylaxis. On the same day, she was also vaccinated with the fourth dose of PREVNAR 13, lot# 794427, intramuscularly in the right thigh (dose and an expiration date were nor reported) for prophylaxis. On 02-JUN-2018, the patient experienced redness and swelling increasingly worse to the injection site in the left thigh, visited physician's office and was diagnosed with cellulitis. The patient received the treatment with cephalexin 250 mg/5ml, twice a day (bid) for 10 days. The patient recovered on an unknown date in 2018. The relatedness between the cellulitis and VAQTA was not reported. Upon internal review the event cellulitis was considered to be medically significant. This is one of the three reports from the same reporter.; Sender's Comments:  US-009507513-1806USA002315: US-009507513-1812USA011677:
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Drug administered in wrong device, Erythema, Hypersensitivity, Incorrect route of product administration, Injection site erythema
Clinical narrative: Patient reported very large, swollen painful at injection site. Patient indicated it hurt to the point she could not sleep on that side. Patient indicated this reaction lasted about 1 week and was treated with APAP.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Patient reported very large, swollen painful at injection site. Patient indicated it hurt to the point she could not sleep on that side. Patient indicated this reaction lasted about 1 week and was treated with APAP.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Patient reported very large, swollen painful at injection site. Patient indicated it hurt to the point she could not sleep on that side. Patient indicated this reaction lasted about 1 week and was treated with APAP.
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, UNK, UNK, FLUX
Symptoms: Bacterial test negative, Erythema, Inflammation, Mass excision, Nodule
Clinical narrative: Patient presented to ortho clinic Dr. for right arm pain following a flu shot. She reported she noticed a "black head" spot that kept getting bigger and turning red. Area became swollen and more painful. Exam revealed 5cm in size abscess. She had an outpatient procedure-I&D right deltoid abscess on 11/16/2018 by Dr. at Clinic.
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, UNK, UNK, FLUX
Symptoms: Tenderness
Clinical narrative: Patient presented to ortho clinic Dr. for right arm pain following a flu shot. She reported she noticed a "black head" spot that kept getting bigger and turning red. Area became swollen and more painful. Exam revealed 5cm in size abscess. She had an outpatient procedure-I&D right deltoid abscess on 11/16/2018 by Dr. at Clinic.
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, UNK, UNK, FLUX
Symptoms: Acne, Erythema, Pain, Swelling
Clinical narrative: Patient presented to ortho clinic Dr. for right arm pain following a flu shot. She reported she noticed a "black head" spot that kept getting bigger and turning red. Area became swollen and more painful. Exam revealed 5cm in size abscess. She had an outpatient procedure-I&D right deltoid abscess on 11/16/2018 by Dr. at Clinic.
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, UNK, UNK, FLUX
Symptoms: Abscess, Peripheral swelling
Clinical narrative: Patient presented to ortho clinic Dr. for right arm pain following a flu shot. She reported she noticed a "black head" spot that kept getting bigger and turning red. Area became swollen and more painful. Exam revealed 5cm in size abscess. She had an outpatient procedure-I&D right deltoid abscess on 11/16/2018 by Dr. at Clinic.
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, UNK, UNK, FLUX
Symptoms: Abscess, Acne, Culture negative, Erythema, Fungal test
Clinical narrative: Patient presented to ortho clinic Dr. for right arm pain following a flu shot. She reported she noticed a "black head" spot that kept getting bigger and turning red. Area became swollen and more painful. Exam revealed 5cm in size abscess. She had an outpatient procedure-I&D right deltoid abscess on 11/16/2018 by Dr. at Clinic.
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA, UNK, UNK, FLUX
Symptoms: Incisional drainage, Mycobacterium test negative, Pain, Pain in extremity, Swelling
Clinical narrative: Patient presented to ortho clinic Dr. for right arm pain following a flu shot. She reported she noticed a "black head" spot that kept getting bigger and turning red. Area became swollen and more painful. Exam revealed 5cm in size abscess. She had an outpatient procedure-I&D right deltoid abscess on 11/16/2018 by Dr. at Clinic.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Limb mass, Pain, Ultrasound scan
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 75-year-old female patient who received SHINGRIX for prophylaxis.  On 11th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th September 2018, immediately after receiving SHINGRIX, the patient experienced erythema of extremities, skin warm and pain in arm. On an unknown date, the patient experienced local swelling and mass. The patient was treated with medication unknown (Cream (Medication Unknown)) and antibiotics nos (Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the erythema of extremities, skin warm and pain in arm were recovered/resolved and the outcome of the local swelling and mass were not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities, skin warm, pain in arm, local swelling and mass to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. Right after receiving the vaccine, the patient experienced red hot spot below the injection site covering an area of 6 to 7 inches and also experienced soreness in arm. The patient also noticed a lump on the right arm inside of the elbow, which had decreased in size. At the time of reporting, it had decreased by half inch in size. The patient also developed another lump in between right elbow and shoulder which was the size of the marble and it felt like there was fluid in there, its size varied sometimes and at the time of reporting it was three quarters of an inch to a inch in size. The patient had visited her doctor on 16th October 2018 and had ultrasound done. The patient was given cream along with antibiotic. The patient was advised to use heating pad. The patient recovered from red hot spot within 3 to 4 weeks and from sore arm within a week. The patient visited her vascular doctor on 30th October 2018.