chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Patient received PREVNAR 13 on 2/09/2017 and again on 02/05/2018. Patient has not reported any side effects besides arm soreness after the vaccine.
Age: 41.0
Sex: F
Vaccine: FLU4, HEPA, TDAP, TYP
Symptoms: Altered state of consciousness, Dizziness, Visual impairment
Clinical narrative: Pt received vaccines in right arm (Typhoid, Flu) with no reaction, after the last of the 2 vaccines (Tdap, Hep A in that order) was given patient stated that she felt lightheaded and like she was going to pass out, stated she saw black spots as well, patient was transferred to exam room 4 where she laid down, b/p taken at 4:37 147/93, HR: 56, O2 99RA. Patient stated she had not eaten since breakfast so she was given Crackers and peanut butter as well as water, patient stated she was feeling better, vitals taken again at 4:51 b/p 137/88,  HR 61 O2 99RA. Patient's mother stated that she has had similar reactions when giving blood or having blood drawn. Patient was advised to eat a little closer to next vaccine time.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypoaesthesia, Paraesthesia, Tachycardia, Throat tightness
Clinical narrative: Within a minute after vaccine administered patient was observed developing diffuse erythema of her arms and face with urticarial lesions, complained of throat tightness and numbness/paresthesias of her R arm. Within a minute no longer complaining of throat tightness and within several minutes numbness/paresthesias resolved. Vital signs stable except tachycardia (HR 136->125). Given BENADRYL and transferred by EMS to local emergency room for further management.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Within a minute after vaccine administered patient was observed developing diffuse erythema of her arms and face with urticarial lesions, complained of throat tightness and numbness/paresthesias of her R arm. Within a minute no longer complaining of throat tightness and within several minutes numbness/paresthesias resolved. Vital signs stable except tachycardia (HR 136->125). Given BENADRYL and transferred by EMS to local emergency room for further management.
Age: 13.0
Sex: M
Vaccine: IPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: NA.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Small blisters, itching, burning, now red dots both arms from shoulder to elbow and upper back and chest. Started 12/1/2017 and remains.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site vesicles, Pruritus, Rash erythematous
Clinical narrative: Small blisters, itching, burning, now red dots both arms from shoulder to elbow and upper back and chest. Started 12/1/2017 and remains.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Sore swollen arm muscular ache up into neck, general malaise.
Age: 11.0
Sex: F
Vaccine: FLU4, HEPA, MNQ, TDAP
Symptoms: Dizziness, Malaise
Clinical narrative: APPROX 5-10 MINUTES AFTER VACCINES ADMINISTERED, CHILD BECAME LIGHTHEADED AND REPORTED NOT FEELING WELL.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Muscle contractions involuntary, Pain in extremity
Clinical narrative: Violent pelvic contractions, severe arm pain, headache.
Age: 72.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient came to pharmacy on 2/21/2018 stating that pain in left arm from FLUAD injection back on 9/12/2017 had not subsided. It hurts to lay on it during sleep and says she has lost some range of motion with it. She has not contacted her doctor with this information. Pharmacist recommended her taking either otc Ibuprofen or Aleve for some relief and use  of an ice pack. Pharmacist will contact her doctor and relay current information.
Age: 72.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient came to pharmacy on 2/21/2018 stating that pain in left arm from FLUAD injection back on 9/12/2017 had not subsided. It hurts to lay on it during sleep and says she has lost some range of motion with it. She has not contacted her doctor with this information. Pharmacist recommended her taking either otc Ibuprofen or Aleve for some relief and use  of an ice pack. Pharmacist will contact her doctor and relay current information.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: The site of injection is red and itchy. The injection site is still red on 02/21/2018.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Syncope
Clinical narrative: Syncope after vaccination child stayed at the office for 15 mins and was well.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: C-reactive protein normal, Influenza virus test negative, Metabolic function test normal, Otitis media, Pyrexia
Clinical narrative: Fever 105 less than 5 hr. after vaccine administration in context of afebrile OM. Flu and RSV neg. WBC 19.5 with left shift, CRP less than 0.3, UA RBC 10 and WBC 5/HPF, CMP normal. Normal PE at time of fever and normal PE at follow up 2 wk. later.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Red blood cells urine positive, Respiratory syncytial virus test negative, Shift to the left, White blood cell count increased, White blood cells urine negative
Clinical narrative: Fever 105 less than 5 hr. after vaccine administration in context of afebrile OM. Flu and RSV neg. WBC 19.5 with left shift, CRP less than 0.3, UA RBC 10 and WBC 5/HPF, CMP normal. Normal PE at time of fever and normal PE at follow up 2 wk. later.
Age: 13.0
Sex: M
Vaccine: FLUC4
Symptoms: Influenza, Vaccination failure
Clinical narrative: This is serious spontaneous case, initially received on 12-Feb-2018, reported by other non-health professional, concerns a 13-year-old, adolescent, male patient. On 30-Sep-2017, the patient was administered with FLUCELVAX QIV (route of administration: intramuscular, anatomical location: right deltoid, batch number: 195210, dose, expiry date: not reported). On 12-Feb-2018, 4 months 14 days after vaccination, the patient was diagnosed with type A Influenza [considered as vaccination failure (lack of efficacy)]. At the time of this report, the outcome of the event type A Influenza was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Gastrointestinal disorder, Haematochezia, Rectal haemorrhage
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of blood in stool in a adult male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced blood in stool (serious criteria GSK medically significant), rectal bleeding (serious criteria GSK medically significant) and gastrointestinal disorder. On an unknown date, the outcome of the blood in stool, rectal bleeding and gastrointestinal disorder were unknown. It was unknown if the reporter considered the blood in stool, rectal bleeding and gastrointestinal disorder to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist was reluctant to report and stated that, she was not sure the cause of the issues but wanted to see if it could be SHINGRIX. The patient had gastrointestinal issues. The pharmacist gave limited information and noted she would report on-line if found to be the vaccine. No further questions were asked.
Age: 1.33
Sex: M
Vaccine: FLU4
Symptoms: Feeling hot, Injection site swelling
Clinical narrative: In the evening of the day flu vaccine given, Mom reported patient "felt very hot" but temperature was not taken. Per Mom pt's left leg began to swell at injection site 24 hours after vaccine received.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Flatulence, Gastrointestinal pain, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of air in intestines in a 59-year-old male patient who received SHINGRIX. On 5th February 2018 19:30, the patient received the 1st dose of SHINGRIX .5 ml. On 5th February 2018, less than a day after receiving SHINGRIX, the patient experienced myalgia and fatigue. On 6th February 2018, the patient experienced injection site pain. On 9th February 2018, the patient experienced air in intestines and gastrointestinal pain. In February 2018, the patient experienced shivering. In February 2018, the outcome of the injection site pain, shivering, myalgia and fatigue were recovered/resolved. On an unknown date, the outcome of the air in intestines and gastrointestinal pain were not recovered/not resolved. It was unknown if the reporter considered the air in intestines, gastrointestinal pain, injection site pain, shivering, myalgia and fatigue to be related to SHINGRIX. Additional information was reported as follows: The patient received SHINGRIX in the left arm. The patient received vaccine at 19:30 hours on 5th February 2018. On 9th February 2018, 4 days after receiving SHINGRIX, the patient experienced intestinal gas and gastrointestinal pain. On 6th February 2018, a day after the vaccination, the patient experienced injection site pain that and it was lasted for 4 days. On 6th February 2018, 9 hours 30 minutes, after receiving SHINGRIX, the patient experienced shivering that started at approximately 5:00 am and lasted for 24 hours after the vaccination. On 5th February 2018, less than a day, after receiving SHINGRIX, the patient experienced myalgia, and fatigue which were worse for the first 24 hours after the vaccination and lessened over the next two days. The patient felt so bad the next day after the injection that he did not go into work until 11:30am. The myalgia and fatigue resolved after 3 days. The patient had denied permission to contact their physician. Reporter did not have the lot number and expiration date for the product.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of air in intestines in a 59-year-old male patient who received SHINGRIX. On 5th February 2018 19:30, the patient received the 1st dose of SHINGRIX .5 ml. On 5th February 2018, less than a day after receiving SHINGRIX, the patient experienced myalgia and fatigue. On 6th February 2018, the patient experienced injection site pain. On 9th February 2018, the patient experienced air in intestines and gastrointestinal pain. In February 2018, the patient experienced shivering. In February 2018, the outcome of the injection site pain, shivering, myalgia and fatigue were recovered/resolved. On an unknown date, the outcome of the air in intestines and gastrointestinal pain were not recovered/not resolved. It was unknown if the reporter considered the air in intestines, gastrointestinal pain, injection site pain, shivering, myalgia and fatigue to be related to SHINGRIX. Additional information was reported as follows: The patient received SHINGRIX in the left arm. The patient received vaccine at 19:30 hours on 5th February 2018. On 9th February 2018, 4 days after receiving SHINGRIX, the patient experienced intestinal gas and gastrointestinal pain. On 6th February 2018, a day after the vaccination, the patient experienced injection site pain that and it was lasted for 4 days. On 6th February 2018, 9 hours 30 minutes, after receiving SHINGRIX, the patient experienced shivering that started at approximately 5:00 am and lasted for 24 hours after the vaccination. On 5th February 2018, less than a day, after receiving SHINGRIX, the patient experienced myalgia, and fatigue which were worse for the first 24 hours after the vaccination and lessened over the next two days. The patient felt so bad the next day after the injection that he did not go into work until 11:30am. The myalgia and fatigue resolved after 3 days. The patient had denied permission to contact their physician. Reporter did not have the lot number and expiration date for the product.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Rash generalised, Rash pruritic
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of generalized rash in a 54-year-old female patient who received SHINGRIX (batch number 3S354, expiry date 4th June 2020). On 9th February 2018, the patient received SHINGRIX. On 9th February 2018, less than a day after receiving SHINGRIX, the patient experienced generalized rash and itchy rash. In February 2018, the patient experienced discomfort. On an unknown date, the outcome of the generalized rash, itchy rash and discomfort were unknown. It was unknown if the reporter considered the generalized rash, itchy rash and discomfort to be related to SHINGRIX. Additional details were provided as follows: There were two reporters who were immunization program coordinators at the clinic who oversee the primary care Immunization program. They stated they received this information from other physicians and nurses regarding the consumer's product experience. Within about 12 hours after receiving the SHINGRIX vaccine, the consumer reported a non-injection site rash. The patient had a generalized rash across the body involving the trunk, described specifically as a flat itchy rash over the chest, back, arms and up the neck. Less than a week after receiving SHINGRIX, the patient had significant discomfort. The patient was alive at the time of reporting, and did not require overnight hospitalization for any of the reported symptoms. The reporter's grant permission to be contacted. The reporter's declined to provide concomitant medications or any further related details beyond what was documented above due to time constraints. This call was transferred to the team. The supervising MD field name was for a nurse practitioner. It was unable to clarify what was meant by significant discomfort during the call due to time constraints.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of rash in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced a bad rash all over the face, eyes and nose. The patient could not get rid of it and was really suffering.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Periarthritis, Vaccination site pain, X-ray limb abnormal
Clinical narrative: Employee states that she developed soreness to vaccine site but pain progressed and went to PCP who diagnosed her with (L) shoulder adhesive capsulitis. She attributes her (L) frozen shoulder from the flu vaccine as per her PCP. She was prescribed tramadol 50 mg BID PRN, Ibuprofen 800 mg Q 8 Hrs PRN x 4 days, PERCOCET 5-325 mg Q 6 hrs. PRN.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Itch, swelling, redness, tenderness at site. Treatment - prednisone and ZYRTEC.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle pain through out body. (mild to moderate). Moderate to severe in arms from shoulder down to hand.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis, Eczema
Clinical narrative: Ongoing dermatitis/eczema all over body. Ongoing chronic flare-ups since the vaccine. Have seen primary, dermatologist and allergist. Used steroids, creams, ointments for over a year. No one can seem to get it under control.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of injection site rash in a female patient who received SHINGRIX. On 7th February 2018, the patient received the 1st dose of SHINGRIX. In February 2018, less than a month after receiving SHINGRIX, the patient experienced injection site rash and injection site burning. On an unknown date, the outcome of the injection site rash and injection site burning were not recovered/not resolved. It was unknown if the reporter considered the injection site rash and injection site burning to be related to SHINGRIX. Additional details were provided as follows: The age of vaccination was not reported. The reporter called because she had a bad reaction to SHINGRIX vaccine and her provider was unsure what to tell to her about whether or not she would have the second dose of vaccine. The patient had a rash at the vaccination site, which was almost felt like an acid burn, it was aggravated at the time of this report, and it was quite a bit more than 3 to 5 days out, which the patient though that one should have this rash. The patient was trying to figure out whether or not she should get the booster or not, and was asking for help.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of injection site rash in a female patient who received SHINGRIX. On 7th February 2018, the patient received the 1st dose of SHINGRIX. In February 2018, less than a month after receiving SHINGRIX, the patient experienced injection site rash and injection site burning. On an unknown date, the outcome of the injection site rash and injection site burning were not recovered/not resolved. It was unknown if the reporter considered the injection site rash and injection site burning to be related to SHINGRIX. Additional details were provided as follows: The age of vaccination was not reported. The reporter called because she had a bad reaction to SHINGRIX vaccine and her provider was unsure what to tell to her about whether or not she would have the second dose of vaccine. The patient had a rash at the vaccination site, which was almost felt like an acid burn, it was aggravated at the time of this report, and it was quite a bit more than 3 to 5 days out, which the patient though that one should have this rash. The patient was trying to figure out whether or not she should get the booster or not, and was asking for help.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). On 13th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain and rash. In February 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the rash was not recovered/not resolved. The reporter considered the injection site pain and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter is the pharmacist who administered the vaccine to the patient in left deltoid. The patient experienced soreness for three days at the site of the injection. The patient also experienced two rashes on her left arm in two different area, not including the site of injection. One rash was on the upper part of her left arm and was larger than the second which was small and located above the larger one. The reporter gave permission to be contacted for further information.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). On 13th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain and rash. In February 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the rash was not recovered/not resolved. The reporter considered the injection site pain and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter is the pharmacist who administered the vaccine to the patient in left deltoid. The patient experienced soreness for three days at the site of the injection. The patient also experienced two rashes on her left arm in two different area, not including the site of injection. One rash was on the upper part of her left arm and was larger than the second which was small and located above the larger one. The reporter gave permission to be contacted for further information.
Age: 25.0
Sex: F
Vaccine: HEPAB
Symptoms: Syncope
Clinical narrative: Patient fainted.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The day after the vaccine was received (2-21-18), patient presents to the pharmacy around 8 PM with an injection site reaction. Pt's experienced erythema, swelling, warmth, with a defined border of 3 inches by 4 inches. Pt also was experiencing soreness. Pt did not say that there were any adverse effects the same day as the vaccine (2-20) except soreness. This had gradually worsened throughout the day (2-21). I told the patient to put some hydrocortisone cream to help with the swelling, take a BENADRYL, and then ice the areas (since the heat was really concerning her). Will follow up with patient 2-22.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse, referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-AUG-2016 and 15-OCT-2016, the patient was vaccinated with the first and second doses (respectively) of GARDASIL 9 lot # L035105 with expiration date on 14-MAY-2017 (administration route and anatomical location were not reported) for prophylaxis. Later, on 25-NOV-2016, the patient was vaccinated with the third dose of GARDASIL 9 lot # M031557 with expiration date on 07-APR-2019 (administration route and anatomical location were not reported) for prophylaxis. The reporting nurse stated that the patient "received the full three dose series of GARDASIL 9 outside of the recommended dosing schedule". No adverse effects reported.
Sex: U
Vaccine: HEPA, HPV9, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a multiple patients of unknown age and gender. On an unknown dates, unspecified amount of patients were vaccinated with improperly stored ROTATEQ lot number: N003984, expiry date 19-NOV-2018 and N003978, expiry date: 04-NOV-2018, GARDASIL 9 lot number: N021475, expiry date: 31-JAN-2020), M-M-R II (lot number: N009172 expiry date: 20-MAR-2019 and N013279 expiry date 28-APR-2019) and VAQTA (lot number: N019924 expiry date: 02-SEP-2018 and lot number: N008823 expiry date: 26-MAY-2018) (doses, strengths and frequencies were not reported) for prophylaxis. Sterile diluent sterile diluent (MRK INJ) was stored properly. The vaccines in refrigerator one (GARDASIL 9, ROTATEQ and VAQTA) had undergone Temperature excursion of 32 F to 35 F (33.8F) for multiple time frame of 18 hours and 45 minutes. The vaccines in refrigerator two (GARDASIL 9, ROTATEQ, VAQTA and MMR II) had undergone Temperature excursion of 47 F to 77 F (52.9F) for multiple time frame of 8 hours and 30 minutes. It was reported that there were no previous temperature excursions. Call was because of a data logger. No adverse effects were reported. No product quality complaint was involved. No further information was available. Follow up information has been received from a nurse on 16-FEB-2018. The Nurse reported that the vaccine M-M-R II with a Lot # N009172 and expiration date 20-MAR-2019, experienced a temperature excursion of 47 to 77  Fahrenheit (51.8°F) for 4 hours and 44 minutes, with a previous temperature excursion of 44 F to 77 F (52.9 °F) for 1 hour and 53 minutes, as recorded by a data logger. It was also reported that the Lot # N013279, expiration date 28-APR-2019 for the vaccine M-M-R II, experienced a temperature excursion of 47 to 77 Fahrenheit (51.8°F) for 1 hour and 53 minutes, with no previous temperature excursion.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Hot flush, Injection site mass, Loss of personal independence in daily activities
Clinical narrative: This spontaneous report was received from patient's mother who is also a pharmacist and refers to her 15-year-old daughter. The patient's concurrent conditions included with migraine, asthma and severe food allergy. On 15-SEP-2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, (dose, anatomical location, lot# and expiration date were not reported). On 05-FEB-2018, the patient received the second dose of the GARDASIL 9 intramuscularly (dose, anatomical location, lot# and expiration date were not reported). Concomitant therapies included SINGULAIR. On 06-FEB-2018, also reported as on Tuesday, the patient experienced a really bad headache. On 07-FEB-2018, reported as on Wednesday, the patient felt dizzy, had a headache, and was nauseous. On Thursday, the patient stayed home from school and still felt dizzy, had a headache, and was nauseous. On Friday, the patient felt a little bit better but on approximately 10-FEB-2018, (Saturday), she had hot flashes and nausea. Subsequently, on Sunday she dry heaved and threw up all day (onset date in approximately 11-FEB-2018). Since an unknown date in February 2018, the patient had a lump at the injection site. The patient was treated with EXCEDRIN MIGRAINE and ZOFRAN (detail were not provided). According to the reporter none of the treatments worked. At the reporting time, the patient had scheduled visit with the physician and missed three days of school. The outcome of the events was reported as not recovered. The relatedness between the events and GARDASIL 9 therapy was not provided.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Retching, Vomiting
Clinical narrative: This spontaneous report was received from patient's mother who is also a pharmacist and refers to her 15-year-old daughter. The patient's concurrent conditions included with migraine, asthma and severe food allergy. On 15-SEP-2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, (dose, anatomical location, lot# and expiration date were not reported). On 05-FEB-2018, the patient received the second dose of the GARDASIL 9 intramuscularly (dose, anatomical location, lot# and expiration date were not reported). Concomitant therapies included SINGULAIR. On 06-FEB-2018, also reported as on Tuesday, the patient experienced a really bad headache. On 07-FEB-2018, reported as on Wednesday, the patient felt dizzy, had a headache, and was nauseous. On Thursday, the patient stayed home from school and still felt dizzy, had a headache, and was nauseous. On Friday, the patient felt a little bit better but on approximately 10-FEB-2018, (Saturday), she had hot flashes and nausea. Subsequently, on Sunday she dry heaved and threw up all day (onset date in approximately 11-FEB-2018). Since an unknown date in February 2018, the patient had a lump at the injection site. The patient was treated with EXCEDRIN MIGRAINE and ZOFRAN (detail were not provided). According to the reporter none of the treatments worked. At the reporting time, the patient had scheduled visit with the physician and missed three days of school. The outcome of the events was reported as not recovered. The relatedness between the events and GARDASIL 9 therapy was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not reported. On 19-FEB-2018, the patient was vaccinated with properly stored but expired dose of M-M-R II (lot # M004063, expiry date: 25-JAN-2018) reconstituted with properly stored sterile diluent, for prophylaxis. No adverse effects were reported.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Eye pain, Fatigue, Headache, Injection site pain
Clinical narrative: Extreme soreness in upper left arm at the site of the injection; extreme fatigue (starting about 4 hours after the injection); headache (particularly behind the eyes); aching in joints all over the body.
Age: 51.0
Sex: U
Vaccine: FLU4, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). Co-suspect products included Influenza vaccine Quadrivalent. On 29th January 2018, the patient received SHINGRIX .5 ml and Influenza vaccine Quadrivalent. On an unknown date, less than a month after receiving SHINGRIX and Influenza vaccine Quadrivalent, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX and Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The health care professional (pharmacist) stated that a patient reported that receiving a SHINGRIX and flu vaccine on the same office visit on 29th January 2018. The patient reported to health care professional contracting shingles soon after. The health care professional declined to share any patient information regarding this potential adverse event. Only shared the vaccine information. The health care professional stated that he/she would speak with safety department with more information once they speak to the patient first.
Sex: F
Vaccine: MENB
Symptoms: Injection site discolouration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site discoloration in a adult female patient who received BEXSERO. Previously administered products included BEXSERO (1st dose received on an unknown date). On 25th January 2018, the patient received the 2nd dose of BEXSERO (intramuscular). On 26th January 2018, 1 days after receiving BEXSERO, the patient experienced injection site discoloration. On an unknown date, the outcome of the injection site discoloration was unknown. The reporter considered the injection site discoloration to be probably related to BEXSERO. Additional details were reported as follows: This case was previously reported to a doctor. The reporter was the patient's mother. The age at vaccination was not reported. A college age patient experienced a white ring around the injection site on her right arm. The date of the first dose was not known at time of report. The patient had denied permission to contact their physician.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Pyrexia, Rash generalised
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of widespread rash in a 49-year-old female patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020). On 15th February 2018, the patient received SHINGRIX. On 15th February 2018, less than a day after receiving SHINGRIX, the patient experienced widespread rash (serious criteria disability). On 16th February 2018, the patient experienced fever. On an unknown date, the outcome of the widespread rash and fever were unknown. It was unknown if the reporter considered the widespread rash and fever to be related to SHINGRIX. Additional details were provided as follows: The health care professional stated that the patient received a dose of SHINGRIX the day before the date of reporting and experienced diffuse rash later that evening. On 16th February 2018, 1 day after vaccination, the patient experienced fever. The patient's body temperature was recorded as 102 degree F. The patient was on their way in for an office visit. No further information was reported regarding the event.
Age: 35.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Medication Error - Client given pediatric dose of Hepatitis A vaccine.
Age: 70.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Medication error, client given pediatric dose of Hepatitis A vaccine.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Cough, Rash, Rhinorrhoea, Skin lesion, Varicella post vaccine
Clinical narrative: On 2/20/2018 patient seen in office with cough, runny nose and bumps on legs and face. No fever.  Diagnosed with vaccine induced varicella. Had at least 50 lesions
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Medication error:  client received a pediatric dose of Hepatitis A vaccine.
Sex: U
Vaccine: MMRV, VARCEL, VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age or gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, multiple unspecified patients were vaccinated with improperly stored ZOSTAVAX lot #N021171 expiration date on 01-NOV-2018; VARIVAX lot #N020014, expiration date on 17-JUL-2019, lot #N020015, expiration date on 17-JUL-2019 and lot #N024566, expiration date on 07-SEP-2019; and PROQUAD Albumin status of rHA (recombinant human albumin) for lot #N024563 expiration date on 06-MAR-2019, lot #N025718 expiration date on 17-MAR-2019 and lot #N023965 expiration date on 28-FEB-2019, (strength, doses, routes and anatomical locations were not reported) for prophylaxis; which experienced a temperature excursion between 6 and 14 Fahrenheit degrees (F) (13.1 F) for 2 hours. No previous temperature excursions were reported. Data logger was involved. No adverse effect reported. A product quality complaint was not involved. The vaccines were reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No further information was provided.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse referring to a patient of unknown age or gender.  The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 26-JAN-2018, the patient was vaccinated with PROQUAD Albumin status of rHA (recombinant human albumin) for lot # N021728, expiration date on 06-FEB-2019, in addition to M-M-R II lot #M045391 and expiration date on 14-NOV-2018; subcutaneously for prophylaxis (strength, doses and anatomical locations were not reported). No adverse effect was reported and no additional information was provided. Sterile diluent (lot # M034911 and expiration date on 05-MAY-2019) was used.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a nurse concerning two unspecified patients. There was no information about patients' concurrent conditions, medical history or concomitant medications.  On unspecified dates, the patients ware vaccinated with PNEUMOVAX 23 lot # N024385 with expiration date of 18-MAY-2019, (route of administration and anatomical location were not reported) for prophylaxis. On an unknown dates, the patients experienced localized pain (injection site pain), swelling (injection site swelling) and warmth at injection site. The outcome of injection site pain, injection site swelling and  injection site warmth and the causal relationship between the events and therapy with PNEUMOVAX 23 were not reported.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash, Rash pustular, Scab
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 58 year old  male patient. The patient's medical history included unspecified accident in 2017 reported as "last year". It was reported that patient had no concomitant medications, drug reactions and allergies. Information regarding patient's concurrent conditions, past therapies were not reported. On 02-FEB-2018 the patient was vaccinated with ZOSTAVAX vial "19400 plaque-forming units (PFU)", lot # N023321, expiry date: 22-NOV-2018 whose dose and frequency were not reported for shingles prevention. On an unspecified date in February 2018 patient had returned to the pharmacy with rash "pustules " on right arm and back on his right side (pustular rash). It was reported that on an unspecified date in February 2018, patient may have started with rash before visit to the pharmacy as he mentioned there may have been a flare up a few days post vaccination then blisters crusted when patient came to the pharmacy on 10-FEB-2018, the blisters looked more newly filled. The reporter did not state patient ever had shingles in the past or was immunocompromised. It was reported that medical attention was sought but no treatment was given to the adverse events. No lab diagnostics or studies performed. The outcome of the events was reported as not recovered. The reporter did not provide the causal relationship of events with ZOSTAVAX. It was reported that there was no product quality complaint (PQC) was involved.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse practitioner, concerning a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 01-FEB-2018, the patient was vaccinated with an improperly stored dose of M-M-R II, lot number M016233 with expiration date in 31-MAR-2018 (strength, dose, dose number, route of administration and anatomical location were not provided), for prophylaxis. The M-M-R II dose was stored at a temperature range of 47 degrees Fahrenheit (degrees F) to 77 degrees F for the time frame of 15 minutes and 45 seconds. There was no previous temperature excursion and the call was because of a data logger. No adverse effects reported. Product Brand: M-M-R II; Lot number: M016233; Expiration Date: 31-MAR-2018; Date of administration of Vaccine:  01-FEB-2018.  Date of Excursion, Temperature of Excursion, Duration of Excursion: 06-FEB-18, 32.90 F degrees, 34 secs; 05-FEB-18, 48.5, 33.8 F degrees, 4 mins 30 secs; 01-FEB-18, 48.20 F degrees, 5 mins 13 secs; 31-JAN-18, 48.30 F degrees, 6 mins 2 secs; 30-JAN-18, 32.50 F degrees, 2 mins 3 secs; 29-JAN-18, 33.40 F degrees, 3 mins 10 secs; 28-JAN-18, 33.80 F degrees, 3 mins 22 secs; 27-JAN-18, 33.00 F degrees, 3 mins 3 secs; 26-JAN-18, 33.20 F degrees, 3 mins 37 secs; 25-JAN-18, 32.50 F degrees, 4 mins 55 secs; 24-JAN-18, 33.40 F degrees, 3 mins 36 secs; 23-JAN-18, 33.80 F degrees, 3 mins 30 secs; 22-JAN-18, 33.40 F degrees, 2 mins 56 secs; 21-JAN-18, 33.60 F degrees, 2 mins 55 secs; 20-JAN-18, 33.90 F degrees, 3 mins 23 secs; 19-JAN-18, 34.50 F degrees, 42 secs.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Full blood count normal, Hepatitis C antibody negative, Injected limb mobility decreased, Injection site pain, Lipids normal
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received PREVNAR 13 at the physician's office via intra-articular (injected into the left shoulder joint) on 10Oct2017 as pneumonia vaccine. Medical history included cataract. He stated no other medical conditions but that he will be having cataract surgery next month. There were no concomitant medications. The patient previously took cortisone injections in his shoulder joint. The patient experienced vaccine administered in the shoulder joint on 10Oct2017 and the next day he saw his orthopedic specialist on 11Oct2017. The patient knew that the injection was not going into the correct place because he had received cortisone injections in his shoulder joint before and he knew it was too high for the vaccine site in the muscle. He stated that this condition was called SIRVA and there was a federal fund set up for claims about this injury. He commented that people have had shoulder replacements due to this. He reported that the injector should have been seated instead of standing when injecting him with the vaccine. He stated that the orthopedic physician confirmed that the vaccine was administered into the left shoulder joint because he could still see the injection site. He experienced a stiffness shoulder and could not move his arm for a week. His orthopedist gave him a cortisone injection for treatment and he was unsure of the dose. It did allow him to move his shoulder again but he still experiences some shoulder and arm pain with movement of his arm. He now had complete movement of his arm, but with pain. He did not have any testing related to the event. He did have a routine physical the day of the injections and routine labwork to include a CBC, lipid panel, and HCV antibody testing that were all normal. The patient just had a shingles vaccine on 14Feb2018 in his right arm. Outcome of the event of could not move his arm was recovered on an unspecified date, for the events of shoulder and arm pain was not recovered, while unknown for the other events. The information on the batch number had been requested.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received PREVNAR 13 at the physician's office via intra-articular (injected into the left shoulder joint) on 10Oct2017 as pneumonia vaccine. Medical history included cataract. He stated no other medical conditions but that he will be having cataract surgery next month. There were no concomitant medications. The patient previously took cortisone injections in his shoulder joint. The patient experienced vaccine administered in the shoulder joint on 10Oct2017 and the next day he saw his orthopedic specialist on 11Oct2017. The patient knew that the injection was not going into the correct place because he had received cortisone injections in his shoulder joint before and he knew it was too high for the vaccine site in the muscle. He stated that this condition was called SIRVA and there was a federal fund set up for claims about this injury. He commented that people have had shoulder replacements due to this. He reported that the injector should have been seated instead of standing when injecting him with the vaccine. He stated that the orthopedic physician confirmed that the vaccine was administered into the left shoulder joint because he could still see the injection site. He experienced a stiffness shoulder and could not move his arm for a week. His orthopedist gave him a cortisone injection for treatment and he was unsure of the dose. It did allow him to move his shoulder again but he still experiences some shoulder and arm pain with movement of his arm. He now had complete movement of his arm, but with pain. He did not have any testing related to the event. He did have a routine physical the day of the injections and routine labwork to include a CBC, lipid panel, and HCV antibody testing that were all normal. The patient just had a shingles vaccine on 14Feb2018 in his right arm. Outcome of the event of could not move his arm was recovered on an unspecified date, for the events of shoulder and arm pain was not recovered, while unknown for the other events. The information on the batch number had been requested.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received PREVNAR 13 (lot number and expiration date requested) via an unspecified route of administration in the left upper arm on 07Feb2018 at a single dose as the patient had pneumonia in 2006 so her physician thought she should get the vaccine. The patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) at the physician's office. Medical history included pneumonia from an unspecified date in 2006. The patient has no family medical history. The patient's concomitant medications were not reported. It was reported that the patient has no previous vaccination within 4 weeks. On 13Feb2018 six days after vaccination, the patient noticed a red mark that got progressively worse in size to about 2.5x2.5 or 3x3. The patient went to her physician on an unspecified date so that she could take a look at it. The physician told the patient to take Allegra for 3 days and maybe prednisone for 5 days depending on the outcome. The patient stated this was the second day that she put an ice on it and has taken Allegra and felt much better. The patient was recovering from red mark that got progressively worse in size.
Sex: F
Vaccine: MENB
Symptoms: Cold sweat, Fatigue, Headache, Hyperhidrosis, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A female patient of an unspecified age received TRUMENBA on an unspecified date at single dose for immunisation.The patient medical history and concomitant medications were not reported. Meningococcal group b rlp2086 was the only shot given at that time. On an unspecified date, 24 hours after the injection, the patient experienced hot and cold sweats, headache, nausea and fatigue. Events were non-serious with outcome of unknown.
Age: 1.25
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: MD notified, no harm to pt; pt did not need this vaccine, MA gave wrong vaccine.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Chest pain, Diarrhoea, Dizziness, Ear pain
Clinical narrative: I started with a headache and chest pains about hr. after shot 1:30 PM. Around 3:30 PM (3 hrs. after shot) my body got tingly, throat felt like it was tight, my tongue felt heavy and tingly, I had diarrhea continually into the evening, nausea, itching all over, hot, body aches, earache, dizziness, headache and I have been tired and weak feeling. Some of the symptoms have lessened but I continue to have a tingly tongue, body aches, headache, ear ache, I just don't feel good.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Feeling abnormal, Feeling hot, Headache, Nausea
Clinical narrative: I started with a headache and chest pains about hr. after shot 1:30 PM. Around 3:30 PM (3 hrs. after shot) my body got tingly, throat felt like it was tight, my tongue felt heavy and tingly, I had diarrhea continually into the evening, nausea, itching all over, hot, body aches, earache, dizziness, headache and I have been tired and weak feeling. Some of the symptoms have lessened but I continue to have a tingly tongue, body aches, headache, ear ache, I just don't feel good.