chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 65-year-old male patient who received SHINGRIX (batch number A2JL7, expiry date 22nd March 2021) for prophylaxis. On 17th September 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). In September 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling and injection site erythema. On 17th September 2018, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. A dose of SHINGRIX was inadvertently administered subcutaneously, which led to inappropriate route of vaccination. On 21st September 2018, the healthcare professional reported that the patient was experiencing redness and swelling at the injection site.
Sex: F
Vaccine: MEN
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of hives in a female patient who received Meningococcal B vaccine for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced hives. On an unknown date, the outcome of the hives was recovered/resolved. It was unknown if the reporter considered the hives to be related to Meningococcal B vaccine. Additional details were reported as follows: The age at vaccination was reported. The reporter's daughter had one on the 29th and experienced hives for over 14 days.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of herpes zoster (vaccination a few years ago). In September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 1 day after receiving SHINGRIX, the patient experienced fever, chills, upset stomach and weakness generalized. On an unknown date, the outcome of the fever, chills, upset stomach and weakness generalized were unknown. It was unknown if the reporter considered the fever, chills, upset stomach and weakness generalized to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received ZOSTAVAX shingles vaccination a few years ago and last year had a very mild case of shingles (a single mark, no itching). The physician said the vaccine had apparently protected me from a more serious case and recommended to get the SHINGRIX vaccine. After several attempts when pharmacy had run out. In September on Friday, the patient received 1st dose of SHINGRIX. The next evening, the patient had fever, chills, upset stomach and general weakness and spent 14 hours in bed. The reporter had already received one dose of older vaccine and one dose of SHINGRIX so she was asking if still she need to receive the 2nd dose of SHINGRIX.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Renal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of renal pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced renal pain and pain in arm. The patient was treated with TYLENOL. On an unknown date, the outcome of the renal pain and pain in arm were unknown. It was unknown if the reporter considered the renal pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient stated that, beside arm being very sore the patient also experienced pain in kidney area on both sides. On 18th September 2018 08:00 am, the patient took 2 TYLENOL and nothing since then. The patient wanted to know was this a side effect. The reporter was not willing to share any contact details.
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO. On an unknown date, less than a week after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient had sore arm for a week after vaccine was given.
Sex: F
Vaccine: FLUX
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a female patient who received Flu unspecified (Influenza vaccine) for an unknown indication. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced adverse event (serious criteria life threatening). On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to Influenza vaccine. Additional details were provided as follows: This case was reported by the patient's mother. The age at vaccination was not reported. The reporter posted on social media that others were taking big chance getting one of these flu shots and advised them to do research on what was in the Flu shot. The mother further stated that she never had flu shot and never had the flu since 1983. However, her daughter got the flu shot and was almost died.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: After shots on Thursday 9/20/18 she ran fever of 101 then began to break-out in rash. Rash started on back went to face and toes. Rash started on Friday morning.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Received Flu vaccine on Monday 9/24/18 (11:45am) at Employee Health. When I woke up the next morning I had a localized reaction at the injection site. It was about 2 inches in diameter, very red, painful, and hot. The pain was not the normal immunization muscle soreness but rather more injury like pain. The reaction remains today (9/26/18) unchanged. I have tried taking Tylenol and applying ice packs to the area and there has been no change.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Fever (100.6 by mouth), body aches, strong headache, vomiting, raised red and hot area at injection site and even larger raised red and hot area below injection site, painful arm, burning at site even 5 days post-injection.
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Fever (100.6 by mouth), body aches, strong headache, vomiting, raised red and hot area at injection site and even larger raised red and hot area below injection site, painful arm, burning at site even 5 days post-injection.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Induration, Pruritus, Skin warm
Clinical narrative: HOT, ITCH AND HARD TO TOUCH AREA.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site erythema, Injection site warmth, Nausea
Clinical narrative: Redness at injection site. 2.5 cm of erythema on left deltoid. Hot to touch. Pt has mild headache and nausea. No fever. Advised to apply warm compresses and watch area for increased redness, swelling and/or fever.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Cytogenetic analysis normal, Decreased eye contact, Developmental regression, Infantile spasms, Partial seizures
Clinical narrative: I'm unsure about the brands of these vaccines. Many of the vaccines were shots, but 1 was oral. Unsure which was a shot and which one was oral, but I am 100% sure of the type of vaccine and the dates. On April 7, 2017, he received these vaccines and on April 15, he began regressing developmentally (no eye contact, inability to track objects, lack of baby sounds). All things that he did well before, as he passed his 2 month check-up, the day of the shots. On April 30, following the regression, he presented the first spasm, and on May 1, he was officially diagnosed with Infantile Spasms (IS) and Multi-focal Epilepsy. He was treated with Prednisolone (steroids) on 2 May, 2017 and TOPAMAX, and all spasms stopped by June 5th. He went 3 months spasm free and began developing again. On August 1, he took the 6 month vaccines (DTAP/HEP B/IPV and PNEUMOCOCCAL Conjugate13-Valent). On Sept 1, 2017, the spasms returned; the delay of spasm return was likely due to the large amount of steroids he still had in his system. He was treated with Prednisolone again on 1 Sept for 3 weeks, and after not working, he began Vigabatrin and continued with TOPAMAX. All spasm stopped on October 5, 2017. He has received no more vaccines since August 1, and remains spasm-free to date. Stopped taking Vigabatrin in April 2018.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Visual tracking test abnormal
Clinical narrative: I'm unsure about the brands of these vaccines. Many of the vaccines were shots, but 1 was oral. Unsure which was a shot and which one was oral, but I am 100% sure of the type of vaccine and the dates. On April 7, 2017, he received these vaccines and on April 15, he began regressing developmentally (no eye contact, inability to track objects, lack of baby sounds). All things that he did well before, as he passed his 2 month check-up, the day of the shots. On April 30, following the regression, he presented the first spasm, and on May 1, he was officially diagnosed with Infantile Spasms (IS) and Multi-focal Epilepsy. He was treated with Prednisolone (steroids) on 2 May, 2017 and TOPAMAX, and all spasms stopped by June 5th. He went 3 months spasm free and began developing again. On August 1, he took the 6 month vaccines (DTAP/HEP B/IPV and PNEUMOCOCCAL Conjugate13-Valent). On Sept 1, 2017, the spasms returned; the delay of spasm return was likely due to the large amount of steroids he still had in his system. He was treated with Prednisolone again on 1 Sept for 3 weeks, and after not working, he began Vigabatrin and continued with TOPAMAX. All spasm stopped on October 5, 2017. He has received no more vaccines since August 1, and remains spasm-free to date. Stopped taking Vigabatrin in April 2018.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dyspepsia, Nausea, Pyrexia
Clinical narrative: Chills, fever started early morning next day. Nausea, weakness, and fever of 101.6 through out most of the day. Heartburn was also a symptom. Had chills and fever again over night. Today lower fever of 99.6 this morning but looks like the fevers has gone as of 11:30 this morning.
Age: 31.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Muscular weakness, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Extreme soreness and weakness in left arm, sore throat, constant headache, body aches, all symptoms started the morning after vaccination and have persisted so far x 2 days.
Age: 71.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: Patient said her right thumb on top keeps going numb. I referred her to her primary doctor.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Very sore arm, fever and chills, headache.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at injection site.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Paraesthesia
Clinical narrative: Patient experienced numbness and tingling down the arm to the fingers as soon as the vaccine was administered. She is still experiencing the numbness and tingling a day later on the arm that was vaccinated.
Age: 11.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Dyskinesia, Immediate post-injection reaction, Skin discolouration, Tearfulness, Tension
Clinical narrative: Patient presented very anxious prior to vaccines; delayed administration due to patient not cooperative and resisting with 2 nurses present as well as parent. Patient's mother responded in hostile manner which escalated patient's anxiety levels. Patient did sit still and cooperate for vaccines; requested both in right arm and immediately after doses given patient responded with "shaking" movements to whole body, tense presentation, dusky appearance to skin, tearful and non-verbal which lasted 2minutes. Patient vitals obtained.
Age: 11.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Tremor
Clinical narrative: Patient presented very anxious prior to vaccines; delayed administration due to patient not cooperative and resisting with 2 nurses present as well as parent. Patient's mother responded in hostile manner which escalated patient's anxiety levels. Patient did sit still and cooperate for vaccines; requested both in right arm and immediately after doses given patient responded with "shaking" movements to whole body, tense presentation, dusky appearance to skin, tearful and non-verbal which lasted 2minutes. Patient vitals obtained.
Age: 43.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from nurse via a company representative and refers to a 43-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with PROQUAD (dose, frequency, route of administration, lot number, expiration date were not provided) for prophylaxis. Other suspect therapies included sterile diluent (manufacturer unknown) (lot number and expiration date were not provided). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Between 14-SEP-2018 and 17-SEP-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R006752, expiration date 06-MAR-2020 for prophylaxis. Sterile diluent (manufacturer unknown) was stored properly. The vaccine underwent a temperature excursion of -9 to 8 degrees Celsius for 21 hours and 35 minutes. There was no previous temperature excursion. The digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA011766.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to her 4.5 year old grandson. The patient's concurrent conditions, medical history, drug allergies/reactions and concomitant medications, if any, were not reported. On an unknown date, the patient was vaccinated with PROQUAD, intramuscular rather than subcutaneous (dose number, dosage, frequency, anatomical site of vaccination, lot number and expiration date were not reported) for prophylaxis. Additionally, no adverse events were reported.
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Tonic clonic movements
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 11 year old male patient. Information regarding the patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On 31-AUG-2018, the patient was vaccinated with a dose of GARDASIL 9 (lot#, expiry date and strength unspecified) via intramuscular route, for prophylaxis. The reporter stated that shortly after the vaccination, the patient experienced tonic clonic movements and passed out. She sought medical attention and was in the physician's office at the time. The events recovered on an unspecified date in 2018 (also reported as present status unknown). Causality assessment was not provided. Upon internal review, tonic clonic movements and loss of consciousness were determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Between 14-SEP-2018 and 17-SEP-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R006752, expiration date 06-MAR-2020 for prophylaxis. Sterile diluent (manufacturer unknown) was stored properly. The vaccine underwent a temperature excursion of -9 to 8 degrees Celsius for 21 hours and 35 minutes. There was no previous temperature excursion. The digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA008086.
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Mobility decreased, Myalgia
Clinical narrative: Initial information received on 20-Sep-2018 regarding an unsolicited valid serious case received from a Nurse via sales representative. This case involves a male patient (age was not reported) (reporter's father) who experienced severe myalgia, extreme fatigue and he could barely lift his head, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date (reported as sometime in the last 2 weeks), the patient received a 0.5 ml of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported. On an unknown date ¸the patient developed a serious severe myalgia, extreme fatigue and the patient could barely lift his head  following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. The patient didn't experience any fever. No lab data reported. Final diagnosis was barely lift his head, extreme fatigue duration was two-days and severe myalgia (duration was two-days). It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered / Resolved on an unknown date for severe myalgia (lasted for two days), as Recovered / Resolved on an unknown date for extreme fatigue (lasted for two days) and as Unknown for he could barely lift his head.; Sender's Comments: This case involves an elderly male patient who experienced myalgia, fatigue and head discomfort after vaccination with FLUZONE HD. Time to onset is unknown. However, further information including patient's medical history, condition at the time of vaccination, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Age: 52.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Received FLUBLOK in left arm. In about an hour started itching. Next morning woke with red arm, swollen and hot. 4.5 inches across and 3.25 inches vertically. Continues to itch.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: EDC 10/22/18, Dime sized reddened area that continued to spread. Warm and firm to touch.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Pruritus, Vomiting
Clinical narrative: Pt was administered shot. Pt was in waiting room approx. 15 minutes later c/o nausea, with vomit x1. Dizzy, and itching. No breathing issues or swallowing issues. Pt A&Ox3 and VSS. Pt was given 50mg of BENADRYL by mouth. Pt was observed for 30 minutes after administration. All symptoms resolved. Was assessed by provider and deemed safe to go home. Pt ambulated to taxi without issue.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain upper, Arthralgia, Chills, Flank pain, Pyrexia
Clinical narrative: High fever, shivers, joint pain, stomach ache, pain along sides of trunk.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient describes soreness in arm and restriction of motion that has not subsided since the injection.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fluid retention, Peripheral swelling, Skin reaction
Clinical narrative: Patient states she felt some fluid build-up start on the evening of the injection at lower part of arm close to her elbow. She states the swelling became worse over the next day and turned red. She scheduled an appointment with her doctor for Wednesday 9/26/18.  He prescribed her Augmentin 875mg BID for 7 days.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives and welts on skin everywhere on body.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Localized rash to left arm, steroids, BENADRYL, ZYRTEC.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Abscess, Culture, Incisional drainage, Pain
Clinical narrative: Immunization given 8/29/18. Per ED note pain started 9-1-18. Went to ED 9-5-18 3cm abscess. I and D with follow up 9-7-18.
Age: 19.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Syncope
Clinical narrative: Syncope after given injections.
Age: 1.33
Sex: M
Vaccine: FLU4
Symptoms: Bronchiolitis, Chest X-ray normal, Condition aggravated, Cough, Dyspnoea
Clinical narrative: Intermittent /waxing/waning cough & congestion over 4-5 weeks prior. Had been dx'd with allergic rhinitis and sinusitis prior to vaccine - on antihistamines and antibiotics. Afebrile prior to and after vaccination. In the 48 hrs following vaccination, worsening cough / congestion and work of breathing requiring admission to hospital. Clinically consistent with bronchiolitis. Required brief (~ 36 hr) hospitalization with steroids, bronchodilators, oxygen by nasal cannula, though unlikely reactive airway disease.
Age: 1.33
Sex: M
Vaccine: FLU4
Symptoms: Enterovirus test positive, Human rhinovirus test positive, Respiratory tract congestion
Clinical narrative: Intermittent /waxing/waning cough & congestion over 4-5 weeks prior. Had been dx'd with allergic rhinitis and sinusitis prior to vaccine - on antihistamines and antibiotics. Afebrile prior to and after vaccination. In the 48 hrs following vaccination, worsening cough / congestion and work of breathing requiring admission to hospital. Clinically consistent with bronchiolitis. Required brief (~ 36 hr) hospitalization with steroids, bronchodilators, oxygen by nasal cannula, though unlikely reactive airway disease.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Erythema multiforme, Myalgia, Urticaria
Clinical narrative: Immunization given 9/20/2018. Hives started 3am 9/24/18, Erythema multiforme 5am 9/25/18. Seen in ER, given IFV, IV solumedrol, pepcid, 50mg prednisone. 9/26/18 8am seen in office, ongoing erythema multiforme, now with oral mucosal involvement, myalgias and arthralgias. Transferred to tertiary care center for ongoing management.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site of injection. Unknown if Hib or PCV13 reaction. Child in no distress.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse outcome.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient called 9-26-18 after receiving both the FLUZONE HD and PNEUMOVAX 23 immunizations on 9-24-18. Complained about left arm hurting and red. He came into the pharmacy where I looked at this reaction. The injection site looked fine, but down the inside aspect of his left arm and down around the outer aspect of his elbow was all red. I called his physician and they immediately took him in for an appointment. They prescribed Bactrim DS q12h for 7 days.
Age: 0.17
Sex: M
Vaccine: HIBV, PNC13, RV1
Symptoms: Enema administration, Full blood count, Intestinal operation, Intussusception, Metabolic function test
Clinical narrative: Patient developed recurrent vomiting and was ultimately diagnosed with intussusception requiring successful operative reduction after failed fluoroscopy enema.
Age: 0.17
Sex: M
Vaccine: HIBV, PNC13, RV1
Symptoms: Ultrasound scan, Urine analysis, Vomiting, X-ray
Clinical narrative: Patient developed recurrent vomiting and was ultimately diagnosed with intussusception requiring successful operative reduction after failed fluoroscopy enema.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Hypersensitivity, Peripheral swelling, Skin warm
Clinical narrative: Red, swollen, fever in arm. Over half way around her arm. Flu given in bottom of left arm, pneumonia in top left arm. Pt went to the MD. he told her it was an allergic reaction. She stated that he gave her antibiotics and that she will get the flu shot again because it will beat getting the flu. (The reaction beats getting the flu). The doctor also stated, acc to her, that it would be ok for her to get the flu shot again. On Tuesday, yesterday, she told employee, that it was alot better.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dysgeusia, Dyspnoea, Hyperhidrosis
Clinical narrative: 15-20 min after receiving flu vaccination, patient reported lightheaded, metallic taste, shortness of breath, and diaphoresis.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Diplopia, Fall, Fatigue, Gait disturbance
Clinical narrative: Double vision, tingling in feet, abnormal walking, fell into wood chair at home, weak and tired. Patient call us and md today, Dr.'s office told her to go to the Emergency Room.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Double vision, tingling in feet, abnormal walking, fell into wood chair at home, weak and tired. Patient call us and md today, Dr.'s office told her to go to the Emergency Room.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Decreased appetite, Pruritus, Rash, Urticaria
Clinical narrative: Patient is a 2 year old male brought in by father who presents with complaints of hives. Got flu shot today at 10 am - Quadr PF (FLUARIX, FLULAVAL) about 1 hr later developed rash; noticed first in stomach and groin area; raised and bumpy has been scratching at it has had flu shot previously; no egg allergy; previously received QuadrPF (FLUZONE) med: Benadryl 1 tsp at 12:30 pm; did not have anything to eat; only played with mounted toys in waiting room; right now its his nap time; was about to eat lunch and started to scratch; did not eat lunch rash is less raised and bumpy after benadryl;  Had seen ENT prior to iz apt had ears checked; tube still in canal had audio test also.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Nausea, Rash generalised, Skin warm
Clinical narrative: Patient wife called me on 9/26/18 and reported that starting the day after the injection, Sunday morning, the patient experienced nausea and lethargy. He also had a all over body rash. She said he felt warm to touch but was not running a fever as the thermometer was reading 98.5 and 98.7. The wife said the patient was not experiencing itching or pain with the rash. I asked that she call the family doctor, and make him aware of the reaction to determine if there was anything the doctor wanted the patient to do to relieve some of the symptoms he was experiencing.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 29-JUN-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) PROQUAD (rHA, lot # R002931, expiration date 29-JUL-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# M039639, expiration date 28-MAY-2019). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Fatigue, Headache, Idiopathic urticaria, Loss of personal independence in daily activities, Pain
Clinical narrative: This spontaneous report was received from a patient's mother, referring to his 10 year old male son. The patient did not have pertinent medical history, concurrent conditions, allergies, drug reactions or concomitant medications reported. On 14-SEP-2016 the patient was vaccinated with the first dose of GARDASIL 9 and on 23-NOV-2016, he received the second dose (0.5 ml in each dose, route was not provided). The patient did not experience any adverse event after the first two doses. On 27-MAR-2017, the patient was vaccinated with the third dose of GARDASIL 9 injection, at 0.5 ml (lot #, expiration date, route and anatomical location of administration were not reported) given to prevent HPV. On 10-APR-2017, reported as "about two weeks after the third dose'', the patient experienced started to experience "very high fevers'', terrible headaches, and achiness. Subsequently, he also experienced fatigue on an unspecified Friday (exact date not provided) after the third dose was given, and approximatelly in April 2017 by (the following) monday, he developed a rash on his torso and back that was raised, red and itchy. Afterwards, the patient was diagnosed with idiopathic urticaria, and he was prescribed with an unspecified medication to treat the rash; it was unknown if the treatment was effective. On an unknown date, the patient recovered from the fever, however the rash, as reported ''comes and goes''. On an unmentioned date, the patient underwent an unspecified test reported as ''marker type things'' and a bloodwork but results were not provided. The patient had been on unknown antibiotics and "several other things" but none of these treatments were effective. At the reporting time, he was still experiencing headaches and fatigue and the patient's mother referred that this was ''unusual for an active kid''. Additionally, it was stated that he had missed a lot of school due to the events. The outcome of idiopathic urticaria was reported as recovering. The causal relationship between vaccination with GARDASIL 9 and the events was not mentioned. The idiopathic urticaria was considered serious due to disability.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report was received from a patient's mother, referring to his 10 year old male son. The patient did not have pertinent medical history, concurrent conditions, allergies, drug reactions or concomitant medications reported. On 14-SEP-2016 the patient was vaccinated with the first dose of GARDASIL 9 and on 23-NOV-2016, he received the second dose (0.5 ml in each dose, route was not provided). The patient did not experience any adverse event after the first two doses. On 27-MAR-2017, the patient was vaccinated with the third dose of GARDASIL 9 injection, at 0.5 ml (lot #, expiration date, route and anatomical location of administration were not reported) given to prevent HPV. On 10-APR-2017, reported as "about two weeks after the third dose'', the patient experienced started to experience "very high fevers'', terrible headaches, and achiness. Subsequently, he also experienced fatigue on an unspecified Friday (exact date not provided) after the third dose was given, and approximatelly in April 2017 by (the following) monday, he developed a rash on his torso and back that was raised, red and itchy. Afterwards, the patient was diagnosed with idiopathic urticaria, and he was prescribed with an unspecified medication to treat the rash; it was unknown if the treatment was effective. On an unknown date, the patient recovered from the fever, however the rash, as reported ''comes and goes''. On an unmentioned date, the patient underwent an unspecified test reported as ''marker type things'' and a bloodwork but results were not provided. The patient had been on unknown antibiotics and "several other things" but none of these treatments were effective. At the reporting time, he was still experiencing headaches and fatigue and the patient's mother referred that this was ''unusual for an active kid''. Additionally, it was stated that he had missed a lot of school due to the events. The outcome of idiopathic urticaria was reported as recovering. The causal relationship between vaccination with GARDASIL 9 and the events was not mentioned. The idiopathic urticaria was considered serious due to disability.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 11-JUL-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) VARIVAX (lot # N029634, expiration date 23-OCT-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# R002715, expiration date 20-FEB-2020). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 11-JUL-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) PROQUAD (rHA, lot # R002931, expiration date 29-JUL-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# M039639, expiration date 28-MAY-2019). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 19-JUL-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) PROQUAD (rHA, lot # R002931, expiration date 29-JUL-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# M039639, expiration date 28-MAY-2019). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 19-JUL-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) PROQUAD (rHA, lot # R002931, expiration date 29-JUL-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# M039639, expiration date 28-MAY-2019). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 10-AUG-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) PROQUAD (rHA, lot # R002931, expiration date 29-JUL-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# M039639, expiration date 28-MAY-2019). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 17-AUG-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) PROQUAD (rHA, lot # R002931, expiration date 29-JUL-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# M039639, expiration date 28-MAY-2019). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 14-SEP-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) PROQUAD (rHA, lot # R002931, expiration date 29-JUL-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# M039639, expiration date 28-MAY-2019). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 05-SEP-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) PROQUAD (rHA, lot # R002931, expiration date 29-JUL-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# M039639, expiration date 28-MAY-2019). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 08-AUG-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) VARIVAX (lot # N029634, expiration date 23-OCT-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# R002715, expiration date 20-FEB-2020). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 08-AUG-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) VARIVAX (lot # N029634, expiration date 23-OCT-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# R002715, expiration date 20-FEB-2020). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.