chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Blepharospasm, Excessive eye blinking
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of excessive eye blinking in a 15-year-old male patient who received FLULAVAL QUADRIVALENT for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced excessive eye blinking and blepharospasm. On an unknown date, the outcome of the excessive eye blinking and blepharospasm were unknown. It was unknown if the reporter considered the excessive eye blinking and blepharospasm to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: This case was reported by the patient's father. The patient who was athletic and healthy received a dose of FLULAVAL QUADRIVALENT vaccine. The patient developed severe ticking, and constantly blinked his eyes. The reporter was not happy and indicated involving a legal action against GlaxoSmithKline. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On 1st July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and general body pain. On an unknown date, the outcome of the fever and general body pain were recovered/resolved. It was unknown if the reporter considered the fever and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The doctor said that the patient experienced fever (the patient's body temperature was recorded as 101 degree F) and body aches for 2 days following the first dose of SHINGRIX. No measures were taken.
Sex: U
Vaccine: FLUA3, VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shivering 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 shivering, fever, fatigue and gastrointestinal upset. On an unknown date, the outcome of the shivering, fever, fatigue and gastrointestinal upset were recovered/resolved. It was unknown if the reporter considered the shivering, fever, fatigue and gastrointestinal upset to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and FLUAD into arm. The pharmacist reported that she had given SHINGRIX to many people and followed up with each recipient. Additionally, she had given 2 patients FLUAD at the same visit as SHINGRIX (in opposite arms). The pharmacist stated that, most of the patient's reported shivering, gastrointestinal (GI) upset, fatigue or low-grade fever which was mild and resolve within 24 hours. The pharmacist stated that these 2 people did not report any different or more severe side effects compared to those who did not receive FLUAD and got SHINGRIX alone. The pharmacist said that, she did not feel like these adverse events were worthwhile to report, as they were all mild and self-limiting. The patients that received FLUAD on the same day did not experience worse symptoms. This case has been linked to case US2018172531 and US2018GSK177719 (the cases for the patients who received SHINGRIX and FLUAD both), reported by the same reporter.
Sex: U
Vaccine: FLUA3, VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUAD for prophylaxis. On an unknown date, the patient received SHINGRIX and FLUAD. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivering, fever, fatigue and gastrointestinal upset. On an unknown date, the outcome of the shivering, fever, fatigue and gastrointestinal upset were recovered/resolved. It was unknown if the reporter considered the shivering, fever, fatigue and gastrointestinal upset to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and FLUAD into arm. The pharmacist reported that she had given SHINGRIX to many people and followed up with each recipient. Additionally, she had given 2 patients FLUAD at the same visit as SHINGRIX (in opposite arms). The pharmacist stated that, most of the patient's reported shivering, gastrointestinal (GI) upset, fatigue or low-grade fever which was mild and resolve within 24 hours. The pharmacist stated that these 2 people did not report any different or more severe side effects compared to those who did not receive FLUAD and got SHINGRIX alone. The pharmacist said that, she did not feel like these adverse events were worthwhile to report, as they were all mild and self limiting. The patients that received FLUAD on the same day did not experience worse symptoms. This case has been linked to the US2018GSK177718 (unspecified number of patients who received only SHINGRIX) and US2018172531 (the 1st patient who received SHINGRIX and FLUAD both), reported by the same reporter.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Developed hives torso area on 9/14/18. Hives spread to bilateral axilla's, face, ears, arms, legs, back with severe itching, continued to worsen even with BENADRYL and CLARITIN. I followed up with RN at clinic and reported adverse reaction. Dr. prescribed MEDROL dose pack which resolved severe itching, and hives.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient with active zoster virus infection less than 1 year after vaccination.
Age: 73.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cold sweat, Erythema, Injected limb mobility decreased, Injection site cellulitis, Nausea
Clinical narrative: Patient presented to PCP office with what she thinks is a reaction to the pneumonia vaccination. Monday (9/24/18) got flu shot and pneumonia shot. Pharmacist said they have seen reactions to Pneumonia vaccines. Could not move left arm 9/25/18, felt clammy and nauseous and had to stay in bed. Redness started 4X4 inches, not at vaccine site, on inside of arm toward chest. Returned to Pharmacy and was told to "watch it". Normal tenderness after shots, then pain worsened as Monday evening progressed. 9/26/18 movement of the arm is normal, but redness continues to spread, and warm to the touch and swollen. No fever, pain is 3/10, whereas on 9/25/18 it was 10/10. Saw PCP on 9/27/18 and received antibiotics for cellulitis of left upper arm to her elbow.
Age: 73.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: Patient presented to PCP office with what she thinks is a reaction to the pneumonia vaccination. Monday (9/24/18) got flu shot and pneumonia shot. Pharmacist said they have seen reactions to Pneumonia vaccines. Could not move left arm 9/25/18, felt clammy and nauseous and had to stay in bed. Redness started 4X4 inches, not at vaccine site, on inside of arm toward chest. Returned to Pharmacy and was told to "watch it". Normal tenderness after shots, then pain worsened as Monday evening progressed. 9/26/18 movement of the arm is normal, but redness continues to spread, and warm to the touch and swollen. No fever, pain is 3/10, whereas on 9/25/18 it was 10/10. Saw PCP on 9/27/18 and received antibiotics for cellulitis of left upper arm to her elbow.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Bacterial test, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: PT HAD REDNESS, SWELLING, AND PAIN IN AND AROUND THE INJECTION SITE APPEARING IN THE ENTIRE UPPER ARM REGION OF THE RIGHT ARM. PT ALSO COMPLAINED OF GENERAL BODY ACHE. PT SAW DOCTOR, PT ADVISED THAT DR WAS UNSURE IF REACTION TO VACCINE OR IF INFECTION. DR PRESCRIBED ANTIBIOTIC AND DID BLOOD WORK TO VERIFY IF BACTERIA IS PRESENT. PATIENT ADVISED SHE WOULD FOLLOW UP WITH US IF REQUIRED.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Trigeminal nerve disorder
Clinical narrative: Patient stated she was fine immediately after injection, finished her shopping, but when she got to her car, the left side of her face felt numb. She immediately went to her doctor's office and talked to them. They told the patient that it looked like her trigeminal nerve was causing spasms and numbness, and to give it a few days to see if it resolved. It did resolve, and she notified the pharmacy on 10/1/2018.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient said he was admitted to hospital with apparently a Guillain-Barre reaction told to him by a Physician.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Atrial fibrillation, Pain, Pyrexia, Rash
Clinical narrative: Patient reported mild rash on left arm, slight fever and severe body aches and pain. Reported blood pressure 197/129, heart rate 126 at doctors office and diagnosed as being in Atrial Fibrillation. Patient did not report adverse reaction to pharmacy until 09/29/2018.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth, Insomnia
Clinical narrative: This spontaneous report was received from a 67 year old female patient, reporting on herself, with arthritis and bipolar disorder. The patient did not have any known allergy or drug reaction. Concomitant therapies included clozapine, NEURONTIN, quetiapine fumarate and PLAQUINOL. On 07-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 at a dose of single dose of 0.5 ml, intramuscularly for prophylaxis (lot# and expiration date were not provided). The patient reported that she received a PNEUMOVAX 23 injection and was still experiencing "site pain, her arm was warm and sore, like she had been punched several times, it was tender and she cannot sleep on that side of her body". No treatment was administered for the adverse events. No laboratory test were performed. At the reporting time, the outcome the events was reported as not recovered. The reporter did not assess the causality between the events and PNEUMOVAX 23.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a physician assistant, via a company representative, referring to a 14 year old female patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated in the left deltoid with the second dose of GARDASIL 9, intramuscularly, for prophylaxis (strength, lot number and expiration date were not reported). On an unspecified date, a few days after vaccination, the patient developed swelling at injection site and supraclavicular lymphadenopathy. No treatment was provided and no laboratory tests were carried out. The reporter informed that the patient was being monitored for any further symptoms. The outcome of injection site swelling and lymphadenopathy was unknown. Causality assessment was not provided.
Sex: M
Vaccine: PNC13
Symptoms: Injection site nodule
Clinical narrative: This is a spontaneous report from a non-contactable consumer received via a Pfizer sales representative. A male patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date in Jun2018 (reported 3 months from the time of the report) at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2018, it was reported that the patient experienced knot in the site of injection. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Initial information received on 24-Sep-2018 regarding an unsolicited valid serious case received from a nurse. This case is linked with 2018SA268932 (same reporter). This case involves a 4 years old male patient who experienced cellulitis, while he received vaccine DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Sep-2018, the patient received a fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5171AA, expiry date- 23-Mar-2019 via unknown route in the left deltoid. On an unknown date, patient developed a serious cellulitis few days following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. On an unknown date patient developed a serious redness (erythema) few days  following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. On an unknown date, developed a serious pain few days following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. On an unknown date patient developed a serious heat (feeling hot) few days following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. On an unknown date patient developed a serious swelling few days following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. (Other relevant tests included No lab test.) Final diagnosis was cellulitis. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A). His parents were instructed to use cold compresses on the affected areas. The patient outcome is reported as Recovering / Resolving for cellulitis, as Recovering / Resolving for redness, as Recovering / Resolving for pain, as Recovering / Resolving for heat and as Recovering / Resolving for swelling. As events marked improvement when patient returned on 24-Sep-2018.; Sender's Comments: This case involves a 4 years old child who presented with cellulitis and associated symptoms after vaccination. Time to onset is not known. There is also no information regarding patient's medical condition at time of vaccination, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies. There is a possibility that the cellulitis is due to a pre-existing nidus of infection or introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Inflammation, Swelling
Clinical narrative: Initial information received on 24-Sep-2018 regarding an unsolicited valid serious case received from a nurse. This case is linked to case 2018SA268918. This case involves a 5 years old male patient who experienced cellulitis, while he received vaccine DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Sep-2018, the patient received a fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5171AA in the left deltoid. On an unknown date, patient developed a serious cellulitis the muscle following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE within days of the vaccine being given. This event was assessed as medically significant. On an unknown date, patient developed a serious swelling and redness following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. (Other relevant tests included no lab data.) Final diagnosis was cellulitis. An unknown corrective treatment was received. The patient outcome is reported as Unknown for swelling and redness and as Unknown for cellulitis. Sender's Comments: Case concerns a 5-year-old male patient who experienced cellulitis with inflammation after vaccination. Time to onset is not known. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, safety of the vaccination procedure, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Drug ineffective, Influenza like illness
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid serious case received from a consumer. This case is linked to case 2018SA271104 (same reporter). This case involves an unknown age male patient who experienced flu like symptoms after they had higher dose of flu vaccine last year which didn't work. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, the patient reported to had serious flu like symptoms with Unknown latency following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event on an unknown date. It was unknown what flu shot this patient had received. Lab data was not provided. Final diagnosis was flu like symptoms and drug ineffective. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. List of documents held by sender- none. Sender's Comments: This case involves a patient of unknown age and developed flu post vaccination with Influenza vaccine produced by unknown manufacturer. Time to onset is unknown. The time to onset, immune status of the patient, lab test ruling out other infectious etiologies are not provided. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Musculoskeletal stiffness, Pain in extremity, Vaccination complication
Clinical narrative: 9/21-Day 1: Injection. No problems. 9/22-Day 2: Slightly sore left arm. 9/23-Day3: Severe stiffness and pain in legs, especially left. Slight numbness in toes on left foot. Slight soreness in both upper arms. 9/24-Day 4: Called Dr. office for appointment. They wanted me to come right in but other factors caused me to go in on Day 5, 9/25. 9/25-Day 5: Symptoms noticeably improved. Doctor examination diagnosed reaction to flu shot. He said that in a couple of days he would expect all symptoms to be resolved. He was right.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Headache, Malaise
Clinical narrative: I'm not 100% sure which manufacturer's flu-vaccine was used. I check the first in the list only because it was an Influenza choice. The malaise and cephalgia in the first 24 hours was expected, but the 10 hours of chills and rigors that came on at 36 hours post vaccination caused me to report. Today is 10/1/18 and I'm just feeling better.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Hyperhidrosis, Pallor, Syncope
Clinical narrative: Client became pale, diaphoretic & faint within one minute of receiving shots. Assisted him to the cot where he lay with legs elevated & drank juice x 5 minutes. He sat on the side of the cot x 3 minutes.  He felt fine & was able to leave in the care of his grandmother within 15 minutes.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Patient experienced numbness and tingling down her arm into her fingers. Still continuing 2 days after injection. Arm is also sore allover, not at injection site.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster
Clinical narrative: DEVELOPED SHINGLES INFECTION THE NEXT DAY PER HUSBAND WHO IS DDS. PT IS IN EXTREME BACK PAIN AS OF TODAY 10/01/2018.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Gait inability, Mobility decreased, Pyrexia
Clinical narrative: Felt like she couldn't walk/get out of bed on evening of 9-28-18, spiked a 102 F fever the next day with chills.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: She developed entire upper body redness like a slight sunburn. No itching. No rash. No difficulty breathing. She had the vaccine on 09/25/18 sometime in the morning and woke up on 09/26/18 with this redness. She applied lotion with aloe. No medications taken. No medical treatment required. I saw her in the employee health clinic on 09/26/2018 that morning. She was given a dose of flu vaccine that was from a multidose vial. She did mention that in the past she has problems with using contact solution which caused redness and itching of her eyes. I saw her after lunch and the redness was subsiding. I spoke with her via phone today 10/01/18 and she stated that the redness had subsided by the following day and that she was fine.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Full blood count, Hypoxia, Pallor, Pyrexia
Clinical narrative: Mother states she was pale and very uncomfortable. EMS arrived at the home and per report had hypoxia and febrile to 104. Evaluated at Hospital at which time she had a seizure. Ativan was given twice.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Respiratory viral panel, Seizure, Urine analysis
Clinical narrative: Mother states she was pale and very uncomfortable. EMS arrived at the home and per report had hypoxia and febrile to 104. Evaluated at Hospital at which time she had a seizure. Ativan was given twice.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Vaccination site rash
Clinical narrative: Patient had fever starting night of 9/29/2018 and called pharamcy on 9/30 to ask what she can do for it. She had been already doing cold compresses and Tylenol she said. Said would follow up with her on 10/1. On 10/1 when spoke to her she said fever had broke (highest point was 102F). Said she now had a small rash around where vaccine where administered.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, aches and pains, chills, headache, injection site pain.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Dysphagia, Face oedema, Pyrexia
Clinical narrative: 18 hours after receiving the FLUCELVAX, the patient noted right side facial edema and difficulty with swallowing, ? fever. Did not seek medial treatment and no over the counter medications were utilized. All S/S had subsided by 2:00pm on 9/27/18.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Nausea, Pain
Clinical narrative: Vaccine was given at pharmacy, not at clinic. General achiness, shivers, possible fever, stomach upset, nauseated.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Injection site discomfort, Injection site pruritus, Malaise, Nodule
Clinical narrative: Swelling and knot on left arm with accompanying fatigue and malaise and discomfort at the site of injection; itching in same location days later.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Peripheral swelling
Clinical narrative: Swelling and knot on left arm with accompanying fatigue and malaise and discomfort at the site of injection; itching in same location days later.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pyrexia, Tremor
Clinical narrative: Fever, Headache, Tremors.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site reaction, Injection site warmth, Local reaction
Clinical narrative: Patient reported to have a local site reaction on her left arm from the shot about 3 hours later. It became red, hot and inflamed with a good size welt that did decrease in size 3 days later when she reported it to the pharmacy. She then stated that after a couple days from the shot she did get a small red spots likes hives on her chest. She did not take any other medication besides an antihistamine a couple times and said it has gotten better since the day of the shot and not worse. Still has a reddish welt on her arm but it did decrease in size.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient reported to have a local site reaction on her left arm from the shot about 3 hours later. It became red, hot and inflamed with a good size welt that did decrease in size 3 days later when she reported it to the pharmacy. She then stated that after a couple days from the shot she did get a small red spots likes hives on her chest. She did not take any other medication besides an antihistamine a couple times and said it has gotten better since the day of the shot and not worse. Still has a reddish welt on her arm but it did decrease in size.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Itchy, swollen, red.
Age: 58.0
Sex: M
Vaccine: FLUR4, HEP, MMR, TDAP, VARCEL
Symptoms: Epstein-Barr virus antibody, Fatigue, Full blood count, Headache, Malaise
Clinical narrative: Patient received MMR, Varicella, and Hep B at Pediatrics and was advised to obtain the TDAP and Influenza vaccine at pharmacy on 9/17/18. A week following the five vaccinations patient began to have symptoms including low grade fevers, fatigue, malaise, and H/A. Patient has now developed a rash on the forearm bilaterally as well as all over his back. Patient was seen at PCP today for treatment. Patient was prescribed prednisone for treatment of the rash and orders were placed for labs including CBC, CMP, and EBV antibodies.
Age: 58.0
Sex: M
Vaccine: FLUR4, HEP, MMR, TDAP, VARCEL
Symptoms: Metabolic function test, Pyrexia, Rash
Clinical narrative: Patient received MMR, Varicella, and Hep B at Pediatrics and was advised to obtain the TDAP and Influenza vaccine at pharmacy on 9/17/18. A week following the five vaccinations patient began to have symptoms including low grade fevers, fatigue, malaise, and H/A. Patient has now developed a rash on the forearm bilaterally as well as all over his back. Patient was seen at PCP today for treatment. Patient was prescribed prednisone for treatment of the rash and orders were placed for labs including CBC, CMP, and EBV antibodies.
Age: 65.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Pruritus, Pyrexia, Swelling face, Vomiting
Clinical narrative: Patient became very itchy. Her face was red and swollen and her scalp was itchy and red. She sounded like she was wheezing but was having no problem breathing. She came back the next day and said she threw up and had a low grade fever the night after she received both vaccines but felt back to normal the next day.
Age: 65.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Wheezing
Clinical narrative: Patient became very itchy. Her face was red and swollen and her scalp was itchy and red. She sounded like she was wheezing but was having no problem breathing. She came back the next day and said she threw up and had a low grade fever the night after she received both vaccines but felt back to normal the next day.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Woke on morning of 09/29/2018 with right arm pain, swelling, redness and warmth to skin. Also had body aches, fever and chills. Symptoms improved at time of report, but slight redness, swelling and warmth noted to right arm.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Woke on morning of 09/29/2018 with right arm pain, swelling, redness and warmth to skin. Also had body aches, fever and chills. Symptoms improved at time of report, but slight redness, swelling and warmth noted to right arm.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: SWOLLEN, RED, ITCHY ARM.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Pt had "welts" over the torso and arms, they weren't apparent at bedtime the day of vaccination, but were present when she woke up. She said they weren't terribly itchy, just looked bad.
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Dizziness, Dyspnoea, Headache, Migraine
Clinical narrative: Pt's daughter arrived Monday (10/1/18) morning to alert the pharmacy of a possible ADR with the Influenza and/or SHINGRIX vaccine. The pt received the vaccines on Saturday morning (9/29/18) and began experiencing a fever and weakness later that day. The fever and weakness got worse on Sunday (9/30/18). The pt experienced a HA that involved both hemispheres, self-diagnosed as a migraine. Her blood pressure was reported as normal, around 114/60-70, throughout the day on Sunday. On Monday (10/1/18) the pt experienced light headedness, dizziness, blurry vision, and collapsed in her bed. The pt trialed ibuprofen for pain/fever. Pt went to hospital. BP was 160/74 at admission, when attached to monitors came down to 114/62. Blood glucose information was not known when reported to the pharmacy. Pt has a history of asthma and pt was slightly SOB in the hospital. Pt has a history of several allergens (environment, bees, among others) for which she receives weekly allergen shots. Pt had marked not allergic to any of the ingredients of the vaccines as far as she knew.
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pyrexia, Syncope, Vision blurred
Clinical narrative: Pt's daughter arrived Monday (10/1/18) morning to alert the pharmacy of a possible ADR with the Influenza and/or SHINGRIX vaccine. The pt received the vaccines on Saturday morning (9/29/18) and began experiencing a fever and weakness later that day. The fever and weakness got worse on Sunday (9/30/18). The pt experienced a HA that involved both hemispheres, self-diagnosed as a migraine. Her blood pressure was reported as normal, around 114/60-70, throughout the day on Sunday. On Monday (10/1/18) the pt experienced light headedness, dizziness, blurry vision, and collapsed in her bed. The pt trialed ibuprofen for pain/fever. Pt went to hospital. BP was 160/74 at admission, when attached to monitors came down to 114/62. Blood glucose information was not known when reported to the pharmacy. Pt has a history of asthma and pt was slightly SOB in the hospital. Pt has a history of several allergens (environment, bees, among others) for which she receives weekly allergen shots. Pt had marked not allergic to any of the ingredients of the vaccines as far as she knew.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Pt has redness, warmth, and swelling at vaccine site. Approximately 4x3 inches. She had 1st vaccine as child.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Pain in extremity, Pyrexia
Clinical narrative: Really sore upper arm, could barely touch; red area, even around to front of upper arm; by evening: chills; at bedtime a bit over 100 degree fever.
Age: 7.0
Sex: U
Vaccine: DTAP, MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case involves a seven years old patient and reported that 7 years old was too old for DAPTACEL, but not old enough for ADACEL, while he/she received vaccines IPOL, QUADRACEL and DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MMR; and VARICELLA ZOSTER VACCINE. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On an unknown date, the patient received a dose of suspect IPV (VERO) (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On 22-May-2018, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5248AA) (Expiry date and dose in series was not reported) via intramuscular route in the right deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Blood test, Febrile convulsion, Pyrexia, Urine analysis
Clinical narrative: FEVER, THAT ELEVATED HIGH ENOUGH TO CAUSE A SIEZURE. TREATMENT: PATIENT WAS TAKEN TO HOPSITAL WAS THERE FROM FRIDAY TO SATURDAY AFTERNOON. BLOOD WORK/ AND UA DONE, IV FLUIDS AND OBSERVATION.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Injection site discolouration, Injection site swelling, Peripheral swelling, Skin discolouration
Clinical narrative: Patient has experienced significant swelling and discoloration at injection site of right deltoid, extending to the lower forearm. Patient also experienced pain, especially in the region of the elbow. Referred to health care provider for possible cellulitis.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Body aches, nausea so far.
Age: 1.83
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: FLUZONE >36 month dose administered to patient, He is <36 month of age. Parent and Supervisor notified.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Malaise, Pain
Clinical narrative: Patient began experiencing symptoms two days after recieving vaccine. Symptoms included chills, malaise, weakness, soreness. Symptoms lasted about 4 days but finally began to subside on the morning of Monday, October 1. Patient occassionally self-treated with Tylenol and did not seek medical attention. Pharmacy was made aware of adverse event on Monday, since patient seemed to be recovering, did not advise further medical assistance.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported redness, swelling, pain, and warmth just below the injection site towards the elbow. She consulted the administering pharmacist, who recommended OTC tylenol. The patient says the swelling has gone down some, and the pain has subsided.
Age: 61.0
Sex: M
Vaccine: FLUR4
Symptoms: Flank pain, Paraesthesia
Clinical narrative: Patient says he felt tingling in his left hand after receiving FLUBLOK. RPh had patient wait in the store longer than usual time. Patient then said according to google RPh may have hit a nerve. He could tell because he had surgery on that arm years ago. RPh checked on patient later that day, patient said he still had tingling in hand on and off. RPh checked on patient today, he said left side of back in flank hurt.
Age: 42.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Mobility decreased, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: Swelling of arm, stiffness, unable to move.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Chest X-ray normal, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Left arm, back, shoulder, head and chest became painful and tight. Breathing was labored and throat felt swollen. It was not a migraine and it wasn't asthma. Oxygen levels dropped below normal when relaxing. After receiving BENADRYL, TORADOL and a breathing treatment, symptoms lessened.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Electrocardiogram normal, Headache, Laboratory test normal, Musculoskeletal pain, Oxygen saturation decreased
Clinical narrative: Left arm, back, shoulder, head and chest became painful and tight. Breathing was labored and throat felt swollen. It was not a migraine and it wasn't asthma. Oxygen levels dropped below normal when relaxing. After receiving BENADRYL, TORADOL and a breathing treatment, symptoms lessened.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Pharyngeal oedema
Clinical narrative: Left arm, back, shoulder, head and chest became painful and tight. Breathing was labored and throat felt swollen. It was not a migraine and it wasn't asthma. Oxygen levels dropped below normal when relaxing. After receiving BENADRYL, TORADOL and a breathing treatment, symptoms lessened.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Heart rate increased, Syncope
Clinical narrative: Syncope. Rapid heart rate.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt. states her arm never hurt, and never itched. She brought in picture on her phone today to be sure that it looked ok today. Saturday, the swelling and rednesss from the picture, went all the way around her arm, and took up the entire upper arm. Today, barely noticeable, but she wanted it documented in her chart as it was pretty significant on the pictures. The redness and swelling was not only where the injection was, but also the other side of the arm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Muscular weakness, Oral pruritus, Pruritus
Clinical narrative: Within 30 minutes of injection, feelings of muscle weakness and tiredness started. Shortly thereafter itching started around my mouth then proceeded to all extremities. This progressive itching continued for at least two hours until I took Diphenhydramine 25mg. I feel asleep for about 15 minutes and when I woke the itching was decreasing, and finally stopped. During the symptoms that were mentioned, I had a general feeling of being unwell, and considered treatment at a hospital. Since the Diphenhydramine was effective I did not seek hospital treatment.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain, Syringe issue
Clinical narrative: Administration attempted in the left arm however when that failed due to issues with the plunger. The administration was given in the right arm on 9/24/18 approximately at 09:40am. Patient complained of severe pain (9 on ascale of 1-10) beginning around 5:00pm in the evening. Pain continued since and has improved as of today (10/1/18) patient has better range of motion and less pain (2). Patient has not seen any physician or sought any medical help despite recommendation by reporting pharmacist.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia
Clinical narrative: PATIENT SAID SHE DEVELOPED A METALLIC TASTE IN HER MOUTH 12 HOURS AFTER FLUARIX AND IT LASTED FOR 5 DAYS.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Nausea, Pyrexia, Rash, Rash erythematous
Clinical narrative: The patient experienced nausea, fever, and pain around the injection sites the day after the immunization on 09/29/2018. On 9/30/2018, the patient came to the pharmacy and presented with redness/rash around the arm. She stated that the nausea and fever have subsided but she was still in pain although not as severe. I followed up with the patient on 10/1/2018 and she states that she is no longer in pain but the rash seems to have spread. She contacted her doctor and he recommended she try BENADRYL and to contact him if the rash doesn't improve so she can be seen (she send a picture of the rash to her doctor).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV, MMRV
Symptoms: Breath sounds abnormal, Dyspnoea, Eye swelling, Lip erythema, Lip swelling
Clinical narrative: To clarify - fifth dose of Dtap and fourth dose of polio, but had never had (and will never again need) the combination injection. To clarify - second dose of both MMR and VZV, first (and last) dose of PROQUAD. To clarify - has had three influenza injections prior to 9/25/18, but had never had FLULAVAL. Patient returned right after his well child check with Dr. He received MMR/Varicella, DTAP/IPV, and influenza vaccines. Mom reported that as they reached the parking lot, he developed congestion and facial swelling. She brought him back to the clinic. I assessed him along with nursing staff. He was noted to have red swollen lips and difficulty breathing. Initial oxygen Sats were 88-92%. Lungs were tight with wheezing and coarseness. He was given albuterol and 6 ml of diphenhydramine (12.5 mg/5 ml). He had improvement in Sats to 98-99%. He continued to have facial swelling around lips and eyes. He developed pallor and was given EPIPEN Jr to the left lateral thigh. His color improved and he had improved aeration. BP was within normal. 911 was called and he was transferred via ambulance to the ED. No history of wheezing, illness or allergies. Discussed with mom may be reasonable to refer to allergy and also treat with prednisolone and ranitidine for 72 hours. 1655 - Patient brought back to clinic by mom. 1656 - BENADRYL 6mls administered by MD. Lot: 7HK0615 Exp: 6/30/19. 1657 - Albuterol neb initiated per MD order, HR at 144, O2 at 97% Lot: 18A94 Exp: 1/31/20. 1701 - Epi injected to left vastus, area was cleansed with an alcohol swab. Mom upset at how "violent" it appeared and that needle was kept in the muscle after injection. Proper mechanics were used. This was verified by Dr. and verbalized to mom. Primary care provider to follow up. Lot: 7FN633 Exp: 2/28/19. 1704 - EMS called. 1705 - BP at 113/73, HR, 98, and O2 at 98%. 1707 - Albuterol administration completed. 1709 - EMS arrived.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV, MMRV
Symptoms: Lung disorder, Pallor, Respiratory tract congestion, Swelling face, Wheezing
Clinical narrative: To clarify - fifth dose of Dtap and fourth dose of polio, but had never had (and will never again need) the combination injection. To clarify - second dose of both MMR and VZV, first (and last) dose of PROQUAD. To clarify - has had three influenza injections prior to 9/25/18, but had never had FLULAVAL. Patient returned right after his well child check with Dr. He received MMR/Varicella, DTAP/IPV, and influenza vaccines. Mom reported that as they reached the parking lot, he developed congestion and facial swelling. She brought him back to the clinic. I assessed him along with nursing staff. He was noted to have red swollen lips and difficulty breathing. Initial oxygen Sats were 88-92%. Lungs were tight with wheezing and coarseness. He was given albuterol and 6 ml of diphenhydramine (12.5 mg/5 ml). He had improvement in Sats to 98-99%. He continued to have facial swelling around lips and eyes. He developed pallor and was given EPIPEN Jr to the left lateral thigh. His color improved and he had improved aeration. BP was within normal. 911 was called and he was transferred via ambulance to the ED. No history of wheezing, illness or allergies. Discussed with mom may be reasonable to refer to allergy and also treat with prednisolone and ranitidine for 72 hours. 1655 - Patient brought back to clinic by mom. 1656 - BENADRYL 6mls administered by MD. Lot: 7HK0615 Exp: 6/30/19. 1657 - Albuterol neb initiated per MD order, HR at 144, O2 at 97% Lot: 18A94 Exp: 1/31/20. 1701 - Epi injected to left vastus, area was cleansed with an alcohol swab. Mom upset at how "violent" it appeared and that needle was kept in the muscle after injection. Proper mechanics were used. This was verified by Dr. and verbalized to mom. Primary care provider to follow up. Lot: 7FN633 Exp: 2/28/19. 1704 - EMS called. 1705 - BP at 113/73, HR, 98, and O2 at 98%. 1707 - Albuterol administration completed. 1709 - EMS arrived.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV, MMRV
Symptoms: Allergy test positive, Dyspnoea, Hypoxia, Lip swelling, Nasal congestion
Clinical narrative: To clarify - fifth dose of Dtap and fourth dose of polio, but had never had (and will never again need) the combination injection. To clarify - second dose of both MMR and VZV, first (and last) dose of PROQUAD. To clarify - has had three influenza injections prior to 9/25/18, but had never had FLULAVAL. Patient returned right after his well child check with Dr. He received MMR/Varicella, DTAP/IPV, and influenza vaccines. Mom reported that as they reached the parking lot, he developed congestion and facial swelling. She brought him back to the clinic. I assessed him along with nursing staff. He was noted to have red swollen lips and difficulty breathing. Initial oxygen Sats were 88-92%. Lungs were tight with wheezing and coarseness. He was given albuterol and 6 ml of diphenhydramine (12.5 mg/5 ml). He had improvement in Sats to 98-99%. He continued to have facial swelling around lips and eyes. He developed pallor and was given EPIPEN Jr to the left lateral thigh. His color improved and he had improved aeration. BP was within normal. 911 was called and he was transferred via ambulance to the ED. No history of wheezing, illness or allergies. Discussed with mom may be reasonable to refer to allergy and also treat with prednisolone and ranitidine for 72 hours. 1655 - Patient brought back to clinic by mom. 1656 - BENADRYL 6mls administered by MD. Lot: 7HK0615 Exp: 6/30/19. 1657 - Albuterol neb initiated per MD order, HR at 144, O2 at 97% Lot: 18A94 Exp: 1/31/20. 1701 - Epi injected to left vastus, area was cleansed with an alcohol swab. Mom upset at how "violent" it appeared and that needle was kept in the muscle after injection. Proper mechanics were used. This was verified by Dr. and verbalized to mom. Primary care provider to follow up. Lot: 7FN633 Exp: 2/28/19. 1704 - EMS called. 1705 - BP at 113/73, HR, 98, and O2 at 98%. 1707 - Albuterol administration completed. 1709 - EMS arrived.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV, MMRV
Symptoms: Pallor, Swelling face
Clinical narrative: To clarify - fifth dose of Dtap and fourth dose of polio, but had never had (and will never again need) the combination injection. To clarify - second dose of both MMR and VZV, first (and last) dose of PROQUAD. To clarify - has had three influenza injections prior to 9/25/18, but had never had FLULAVAL. Patient returned right after his well child check with Dr. He received MMR/Varicella, DTAP/IPV, and influenza vaccines. Mom reported that as they reached the parking lot, he developed congestion and facial swelling. She brought him back to the clinic. I assessed him along with nursing staff. He was noted to have red swollen lips and difficulty breathing. Initial oxygen Sats were 88-92%. Lungs were tight with wheezing and coarseness. He was given albuterol and 6 ml of diphenhydramine (12.5 mg/5 ml). He had improvement in Sats to 98-99%. He continued to have facial swelling around lips and eyes. He developed pallor and was given EPIPEN Jr to the left lateral thigh. His color improved and he had improved aeration. BP was within normal. 911 was called and he was transferred via ambulance to the ED. No history of wheezing, illness or allergies. Discussed with mom may be reasonable to refer to allergy and also treat with prednisolone and ranitidine for 72 hours. 1655 - Patient brought back to clinic by mom. 1656 - BENADRYL 6mls administered by MD. Lot: 7HK0615 Exp: 6/30/19. 1657 - Albuterol neb initiated per MD order, HR at 144, O2 at 97% Lot: 18A94 Exp: 1/31/20. 1701 - Epi injected to left vastus, area was cleansed with an alcohol swab. Mom upset at how "violent" it appeared and that needle was kept in the muscle after injection. Proper mechanics were used. This was verified by Dr. and verbalized to mom. Primary care provider to follow up. Lot: 7FN633 Exp: 2/28/19. 1704 - EMS called. 1705 - BP at 113/73, HR, 98, and O2 at 98%. 1707 - Albuterol administration completed. 1709 - EMS arrived.
Age: 47.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Pt states on 9/19 she got a fever of 102 around 4pm. Pt was advised to start ADVIL 800 q8h with food, also TYLENOL 1000mg q4hrs, Cold packs for arm soreness. 9/20 Pt states she was up to a temp of 104.4 an hour ago and took some ADVIL and is now 103.8. Pt states she ran out of TYLENOL so hadn't taken anything for the past 6hrs previous to 30 min ago when she took the ADVIL. 9/21- Pt states her fever is down to 101 with the rotation of the TYLENOL and ADVIL.