chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Pain at the time of inject, limited range of motion, painful motion of arm.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Pain, stiffness, and limited range of motion.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient states arm has been sore/hurting since they recieved the vaccine in May. Went to a doctor, but was inconclusive about why the arm was still hurting. Says it always hurts if they sleep on that side.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Radiating pain, most bothersome at night, sometimes feels in his forearm and ring finger, first noticed about a week after vaccination.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Cough, Diarrhoea, Malaise, Nausea
Clinical narrative: Pt states had severe reaction to vaccine; next morning woke up with nausea, got on a plane to fly out, prior to it got leg and joint pain, nerve pain, sneezing, coughing, diarrhea; went to airport; 9.5/10 pain. Had flu shot her entire life but this one had reaction; 2nd day pain went away but still feeling sick.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Neuralgia, Pain, Pain in extremity, Sneezing, Vaccination complication
Clinical narrative: Pt states had severe reaction to vaccine; next morning woke up with nausea, got on a plane to fly out, prior to it got leg and joint pain, nerve pain, sneezing, coughing, diarrhea; went to airport; 9.5/10 pain. Had flu shot her entire life but this one had reaction; 2nd day pain went away but still feeling sick.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site cellulitis, Injection site discolouration, Injection site discomfort, Injection site erythema, Injection site pruritus
Clinical narrative: Reaction was on left thigh where MMR/Varicella was given. It began to swell the following day (08/31/2018) around the injection site. Swelling and redness continued to spread until it enveloped the entire front of the thigh and beginning to go around the sides surrounding the injection site. Extreme swelling, redness, hot to the touch, itchy, scabbing and uncomfortable. Resembled cellulitis and an urgent care doctor did diagnose it so on 08/31/2018. Followed up with regular doctor the following day (09/01/2018) and was told it was a "localized reaction" and not an allergy. Treatment: none; Skin is still discolored and scabs have not yet healed. Swelling has decreased and the thigh is now normal size.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site scab, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Reaction was on left thigh where MMR/Varicella was given. It began to swell the following day (08/31/2018) around the injection site. Swelling and redness continued to spread until it enveloped the entire front of the thigh and beginning to go around the sides surrounding the injection site. Extreme swelling, redness, hot to the touch, itchy, scabbing and uncomfortable. Resembled cellulitis and an urgent care doctor did diagnose it so on 08/31/2018. Followed up with regular doctor the following day (09/01/2018) and was told it was a "localized reaction" and not an allergy. Treatment: none; Skin is still discolored and scabs have not yet healed. Swelling has decreased and the thigh is now normal size.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient states soreness and severe pain in arm that hasn't gone away since the vaccination date.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Lethargy, Myalgia
Clinical narrative: Extremely sore arm, muscle soreness, head ache, lethargy, stomach ache, and diarrhea.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity
Clinical narrative: Extremely sore arm, muscle soreness, head ache, lethargy, stomach ache, and diarrhea.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Patient starting developing tenderness and warmth feeling on her left arm where she got the PNEUMOVAX shot followed by swelling and redness around the injection site. Later on she also has hives around her elbow. Treatment advised was ice compress, Ibuprofen 800 mg every 6 hours and BENADRYL at night.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm swelling, redness, red and warm to touch large portion of upper arm and shoulder.
Age: 50.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Rash
Clinical narrative: Rash on neck tx'd w/topical steroid cream - sx's improved. Pt very anxious about potential SE.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Back pain, Chest discomfort, Dyspnoea, Heart rate increased, Loss of personal independence in daily activities
Clinical narrative: 2 days following administration of this vaccine patient presents to walk in clinic due to shortness of breath, back pain, chest discomfort and increased heart rate. Since the administration of the 3rd dose of GARDASIL on 8/15/2016 this patient has been diagnosed with Amplified Pain Syndrome. This patient is unable to perform many of the physical activities she could perform prior to the administration of this vaccine due to the pain she experiences. Patient does now follow with specialty clinic due to pain.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Pain
Clinical narrative: 2 days following administration of this vaccine patient presents to walk in clinic due to shortness of breath, back pain, chest discomfort and increased heart rate. Since the administration of the 3rd dose of GARDASIL on 8/15/2016 this patient has been diagnosed with Amplified Pain Syndrome. This patient is unable to perform many of the physical activities she could perform prior to the administration of this vaccine due to the pain she experiences. Patient does now follow with specialty clinic due to pain.
Age: 77.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Pt received PNEUMOVAX 23 in upper left arm. After working outside all day doing yardwork, he woke up the next morning with a swollen and warm lower/upper arm. We referred him to his PCP who could not determine if it was an allergic rxn or a possible bug bite. Pt received a steroid from PCP.
Age: 52.0
Sex: F
Vaccine: HEPAB, PPV, TDAP
Symptoms: Contusion, Pain, Swelling
Clinical narrative: Bruise, swollen, pain, rec. ice pack and TYLENOL for pain. Pt would like us call her PCP schedule appointment for 9/7/18.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Injection site pain, Nausea, Pain in extremity, Presyncope
Clinical narrative: Approximately 3 hours after vaccine given patient reported feeling lightheaded nauseated, faint feelings. Subsided with rest. Next morning felt better but pain from (L) deltoid down to wrist and nausea. 9/6/18-spoke to mother-still with pain at site and nausea. On the date of vaccination-she was not well hydrated with minimal lunch 3 hr prior.
Age: 78.0
Sex: U
Vaccine: PNC13
Symptoms: Biopsy artery, C-reactive protein increased, Headache, Lumbar puncture, Pain
Clinical narrative: Body aches, fever, headache, elevated ESR and CRP, also took NSAIDs for symptoms and developed UGI bleed.
Age: 78.0
Sex: U
Vaccine: PNC13
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Upper gastrointestinal haemorrhage
Clinical narrative: Body aches, fever, headache, elevated ESR and CRP, also took NSAIDs for symptoms and developed UGI bleed.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Pain in right arm starting 3 days after vaccination. Still complains of shoulder pain and pain with certain motion today 8/30/18 pain worse in the evening/night.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pityriasis rosea, Rash
Clinical narrative: My daughter started getting a rash a few days after shot. Went to urgent care back to pediatrician office twice with no help. Went to dermatologist and he confirmed she had pityriasis rosea which was likely caused by the shot. He stated he had seen that before.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right vastus lateralis was red and swollen.
Age: 1.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician, regarding a 1 year old female patient. The patient's concurrent, historical conditions and concomitant medications were not provided. On 13-AUG-2018 the patient and his sibling (MARRS#1808USA006971) were each inadvertently administered with an expired dose of Oka/Merck VARIVAX subcutaneous, lot# M035688, 10-AUG-2018 (strength and dosage were not reported) (Expired product administered) for prophylaxis. No adverse effect reported (No adverse event). Sender's Comments: US-009507513-1808USA006971.
Age: 43.0
Sex: M
Vaccine: FLU4, PPV, TDAP, FLU4, PPV, TDAP
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Sore left arm, swollen, red, and slightly warm to touch. Stiff neck, chills with occasional fever. Given MEDROL DOSE PACK to take along with BACTRIM given for cellulitis.
Age: 43.0
Sex: M
Vaccine: FLU4, PPV, TDAP, FLU4, PPV, TDAP
Symptoms: Musculoskeletal stiffness
Clinical narrative: Sore left arm, swollen, red, and slightly warm to touch. Stiff neck, chills with occasional fever. Given MEDROL DOSE PACK to take along with BACTRIM given for cellulitis.
Age: 43.0
Sex: M
Vaccine: FLU4, PPV, TDAP, FLU4, PPV, TDAP
Symptoms: Chills, Erythema, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: Sore left arm, swollen, red, and slightly warm to touch. Stiff neck, chills with occasional fever. Given MEDROL DOSE PACK to take along with BACTRIM given for cellulitis.
Age: 43.0
Sex: M
Vaccine: FLU4, PPV, TDAP, FLU4, PPV, TDAP
Symptoms: Pyrexia, Skin warm
Clinical narrative: Sore left arm, swollen, red, and slightly warm to touch. Stiff neck, chills with occasional fever. Given MEDROL DOSE PACK to take along with BACTRIM given for cellulitis.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 hr after receiving Shingrix, the patient experienced swelling arm, erythema of extremities and pain in arm. On an unknown date, the outcome of the swelling arm, erythema of extremities and pain in arm were unknown. It was unknown if the reporter considered the swelling arm, erythema of extremities and pain in arm to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on left upper arm and 1-2 hours after receiving vaccine, the patient's arm swelled up and was red and tender for a week after.
Age: 79.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Back pain, Dizziness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: All of the following described symptoms lasted for 4 days before completely resolving. Patient's left arm from mid-upper arm to the top of the shoulder was sore, swollen, and red-hot to the touch. Patient was not able to lift or use arm for the duration of the symptoms. Patient was dizzy, had generalized body aches, with more significant pain in her back which caused her to stay in bed for a significant duration of the symptoms.
Age: 79.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site warmth, Pain
Clinical narrative: All of the following described symptoms lasted for 4 days before completely resolving. Patient's left arm from mid-upper arm to the top of the shoulder was sore, swollen, and red-hot to the touch. Patient was not able to lift or use arm for the duration of the symptoms. Patient was dizzy, had generalized body aches, with more significant pain in her back which caused her to stay in bed for a significant duration of the symptoms.
Age: 61.0
Sex: F
Vaccine: FLUC4, PNC13, VARZOS
Symptoms: Blindness, Dry eye, Injected limb mobility decreased, Ophthalmological examination
Clinical narrative: Patient left a voicemail claiming that she could not move her arms and that she lost her vision. Upon visiting Dr., he phoned in LOTEMAX for her on 09-6-2018 at 11:12 AM for dry eyes.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Nausea
Clinical narrative: Nausea, injection site soreness.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 24 hours after receiving the vaccine, I had a severe debilitating headache, serious enough to make my teeth hurt, I ran a fever of at least 101, had flu like symptoms. The injection site was very hot to touch, tender, and was quite enlarged. I seriously felt like I had the worst flu I had ever had.  The headache would not go away regardless of any medication I took. The fever was with me for a solid 24 hours. The headache has lessened in intensity but the feeling of being ill is still with me.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia, Toothache
Clinical narrative: 24 hours after receiving the vaccine, I had a severe debilitating headache, serious enough to make my teeth hurt, I ran a fever of at least 101, had flu like symptoms. The injection site was very hot to touch, tender, and was quite enlarged. I seriously felt like I had the worst flu I had ever had.  The headache would not go away regardless of any medication I took. The fever was with me for a solid 24 hours. The headache has lessened in intensity but the feeling of being ill is still with me.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Insomnia, Pain, Pyrexia
Clinical narrative: Aching, chilling to point of shaking, fever, inability to get comfortable to sleep.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Aching, chilling to point of shaking, fever, inability to get comfortable to sleep.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Heart rate increased, Nausea, Nervousness
Clinical narrative: Pt reports nausea, "shaky" feeling, weakness. Also states her heart rate was elevated over 100bpm throughout the night.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Chills, Dizziness, Exposure during pregnancy, Fatigue
Clinical narrative: Patient received TDAP Vaccination on 9/4/18 at 1:20pm. Patient is 32.5 weeks pregnant at present time, was sent for Vaccination by OB/GYN Dr. Patient called to Infectious Disease Office on 9/6/18 with complaints ranging over the past 2 days of receiving vaccination. Complaints include Fever 99.1-99.5 degrees Fahrenheit, chills, dizziness at times, fatigue, and nausea. Patient then stated that she had slight chest pain x2 starting 9/5/18 and then once again on 9/6/18. Patient instructed to follow up with OB/GYN in order to ensure wellbeing of baby and pregnancy, stated that she had been there on 9/5/18 and check up was good but that she would contact them once more. Patient also instructed to follow up with primary care MD or go to nearest Emergency Department for complaints of chest pain. Patient reports on 9/7/18 that she is feeling good, other than a possible sinus infection. States that she "slept solid last night, no fever, no chills, and no chest pain." States, "maybe it was just a thing and it's gone now."
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pyrexia
Clinical narrative: Patient received TDAP Vaccination on 9/4/18 at 1:20pm. Patient is 32.5 weeks pregnant at present time, was sent for Vaccination by OB/GYN Dr. Patient called to Infectious Disease Office on 9/6/18 with complaints ranging over the past 2 days of receiving vaccination. Complaints include Fever 99.1-99.5 degrees Fahrenheit, chills, dizziness at times, fatigue, and nausea. Patient then stated that she had slight chest pain x2 starting 9/5/18 and then once again on 9/6/18. Patient instructed to follow up with OB/GYN in order to ensure wellbeing of baby and pregnancy, stated that she had been there on 9/5/18 and check up was good but that she would contact them once more. Patient also instructed to follow up with primary care MD or go to nearest Emergency Department for complaints of chest pain. Patient reports on 9/7/18 that she is feeling good, other than a possible sinus infection. States that she "slept solid last night, no fever, no chills, and no chest pain." States, "maybe it was just a thing and it's gone now."
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen and warm to touch.
Age: 30.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Information has been received from a pharmacist, referring to a 30 year old patient. Information of concurrent condition, medical history and concomitant therapy was not provided. On 17-OCT-2017, the patient was vaccinated with PROQUAD (strength, lot# and expiry date unknown) one dose, subcutaneous for prophylaxis(drug administered to patient of inappropriate age). There was no known adverse effects.
Sex: M
Vaccine: HPV9
Symptoms: Malaise, Syncope
Clinical narrative: This spontaneous report was received from a Nurse via field representative refers to a male patient of an unknown age. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL 9 injection for prevention of human papilloma virus (HPV) (lot#, expiry date, route, anatomical location and dosage details were not reported). On 28-AUG-2018, the patient was vaccinated with second dose of GARDASIL 9 injection for prevention of human papilloma virus (HPV) (lot#, expiry date, route, anatomical location and dosage details were not reported). On the same day, an unspecified amount of time later, while at the office, the patient "was not feeling well and felt sick" (malaise). The reporter at the office "believed the patient had a syncopal episode". The patient sought medical attention. The outcome of the events was unknown. No product quality complaint (PQC) was involved. The reporter did not provide any causality assessment.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to one patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date the patient was vaccinated with improperly stored VARIVAX (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. The VARIVAX was stored in temperature of -12.45 degree Celsius (C) for 30 minutes. There was previous temperature excursion reported: -9 C to 8 C for 3 hours 30 minutes and -14 C to -10 C for 4 hours 45 minutes. A digital data logger was involved. No product quality complaint was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered pharmacist and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 06-AUG-2018, the patient was vaccinated with improperly stored dose of VARIVAX (exact dose, frequency, site and route of administration, lot# and expiration date were not reported) for prophylaxis. Administered dose of vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine was exposed to a temperature excursion between 47 degrees Fahrenheit to 77 degrees Fahrenheit (also reported as 55 degrees Fahrenheit) for 5 days. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided. On 27-AUG-2018, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX lot # N034558, expiration date: 05-DEC-2019 (strength, dose, route of administration and anatomical location were not reported) indicated for prophylaxis which was reconstituted with MERK STERILE DILUENT (lot# and expiration date not reported) properly stored. The administered dose of the vaccine Oka/Merck VARIVAX experienced multiple temperature excursions of 6 degrees Fahrenheit (°F) to 14 degrees Fahrenheit (°F) for 303 minutes, as recorded by a data logger. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA002034: US-009507513-1809USA002035: US-009507513-1809USA002036: US-009507513-1809USA002033: US-009507513-1809USA002037: US-009507513-1809USA001866: US-009507513-1809USA002031.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided. On 31-JUL-2018, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX lot # R002051, expiration date: 22-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) indicated for prophylaxis which was reconstituted with MERK STERILE DILUENT (lot# and expiration date not reported) properly stored. The administered dose of the vaccine Oka/Merck VARIVAX experienced multiple temperature excursions of 6 degrees Fahrenheit (°F) to 14 degrees Fahrenheit (°F) for 303 minutes, as recorded by a data logger. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA002034: US-009507513-1809USA002035: US-009507513-1809USA002036: US-009507513-1809USA002037: US-009507513-1809USA001866: US-009507513-1809USA002032: US-009507513-1809USA002031.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided. On 31-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R002051, expiration date: 22-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) indicated for prophylaxis which was reconstituted with sterile diluent (MERK STERILE DILUENT) (lot# and expiration date not reported) properly stored. The administered dose of the VARIVAX experienced multiple temperature excursions of 6 degrees Fahrenheit (°F) to 14 degrees Fahrenheit (°F) for 303 minutes, as recorded by a data logger. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1809USA002034: US-009507513-1809USA002035: US-009507513-1809USA002033: US-009507513-1809USA002037: US-009507513-1809USA001866: US-009507513-1809USA002032: US-009507513-1809USA002031:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided. On 06-AUG-2018, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX lot # R002051, expiration date: 22-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) indicated for prophylaxis which was reconstituted with MERK STERILE DILUENT (lot# and expiration date not reported) properly stored. The administered dose of the Oka/Merck VARIVAX experienced multiple temperature excursions of 6 degrees Fahrenheit (°F) to 14 degrees Fahrenheit (°F) for 303 minutes, as recorded by a data logger. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA00203: US-009507513-1809USA002035: US-009507513-1809USA002036: US-009507513-1809USA002033: US-009507513-1809USA001866: US-009507513-1809USA002032: US-009507513-1809USA002031.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a register nurse referring to a 6 month old patient.  The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 04-SEP-2018, the patient was vaccinated by oral route with ROTATEQ lot # R003111 expiration date 12-SEP-2019, (dose was not provided) for prophylaxis. On the same date,  the nurse reported she administered an improperly stored dose of the vaccine(medication error), no adverse effects were reported. Temperature: 47 Fahrenheit to 77 Fahrenheit (47.1 Fahrenheit)  for 20 minutes, the call was due to a "data logger".
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. On 21st April 2018, the patient received the 1st dose of SHINGRIX. On 22nd April 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms and headache. On an unknown date, the outcome of the influenza-like symptoms and headache were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and headache to be related to SHINGRIX. Additional information was reported as follows: The reporting pharmacist was the patient himself who stated that after vaccination with the 1st dose of SHINGRIX, next day the patient experienced flu-like symptoms and headache. The adverse events experienced by the patient were resolved within 24 hours.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a elderly patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was received as follows: The reporter said that the patient had to receive the second dose of SHINGRIX in August 2018, but the patient came down with clinical shingles and treated with Valtrex. It has resolved. The reporter asked that if the patient could receive the second shot and if so when. The reporter received answer that it was not a contraindication to give the 2nd dose of SHINGRIX if there was an episode of Herpes zoster after the first dose of SHINGRIX. The center of disease control and prevention recommendation for vaccinating after an episode only stateed the lesions need to be resolved. There was no additional period of time that needed to pass. In September 2018, the reporter would probably give the second dose of SHINGRIX to the patient.
Sex: U
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a patient who received FLUARIX QUADRIVALENT 2017-2018 season for an unknown indication. On an unknown date, the patient received FLUARIX QUADRIVALENT 2017-2018 season at an unknown dose. On an unknown date, unknown after receiving FLUARIX QUADRIVALENT 2017-2018 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown  if the reporter considered the injection site pain to be related to FLUARIX QUADRIVALENT 2017-2018 season. Additional details were provided as follows: The age at vaccination was not applicable. The pharmacist said that they had been giving SHINGRIX vaccine (refer case US2018158121) and in general they had observed more soreness at the injection site than what they normally saw with the flu shot. No particular patient's information was associated with this report. This case has been linked with case US2018158125 reported by the same reporter.
Age: 7.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Dose of KINRIX given at 7yrs 1 mo.
Age: 21.0
Sex: F
Vaccine: FLU4, HEPAB
Symptoms: Asthma, Condition aggravated, Cough, Injection site bruising, Injection site erythema
Clinical narrative: Pt reported back to pharmacy after several hours of receiving both immunizations with redness on both arms near injection sites and mild bruising on right arm at injection site where FLUARIX QUAD was administered. Patient also reported just having an asthma attack, cough and body ache.
Age: 21.0
Sex: F
Vaccine: FLU4, HEPAB
Symptoms: Pain
Clinical narrative: Pt reported back to pharmacy after several hours of receiving both immunizations with redness on both arms near injection sites and mild bruising on right arm at injection site where FLUARIX QUAD was administered. Patient also reported just having an asthma attack, cough and body ache.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 2 days of soreness/redness on L arm at site of injection, not worsening, no fever. 6-8 cm erythema without induration or tenderness. Reassured mild reaction, RXed steroid treatment. RTC in 2 days if worsening or not resolved.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local injection site reaction: swelling, warmth, soft tissue edema. No fever, systemic symptoms.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Mom reports fever starting on 9/4/18 to 9/5/18 did not report how high temp was. Also reports rash that started after fever, on 9/7/18.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Rash
Clinical narrative: Rash on torso and upper extremities.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Child received 5th dose of Dtap on 9/4/18 in left deltoid. Mother noted redness and swelling spreading to left forearm next. Afebrile. Child complains soreness in entire arm following day on 9/5/18. Per CDC, complained reaction is more common in 4th or 5th dose of Dtap, usually involving entire arm, may last from 1-7 days. Provider explained to mother about reaction, reassurance given. Warm compress to left arm. Tylenol for pain. Call if symptoms continue beyond 7 days without improvement or increase redness, swelling, and pain, or fever.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 62-year-old female patient. The patient's concurrent conditions included diabetes and hypertension. The patient's drug reactions or allergies were reported as onion, aspirin, gluten, erythromycin, latex, soy, tetracycline, sulfa, PERCODAN and PERCOCET. On 16-AUG-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular injection, lot # R009163, expiration date 06-JAN-2020 (dose and anatomical location of injection were not reported) for prophylaxis. Concomitant therapies included albuterol, alprazolam, EDARBI, NORVASC, LIPITOR, CARDURA, FARXIGA and FLEXERIL. On 16-AUG-2018, the patient experienced swelling at the injection site. The patient sought medical attention via calling a physician. There was treatment given for the event. Lab diagnostic and studies were not performed. On 18-AUG-2018 (reported as within 48 hours), the swelling at the injection site resolved. The causality assessment between the event and PNEUMOVAX 23 was not provided. This is one of the two reports from the same reporter. Sender's Comments: US-00950713-1808USA009424.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, Extra dose administered, Product storage error
Clinical narrative: Initial unsolicited report received from pharmacist on 30-Aug-2018. This case involves five patients (reported as 18 years old and older) who were vaccinated with a 0.5 ml double dose of vaccine TENIVAC (Batch number, expiration date, route and site of administration was not reported) on 30-Aug-2018 which was expired and had a temperature excursion of 0 Celsius. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage, extra dose administered and expired vaccine used. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 30-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not reported. On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ000AB via intramuscular route. It was a case of actual medication error due to Product storage error as the vaccines were improperly stored and was vaccinated later on. It was unknown if patient experienced any adverse event. 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.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 31-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA248540. This case involves a 16 months old female patient who experienced ACTHIB was used with sterile water, while she received vaccines PREVNAR 13, DTAP and ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not reported. On 16-Aug-2018, the patient received a dose of suspect ACTHIB VACCINE lot U1945AAA via unknown route. On an unknown date, the patient received a dose of suspect DTAP not produced by Sanofi Pasteur lot number not reported via intramuscular route in the right thigh. On an unknown date, the patient received a dose of suspect PREVNAR 13 not produced by Sanofi Pasteur lot number not reported via intramuscular route in the right thigh. It was a case of actual medication error due to Inappropriate reconstitution technique. It was unknown whether adverse event occurred or not. 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 and Module VI of the 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.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 31-Aug-2018 regarding an unsolicited valid non-serious case received from a health professional. This case involves a 15 months old male patient who was vaccinated with an expired dose of PENTACEL (Lot number: C5390AA; expiry date:17-Jul-2018) in the left thigh on 30-Aug-2018. The patients medical history, previous medications were not reported. The patients concomitant medications included a dose of FLUZONE QUADRIVALENT. It was a case of actual medication error due to expired vaccine used. It was not reported whether the patient experienced any adverse events or not. 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. Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Wrong drug administered
Clinical narrative: Initial unsolicited report received from an other health professional on 31-Aug-2018. This case involves an 80-year-old female patient who was vaccinated with a dose of 0.5 ml of FLUZONE QUADRIVALENT (Batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date instead of FLUZONE HIGH DOSE. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered. It was unknown whether the patient had any adverse event. 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: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Large red rash 6 inches wide and 4 inches long.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, General symptom, Local reaction, Peripheral swelling, Pyrexia
Clinical narrative: Severe local reaction - erythema, swelling entire upper arm, moderate fever 101 - 102 degree generalized systemic symptoms lasted 7-10 days.
Age: 49.0
Sex: M
Vaccine: UNK
Symptoms: Dyspnoea, Erythema, Injection site swelling, Pain, Skin discomfort
Clinical narrative: Severe body ache, trouble breathing, swelling of injection site, severe headache, soreness of skin and redness of skin on arms. Im going on third day and it hurts to touch my head anywhere.
Age: 49.0
Sex: M
Vaccine: UNK
Symptoms: Tenderness
Clinical narrative: Severe body ache, trouble breathing, swelling of injection site, severe headache, soreness of skin and redness of skin on arms. Im going on third day and it hurts to touch my head anywhere.
Age: 21.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Fatigue, Headache, Rash pruritic
Clinical narrative: Develop itchy bumps on forehead and neck 3 hours after vaccination. Took two zyrtec and it settled down. Headache and fatigue the morning of 9/7.
Age: 30.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The client is 30 yrs. old and was given a PROQUAD in error.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Pt states that she became nauseated at 9 PM and vomited egg smelling substance several times. She has been drinking fluids to stay hydrated. She reports NO rash, NO difficulty breathing at present, and symptoms seem to be improving. Pt was advised to seek medical attention if does not resolve or if she starts to feel worse.
Age: 94.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Insomnia, Musculoskeletal pain, Pain
Clinical narrative: Acute intense R shoulder pain the day of immunization. Unable to move R arm without significant pain. Spread to L shoulder by next day. Unable to sleep on either side. Mostly resolved by appt on 9/7/18.
Age: 12.0
Sex: M
Vaccine: DTAPIPV, HEP, MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events happened. Was directed by M.D., M.P.H. via email to fill this out.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse S/E or events, patient received 4th dose of HPV in error.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Swelling, Urticaria
Clinical narrative: Full body hives and swelling immediately after giving vaccine - gave BENADRYL and observed in the office for 2 hours.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Influenza like illness, Productive cough, Pyrexia
Clinical narrative: About 12 hours after the shot, in the middle of the night, I woke up with flu-like symptoms, so that I could hardly breathe, this went on for several hours, but in the morning was okay. At about 24 hours, I started getting chest congestion and coughing up gook. About 29 hours, I had a fever that maxed out at 102.1 with violent chills, that lasted about 1.5 hours (The worst chills I have ever had). Fever was still 102 when I went to be at 11:00. When I woke up this morning, temperature was 97.4 so now it was below normal. However, I do feel fine now.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Respiratory tract congestion
Clinical narrative: About 12 hours after the shot, in the middle of the night, I woke up with flu-like symptoms, so that I could hardly breathe, this went on for several hours, but in the morning was okay. At about 24 hours, I started getting chest congestion and coughing up gook. About 29 hours, I had a fever that maxed out at 102.1 with violent chills, that lasted about 1.5 hours (The worst chills I have ever had). Fever was still 102 when I went to be at 11:00. When I woke up this morning, temperature was 97.4 so now it was below normal. However, I do feel fine now.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Pain at injection site and surrounding area lasting less than 7 days. Advised patient to follow up with physician to rule out other causes.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms. Fever, aches, headache.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Pediatric dose given to adult patient.
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 31-Aug-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked to case 2018SA248558. This case involves a 16 months old male patient who received vaccines ACT-HIB (lot U1945AAA via unknown route) on 13-Aug-2018, PREVNAR 13 not produced by Sanofi Pasteur (lot number not reported) via intramuscular route in the right thigh on an unknown date and DTAP not produced by Sanofi Pasteur (lot number not reported) via intramuscular route in the right thigh on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique. It was also reported that ACTHIB was used with sterile water. It was unknown whether adverse event occurred or not. 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: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain reports pain that bothers patient at site of injection. Patient states she has never experienced pain like this from any of her other vaccinations. Informed patient to see MD if pain is bothersome.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Central nervous system lesion, Facial paralysis, Feeding disorder, Gait disturbance, Gait inability
Clinical narrative: Days later daughter had left side facial droop and had trouble with walking dragged left leg. Found out she got a brain lesion and doctors can't found nothing wring. Now not able to walk, talk or eat. All this started right after the flu shot.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Speech disorder
Clinical narrative: Days later daughter had left side facial droop and had trouble with walking dragged left leg. Found out she got a brain lesion and doctors can't found nothing wring. Now not able to walk, talk or eat. All this started right after the flu shot.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Neuralgia
Clinical narrative: Patient, who is a retired physician, describes an intense pain, unrelieved by over-the-counter pain medications as well as prescription opioids and muscle relaxants starting day of injection, though not immediately following vaccine administration. The pain was located around the injection site and traveled up the arm near the scapula. She describes the pain as sharp and stabbing and left her unable to move her arm. She reports the pain is better one week later but is still present. As a previous physician, she describes it as a neuritis-like pain.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash, Skin exfoliation
Clinical narrative: Small bumps appeared under the skin on left upper arm with more bumps on right upper arm, chest & upper back (shoulders). These bumps did not blister, but after a few days the skin broke and began to peel. Dermatologist prescribed steroid cream 3 times per day. After 10 days, some of the bumps are still visible and may leave scars.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Nausea
Clinical narrative: Fatigue, malaise, nausea.