chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 10-FEB-2018, the patient was vaccinated with a dose of VARIVAX (dose, units, frequency, lot number, expiration date not reported) reconstituted with sterile diluent (MRK INJ) (dose, units, frequency, lot number, expiration date not reported) via intramuscular route. On 24-MAR-2018 the patient was vaccinated with a second dose of VARIVAX (dose, units, frequency, lot number, expiration date not reported) reconstituted with sterile diluent (MRK INJ) (dose, units, frequency, lot number, expiration date not reported) via subcutaneous route. On 24-MAR-2018, within 24 hours after the 2nd dose of VARIVAX, the patient experienced swelling around the injection site. On an unknown date in March 2018, the injection site was described as "really sore and warm" and the patient was "running a fever". The reporter stated that the patient showed up at the pharmacy on an unknown date in March 2018, and about 3.5 inches around the injection site was "red and warm". The pharmacist also stated that there were "little dots around the injection site". The reporter was not sure whether the events were a "side effect" or an "adverse event". The outcome of vaccination site swelling, vaccination site reaction, vaccination site erythema, pyrexia, vaccination site pain and vaccination site warmth was reported as not recovered/not resolved. The reporter did not provide the causality of vaccination site swelling, vaccination site reaction, vaccination site erythema, pyrexia, vaccination site pain and vaccination site warmth with sterile diluent and VARIVAX. No product quality complaint (PQC) was present.
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 10-FEB-2018, the patient was vaccinated with a dose of VARIVAX (dose, units, frequency, lot number, expiration date not reported) reconstituted with sterile diluent (MRK INJ) (dose, units, frequency, lot number, expiration date not reported) via intramuscular route. On 24-MAR-2018 the patient was vaccinated with a second dose of VARIVAX (dose, units, frequency, lot number, expiration date not reported) reconstituted with sterile diluent (MRK INJ) (dose, units, frequency, lot number, expiration date not reported) via subcutaneous route. On 24-MAR-2018, within 24 hours after the 2nd dose of VARIVAX, the patient experienced swelling around the injection site. On an unknown date in March 2018, the injection site was described as "really sore and warm" and the patient was "running a fever". The reporter stated that the patient showed up at the pharmacy on an unknown date in March 2018, and about 3.5 inches around the injection site was "red and warm". The pharmacist also stated that there were "little dots around the injection site". The reporter was not sure whether the events were a "side effect" or an "adverse event". The outcome of vaccination site swelling, vaccination site reaction, vaccination site erythema, pyrexia, vaccination site pain and vaccination site warmth was reported as not recovered/not resolved. The reporter did not provide the causality of vaccination site swelling, vaccination site reaction, vaccination site erythema, pyrexia, vaccination site pain and vaccination site warmth with sterile diluent and VARIVAX. No product quality complaint (PQC) was present.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Painful palpable lump at site of injection 3 days post vaccine, still present as of 3/29/18.
Age: 48.0
Sex: F
Vaccine: HEPAB, VARCEL
Symptoms: Unevaluable event
Clinical narrative: The Client stated that she was not immunocompromised. There was a note in her E-chart about her taking these medications but I did not see the note until after I had given her the shot. I called the Client and spoke to her and to her daughter who is more fluent in English. I referred her to her RA DR. I also called and left a message for her RA DR.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Nausea
Clinical narrative: Redness at shot area and nausea.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hyperhidrosis, Pallor, Vomiting
Clinical narrative: Pt given HPV, Tdap, and MENVEO vaccines around 9:10 AM. Verified with mom prior to injections pt has NKA, never had any adverse reactions with previous vaccines, orange juice was given prior to injections, side effects discussed. Pt tolerated injections well. Then about 5-10 min after pt appeared pale and diaphoretic. Pt assessed, BP at 9:20 AM was 71/40, pulse 57, pt put head of exam chair lowered, cool compress applied, pt given water and tolerated well. Pt continued to be monitored. BP and pulse rechecked at 9:27 AM, BP 89/57, pulse 78. Continued to monitor patient. Then a few minutes later pt vomited x1. MTH was made aware of patient status and had checked on pt when he first became diaphoretic. Rechecked pt BP and pulse at 9:40 AM, BP 90/60, pulse 83. MTH rechecked pt prior to discharge and ok to be discharged. Will follow up with patient later to see how pt is doing.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia
Clinical narrative: Severe muscle aches, head ache throughout the night.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Rash generalised, Rash papular, Urticaria
Clinical narrative: Report form school-based health provider that patient woke up the next morning with a head-to-toe, fine papular rash with uticaria. No new detergents, foods, or medications, mostly resolved as of 3/29/18.
Age: 40.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Breast swelling, Imaging procedure, Immediate post-injection reaction
Clinical narrative: Patient was reporting immediate swelling occurred in the right breast, but was not reported to providers office until 3/29/18.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Pain in extremity, Rash vesicular, Urticaria
Clinical narrative: Extreme redness at site, blisters and shingles like area below site, soreness in arm, hives.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Eye movement disorder, Pallor, Syncope
Clinical narrative: Pt was ok after i have him his third dose. I asked him if he was ok he stated yes, then he looked a bit pale, pt rolled his eyes back then he said he felt dizzy then he fainted I caught him mom grabbed his feet we both laid him down. Pt said did I just faint? I left the room to go get help, then the NP came in we gave him an ice pack. I took his BP it was 110/68 his color came back slowly.
Age: 0.67
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: Patient was given KINRIX at age 8 months instead of Dtap, polio separated. Called HD and stated it was a valid dose.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Red, Warm to the touch, itchy rash. All at injection site. Patient also complained of headache.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Musculoskeletal pain, Neck pain
Clinical narrative: Went to gym after vaccination for a strength/cardio workout. Developed headache that night. Next day had top to bottom "pulsating pain". Chills the following day and that night woke up in a sweat. Seen in the office 03/24/2018 with complaints of severe pain in both shoulders up to neck. Was afebrile in the office, never took her temp at home. History of shingles on right shoulder 10 years ago.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Night sweats, Pain
Clinical narrative: Went to gym after vaccination for a strength/cardio workout. Developed headache that night. Next day had top to bottom "pulsating pain". Chills the following day and that night woke up in a sweat. Seen in the office 03/24/2018 with complaints of severe pain in both shoulders up to neck. Was afebrile in the office, never took her temp at home. History of shingles on right shoulder 10 years ago.
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Red area around injection site.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a physician via company representative referring to an 18-year-old male patient. He did not have any pertinent medical history, concurrent conditions and he did not take any concomitant medications. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (dose, vaccination site, lot number and expiration date were not reported) as prophylaxis. On an unknown date, 24 hrs after the vaccination, the patient broke out with hives. No lab diagnostics/studies were performed. The patient received an unspecified treatment and recovered from the event on an unknown date. The causality between the event and GARDASIL 9 was not reported.
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Dyskinesia, Irritability
Clinical narrative: This is a spontaneous report from a contactable physician, via a sales representative. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation, PENTACEL, via an unspecified route of administration on an unspecified date at unknown dose for immunisation, rotavirus vaccine, via an unspecified route of administration on an unspecified date at unknown dose for immunisation. The patient medical history and concomitant medications were not reported. 1-2 days after vaccination the patient experienced irritable/fussy with outcome of recovered, had brief episodes (1-2 seconds at a time) of mouth movement/head jerking with outcome of recovered. The information on the batch number has been requested.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Face oedema, Pruritus, Rash generalised
Clinical narrative: Generalized rash, facial edema and pruritus.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Myalgia, Pyrexia
Clinical narrative: Sore muscle with hours, fever of 101 at 3 AM that kept patient down for most of the day, itchy hot rash of about 2.5 inch radius around injection site that lasted for almost a week after.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Patient reports redness at the injection site which lasted about 24 hours. Patient also reports pain at injection site, muscle pain, tiredness and fever.
Age: 67.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Full blood count normal, Headache, Joint stiffness, Laboratory test normal
Clinical narrative: Received MMR immunization (3/12/18). Started with symptoms of low grade fever, body and headaches (3/22/18). Pain in finger joints and wrists (3/27/18). Tightness and pain in both knees 3/28/18.
Age: 67.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Pyrexia, Red blood cell sedimentation rate normal, Urine analysis normal
Clinical narrative: Received MMR immunization (3/12/18). Started with symptoms of low grade fever, body and headaches (3/22/18). Pain in finger joints and wrists (3/27/18). Tightness and pain in both knees 3/28/18.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Suicidal ideation
Clinical narrative: In minutes I had pain so bad I was hoping I would die. If I had a gun and no one to stop me I would have killed myself.
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Blindness, Blindness cortical, Guillain-Barre syndrome, Hallucination
Clinical narrative: This case was reported in a literature article and described the occurrence of posterior reversible encephalopathy syndrome in a female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced posterior reversible encephalopathy syndrome (serious criteria hospitalization and GSK medically significant), hallucination (serious criteria hospitalization), weakness (serious criteria hospitalization), cortical blindness (serious criteria hospitalization and GSK medically significant), metamorphopsia (serious criteria hospitalization) and loss of vision (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the posterior reversible encephalopathy syndrome, hallucination, weakness and metamorphopsia were unknown and the outcome of the cortical blindness and loss of vision were recovering/resolving. The reporter considered the posterior reversible encephalopathy syndrome, hallucination, weakness, cortical blindness, metamorphopsia and loss of vision to be related to Influenza vaccine Quadrivalent. Additional information was provided. This case was reported in a literature article and described the occurrence of posterior reversible encephalopathy syndrome (PRES) in female patient of unspecified age who was vaccinated with unspecified influenza vaccine (manufacturer unknown). No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient initially developed ascending weakness. Subsequently, the patient was treated for suspected acute inflammatory demyelinating polyradiculoneuropathy (AIDP). Over the course of her hospitalisation, the patient had a progressive loss of vision which led to cortical blindness. The patient had typical magnetic resonance imaging (MRI) findings suggestive of PRES, including scattered areas of cortical and subcortical T2 and T2 Flair hyperintensities within the occipital and parietal lobes. Her vision had improved, but during this time, the patient noted an increase in what she had described as hallucinations, including people changing appearances, as well as objects around the room changing in size. This case has been considered serious due to hospitalisation. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between PRES and unspecified influenza vaccine.
Sex: F
Vaccine: FLU4
Symptoms: Metamorphopsia, Nuclear magnetic resonance imaging brain abnormal, Posterior reversible encephalopathy syndrome
Clinical narrative: This case was reported in a literature article and described the occurrence of posterior reversible encephalopathy syndrome in a female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced posterior reversible encephalopathy syndrome (serious criteria hospitalization and GSK medically significant), hallucination (serious criteria hospitalization), weakness (serious criteria hospitalization), cortical blindness (serious criteria hospitalization and GSK medically significant), metamorphopsia (serious criteria hospitalization) and loss of vision (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the posterior reversible encephalopathy syndrome, hallucination, weakness and metamorphopsia were unknown and the outcome of the cortical blindness and loss of vision were recovering/resolving. The reporter considered the posterior reversible encephalopathy syndrome, hallucination, weakness, cortical blindness, metamorphopsia and loss of vision to be related to Influenza vaccine Quadrivalent. Additional information was provided. This case was reported in a literature article and described the occurrence of posterior reversible encephalopathy syndrome (PRES) in female patient of unspecified age who was vaccinated with unspecified influenza vaccine (manufacturer unknown). No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient initially developed ascending weakness. Subsequently, the patient was treated for suspected acute inflammatory demyelinating polyradiculoneuropathy (AIDP). Over the course of her hospitalisation, the patient had a progressive loss of vision which led to cortical blindness. The patient had typical magnetic resonance imaging (MRI) findings suggestive of PRES, including scattered areas of cortical and subcortical T2 and T2 Flair hyperintensities within the occipital and parietal lobes. Her vision had improved, but during this time, the patient noted an increase in what she had described as hallucinations, including people changing appearances, as well as objects around the room changing in size. This case has been considered serious due to hospitalisation. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between PRES and unspecified influenza vaccine.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema
Clinical narrative: Redness of arm - 4PM took 2 BENADRYL 10PM took 1 BENADRYL. Awakened at 2AM on 3/29/18 and took ADVIL. 3/29/18 at 8AM saw Dr about rxn, prescribed BACTRIM DS, 20 1 BID for cellulitis.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Angioedema, Injection site pain, Lip swelling
Clinical narrative: Angioedema and angioedema-swollen lips; mild tenderness at injection site. Diphenhydramine 25 mg BID.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Angioedema
Clinical narrative: Angioedema and angioedema-swollen lips; mild tenderness at injection site. Diphenhydramine 25 mg BID.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Insomnia, Pain, Screaming
Clinical narrative: Extremely painful dark pink area approximately 9 cm x 5 cm. Any contact while in bed awakened me and elicited screams.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Fever; Chills; Headache; Sore joints; Body Aches; Fatigue. Severe pain in left arm. I called my doctor's office after feeling very ill and described all symptoms. Was told there was absolutely no way it was possibly from the vaccine and I likely picked something up there during my visit. Even though they gave me a handout that has all these symptoms under "risks".
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever; Chills; Headache; Sore joints; Body Aches; Fatigue. Severe pain in left arm. I called my doctor's office after feeling very ill and described all symptoms. Was told there was absolutely no way it was possibly from the vaccine and I likely picked something up there during my visit. Even though they gave me a handout that has all these symptoms under "risks".
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Within 10 minutes of receiving vaccines, the patient started itching and had hives appear behind his ear, right arm, stomach, and face. Mother unsure if patient's throat was itching. Mother reported that he had no trouble talking and denies any shortness of breath. Mother then gave a dose of CLARITIN followed by 5 ml of children's BENADRYL. After administering the medications to the patient, the mother and patient returned to the clinic where symptoms improved and hives were absent 10 minutes following medication administration. Patient and mother stayed at clinic for assessment for approximately 20 minutes after medication administration. Patient's mother encouraged to notify primary care physician as well as if symptoms reoccurred or patient had difficulty speaking or was short of breath, to call 911. Mother voiced understanding. At 12:45, mother of patient was contacted via telephone for status of patient. Mother reported that patient had no other signs or symptoms and was acting and playing appropriately.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: I just wanted to update you that patient had a pretty significant reaction to the flu shot that she received at her annual visit. I just wasn't sure how to go about reporting it so that the powers that be who collect records are aware. Patient developed an area that extended from her elbow to her shoulder and caused pain in her forearm. It was hot and red and lasted for 5 days before it was resolved. I did take her to urgent care because I was concerned about the degree to which it swelled and how hot it felt, but we were instructed to monitor and ice it. Just FYI for the CDC or whoever else these things get reported to.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Fatigue, Hypoaesthesia, Injected limb mobility decreased, Injection site bruising
Clinical narrative: Pt showed to clinic 2 days after vaccine administration (for TST reading), left arm bruised and swollen at injection site, redness below the site. Pt states entire arm is numb, unable to lift arm above shoulder, body aches, fatigue, low grade fever. Therefore assessed site, referred to PCP if no improvement tomorrow.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Pt showed to clinic 2 days after vaccine administration (for TST reading), left arm bruised and swollen at injection site, redness below the site. Pt states entire arm is numb, unable to lift arm above shoulder, body aches, fatigue, low grade fever. Therefore assessed site, referred to PCP if no improvement tomorrow.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, MMRV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Mom called on 03-27-2018 and mentioned that his left thigh looked like he had gotten a mosquito bite and was a little soar. We saw patient on 03-28-2018 where he presented with left thigh erythema, 7 x 4 cm rash, and warm to the touch. No fever, or itchiness.
Age: 20.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: On the same afternoon that the vaccine was given, 03/27/2018, patient started to generally not feel well. The next day, 03/28/2018, his temperature went up to 104 and he began to cough and had general fatigue. He began taking OTC medication for his fever and symptoms. By the evening of 03/28/2018, he noticed that the site where the vaccine was administered was sore, puffy and red.
Age: 20.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Pyrexia
Clinical narrative: On the same afternoon that the vaccine was given, 03/27/2018, patient started to generally not feel well. The next day, 03/28/2018, his temperature went up to 104 and he began to cough and had general fatigue. He began taking OTC medication for his fever and symptoms. By the evening of 03/28/2018, he noticed that the site where the vaccine was administered was sore, puffy and red.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Rash generalised, Vaccination complication
Clinical narrative: Whole body rash - itching - 4 days of up every hour. Gave BENADRYL. Two doctors cited either unknown rash/virus or likely reaction to MMR vaccine. Luckily no fever.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to an identifiable patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with improperly stored VARIVAX (dose and frequency were unknown by reporter) from lot N022979 expiry date 23-AUG-2019 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MRK) (lot/expiry date unknown by reporter). No adverse effects were reported. Temperature was reported as 15 degree Fahrenheit to 46 degree Fahrenheit (32 degree Fahrenheit). Time frame was reported as 7 hours. There was no previous temperature excursion involved. The call was because of a data logger. No product quality complaint was involved. This is one of the three reports linked via same reporter link. Sender's Comments: US-009507513-1803USA012517: US-009507513-1803USA012518.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 16-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. Since 24-JAN-2018, the vaccine was incorrectly stored at temperature of 29.7 Fahrenheit degrees for total of 32.23 hours. On 30-JAN-2018, the patient was vaccinated with the second dose of GARDASIL 9, in the left deltoid, lot # N022584, expiration date 15-JUN-2020 (dose and route of administration were not reported) for prophylaxis. The temperature excursion had not occurred as a result of a reading from a Digital Data logger. No adverse effects were reported. There was no prescription drug treatment for the experience required. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA012501: US-009507513-1803USA012502: US-009507513-1802USA003340.
Age: 23.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 23-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-JAN-2018, the patient was vaccinated with the first dose of GARDASIL 9, in the left deltoid, lot # N017833, expiration date 16-NOV-2019 (dose and route of administration were not reported) for prophylaxis. On an unknown date, the vaccine had been incorrectly stored at temperature of 32 Fahrenheit degrees up to 35 Fahrenheit degrees (0 Celsius degrees to 1 Celsius degrees) for a total time of approximately 11 hours. The temperature excursion had not occurred as a result of a reading from a Digital Data logger. No adverse effects were reported. There was no prescription drug treatment for the experience required. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA012500: US-009507513-1803USA012502: US-009507513-1802USA003340.
Age: 20.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 20-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-JAN-2018, the patient was vaccinated with the first dose of GARDASIL 9, in the right deltoid, lot # N017833, expiration date 16-NOV-2019 (dose and route of administration were not reported) for prophylaxis. On an unknown date, the vaccine had been incorrectly stored at temperature of 32 Fahrenheit degrees up to 35 Fahrenheit degrees (0 Celsius degrees to 1 Celsius degrees) for a total time of approximately 11 hours. The temperature excursion had not occurred as a result of a reading from a Digital Data logger. No adverse effects were reported. There was no prescription drug treatment for the experience required. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA012500: US-009507513-1803USA012501:US-009507513-1802USA003340.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to an identifiable patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with improperly stored VARIVAX (dose and frequency were unknown by reporter) from lot N022979 expiry date 23-AUG-2019 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MRK) (lot/expiry date unknown by reporter). Temperature was reported as 15 degrees Fahrenheit to 46 degrees Fahrenheit (32 degrees Fahrenheit). Time frame was reported as 7 hours. There was no previous temperature excursion involved. The call was because of a data logger. No product quality complaint was involved. This is one of the three reports linked via same reporter link. Sender's Comments: US-009507513-1803USA012518: US-009507513-1803USA012301.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a identifiable patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with improperly stored VARIVAX (dose and frequency were unknown by reporter) from lot N022979 expiry date 23-AUG-2019 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MRK) (lot/expiry date unknown by reporter). Temperature was reported as 15 degrees Fahrenheit to 46 degrees Fahrenheit (32 degrees Fahrenheit). Time frame was reported as 7 hours. There was no previous temperature excursion involved. The call was because of a data logger. No product quality complaint was involved. This is one of the three reports linked via same reporter link. Sender's Comments: US-009507513-1803USA012301: US-009507513-1803USA012517.
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: (R) deltoid swelling, redness, warmth, fever.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Child presented to clinic on 3/28/18 with redness and swelling of upper right arm. Swelling started 3/27/18 in the morning. VIS sheets read to parent and explained in further detail, warm compresses to arm along with ibuprofen for discomfort or fever.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Back pain, Body temperature increased, Chest discomfort, Feeling hot, Tremor
Clinical narrative: Pt came to clinic hours after injections complaining of severe back pain, tremors, being hot. She was checked in and found to have temp of 101. After being placed on stretcher vitals were checked. BP 125/84, HR 133, Sao2 98%, resp  26. Temp 5 minutes after arrival 103.4. 2:40pm- Ibuprofen 200mg tablets (x2 ) and 200mg liquid given PO. 2:42pm- benadryl 25mg given PO. 2:49pm Albuterol 0.083% given per hand held nebulizer for complaint of chest tightness. Ambulance called. 3:03pm Epinephrine 0.3mg SQ given for chest tightness as albuterol did not relieve the symptoms. 3:08pm Ambulance arrived and took patient to ER.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Seizure
Clinical narrative: Seizure in patient with seizure history.
Age: 1.25
Sex: F
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: Patient was suppose to receive a PCV13 and was given HEP B instead.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Roughly 36 hours post vaccination, patient's right arms is red and extremely swollen all the way down the arm to the elbow.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Feeding disorder, Injection site reaction, Local reaction, Mobility decreased
Clinical narrative: 24 hours after receiving vaccine, the patient became extremely weak. He could not eat or get out of bed. Localized injection site reaction lasted for a week and was severe. He experienced an extremely large shot and was very swollen for a week post injection.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: 24 hours after receiving vaccine, the patient became extremely weak. He could not eat or get out of bed. Localized injection site reaction lasted for a week and was severe. He experienced an extremely large shot and was very swollen for a week post injection.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Eructation, Pallor, Pyrexia
Clinical narrative: Started with strong joint pain (knees, elbow and shoulder). Patient started to get very pale and shaking in bed, no fever at this point. Shivering and shakiness grew stronger and emergency nurse on phone asked to bring to ER. Started the high fever while in the ER and she was released after pain and fever medication. While home vomiting and extreme burping started. Scheduled a sick visit where she got the shot. They gave her ZOFRAN and antacid. Monitoring and medicating fever every each 3-4 hours.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Tremor, Vomiting
Clinical narrative: Started with strong joint pain (knees, elbow and shoulder). Patient started to get very pale and shaking in bed, no fever at this point. Shivering and shakiness grew stronger and emergency nurse on phone asked to bring to ER. Started the high fever while in the ER and she was released after pain and fever medication. While home vomiting and extreme burping started. Scheduled a sick visit where she got the shot. They gave her ZOFRAN and antacid. Monitoring and medicating fever every each 3-4 hours.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Feeding disorder, Influenza like illness, Injection site erythema
Clinical narrative: 12 hours post immunization patient came down with severe muscle pains, chills, and intense flu like symptoms that lasted for 48 hours. She was bed ridden and unable to eat. She also developed severe injection site reaction that lasted for 7 days. Site was very swollen, very red, and sore.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Myalgia
Clinical narrative: 12 hours post immunization patient came down with severe muscle pains, chills, and intense flu like symptoms that lasted for 48 hours. She was bed ridden and unable to eat. She also developed severe injection site reaction that lasted for 7 days. Site was very swollen, very red, and sore.
Age: 53.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Dyspepsia, Mouth swelling, Pharyngeal oedema
Clinical narrative: The patient's wife called to report that patient developed last night severe heartburn throughout the night. He developed also mouth and throat swelling. She reported this today at 12:29 pm. She states his mouth and throat swelling has stabilized. Recommended ER now. She agreed with plan and is taking him to the ER.
Age: 28.0
Sex: F
Vaccine: HPV9
Symptoms: Cervical dysplasia, Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to an adult female patient of unknown age. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date in January 2015, when the patient was 26 years old, she was vaccinated with the first GARDASIL 9 (lot # K018149, expiry date and dosing details unknown) for prophylaxis. On an unknown date in July 2015, the patient developed low-grade squamous intraepithelial lesion (LGSIL) which may have been developing before vaccination (cervical dysplasia). The patient had an unknown human papilloma virus (HPV) status in July 2015. On an unknown date in late July 2017, at the age of 28 years old, the patient was vaccinated with the second dose of GARDASIL 9 (lot # N004799, expiry date and dosing details unknown) for prophylaxis (inappropriate schedule of drug administration). The third dose of the GARDASIL 9 was not administered. No treatment was provided for the event. The outcome of cervical dysplasia was unknown. Causality assessment was not provided by the reporter. Lot number K018149 is an invalid lot number for GARDASIL 9.
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Incomplete course of vaccination, Influenza like illness, Myalgia, Pain
Clinical narrative: This is a spontaneous report from a contactable Medical assistant communicated with a Pfizer sales representative reported for her son. A 19-year-old male patient received TRUMENBA, via an unspecified route of administration at single dose on 05Oct2017 for immunisation. The patient medical history and concomitant medications were not reported. On 05Oct2017, the patient experienced high fever, pain, muscle aches, weakness, became pale, almost flu like, all with outcome of recovered on an unspecified date in Oct2017, it was severe enough that he will not get the second dose on an unspecified date. The information on the lot number has been requested.
Sex: M
Vaccine: MENB
Symptoms: Pallor, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable Medical assistant communicated with a Pfizer sales representative reported for her son. A 19-year-old male patient received TRUMENBA, via an unspecified route of administration at single dose on 05Oct2017 for immunisation. The patient medical history and concomitant medications were not reported. On 05Oct2017, the patient experienced high fever, pain, muscle aches, weakness, became pale, almost flu like, all with outcome of recovered on an unspecified date in Oct2017, it was severe enough that he will not get the second dose on an unspecified date. The information on the lot number has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza, Muscular weakness, Myalgia
Clinical narrative: Left arm extremely sore. Muscle aches, headache and chills beginning approximately 3 hours after vaccine injection and resolving after 24 hours. Symptoms consistent with typical flu symptoms.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Left arm extremely sore. Muscle aches, headache and chills beginning approximately 3 hours after vaccine injection and resolving after 24 hours. Symptoms consistent with typical flu symptoms.
Age: 58.0
Sex: F
Vaccine: DTAP
Symptoms: Injected limb mobility decreased, Injection site pain, Periarthritis, X-ray limb
Clinical narrative: Patient reports frozen shoulder and deep pain in left upper arm. Difficulty raising arm over head, started 1 week ago.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hyperaesthesia, Insomnia, Nausea
Clinical narrative: Approximately 10 hours after receiving the vaccine, I felt like I had been hit with a ton of bricks. I had a fever, headache, my body ached and my skin hurt to the touch. I was exhausted but unable to sleep. The fever lasted for approximately 6 hours. The headache, body aches and skin sensitivity lasted approximately 24 hours. After the fever abated, I felt nauseous for approximately 12 hours.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain of skin, Pyrexia
Clinical narrative: Approximately 10 hours after receiving the vaccine, I felt like I had been hit with a ton of bricks. I had a fever, headache, my body ached and my skin hurt to the touch. I was exhausted but unable to sleep. The fever lasted for approximately 6 hours. The headache, body aches and skin sensitivity lasted approximately 24 hours. After the fever abated, I felt nauseous for approximately 12 hours.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Throat tightness
Clinical narrative: Patient returned to pharmacy within 20 minutes of receiving vaccine complaining of "throat tightness". Discussed potential for allergic reaction with patient along with risks. He decided to go home at that time and that afternoon he went to his physician's office. Spoke to nurse at Dr's office. She gave the patient MEDROL 40mg intramuscular. She stated that his symptoms still continued for the next couple days. I spoke to patient on 3/28/18 and he stated that he was feeling back to normal.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 3/28 - Early morning. Red, swollen, hot reaction at injection site. Went to Urgent Care and they drew a line around the red. I was told to monitor for increase in size of the red area. I applied ice and took 25 mg of Diphenhydramine. 7 hours later I took another 25 mg of Diphenhydramine.3/29 - Early morning. Redness had spread (almost double) below the original circled outline. Less swelling. Still very hot to the touch. Took 180 mg of Fexofenadine. Went to my doctor. My blood pressure was elevated. Advised continued use of antihistamine and ice. Both the doctor at the Urgent Care and the PA at Dr.'s office were concerned that it was an infection (Cellulitis). If the symptoms continue, I'm supposed to take antibiotics. I had other symptoms such as mild shivering, night sweats, flushed face.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pruritus, Pyrexia
Clinical narrative: Chills, body aches, itching, fever 100.6.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Reported 1 month after given the vaccination. Patient reports pain in arm (say it's not the shoulder joint but upper "meaty" part of arm). States that there is a constant dull pain but no limited mobility (he is able to play his guitar with no difficulity) states that he experiences most pain when laying on his side at night. Reports no swelling or redness. Pain scale 3.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea
Clinical narrative: EMPLOYEE STATED THAT SUDDENLY SHE JUST STARTED FEELING NAUSEATED AND LIGHT HEADED.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Patient stated that since his vaccination on 3/7/18 his arm has been sore. No changes in motility, no redness or swelling.
Age: 59.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chest pain, Herpes zoster
Clinical narrative: Pt received SHINGRIX and PNEUMOVAX 23 on 3/20/18. A week later she developed pain in her chest. She presented to Hospital ER where Dr. diagnosed her with shingles underneath her breasts. Pt was given VALTREX 3/29/18.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: "Whole left upper arm turned red and swollen, all the way around" and was tender to touch, as well as pruritic. 20 Sep 2017, exam showed erythematous region that was indurated on the left shoulder measuring approximately 6 x 8 cm in diameter. Patient treated with anti-inflammatories and BENADRYL with resolution of symptoms within 4 days.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Rash, Swelling, Swelling face
Clinical narrative: Rash, redness and swelling on face, chest, back.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Borrelia test positive, Facial paralysis, Lyme disease, Swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of Bell's palsy in a 6-year-old male patient who received Influenza vaccine Quadrivalent. Concurrent medical conditions included local swelling (which was believed to be viral). On 12th October 2017, the patient received Influenza vaccine Quadrivalent. On 15th October 2017, 3 days after receiving Influenza vaccine Quadrivalent, the patient experienced Bell's palsy (serious criteria GSK medically significant). On 16th October 2017, the patient experienced Lyme disease (serious criteria GSK medically significant). The patient was treated with erythromycin, Steroids, Artificial Tears and TYLENOL. On an unknown date, the outcome of the Bell's palsy was recovered/resolved and the outcome of the Lyme disease was unknown. It was unknown if the reporter considered the Bell's palsy and Lyme disease to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: On 11th October 2017, the patient had a lump on their neck. On 15th October 2017, at home the patient was applied moist heat. On 16th October 2017, 4 days after receiving Influenza vaccine Quadrivalent, the patient had blood work and tested positive for Lyme disease. The Bell's palsy resolved, without any further medical intervention, or hospitalization, and the patient's symptoms were not considered disabling, or life threatening. The healthcare professional was unsure of which brand flu vaccine the patient received as the vaccine was administered by the patient's school.
Age: 27.0
Sex: M
Vaccine: VARCEL
Symptoms: Dysphonia, Oropharyngeal pain, Throat tightness
Clinical narrative: 2-22-18 c/o of hoarseness and a tightness in throat that started on day of vaccine. Pain in throat now.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site erythema, Injection site warmth
Clinical narrative: Developed redness at area of injection - warm to touch. Redness spreading down arm. Given antibiotic - cephalexin 250/5ml one tsp BID x 10 days. Given Antihistamine - cetirizine 5mg/5ml 1/2 tsp PRN BID.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort, Diarrhoea, Fatigue, Feeling abnormal, Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 81-year-old male patient who received SHINGRIX (batch number P3777, expiry date unknown). Concurrent medical conditions included rheumatoid arthritis. Concomitant products included carvedilol, hydrochlorothiazide, LANOXIN, methotrexate, Multi Vitamin, Potassium, prednisone, tramadol, Vitamin B12, Vitamin B6 and ZESTRIL. On 9th March 2018, the patient received SHINGRIX .5 ml. On 9th March 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness and pain in arm. On 11th March 2018, the patient experienced chest pressure. On 12th March 2018, the patient experienced diarrhea. On 13th March 2018, the patient experienced sickness. On 14th March 2018, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles, rash, sickness, tiredness and pain in arm were not recovered/not resolved and the outcome of the chest pressure and diarrhea were recovered/resolved. The reporter considered the shingles to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the rash, sickness and diarrhea to be related to SHINGRIX. The reporter considered the chest pressure, tiredness and pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's wife. The patient received ELIQUIS, LASIX and EYECAP as concomitant. 5 days, after receiving SHINGRIX, the night before reporting date, the patient broke out in a rash in the front and the back of his chest which the reporter believed was shingles. The patient was tired and in bed all day and he did not feel well. On Monday, 3 days after receiving SHINGRIX, the patient had diarrhea. 2 days, after receiving SHINGRIX, the patient felt pressure in his chest a couple of days ago and he thought he was having a heart attack. The patient's arms were sore and achy and felt like he had a bug.