chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Fall, Feeling cold, Feeling hot
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a 64 year old female patient with concurrent condition of low white blood cell count and urinary tract infection. The patient also had right arm pain the night before administration of PNEUMOVAX 23 and the provider did not think it was an allergic reaction. Her past drugs included nitrofurantoin, azelastine, CIPRO, sulfamethoxazole (+) trimethoprim, fluoxetine, and paroxetine. She had drug reactions/allergies with nitrofurantoin, azelastine, CIPRO, sulfamethoxazole (+) trimethoprim, fluoxetine, and paroxetine. On 22-MAR-2017, the patient was vaccinated with PNEUMOVAX 23 (lot # N000508, expiry 19-OCT-2018) intramuscularly for physical exam, getting up to date on vaccines. Her concomitant therapies included levothyroxine sodium (manufacturer unknown), amoxicillin, and LEXAPRO. On the same day at night, the patient experienced severe right arm pain at the injection site, hyperhidrosis, asthenia, dizziness, and fell twice described as slowly went to the floor, then she got cold and went to a chair, and then felt hot overnight, she experienced severe arm pain with moving her arm and could only abduct the shoulder 20 degrees (injected limb mobility decreased) and then stopped due to pain. She rated her arm pain 3 out of 10 at the injection site. The patient sought medical attention. Treatment included TYLENOL 1000 mg three times a day as needed for pain or ibuprofen 400mg-800mg three times a day as needed for pain. No lab diagnostics/studies were performed. The outcome of hyperhidrosis, asthenia, injection site pain, injected limb mobility decreased, feeling hot, dizziness, pain in extremity, feeling cold and fall was reported as recovered/resolved on an unknown date. Causality for the events was unknown. No PQC was present.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Hyperhidrosis, Injection site pain, Mobility decreased, Pain
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a 64 year old female patient with concurrent condition of low white blood cell count and urinary tract infection. The patient also had right arm pain the night before administration of PNEUMOVAX 23 and the provider did not think it was an allergic reaction. Her past drugs included nitrofurantoin, azelastine, CIPRO, sulfamethoxazole (+) trimethoprim, fluoxetine, and paroxetine. She had drug reactions/allergies with nitrofurantoin, azelastine, CIPRO, sulfamethoxazole (+) trimethoprim, fluoxetine, and paroxetine. On 22-MAR-2017, the patient was vaccinated with PNEUMOVAX 23 (lot # N000508, expiry 19-OCT-2018) intramuscularly for physical exam, getting up to date on vaccines. Her concomitant therapies included levothyroxine sodium (manufacturer unknown), amoxicillin, and LEXAPRO. On the same day at night, the patient experienced severe right arm pain at the injection site, hyperhidrosis, asthenia, dizziness, and fell twice described as slowly went to the floor, then she got cold and went to a chair, and then felt hot overnight, she experienced severe arm pain with moving her arm and could only abduct the shoulder 20 degrees (injected limb mobility decreased) and then stopped due to pain. She rated her arm pain 3 out of 10 at the injection site. The patient sought medical attention. Treatment included TYLENOL 1000 mg three times a day as needed for pain or ibuprofen 400mg-800mg three times a day as needed for pain. No lab diagnostics/studies were performed. The outcome of hyperhidrosis, asthenia, injection site pain, injected limb mobility decreased, feeling hot, dizziness, pain in extremity, feeling cold and fall was reported as recovered/resolved on an unknown date. Causality for the events was unknown. No PQC was present.
Age: 11.0
Sex: F
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a consumer (mother of the patient) via employee refers to a 11 year old female patient. On 11-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 (also reported as adult pneumonia vaccination) (lot # and expiry date were unknown) for prophylaxis (Drug administered to patient of inappropriate age). It was reported that the mother of the patient wanted to know what was the name of the adult pneumonia vaccine manufactured by Merck, as she is trying to gather her daughter's immunization records. The reporter also mentioned that they have moved a few times in the past couple of years, and her daughter was seen at a medical practice group, where she was given an unspecified adult pneumonia vaccination on 11-SEP-2014 in error. Mother of patient stated a couple of days later her daughter was seen at the physician's office again, where she was given the correct (unspecified name) vaccination. No adverse reactions were reported. No product quality complaint was involved.
Sex: M
Vaccine: HPV4
Symptoms: Antibody test negative, CSF oligoclonal band present, Eye pain, Multiple sclerosis, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Information has been received from the authors in a literature article, concerning a 14 year old male patient. The patient's concurrent conditions, medical history, allergies, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the third dose of GARDASIL as prevention of human papilloma virus (HPV) infection (strength, dosage schedule, route, anatomical location, lot number and expiration date were not reported).  On an unknown date, two weeks after third dose of the vaccine was administered, the patient presented with left retro-orbital pain and blurry vision in the left eye, diagnosed with left optic neuritis. He had a second attack of left optic neuritis two months after initial presentation, it was reported that the patient experienced multiple sclerosis (MS). On unknown dates, a cerebrospinal fluid (CSF) showed presence of oligoclonal bands, magnetic resonance imaging (MRI) of the brain showed presence of white matter lesions with periventricular and corpus collosal involvement, and the rest of the work-up was unremarkable including neuromyelitis optica (NMO) antibody. The patient was treated with intravenous (IV) steroids for relapses, and started on disease modifying therapy with interferon beta-1a for relapsing remitting MS after second event. The patient was followed for two years. The authors indicated that this case and the others that had been previously reported, suggested a temporal association between HPV vaccination and onset of MS. Although live, attenuated vaccines had generally not recommended in MS patients, GARDASIL is an inactivated and recombinant vaccine, and does not contain any viral DNA. Whether the vaccine increases the risk of the initial demyelinating event in an already predisposed population or triggers the onset of MS, by way of an immune response, remains to be studied. Upon internal review, the multiple sclerosis was considered medically significant event. This is one of two cases from the same literature article (MARRS# 1804USA010662). US-009507513-1804USA010662:
Sex: M
Vaccine: HPV4
Symptoms: Optic neuritis, Vision blurred, White matter lesion
Clinical narrative: Information has been received from the authors in a literature article, concerning a 14 year old male patient. The patient's concurrent conditions, medical history, allergies, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the third dose of GARDASIL as prevention of human papilloma virus (HPV) infection (strength, dosage schedule, route, anatomical location, lot number and expiration date were not reported).  On an unknown date, two weeks after third dose of the vaccine was administered, the patient presented with left retro-orbital pain and blurry vision in the left eye, diagnosed with left optic neuritis. He had a second attack of left optic neuritis two months after initial presentation, it was reported that the patient experienced multiple sclerosis (MS). On unknown dates, a cerebrospinal fluid (CSF) showed presence of oligoclonal bands, magnetic resonance imaging (MRI) of the brain showed presence of white matter lesions with periventricular and corpus collosal involvement, and the rest of the work-up was unremarkable including neuromyelitis optica (NMO) antibody. The patient was treated with intravenous (IV) steroids for relapses, and started on disease modifying therapy with interferon beta-1a for relapsing remitting MS after second event. The patient was followed for two years. The authors indicated that this case and the others that had been previously reported, suggested a temporal association between HPV vaccination and onset of MS. Although live, attenuated vaccines had generally not recommended in MS patients, GARDASIL is an inactivated and recombinant vaccine, and does not contain any viral DNA. Whether the vaccine increases the risk of the initial demyelinating event in an already predisposed population or triggers the onset of MS, by way of an immune response, remains to be studied. Upon internal review, the multiple sclerosis was considered medically significant event. This is one of two cases from the same literature article (MARRS# 1804USA010662). US-009507513-1804USA010662:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse (patient's mother) refers to a patient of unknown demographics. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date in 2014 and 2015 the patient was vaccinated with first and second dose of GARDASIL 9 respectively, (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. On an unknown date in 2018 the patient finished the series with GARDASIL 9 (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint was involved.
Sex: F
Vaccine: HPV4
Symptoms: Antibody test negative, CSF oligoclonal band present, Hypoaesthesia, Multiple sclerosis, Muscular weakness
Clinical narrative: Information has been received from the authors in a literature article, concerning a 17 year old female patient. The patient's concurrent conditions, medical history, allergies, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL as prevention of human papilloma virus (HPV) infection (strength, dosage schedule, route, anatomical location, lot number and expiration date were not reported). On an unknown date, two weeks after the vaccine was administered, the patient presented with blurry vision in the right eye, diagnosed with right optic neuritis. On an unknown date, the patient was hospitalized. Then, on an unknown date, a magnetic resonance imaging (MRI) of the brain showed right frontal enhancing lesion. The patient was discharged from the hospital on an unknown date. One week after discharge, she experienced intermittent numbness and weakness in her lower extremities, and blurry vision in the right eye. Repeat MRI of the brain showed new left parieto-occipital enhancing lesion; it was reported that the patient experienced multiple sclerosis (MS). On unknown dates, a cerebrospinal fluid (CSF) showed presence of oligoclonal bands, magnetic resonance imaging (MRI) of the brain showed presence of white matter lesions with periventricular and corpus collosal involvement, and the rest of the work-up was unremarkable including neuromyelitis optica (NMO) antibody. The patient was treated with intravenous (IV) steroids for relapses, and started on disease modifying therapy with interferon beta-1a for relapsing remitting MS after second event. She did not receive further doses GARDASIL. The patient was followed for two years. The authors indicated that this case and the others that had been previously reported, suggested a temporal association between HPV vaccination and onset of MS. Although live, attenuated vaccines had generally not recommended in MS patients, quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) is an inactivated and recombinant vaccine, and does not contain any viral DNA. Whether the vaccine increases the risk of the initial demyelinating event in an already predisposed population or triggers the onset of MS, by way of an immune response, remains to be studied. Upon internal review, the multiple sclerosis was considered medically significant event. This is one of two cases from the same literature article (MARRS# 1804USA008385). Sender's Comments: US-009507513-1804USA008385:
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Optic neuritis, Vision blurred, White matter lesion
Clinical narrative: Information has been received from the authors in a literature article, concerning a 17 year old female patient. The patient's concurrent conditions, medical history, allergies, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL as prevention of human papilloma virus (HPV) infection (strength, dosage schedule, route, anatomical location, lot number and expiration date were not reported). On an unknown date, two weeks after the vaccine was administered, the patient presented with blurry vision in the right eye, diagnosed with right optic neuritis. On an unknown date, the patient was hospitalized. Then, on an unknown date, a magnetic resonance imaging (MRI) of the brain showed right frontal enhancing lesion. The patient was discharged from the hospital on an unknown date. One week after discharge, she experienced intermittent numbness and weakness in her lower extremities, and blurry vision in the right eye. Repeat MRI of the brain showed new left parieto-occipital enhancing lesion; it was reported that the patient experienced multiple sclerosis (MS). On unknown dates, a cerebrospinal fluid (CSF) showed presence of oligoclonal bands, magnetic resonance imaging (MRI) of the brain showed presence of white matter lesions with periventricular and corpus collosal involvement, and the rest of the work-up was unremarkable including neuromyelitis optica (NMO) antibody. The patient was treated with intravenous (IV) steroids for relapses, and started on disease modifying therapy with interferon beta-1a for relapsing remitting MS after second event. She did not receive further doses GARDASIL. The patient was followed for two years. The authors indicated that this case and the others that had been previously reported, suggested a temporal association between HPV vaccination and onset of MS. Although live, attenuated vaccines had generally not recommended in MS patients, quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) is an inactivated and recombinant vaccine, and does not contain any viral DNA. Whether the vaccine increases the risk of the initial demyelinating event in an already predisposed population or triggers the onset of MS, by way of an immune response, remains to be studied. Upon internal review, the multiple sclerosis was considered medically significant event. This is one of two cases from the same literature article (MARRS# 1804USA008385). Sender's Comments: US-009507513-1804USA008385:
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Toothache
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of eruption in a 76-year-old female patient who received SHINGRIX (batch number 3S354, expiry date 4th July 2020). Concomitant products included levothyroxine and pravastatin. On 5th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced eruption and toothache. On an unknown date, the outcome of the eruption was not recovered/not resolved and the outcome of the toothache was unknown. The reporter considered the eruption and toothache to be possibly related to SHINGRIX. Additional details were provided as follows: The patient experienced bumps on the right side of face, eyelid, and right side of nose and in the scalp. The bump was not itchy. The patient was having tooth pain on the right side and was seen by dentist and advised by the dentist that the bumps should be evaluated.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Local reaction, Pain, Pruritus, Skin discolouration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of contusion in a 59-year-old female patient who received SHINGRIX (batch number X3M27, expiry date unknown). On 20th March 2018 11:20, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a day after receiving SHINGRIX, the patient experienced contusion, skin discoloration, skin warm, pruritus, swelling and pain. On an unknown date, the outcome of the contusion, skin warm, pruritus, swelling and pain were recovered/resolved and the outcome of the skin discoloration was recovering/resolving. The reporter considered the contusion, skin discoloration, skin warm, pruritus, swelling and pain to be related to SHINGRIX. Additional details were provided as follows: The health care professional called to report that within 24 hours of vaccination, the patient experienced local reaction of bruising, swelling, pain, and warmth to the touch. The pain lasted for 1 week and then she had residual pain for another 2 weeks. The patient also experienced itching which started after the pain went away (less than a month after vaccination). Everything had resolved except for faint discoloration in which the health care professional described as a distinct line that went from the deltoid to the elbow. This was resolving as well but had not fully resolved till the time of reporting. The patient was the health care professional's hairdresser and she told him the main issue she had was that she used her arms to cut hair all day and she experienced a lot of pain and this was bothersome for her.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of contusion in a 59-year-old female patient who received SHINGRIX (batch number X3M27, expiry date unknown). On 20th March 2018 11:20, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a day after receiving SHINGRIX, the patient experienced contusion, skin discoloration, skin warm, pruritus, swelling and pain. On an unknown date, the outcome of the contusion, skin warm, pruritus, swelling and pain were recovered/resolved and the outcome of the skin discoloration was recovering/resolving. The reporter considered the contusion, skin discoloration, skin warm, pruritus, swelling and pain to be related to SHINGRIX. Additional details were provided as follows: The health care professional called to report that within 24 hours of vaccination, the patient experienced local reaction of bruising, swelling, pain, and warmth to the touch. The pain lasted for 1 week and then she had residual pain for another 2 weeks. The patient also experienced itching which started after the pain went away (less than a month after vaccination). Everything had resolved except for faint discoloration in which the health care professional described as a distinct line that went from the deltoid to the elbow. This was resolving as well but had not fully resolved till the time of reporting. The patient was the health care professional's hairdresser and she told him the main issue she had was that she used her arms to cut hair all day and she experienced a lot of pain and this was bothersome for her.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 58-year-old female patient who received SHINGRIX (batch number P3777, expiry date unknown). On 18th January 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site muscle pain (serious criteria disability) and joint range of motion decreased. On an unknown date, the outcome of the injection site muscle pain was unknown and the outcome of the joint range of motion decreased was not recovered/not resolved. It was unknown if the reporter considered the injection site muscle pain and joint range of motion decreased to be related to SHINGRIX. Additional information was reported as follows: The healthcare professional reported that a patient who received his first dose of SHINGRIX on developed muscular twinge, 2 inches below the injection site which radiated down to right below the elbow, this had also resulted in joint range of motion decreased and was still ongoing. No further information was reported regarding the event. The reporter also reported that she called one day before the day of reporting to speak further about the adverse reaction, however she was unable to provide further details of the event. So she called back on the date of reporting to provide further details and seek recommendations from MES on how to proceed with patient's second dose in series. An initial adverse event report had not been able to be located aside from the current information in the case.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of patients who received SHINGRIX. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patients reported that the SHINGRIX injection was painful. No further information was provided or it was unknown. The healthcare professional declined to proceed with safety report.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 52-year-old male patient who received SHINGRIX. On 11th April 2018, the patient received SHINGRIX (subcutaneous). On 11th April 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In April 2018, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The reporter did not have the lot number. The reporter works at the physician's office and said that on Wednesday, 11th April 2018, someone at her clinic gave the SHINGRIX vaccine subcutaneously to the patient instead of intramuscularly. She spoke with the patient on the day of reporting and the patient said that he was fine. The patient's arm was a little bit sore at the injection site this morning, but he was fine and he did not thought that the reaction was worse than what he normally gets with other vaccines. The reporter said that this was already reported to the local representative and she was just called to provide the additional details.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Incorrect route of drug administration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a female patient who received SHINGRIX. On 9th April 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. On 9th April 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In April 2018, the patient experienced injection site swelling, injection site warmth, injection site erythema and headache. The patient was treated with ibuprofen and Cold Compress. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site erythema, headache and intramuscular formulation administered by other route were unknown. The reporter considered the injection site swelling, injection site warmth, injection site erythema and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in an unknown arm subcutaneously in error, which led to intramuscular formulation administered by other route. Less than a week after vaccination, the patient experienced injection site swelling, injection site redness, injection site warmth and headache. The patient came back to office 48 hours later experiencing a sudden swelling of her arm at the site of the injection. The local swelling was the size of a softball, red in color, hot to touch, with no rash. The medical staff administered Ibuprofen and a cold compress to reduce swelling. No follow up with the patient had occurred since the office visit treatment or exam. The reporter did not agree to follow up contact.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received SHINGRIX (batch number 49ST9, expiry date 4th July 2020). Concomitant products included Aspirin, Calcium, CRESTOR, Probiotics, ZOLOFT and Multivitamin. On 9th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site rash. On an unknown date, the outcome of the injection site erythema and injection site rash were unknown. The reporter considered the injection site erythema and injection site rash to be related to SHINGRIX. Additional information was reported as follows: The physician reported that, her patient received SHINGRIX on Monday. The patient came back to the office on the date of reporting, and presented erythematous patch below the injection site, that was 3 to 4 centimeters in size. The caller categorized the event as rash.
Age: 67.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea, vomiting.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red rash around inj site and around arm. Prednisone x 5 days.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: At injection site her arm is red dime sized welts.
Sex: M
Vaccine: FLU4
Symptoms: Angioedema
Clinical narrative: Angioedema. Epinephrine 0.3 mg once, Diphenhydramine.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Musculoskeletal pain, Pain in extremity, Skin warm, Swelling
Clinical narrative: Sore arm initially into shoulder then red and swollen and hot notable reaction appeared 5-6 days later.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site bruising, Injection site discolouration, Injection site rash
Clinical narrative: Approx 3 hours after injection developed rash at injection site (left upper arm, extended 3-4 inches away from injection site). Gave CLARITIN. Symptoms subsided on exam 4/25/18 3/4 inch area of fading greenish bruising left deltoid at injection site. No swelling.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event noted. Vaccine was 2 months out of date. Patient was administered PENTACEL on 4/6/18 at 5:13 pm. Shortly after, it was noted that the PENTACEL given had expired in 2/2018. Mother was immediately notified and she was not charged for this vaccination. She denied any adverse reaction to vaccine. Dr. also notified same day.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Fatigue, Influenza like illness, Pain, Vaccination site inflammation, Vaccination site swelling
Clinical narrative: Severe swelling/inflammation at Shingrix vaccine site; flu-like joint aches and pains throughout the body; extreme fatigue. Symptoms lasted 4-5 days.
Age: 0.08
Sex: F
Vaccine: DTAP, HIBV, RV1
Symptoms: Screaming
Clinical narrative: High pitched screaming for hours.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Extreme pain at injection site within a few hours; fever, body aches, fatigue/malaise and chills within 24 hours and still ongoing; red, raised welt at injection site as of today, Wednesday, April 25 (3 days out).
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pyrexia, Urticaria
Clinical narrative: Extreme pain at injection site within a few hours; fever, body aches, fatigue/malaise and chills within 24 hours and still ongoing; red, raised welt at injection site as of today, Wednesday, April 25 (3 days out).
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Eczema, Jaundice
Clinical narrative: Eczema and jaundice.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Injection site pain
Clinical narrative: Fatigue, muscle pain, joint pain decreased appetite, fever, chills, weight loss trouble sleeping, injection site ached.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Insomnia, Myalgia, Pyrexia, Weight decreased
Clinical narrative: Fatigue, muscle pain, joint pain decreased appetite, fever, chills, weight loss trouble sleeping, injection site ached.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Hyperaesthesia, Pain in extremity, Pyrexia, Rash
Clinical narrative: CHILLS X24 HRS; FEVER X8HRS ON AND OFF; SMOOTH, RAISED, WARM TO TOUCH RASH XTHIS MORINING; TUESDAY NIGHT SENSITIVITY TO TOUCH WORSENED OVERNIGHT GONE BY MORNING. IBUPROFEN STARTED FROM START OF PAIN OF ARM 2PM TO ABOUT 7PM (600MG TOTAL). PATIENT WAS SEEN IN OFFICE TODAY 04/15/18 @11:40 AM PT REASSURED NO TREATMENT NEEDED.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: CHILLS X24 HRS; FEVER X8HRS ON AND OFF; SMOOTH, RAISED, WARM TO TOUCH RASH XTHIS MORINING; TUESDAY NIGHT SENSITIVITY TO TOUCH WORSENED OVERNIGHT GONE BY MORNING. IBUPROFEN STARTED FROM START OF PAIN OF ARM 2PM TO ABOUT 7PM (600MG TOTAL). PATIENT WAS SEEN IN OFFICE TODAY 04/15/18 @11:40 AM PT REASSURED NO TREATMENT NEEDED.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Patient reported to office that she has hives to abdomen that have become worse over the last 24 hours.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: It wasnt immediately, but that evening the arm was very sore, and a large swollen red area appeared. Lasted for about 6 days, put aloe vera on it, but did not seek additional medical attention.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Malaise, Peripheral swelling, Pyrexia
Clinical narrative: Patient states she was up all night "sick". She was chilled and felt she was running a fever. She has history of left breast cancer and has had mastectomy on that side. She woke up this morning with L arm swelling and redness. She has history of lymphedema. Injection was given in R arm.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Injection site erythema, Myalgia, Rash erythematous, Rash pruritic
Clinical narrative: Muscle aches, headaches, redness at injection site and small red bumps appearing which are extremely itchy.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Pain
Clinical narrative: Nausea, body aches, tired, chills.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Musculoskeletal stiffness, Nausea
Clinical narrative: Fatigue, Nausea, Stiffness/Pain throughout body and injection sight, Fever (101.3 max), chills.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fatigue, Nausea, Stiffness/Pain throughout body and injection sight, Fever (101.3 max), chills.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Musculoskeletal discomfort, Pain in extremity, Rash, Rash erythematous
Clinical narrative: Pt stated she developed an uncomfortable red itchy rash warm to the touch on the right side of her neck a couple days after receiving the vaccine. It kept spreading and also started across her lower back and upper right thigh when she came to the pharmacy about 10 days later on 4/25. She also reported feeling fatigued. Reported arm pain for 1 to 2 days after vaccine.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Skin warm
Clinical narrative: Pt stated she developed an uncomfortable red itchy rash warm to the touch on the right side of her neck a couple days after receiving the vaccine. It kept spreading and also started across her lower back and upper right thigh when she came to the pharmacy about 10 days later on 4/25. She also reported feeling fatigued. Reported arm pain for 1 to 2 days after vaccine.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: Bloody diarrhea.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Local reaction, Rash
Clinical narrative: Per verbal report over phone from patient: Patient's lips got "tight" approximately five minutes after administration. A rash formed around the patient's neck that lasted around 30 minutes. Local reaction - swelling around injection site, warm to touch. Local reaction took approximately 1 day to go away. No difficulty breathing. Pharmacist who administered vaccination advised pt to take a benedryl, but pt did not take against medical advice. Pt made full recovery with no lasting adverse effects.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Feeling abnormal, Headache, Heart rate increased, Injection site discolouration
Clinical narrative: 23 yo F w/ CC: HA/Rash L arm x 5 days after HPV#3 Vaccine, H/A with going from sitting to standing or laying to Monday night low grade subjective F and L arm rash w/increased pain at injection site Color also at site, fast pounding heart rate w/ F. H/A mild to severe if stands up, sharp Continuous since onset Monday night, Dizziness like fuzzy in head. No problem with 1st 2 HPV shots. D/w pt assessment and self care medications useful for H/A and their SE including N,stomach pain and rebound H/A. Given Naproxen for HA pain.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site rash, Palpitations, Pyrexia, Rash
Clinical narrative: 23 yo F w/ CC: HA/Rash L arm x 5 days after HPV#3 Vaccine, H/A with going from sitting to standing or laying to Monday night low grade subjective F and L arm rash w/increased pain at injection site Color also at site, fast pounding heart rate w/ F. H/A mild to severe if stands up, sharp Continuous since onset Monday night, Dizziness like fuzzy in head. No problem with 1st 2 HPV shots. D/w pt assessment and self care medications useful for H/A and their SE including N,stomach pain and rebound H/A. Given Naproxen for HA pain.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient states she went to take off the spot band aid from the injection on 4/24/18 in the shower 0700 and noticed her right arm at the injection site was hot to the touch, red, raised at injection site, and itchy. 4/25/18 Patient had shown the injection site to me and it was red and size was 2x2 on right arm.  Patient will observe and if worsens will be seen by a provider.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Vaccine diluent only given, did not mix with powder.
Age: 1.42
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Vesicular Eruption 8 days after vaccine administration, low grade fever(subjective). Resolved 4/21/2018.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: SHINGRIX vaccine occurred prior to flu like symptoms.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Almost immediate mild swelling an pain in area of injection. This got somewhat worse by 2 - 3 hours after the vaccination and continued for over 6 days.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Red rash noted to patient's left upper arm at site of immunizations (Tdap and MENACTRA). Rash measures 6cm x 8cm. Patient noticed the rash today after school and his father brought him to the clinic at that time. Patient reports the rash itches, and burns when he itches it. Patient's temperature 98.9 degrees Farenheit.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Injection site reaction; now reported on 4/25/18 site is red larger and inflamed. Advise patient to follow up with family physician.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Musculoskeletal pain
Clinical narrative: The patient reported there was a large red area that developed on shoulder after receiving her shot. It was about 5 inches in diameter, and she complained that it ached a little. Denied any other symptoms (ie itch). It started yesterday, and she says it already aches a little less today.
Age: 78.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Pain, Pruritus, Pyrexia
Clinical narrative: Patient experienced redness, pain,itching,fever, and treated with BENADRYL cream and TYLENOL with some improvement.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Lymphadenopathy, Pain
Clinical narrative: New shingles vaccine, shot #1: Flu like symptoms: aches, chills, swollen lymph node under left arm.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Headache, Injection site erythema, Injection site pain, Malaise
Clinical narrative: Bad muscle pain, headache, redness and soreness of injected arm, loss of appetite, queasiness, malaise. Arm soreness went away at day five after shot. Other symptoms remain as of today, day 6 post shot.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: Bad muscle pain, headache, redness and soreness of injected arm, loss of appetite, queasiness, malaise. Arm soreness went away at day five after shot. Other symptoms remain as of today, day 6 post shot.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No Adverse effects noted at this time. 4 month old was given a varicella and a MMR vaccine.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Fatigue, Headache, Pain in extremity
Clinical narrative: PATIENT REPORTS OF GENERAL BODY WEAKNESS, FATIGUE, SORE ARM,REDNESS IN ARM,HEADACHE,FEVER. SYMPTOMS WERE TREATED WITH TYLENOL,AND BENADRYL TABLETS WITH MILD IMPROVEMENTS.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: PATIENT REPORTS OF GENERAL BODY WEAKNESS, FATIGUE, SORE ARM,REDNESS IN ARM,HEADACHE,FEVER. SYMPTOMS WERE TREATED WITH TYLENOL,AND BENADRYL TABLETS WITH MILD IMPROVEMENTS.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Chills, Pyrexia
Clinical narrative: At 4:12 am on 4/25/2018 patient awoke shivering with a fever. I took his temperature and it was 104.9. I immediately gave him a dose of TYLENOL and placed wet, cold cloths on him. His fever reduced to 100.9 within 30 minutes. I have unsuccessfully kept his temperature under 99.1 since that time. I took him to see an on-call doctor at the clinic he usually goes too, per their request when I called to report his reaction. I was told his fever was from the vaccine and to just to give him TYLENOL.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal disorder, Musculoskeletal pain
Clinical narrative: Having severe pain in my left shoulder. I can't even lift my arm or use my arm at all. I already took 625 mg TYLENOL and an anti-inflammatory.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain
Clinical narrative: Pt complained of excruciating pain that traveled up her neck, but wasn't sure if it was from immunization or the metal hardware that is becoming loose in her neck.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Vial 1# exp/lot t5242 exp 3/31/2020, vial #2 exp/lot 5223c 4/28/2020 Patient came back the next day after first shot and right arm at site of injection was red/swollen/ sore/fever, prob about 2 inches by 2 inches in size, informed patient that we needed to monitored and ice on site to help with heat/fever and TYLENOL/ibu for swelling and pain.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Seizure
Clinical narrative: Fever of 105, resulted in seizure. Fever lasted 48 hours. Then rash breakout.
Age: 0.33
Sex: M
Vaccine: PNC13
Symptoms: Hyperacusis, Insomnia, Irritability, Migraine, Photophobia
Clinical narrative: Baby was very fussy for two weeks, had lots of trouble sleeping, did not want to lay down horizontally, was very sensitive to light, and very sensitive to loud sounds. I suspect baby migraines.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth, Lethargy, Lymphadenopathy
Clinical narrative: Symptoms about 16 hours after injection: extreme lethargy, achiness if both arms and neck, swollen lymph nodes on opposite side of my neck (left side while vaccine given in right arm), small red nodule at injection site (raised, warm, non-pustule). Symptoms 36 hours after injection: extreme lethargy, achiness in vaccination arm only, swollen lymph nodes on opposite side of my neck though less marked (left), nausea, moderate red nodule at injection site (raised, warm, non-pustule). I have never had these symptoms before.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Neck pain, Pain in extremity
Clinical narrative: Symptoms about 16 hours after injection: extreme lethargy, achiness if both arms and neck, swollen lymph nodes on opposite side of my neck (left side while vaccine given in right arm), small red nodule at injection site (raised, warm, non-pustule). Symptoms 36 hours after injection: extreme lethargy, achiness in vaccination arm only, swollen lymph nodes on opposite side of my neck though less marked (left), nausea, moderate red nodule at injection site (raised, warm, non-pustule). I have never had these symptoms before.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose increased
Clinical narrative: Pt blood glucose went up to 380 2 hrs after receiving vaccine.
Age: 78.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain
Clinical narrative: Patient complained of constant pain from injection site even months following injection. Patient states she visited a physician who told her it may be from the vaccination in which a nerve was affected.
Age: 40.0
Sex: M
Vaccine: TD
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red bump warm to the touch at the site of the injection has developed along with headache.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Electrocardiogram normal, Syncope
Clinical narrative: Pt developed lightheadedness then had fainting spell suspected cabal reaction based on normal ekg and clinical exam on 4/25/18, 2 days after immunization.
Age: 0.25
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse events. Patient was given ZOSTAVAX rather than pneumococcal 13. Patients mother was informed and told to watch for rash, fevers, etc. and to go to ED if symptoms appeared.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Allergic colitis, Diarrhoea, Faecal calprotectin increased, Feeding disorder, Food allergy
Clinical narrative: Immediate initiation of vomiting and diarrhea within 24 hours followed by protracted GI and feeding distress with eventual evidence of GI inflammation - increased calprotectin, hematochezia and diagnosis of allergic colitis in breast fed infant.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Gastrointestinal inflammation, Haematochezia, Milk allergy, Occult blood positive, Vomiting
Clinical narrative: Immediate initiation of vomiting and diarrhea within 24 hours followed by protracted GI and feeding distress with eventual evidence of GI inflammation - increased calprotectin, hematochezia and diagnosis of allergic colitis in breast fed infant.
Age: 17.0
Sex: M
Vaccine: MENB, MMR, MNQ, VARCEL
Symptoms: Injected limb mobility decreased, Injection site pain, Limb discomfort, Pain in extremity
Clinical narrative: Received phone call from patient at 1:30pm today, complaining of discomfort to left arm since 9:00 pm last night. Patient stated, "My left arm was hurting me yesterday evening, and this morning I did not go to school because it was really sore that I could not move it very much." Patient was asked to describe pain and rate on a scale of 0-10, Patient stated "My pain is a feeling of soreness at the injection site and I would say the pain is a 7.2." Advised patient that soreness may occur per Vaccine Information Statements. Patient instructed to take a shower and let warm water flow on his arm and take a pain reliever (TYLENOL or MOTRIN) for the discomfort. Denies any other side effects at this time. Advised if symptoms worsen to go to the nearest Emergency Room for further evaluation and management. Patient verbalized understanding. Patient contacted again at 2:30pm today to follow up on discomfort. Per patient, "I took a shower and did as instructed and my arm feels better now." Reinforced if pain or any other side effects noted or worsens to go to the nearest Emergency Room. Patient verbalized understanding.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Dyspnoea, Swelling, Urticaria
Clinical narrative: Information has been received from a physician via company representative, concerning a male patient of an unknown age. There was no information about patient's medical history, previously drug reactions or allergies, concurrent conditions or concomitant medication. On an unknown date, the patient was vaccinated with one dose of GARDASIL 9 (strength, dose number, anatomical location, route of administration, lot number and expiration date were not provided), for human papillomavirus (HPV) prevention. Then, on an unspecified date, the patient began to experience "hives and trouble breathing"; the physician reported that the patient was having an anaphylactic reaction; therefore, the patient was sent to emergency room, and unspecified treatment was given. It was unknown if laboratory diagnostics or studies were performed. At the time of report, the patient was recovered since an unknown date. The causal relationship between the adverse event and GARDASIL 9 was not provided. The reporter physician considered the anaphylactic reaction as a life threatening event and upon internal review, the anaphylactic reaction was considered a medically significant event.