chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Initial information received on 09-Jan-2019 regarding an unsolicited valid non-serious case received from Other health care professional. This case is linked to case 2019SA010202, same reporter. This case involves a 3 years old male patient who experienced reaction to right thigh complaining of redness, swelling, hot to touch and the site measured as 10x7 cm, while he received vaccine FLUZONE QUADRIVALENT. The patients past medical history included Sinusitis in DEC-2018 and patient was treated with Cefdinir 250mg/5 ml dose history of allergy to Amoxicillin but no allergy to eggs. The patient's past vaccination(s) included 3 flu shots in the past. The patient did not receive any concomitant medication. On 07-Jan-2019, the patient received a 0.5ml dose of suspect Influenza Quadrival A-B Vaccine, lot UJ087AA, expiry date 30-Jun-2019 via intramuscular route in the right thigh. On 07-Jan-2019, the patient developed a non-serious reaction to right thigh complaining of redness, swelling, hot to touch and the site measured as 10x7 cm (inflammation) (vaccination site reaction) 2 days following the administration of Influenza Quadrival A-B Vaccine. Lab data was not provided. Final diagnosis was reaction to right thigh complaining of redness, swelling, hot to touch and the site measured as 10x7 cm. As a corrective treatment physician ordered Prednisolone 2.5 ml BID for 5 days. The patient outcome is reported as Unknown for reaction to right thigh complaining of redness, swelling, hot to touch and the site measured as 10x7 cm. List of documents held by sender- none.
Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HIBV, DTAP, FLU4, HIBV
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Patient developed fever after shots and following day had rapid fever rise and febrile seizure. Taken by EMS to ER. Seizures lasted 2-3 minutes with pallor and perioral cyanosis. Post-ictal during transport. ER eval was unremarkable and d/c with no medications besides fever management meds. Saw pt in clinic next day with normal neurological exam and low-grade temp. Ibuprofen given.
Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HIBV, DTAP, FLU4, HIBV
Symptoms: Cyanosis, Febrile convulsion, Neurological examination normal, Pallor, Postictal state
Clinical narrative: Patient developed fever after shots and following day had rapid fever rise and febrile seizure. Taken by EMS to ER. Seizures lasted 2-3 minutes with pallor and perioral cyanosis. Post-ictal during transport. ER eval was unremarkable and d/c with no medications besides fever management meds. Saw pt in clinic next day with normal neurological exam and low-grade temp. Ibuprofen given.
Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HIBV, DTAP, FLU4, HIBV
Symptoms: Pyrexia, Seizure, Urine analysis normal
Clinical narrative: Patient developed fever after shots and following day had rapid fever rise and febrile seizure. Taken by EMS to ER. Seizures lasted 2-3 minutes with pallor and perioral cyanosis. Post-ictal during transport. ER eval was unremarkable and d/c with no medications besides fever management meds. Saw pt in clinic next day with normal neurological exam and low-grade temp. Ibuprofen given.
Age: 1.0
Sex: M
Vaccine: FLUR3, HEPA, MMR, PNC13, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of patients. The patient's historical conditions, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On an unspecified date, the patients were vaccinated with an unspecified number of doses of PROQUAD subcutaneously, reported lot number R011217, expiry date 15-OCT-2019, reported lot number R011802, expiry date 21-OCT-2019, (laterality, strength, dose and frequency were not reported) and VARIVAX reported lot number R009411, expiry date 29-MAR-2020, reported lot number R003300, expiry date 01-FEB-2020, reported lot number N035940, expiry date 18-DEC-2019 and reported lot number N034551, expiry date 05-DEC-2019 (laterality, strength, dose, route and frequency were not reported) both vaccines for prophylaxis, following a temperature excursion. The administered doses of the vaccines experienced a temperature excursion of 6°F to 14°F (-14°C to -10°C) for 14 hours 30 minutes and of 15°F to 46°F (-9°C to 8°C) (-6.1°C) for 20 minutes, as recorded by a data logger. No previous temperature excursion was reported. As of 09-NOV-2018, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information was received from a registered nurse on 08-JAN-2019. This spontaneous report refers to a 12 month old male patient. The patient did not have any pre-existing physician-diagnosed allergy, birth defects, medical conditions or illness at time of vaccination. On 14-SEP-2018, the patient was vaccinated with the first dose of VARIVAX lot # R009820, expiration date: 03-APR-2020, subcutaneously (SC) in the left thigh (LT); first dose of M-M-R II lot # N026828, expiration date: 27-APR-2019, SC. in the right thigh (RT); first dose of VAQTA lot # R006210 , expiration date: 22-APR-2019, intramuscularly (IM), RT; fourth dose of PREVNAR 13 lot # W11304 (expiration date not provided), IM, LT; and FLUBLOK lot # NT6242MA (expiration date not provided), IM, RT. All the vaccines were administered for prophylaxis and purchased with private funds. The administered doses of the vaccines experienced a freezer temperature excursion (not specified) as recorded from a digital data logger which occurred at the time of storage in clinical practice. None adverse effects were reported. Also, the patient received an unspecified treatment for the experience. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA002757: US-009507513-1901USA002758: US-009507513-1901USA002759: US-009507513-1901USA002760: US-009507513-1901USA002761: US-009507513-1901USA002762: US-009507513-1901USA002763: US-009507513-1901USA002764: US-009507513-1901USA002765: US-009507513-1901USA002756: US-009507513-1901USA002755: US-009507513-1901USA002753: US-009507513-1901USA002754.
Age: 40.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site reaction, Local reaction, Pain in extremity
Clinical narrative: Information has been received from a pharmacist referring to a 40 year old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown. On 07-NOV-2018, the patient was vaccinated with varicella VARIVAX (lot # R008393 and expiration date 20-MAR-2020; strength, dose and frequency were not reported) and M-M-R II (strength, dose, frequency, batch/lot # and expiration date were not reported) subcutaneously "on the top part of the arm" for prophylaxis (reported as for school) (vaccine administered at inappropriate site). On the same date, the patient developed "pain in the arm and a local reaction at the injection site". No treatment was given to the patient. Information about lab diagnostics/studies was unknown by the reporter. The patient did not seek medical attention. The outcome of pain in the arm and a local reaction at the injection site was reported as recovered. The causality between the events and VARIVAX and M-M-R II was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In May 2016, a healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 03-MAR-2015, a healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 29-SEP-2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2007, a healthcare provider at a county health department (public) administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 22-MAY-2018, the patient was treated by a healthcare provider at a county health department (public) for shingles. The patient was diagnosed with shingles and or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (not specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from an medical assistant regarding an adult patient of unknown gender. Information on pertinent medical history, drug reaction/allergies and concomitant medications were not reported. On an unknown date, the patient received a pediatric dose (Product administered to patient of inappropriate age) of VAQTA for prophylaxis (dosage schedule was not reported). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Information on pertinent medical history and drug reactions/allergies were not reported. The nurse reported that on 09-JAN-2019, one patient received improperly stored VARIVAX. The VARIVAX was reconstructed with properly stored diluent MRK Injection lot# N030404 with expiry date of 16-JUL-2020. No adverse effect was reported. Names of vaccines involved VARIVAX lot# R022116 with expiry date of 02-AUG-2020, R022113 with expiry date of 02-AUG-2020 and R018931 with expiry date of 02-JUL-2020. The nurse did not have the specific lot/expiration given to the patient available, but it was one of these. Temperature/time frame: 6 F to 14 F (09.93 F) 2 hours and 8 minutes and 15 F to 46 F (17 F) for 1 hour and 15 minutes. There was no previous temperature excursion. The call was because of data logger. No product quality complaint (PQC) was present.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, past drugs and concomitant medications were unknown. On 09-JAN-2019 the patient was vaccinated with VARIVAX (dose, frequency, lot# and expiration date were unknown) via intramuscular route (incorrect route of product administration) for prophylaxis, which was reconstituted with sterile diluent (lot# and expiration date were unknown). There were no adverse effects (no adverse event) reported. The outcome of incorrect route of product administration and no adverse event was unknown.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 29-NOV-2018, the patient was vaccinated with an expired PROQUAD for prophylaxis, lot #N016113 and expiration date 21-NOV-2018 (strength, dose, frequency and route of administration were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported.
Age: 1.0
Sex: U
Vaccine: MMR, MNQ
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 04-Jan-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves twins of 12 months old patient who received vaccines MENACTRA lot number not reported via unknown route in unknown administration site instead of MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration. It was reported that a 12 month old getting a MENACTRA instead of an MMR. The injection was given to twins when theycame into the practice to get an MMR. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 04-Jan-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 11 years old female patient who received a 0.5 ml first dose of an expired vaccine MENACTRA (lot number: U5746AD, expiry date: 14-Oct-2018) via intramuscular route in right deltoid on 27-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included GARDASIL 9 for Immunisation; and ADACEL for Immunisation. It was a case of actual medication error due to expired vaccine used. No Adverse Event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 04-Jan-2019 regarding an unsolicited valid non-serious case received from a physician in the. This case involves a male patient (age reported as 15 and 16, units not reported) who received his second dose of 0.5 ml MENACTRA dose at age 15 and the the third dose of the same vaccine at 16. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines were given. It was actual medication error due to extra dose administered. It was reported that the HCP was not sure that the second MENACTRA dose was valid. No AE reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: Initial information received on 04-Jan-2019 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves 18 years old female patient where MENACTRA (lot U6015AA and Exp. Date: 06-Oct-2019) was used as a diluent for the MMR, dosage was slightly above 0.5ml via subcutaneous route in the left arm on 03-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error case due to overdose, product preparation error and incorrect route of product administration. It was reported that she gave a MENACTRA as a diluent to mix with the MMR and gave it subcutaneously and the dosage was slightly above 0.5ml. No adverse reactions reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Brused left arm, very red, swollen and hot. Patient will take today, 5 days later oral benadryl and topical hydrocortison, will seek medical treatment at 1:00pm today.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Arthralgia, Confusional state, Crying, Disorientation, Erythema
Clinical narrative: After my interview and examination, patient was in exam room with her mother and nurse, RN receiving immunizations. While I was seeing the  next patient in next exam room, I heard a loud "thud" followed by her mother screaming as well as nurse calling out for me to come quickly. I immediately left my other patient and ran into pt's room where she was sitting in the floor with nurse holding her up and speaking to her. Patient was confused and slightly disoriented and starting to cry out in pain. Within just a brief minute of us assessing and reassuring her that we were taking care of her, she was alert and oriented but still did not recall what had just occurred. Her left lower forehead was showing some signs of possible swelling but no bleeding or indentation. She started complaining of her left knee and nurse was holding her forehead saying she fell over the right side of the exam table and onto her forehead. Patient was quickly calmed down and told she had fallen, as she was asking what happened.  It became apparent quickly that she must have fainted immediately following her last shot and subsequently fallen off the exam table when nurse was reaching for the sharps container. Nurse said she had just put the bandaid on the injection site and patient had no immediate complaints or signs of impending syncope. Patient, still sitting on floor, was quickly coherent and ice compress was applied to head within just a few minutes of fall. She mentioned she had not eaten anything at all today because she thought she might need labs drawn and wanted to be ready for them. Juice was given to patient to drink while sitting in floor with nurse. Once she completed the juice box and reported that she felt no dizziness or light-headedness, she was helped by myself and nurse to a chair directly behind her. A brief neurological exam showed no signs of confusion or changes in level of consciousness. Patient began then complaining of her left wrist, which was starting to appear slightly edematous with some erythema to top and radial wrist. Patient was alert and joking with her mother about the incident and did not appear to be experiencing any concerning symptoms at that time. Instructed her to sit for about 20 minutes and continue to drink juice and eat a snack before I reassessed her and completed a neuro exam. After about 20-30 minutes, neuro exam was unremarkable, as follows in assessment below. Patient denied any dizziness, blurry vision, HA, nausea or further feeling of faintness. CRNP.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Fall, Head injury, Immediate post-injection reaction, Neurological examination normal, Oedema peripheral
Clinical narrative: After my interview and examination, patient was in exam room with her mother and nurse, RN receiving immunizations. While I was seeing the  next patient in next exam room, I heard a loud "thud" followed by her mother screaming as well as nurse calling out for me to come quickly. I immediately left my other patient and ran into pt's room where she was sitting in the floor with nurse holding her up and speaking to her. Patient was confused and slightly disoriented and starting to cry out in pain. Within just a brief minute of us assessing and reassuring her that we were taking care of her, she was alert and oriented but still did not recall what had just occurred. Her left lower forehead was showing some signs of possible swelling but no bleeding or indentation. She started complaining of her left knee and nurse was holding her forehead saying she fell over the right side of the exam table and onto her forehead. Patient was quickly calmed down and told she had fallen, as she was asking what happened.  It became apparent quickly that she must have fainted immediately following her last shot and subsequently fallen off the exam table when nurse was reaching for the sharps container. Nurse said she had just put the bandaid on the injection site and patient had no immediate complaints or signs of impending syncope. Patient, still sitting on floor, was quickly coherent and ice compress was applied to head within just a few minutes of fall. She mentioned she had not eaten anything at all today because she thought she might need labs drawn and wanted to be ready for them. Juice was given to patient to drink while sitting in floor with nurse. Once she completed the juice box and reported that she felt no dizziness or light-headedness, she was helped by myself and nurse to a chair directly behind her. A brief neurological exam showed no signs of confusion or changes in level of consciousness. Patient began then complaining of her left wrist, which was starting to appear slightly edematous with some erythema to top and radial wrist. Patient was alert and joking with her mother about the incident and did not appear to be experiencing any concerning symptoms at that time. Instructed her to sit for about 20 minutes and continue to drink juice and eat a snack before I reassessed her and completed a neuro exam. After about 20-30 minutes, neuro exam was unremarkable, as follows in assessment below. Patient denied any dizziness, blurry vision, HA, nausea or further feeling of faintness. CRNP.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Pain, Syncope
Clinical narrative: After my interview and examination, patient was in exam room with her mother and nurse, RN receiving immunizations. While I was seeing the  next patient in next exam room, I heard a loud "thud" followed by her mother screaming as well as nurse calling out for me to come quickly. I immediately left my other patient and ran into pt's room where she was sitting in the floor with nurse holding her up and speaking to her. Patient was confused and slightly disoriented and starting to cry out in pain. Within just a brief minute of us assessing and reassuring her that we were taking care of her, she was alert and oriented but still did not recall what had just occurred. Her left lower forehead was showing some signs of possible swelling but no bleeding or indentation. She started complaining of her left knee and nurse was holding her forehead saying she fell over the right side of the exam table and onto her forehead. Patient was quickly calmed down and told she had fallen, as she was asking what happened.  It became apparent quickly that she must have fainted immediately following her last shot and subsequently fallen off the exam table when nurse was reaching for the sharps container. Nurse said she had just put the bandaid on the injection site and patient had no immediate complaints or signs of impending syncope. Patient, still sitting on floor, was quickly coherent and ice compress was applied to head within just a few minutes of fall. She mentioned she had not eaten anything at all today because she thought she might need labs drawn and wanted to be ready for them. Juice was given to patient to drink while sitting in floor with nurse. Once she completed the juice box and reported that she felt no dizziness or light-headedness, she was helped by myself and nurse to a chair directly behind her. A brief neurological exam showed no signs of confusion or changes in level of consciousness. Patient began then complaining of her left wrist, which was starting to appear slightly edematous with some erythema to top and radial wrist. Patient was alert and joking with her mother about the incident and did not appear to be experiencing any concerning symptoms at that time. Instructed her to sit for about 20 minutes and continue to drink juice and eat a snack before I reassessed her and completed a neuro exam. After about 20-30 minutes, neuro exam was unremarkable, as follows in assessment below. Patient denied any dizziness, blurry vision, HA, nausea or further feeling of faintness. CRNP.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Cough, Pyrexia, Respiratory syncytial virus test positive, Upper respiratory tract infection, Vomiting
Clinical narrative: Fever, vomiting, cough, URI symptoms.
Age: 20.0
Sex: M
Vaccine: FLU4, HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: 1400 - hives on left arm, back, and upper thorax, pruritus. Hives and pruritus persisted until Sunday morning 13Jan19.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Discomfort, Erythema
Clinical narrative: Patient states reaction started that evening with redness and burning to the left upper forearm. Patient states it felt as if her arm was on fire and denied using any oral or topiical agents to releive discomfort.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Two days after vaccination patient presented with red skin reaction about 2 inches below the site of injection. It appeared to almost be a band that went across the skin. He did report some tenderness at the injection site but described no pain and was able to use his arm alright.
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Electroencephalogram normal, Generalised tonic-clonic seizure, Pyrexia, Seizure
Clinical narrative: Pt had been well; no illnesses. Suddenly, on Friday, November 2, 2018, she had a low grade fever. I gave her a dose of Tylenol; and sat down with her on our living room couch. Not even a half an hour later, around 7pm, she began uncontrollably seizing. I immediately placed her on the ground, on her side, and called 911. Pt's full seizure lasted an hour. By the time we got to the hospital, her fever had spiked to over 103. We started our evening at one hospital, but were transferred to another Hospital. Pt spent the night there for observation. The event was diagnosed as a complex grand mal tonic clonic seizure. Due to family history, pt did receive an EEG to rule out epilepsy. The EEG was performed at Hospital a few weeks after our stay. The EEG was normal.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a pharmacist administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: HPV9
Symptoms: Skin papilloma
Clinical narrative: This spontaneous report was received from a physician and refers to a 20 -year-old male patient. The patient had no known pertinent medical history, concomitant medications and drug reactions or allergies. On an unknown dates (reported as "6 years ago"), the patient was vaccinated with series of GARDASIL 9 (exact doses, routes of administration, anatomical locations, lot numbers and expiration dates were not provided) for prophylaxis. On 09-JAN-2019, the patient presented to the physician office as he developed wart on an unspecified cheek on his face. The patient as a treatment received a dose of GARDASIL 9 lot # R024264, expiration date 29-OCT-2019. There was no diagnostic tests performed. The outcome of skin papilloma was reported as not recovered. The causality assessment between the events and the suspect therapy was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 10-JAN-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around December 2014, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles. Shortly after receiving the ZOSTAVAX, the patient suffered shingles. As a direct and proximate result of ZOSTAVAX the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including but not limited to the patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life and other losses and damages. The patient has paid and has become liable to pay for medical aid, treatment, monitoring, medications and other expenditures and will necessarily incur further expenses of a similar nature in the future as a proximate result of ZOSTAVAX. The outcome of the events is not recovered. The causality of the events is related. Shingles was considered to be disabling. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: My arm has been painful since the day of the shot. I have a difficult time lifting my left arm without associated pain.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Condition aggravated, Facial paralysis, Inflammation, Pain in extremity
Clinical narrative: Patient states that they are experiencing pain and soreness in the upper arm. Have been experiencing pain since the vaccine was administered 1 month ago. Patient does have a condition called Bell's Palsy and the vaccine may have aggravated their condition.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Injection site urticaria, Rash macular
Clinical narrative: Swelling, itching and hives starting at the injections site with itching spreading on the left arm all within a 10 minute time-frame. Itching intensified and hive was > 5 inches in diameter. Took (2) 25mg diphenhydramine tablets orally. Itching slowly subsided. Twelve hours later, skin remains blotchy in place where hive was, but itching completely gone.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Culture positive, Headache, Injection site erythema, Injection site warmth
Clinical narrative: Site reaction (red/heat), malaise, vomiting, headache, soreness. MD culture confirmed cellulitus and started patient of CEFTIN 250 mg #14- 1 BID x7.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Vomiting
Clinical narrative: Site reaction (red/heat), malaise, vomiting, headache, soreness. MD culture confirmed cellulitus and started patient of CEFTIN 250 mg #14- 1 BID x7.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Fainted after receiving vaccine. Legs elevated, sternal rub, oxygen at 2 liters applied. Pt given supplement after becoming alert. Time frame 8 minutes. Pt ambulated out of clinic with steady gait alert and oriented x 3. Mother states patient has vasovagal response with vaccines in past.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Tremor
Clinical narrative: Severe shaking chills after 2nd dose of SHINGRIX which lasted several hours.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: PT REPORTED RASH NEAR INJECTION SITE  ON LEFT ARM AS WELL AS ON THE ABDOMEN 01/12/19 PM . 01/14/19 PT REPORTS RASH NOW INCLUDES LEGS.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Chills, Computerised tomogram normal, Dizziness, Dysstasia
Clinical narrative: THE MORNING FOLLOWING THE IMMUNIZATION I WOKE UP WITH EXTREME DIZZINESS, NAUSEA, CHILLS, SWEATS. I WAS UNABLE TO STAND AND TO WALK. I WAS TRANSPORTED BY AMBULANCE TO HOSPITAL WHERE MANY TESTS WERE PERFORMED AND NOTHING WAS FOUND. I WAS TREATED WITH IV'S TO COUNTERACT NAUSEA AND DIZZINESS. I WAS DISCHARGED FROM ER THE SAME DAY. I SLEPT THE REST OF THE DAY AND ALL NIGHT. I WAS FINE THE NEXT MORNING.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait inability, Hyperhidrosis, Nausea, Urine analysis normal
Clinical narrative: THE MORNING FOLLOWING THE IMMUNIZATION I WOKE UP WITH EXTREME DIZZINESS, NAUSEA, CHILLS, SWEATS. I WAS UNABLE TO STAND AND TO WALK. I WAS TRANSPORTED BY AMBULANCE TO HOSPITAL WHERE MANY TESTS WERE PERFORMED AND NOTHING WAS FOUND. I WAS TREATED WITH IV'S TO COUNTERACT NAUSEA AND DIZZINESS. I WAS DISCHARGED FROM ER THE SAME DAY. I SLEPT THE REST OF THE DAY AND ALL NIGHT. I WAS FINE THE NEXT MORNING.
Age: 1.17
Sex: F
Vaccine: DT, HIBV, IPV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Urticaria, Viral infection
Clinical narrative: The patient's mother states the patient had "welts all over her body" 3 hours after receiving the vaccines. The patient's mother then gave the patient BENADRYL. She states the welts went away. Then, in the morning, the patient's mother noticed that the patient's right leg "is swollen and has a big, red bump". The patient's mother has been applying ice and has been alternating in between TYLENOL and MOTRIN. She states the patient had a "low-grade" fever. She states she also called her child's PCP, and they informed her that she likely has a viral infection. She is also scheduled to see her allergist.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Pyrexia
Clinical narrative: Patient woke up in the early morning with a fever (101.3 axillary) and occipital headache 4/10.  Denied reacent head injury, history of migraines, stiff neck, body aches, rash on LE.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Influenza like illness, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient complained of body aches and pain and flu like symptoms. Her injection site was very swollen and red. She was also very very sleepy. Her teeth hurt and her fingers were numb. Patient was encouraged to contact physician.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence, Toothache
Clinical narrative: Patient complained of body aches and pain and flu like symptoms. Her injection site was very swollen and red. She was also very very sleepy. Her teeth hurt and her fingers were numb. Patient was encouraged to contact physician.
Age: 68.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Asthenia, Chills, Decreased appetite, Diarrhoea, Headache
Clinical narrative: Severe pain itching and Rt. arm swollen twice the size and very warm to the touch. Headache, nausea, and extreme weakness. Diarrhea, loss of appetite, numbness on rt. side and severe chills. Very sleepy all day and did not eat anything. Applied ice to arm at the advice of Pharmacist. Spent the entire day covered up with blankets shaking with chills. Did not take daily meds. Only had sips of water.
Age: 68.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Hypoaesthesia, Nausea, Pain, Peripheral swelling, Pruritus
Clinical narrative: Severe pain itching and Rt. arm swollen twice the size and very warm to the touch. Headache, nausea, and extreme weakness. Diarrhea, loss of appetite, numbness on rt. side and severe chills. Very sleepy all day and did not eat anything. Applied ice to arm at the advice of Pharmacist. Spent the entire day covered up with blankets shaking with chills. Did not take daily meds. Only had sips of water.
Age: 68.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Skin warm, Somnolence, Tremor
Clinical narrative: Severe pain itching and Rt. arm swollen twice the size and very warm to the touch. Headache, nausea, and extreme weakness. Diarrhea, loss of appetite, numbness on rt. side and severe chills. Very sleepy all day and did not eat anything. Applied ice to arm at the advice of Pharmacist. Spent the entire day covered up with blankets shaking with chills. Did not take daily meds. Only had sips of water.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an adult patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 10-JAN-2019, the patient was vaccinated with PROQUAD, intramuscularly (dose, lot# and expiration date were not reported) for prophylaxis. No known adverse effects were reported.
Sex: U
Vaccine: DTAPIPVHIB, HEP, RV1
Symptoms: Expired product administered
Clinical narrative: Initial information received on 07-Jan-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a two months old (unknown gender) patient who received first dose of PENTACEL (lot C5451AC, expiration date: 17-Dec-2018 via unknown route in the right thigh on 07-Jan-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included was HEPATITIS B VACCINE (HEPATITIS B VACCINE) and ROTARIX. It was an actual medication error due to expired vaccine used. A two month old patient received PENTACEL which was expired. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 1.42
Sex: U
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 07-Jan-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 18 months old patient who received injection of suspect ACT-HIB lot number, expiry date not reported via unknown route in unknown administration site. The patients past medical history, concomitant medication and family history were not provided. It was an actual medication error due to inappropriate reconstitution technique. It was reported that sterile water was used to reconstitute ACTHIB, invalid dose was given to a patient, 1.5 years old. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 08-Jan-2019 regarding an unsolicited valid non-serious case received from Other health care professional (PA). This case involves a 39 years old female patient who received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, concomitant medication and family history were not provided. On 08-Jan-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT5911JA, expiry date 30-Jun-2018 via intramuscular route in the left deltoid. It was an actual medication error due to expired vaccine used. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.